1. De Clercq and Partners: The firm
De Clercq & Partners is an established firm of experienced European patent attorneys providing a full range of Intellectual Property (IP) and legal services with offices in Sint-Martens-Latem (close to Ghent) and Leuven in Belgium. Belgium is situated in the centre of Europe and allows easy travel to both Munich and The Hague where the branches of the European Patent Office (EPO) are located.
Our firm offers a range of expert services covering all aspects of intellectual property (IP), such as filing and prosecution of PCT, European and national patent applications (such as Belgian and Dutch patent applications directly and others via a network of associates), evaluating intellectual property rights, conducting searches, representing parties in oppositions, appeals and revocation actions, advising prosecuting supplementary protection certificates (SPCs), validating EP patents in Belgium and the Netherlands, advising on IP protection optimization strategies, portfolio management and strategic IP advice, legal IP opinions such as freedom-to-operate, infringement or validity opinions, due diligence, and advising on licensing matters. Our firm also provides renewal and translation services as well as advice by financial experts on tax deduction for patent income. We can provide you expert advice in patent invalidation and infringement procedures before the Belgian and Dutch courts. We also act as court or party appointed experts in proceedings before the Courts in IP matters in Belgium, such as descriptive seizure proceedings, summary proceedings and proceedings to the merits in infringement or invalidity disputes.
Historically, our firm has an emphasis on life sciences including all domains of green, red and white biotechnology. Through the expansion of the team our firm nowadays is also known for offering high level IP services in the domain of chemistry, pharmaceuticals, food industry, mechanics and engineering. The firm thrives on a highly specialized and experienced group of over thirty enthusiastic people that have as a common aim to serve clients at high level for very competitive prices in a European setting. Our multinational team of scientifically, technically and legally specialized professionals and their experience enables the firm to provide high quality service in all aspects of patent practice. Thanks to the national diversity of our professionals, we can offer our services in at least 6 different languages. The firm further relies on a network of highly skilled IP specialists for matters such as trademarks, utility models and designs when needed for our clients.
2. Join De Clercq & Partners at events around the globe
De Clercq & Partners is organizing, or will be present at the following events the coming months:
The yearly Seminar of De Clercq & Partners in the Auberge du Pecheur in Sint-Martens-Latem (Belgium) took place on November 16, 2012. It was a very successful edition with contributions from speakers of the EPO and renowned law firms and industry from the US, Belgium and the Netherlands, and was again the place to be for every practitioner in patenting and litigation in Biotech, Pharma and beyond.
FlandersBio’s Services for Growth event: De Clercq and Partners was present, and Dr. Liesbet Paemen discussed "An integrated IP approach to avoid pitfalls encountered by start-ups" in Berchem on November 22, 2012. More info on http://flandersbio.be/events/service-for-growth.
C5 Conference Biotech Patenting Munich from March 13 to 14, 2013. Dr. Liesbet Paemen will present a session on “Wrinkled Tomatoes, Broccoli & Melon Disputes: The Latest Developments in Plant & Seed Breeding Patents”. More information concerning this conference can be found in this PDF brochure.
BIO 2013 Chicago (www.convention.bio.org): Also next year, De Clercq and Partners will attend the BIO International Convention taking place from April 22 to 25, 2013 in the US. The event features keynotes and sessions from key policymakers, scientists, CEOs, and celebrities. Come visit our European Patent Attorneys at the Belgian Pavilion, at the largest global event for the biotechnology industry.
Knowledge for Growth (www.knowledgeforgrowth.be): The Ninth edition of FlandersBio’s annual life sciences convention will be held in Ghent on May 30, 2013. We hope to meet you at booth No. 35. It is the meeting place for everyone interested in Biotech, and is Europe's largest regional biotech event.
3. Patentability of human embryonic stem cells inventions after the CJ-EU decision C-34/10: changes in practice at the EPO?
Introduction
In our previous Newsletters, we reported on the issuance of Judgment C-34/10 by the Court of Justice of the European Union (CJ-EU) relating to the patentability of inventions using human embryonic stem cells (hES cells) and the ways it was thought the EPO would be likely to orient its policy on this matter.
Now, it appears that the EPO has recently decided to implement the Judgment into in what they call a “lenient” approach in their examination practice. The EPO’s Examiners have received new specific instructions on how to deal with inventions relating to human embryonic stem cells as from September 1, 2012 but there was only limited communication about the matter to the public up till now. The President of the EPO did not yet decide to communicate openly yet as we write this newsletter.
In this article, we would like to illustrate some of the ways in which the EPO is currently trying to tackle the matter, we also want to make it clear that there is a need for practitioners from private practice and industry to have more information from the EPO and to have the ability to give feedback or comments to the EPO with respect to the new practices the EPO would like to adopt after the issuance of C-34/10 CJ-EU.
New Guidelines for Examination issued
The new Guidelines for examination which entered into force on the 1st of June 2012, indicate that the moment of destruction of the embryo, for instance years ago in case of establishment of hES cell-lines, is irrelevant for escaping the exclusion from patentability. This is contrary to the practice that was being applied by the EPO until last year.
“(iii) Uses of human embryos for industrial or commercial purposes (Rule 28(c))
A claim directed to a product, which at the filing date of the application could be exclusively obtained by a method which necessarily involved the destruction of human embryos from which the said product is derived is excluded from patentability under Rule 28(c), even if said method is not part of the claim (see G 2/06). The point in time at which such destruction takes place is irrelevant.
When examining subject-matter relating to human embryonic stem cells under Art. 53(a) and Rule 28(c), the following has to be taken into account:
(a) the entire teaching of the application, not only the claim category and wording, and
(b) the relevant disclosure in the description in order to establish whether products such as stem cell cultures are obtained exclusively by the use, involving the destruction, of a human embryo or not. For this purpose, the disclosure of the description has to be considered in view of the state of the art at the date of filing.
The exclusion of the uses of human embryos for industrial or commercial purposes does not affect inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it (EU Dir. 98/44/EC, rec. 42).”(The underlined part is new vis à vis the previous Guidelines)
As could be deduced from the text of the Guidelines, the EPO interpretation of the CJ-EU decision seemed to be going quite far. More clarification than this was certainly needed.
The European Patent Institute (epi), the organisation embracing all European patent attorneys, has set out its views on this matter in a position paper of February 2, 2012, addressed to the SACEPO (Standing Advisory Committee before the EPO). The epi has submitted its reservations regarding the blind implementation of the CJ-EU decision on hES cells in the EPO examination practice. Unfortunately, neither the epi nor any other industry organization was heard before the EPO decided to adopt its new examination guidelines.
Is the EPO obliged to implement the Judgement as it wishes?
The EPO and the CJ-EU have no institutional link, as was confirmed by the Enlarged Board of Appeal of the EPO in decision G2/06 (the “WARF “ hES cell case), when denying the request of the Apellant to refer the case to the CJ-EU. The EPO can hence not be obliged to implement the Judgment. Furthermore, the European Patent Convention (EPC) providing the legal basis for granting European Patents has been acceded by 38 contracting states, while the European Union only holds 27 member states. It is clear that the courts of non-EU member states such as Norway, Switzerland, and Turkey are not necessarily bound by the judgment of the CJ-EU decision. Further the CJ-EU is not a specialized court in IP matters.
In addition, according to the epi, it is not up to the European Patent Office to change the convention or its interpretation. Changing the EPC can only be done by the Administrative Council and interpretation thereof needs to be done by the (Enlarged) Boards of Appeal of the EPO. Up to now, no Board has been asked to give its opinion on how to implement the CJ-EU judgment.
We do understand that the EPO needs to consider how to deal with this Brüstle decision at CJ-EU level, even though as yet it has no guidance from the Boards of Appeal. Because of this, a cautious approach needs to be taken according to the epi, since otherwise the EPO could end up refusing patent applications on grounds which might later be considered by a Board of Appeal to be unfounded. Examining Divisions should not raise objections under Rule 28 EPC that could later be ruled as wrong by the Boards of Appeal. The EPO’s view that it should not grant patents that will clearly be invalid in the EU member states is sensible (even though this may be contrary to the EPC). However, that raises the question of what precisely is in fact patentable in various EU member states in view of decision C-34/10, which has yet to be determined. Indeed, the German court referring the questions to the CJ-EU will now have to decide, as a result of C-34/10, how that will impact on the patentability of the invention by Oliver Brüstle, and it has not yet made a decision. The epi thought it would be sensible for the EPO not to “jump the gun”, and implement a policy on patentability of hESCs without at least first seeing the decision from the German courts and waiting for a decision from a Board of Appeal. Nevertheless, the Examining Divisions are applying a new policy anready as illustrated below.
The interpretation of the CJ-EU Judgment, both by the users and by the German Court referring the questions, is still largely ongoing. SACEPO has provided the EPO with its insights regarding the decision last February. The SACEPO paper was published in epi information 2/2012.
The relevant legal provision in C-34/10 is that inventions are unpatentable if they relate to “uses of human embryos for industrial and commercial purposes”. It was on this provision that the three questions were referred to the CJ-EU. The answer to the third question is perhaps the most important, where it is stated that an invention is not patentable where: “the technical teaching which is subject matter of a patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and if the description of technical teaching claimed does not refer to the use of human embryos”.
The answer to question 3 given in C-34/10 would at first sight appear to go beyond the WARF decision (G2/06). Consequently, the Brüstle CJ-EU decision is highly debatable. The EPO’s practice prior to September 1, 2012 was to allow human embryonic stem cell patent applications if they were filed after May 2003 and where reliance can be made on a publicly available stem cell line. The practice of the EPO concerning deposited stem cells lines flows from the G2/06 decision, and any policy by the EPO, prior to a decision of the Boards of Appeal, that goes beyond G2/06 is arguably wrong. Decision C-34/10 goes beyond G 2/06, and apparently inspired the EPO Examining Divisions to review their policy which they had been applying for a few years which included a May 2003 threshold or cut-off date as a date from which the skilled person could obtain human embryonic stem cell lines as starting material.
The EPO Examiners’ new “lenient” approach
At a recent C5 conference one of the EPO Directors disclosed a new allegedly “lenient” EPO approach which apparently came into effect with the Examining Division’s new policy as from September 1st, 2012. This new approach, which has not been officially announced, implies that the EPO maintains a threshold date, 10th of January 2008.
As this new approach has not been communicated officially yet, it can not be generally challenged or commented on. The first office actions have been communicated by the Examiners alluding to this new date since September 2012. The new 2008 date being considered by the EPO refers to an online publication date of a Chung et al. paper (Cell Stem Cell 2(2), 113-117). This paper discusses Single Blastomere Biopsy (SBB) as a non-destructive alternative to inner cell mass isolation. Another date that is being discussed is a 2006 date which is based on the publication of Advanced Cell Technology’s (ACT’s) non-destructive “single-cell blastomere” technology (Nature, August 2006), which also described the development of hESC lines from single blastomeres obtained by a non-destructive method but whereby cultivation involved co-culture of the single blastomeres with other blastomeres. Only the 2008 paper, some Examiners claim, undoubtedly allows the provision of hESCs without the destruction of a human embryo at any time.
It appears however that arguments can be made in favour of maintaining the 2003 date or at least the 2006 date. The EPO however aims to implement a cut-off date as of which human ESCs could be obtained without any destruction of an embryo ever having been necessary, which is considered by the EPO to be January 2008. However, it would seem that, as for the implementation of the 2003 cut-off date, a decision to change this date can only be taken by the Boards of Appeal. Also it can be expected that practitioners will come up with even more literature articles which may be of relevance and so the date could change yet again.
This “unofficial” change in practice, even if called “lenient”, has the result that certain granted patents may suddenly get a stamp as being invalid. The implementation of this new examination policy could thus potentially cause quite some harm and should also for this reason be backed by a decision from the Boards of Appeal.
The EPO is putting forward four scenario’s of methods involving human ESCs as depicted in the scheme which was kindly provided by the EPO (see bottom article). It appears that this will be the subject of quite some debate still.
According to the new so called “lenient” EPO policy, only an invention relating to the use of human ESCs of established stem cell lines as depicted in the right bottom part of the scheme would be considered patentable (indirect non-destructive use of human ESCs), which would correspond to the threshold of January 2008. It is noted that G2/06 only dealt with the situation where the performance of the invention “necessarily” involved the destruction of a human embryo. This is not the case for many later, downstream inventions.
According to this scheme, claims relating to processes for deriving hESCs from blastocysts which involve the destruction of the blastocyst, as well as claims to the hESCs obtained by this process are excluded under Rule 28(c) EPC since both the product and the process require the use and destruction of an embryo. Claims relating to methods for establishing hESCs from blastocysts, even if they do not require destruction of the embryo are excluded under Rule 28(c)EPC as they require the use of an embryo. Claims relating to the use of hESCs, such as in a method for differentiation of hESCs into other cells or in a method of culture and expanding hESCs (where the application makes a reference to publicly available established human ES cell lines as starting material) are excluded from patentability under Rule 28(c) if filed prior to 10 January 2008 as it is considered by the EPO that before that date hESCs or hESC lines could only be obtained by destruction of an embryo, while it is considered that after that date, hESC lines could be obtained without destruction of the embryo.
The EPO however is confirming that culture media, supports or apparatuses “suitable for” use with hESCs, or even “specifically designed” for this purpose, are not per se excluded from patentability. Their production normally does not require the use of human embryos. Further the EPO has confirmed the patentability of induced pluripotent stem cells reprogramming factors and iPS cells. This seems to be the “lenient” part of the new examining policy regarding hESCs.
We would like to stress again that paragraph 49 of the CJ-EU Judgment states that an invention is unpatentable when “the implementation (“die Verwertung” in the original German text of the judgment) of the invention requires destruction of human embryo’s…”. This sentence appears to be very important, since the EPO patent law (Art. 53(a) EPC and Art. 6 of the Biotech Directive (98/44/EC)) does not state that an invention should be unpatentable when human embryo’s are needed during the development or “conception” of the invention, but states that “inventions, the commercial exploitation of which would be contrary to ordre public or morality” are excluded from patentability. It is not excluded that some inventions would suddenly turn out to be unpatentable because in the past one step that was contrary to ordre public was performed by someone developing the basic process or material on which the invention is founded.
In the epi’s view, Art. 53(a) and Art. 6 of the Biotech Directive do not mean that an invention is unpatentable if at some stage, far upstream and distant from making the invention, a human embryo was destroyed. In any event it may not be possible for the EPO (or indeed the applicant) to be absolutely sure that an embryo was in fact never destroyed many years before the invention as claimed was performed, possibly even by a third party and even in a different country. Thus the EPO faces a real practical problem in that it will not be able to clearly check for embryo destruction, and so apply the law, when the invention claimed is so far removed and distant from any such destruction.
The answer to question 3 put to the CJ-EU refers to the prior destruction of human embryos, or their use as base material, even if the technical teaching claimed does not refer to the use of human embryos. However, it is established and incontrovertible EPO law that the invention is defined by the claims, and supported by the description. So, as a practical matter, one cannot ignore the description, nor the scope of matter that is being claimed. In practice, this implies that every European patent application, even ones that only in passing mention hES cells, would become unpatentable.
The technical teaching of the patent application must therefore be considered, and cannot, as a practical matter, just be ignored. If, for example, a technical teaching refers to other cell types as well as hES cells, this must not be used to taint the entire application given that there may be non-ES cell aspects to the invention.
What will the future bring?
It is up to practitioners and industry now to provide the EPO with convincing arguments why the present view of the EPO Examining Divisions with their new practice as apparently being put into practice as from September 1, 2012 is not correct. Difficult of course to comment on a policy that is not communicated to the public. The observations which have been put forward via certain channels have apparently not been heard by the EPO.
Industry and/or patent attorney groups may wish to formulate their opinions in a way which can be heard and evaluated and tested by the EPO Boards of Appeal.
We hope the EPO will also take the opportunity to take into account the observations already made by the epi and other circles, which make clear that there should be a difference between the involvement of hES cells upon conception of the invention versus the actual involvement or use of hES cells upon putting the invention into practice. The latter could indeed be seen as true commercial exploitation, while the conception phase can in our view clearly not.
This is an important distinction, since it would not render an invention which used hES cells as a base material to produce a new product unpatentable. For example, a claim to a medical use of a cell-type derived from a hES cell-line through being an inventive method of differentiating hES cells should not be seen as being unpatentable merely because the hES cells were used as a base material, since the actual invention which is commercially exploitable, i.e. the use of the differentiated cell line for treating a subject, does not involve the destruction of a human embryo. Only the method of obtaining the starting hES cell would potentially, if one goes back to the original establishment of the commercial hES cell-line used, include the destruction of an embryo.
Also it may not be stressed enough that exceptions to patentability are to be interpreted narrowly by the EPO. The Boards of Appeal have confirmed this several times and the Examining Divisions should realize this and know the EPO’s case law.
It should always be taken into account that: stem cell research is an extremely important and growing area of science. It is capable of huge potential, and shows enormous promise for medical treatments. It may provide ways to treat diseases which otherwise do not currently have a cure, such as neurodegenerative disorders such as ALS and Parkinson’s disease. It should be remembered that the EU actually funds research in this area. The EPO’s mandate is to grant patents, and to encourage innovation in the EPC member states. It should therefore not deny patent protection for inventions arising from scientific research in this area. At least not until a Board of Appeal or the Enlarged Board of Appeal has decided on the impact of the Judgment of the CJ-EU.
So what will the future bring? Nobody can predict with certainty at this stage, since it is even possible that someone appeals the decision of the CJ-EU because he potentially looses out on a promising therapeutic tissue regeneration tool. In the UK a recent case (International Stem Cell Corp Case) relating to a non-fertilized ovum stimulated by parthenogenesis led strangely enough to a conclusion of unpatentablility on the basis of the Brüstle CJ-EU decision since it was considered that this cell type is capable of commencing the process of development even if it is not able to complete this development. In the Court’s mind the “train has gone into the tunnel” and that was enough. A revised UK practice note has also been delivered (similar to the EPO position) which confirms that human stem cells that are not derived from human embryos, such as induced pluripotent stem cells and adult stem cells, are patentable. Patents for inventions concerning such cells will be granted if the claimed subject matter complies with the classical patentability requirements of novelty, inventive step, clarity and sufficiency of disclosure.
The German Federal Court could still decide to refer new questions to the CJ-EU in order to clarify the issue further. The Brüstle hearing will take place end of November at the Patent Court in Germany. Public oral proceedings before the TBA at the EPO are scheduled for 16 January 2013 on the Brüstle EP patent application published under number 1040185. And finally, the EPO could listen to its end-users and critically revise the decision before implementing it blindly.
Needless to say we will keep a close eye on the hESC case law as it will develop.
Please do not hesitate to contact us in case you have more specific questions regarding this issue, since it will influence the drafting, prosecution and post-grant strategies in any existing or future stem cell-related patent portfolio.
4. New biotech referral to the EBA on plants - Wrinkly tomato case (G2/12): a bright future or an early death?
In our last newsletter we reported on the possible (2nd) referral to the Enlarged Board of Appeal of the EPO (EBA) in the so-called Wrinkly tomato case. It is now a fact! G2/12 exists.
The last Official Journal of the EPO OJ EPO (8-9/12) mentions the Communication of the EBA concerning G2/12. It reports on the fact that Technical Board of Appeal 3.3.04 has now referred the following points of law to the EBA with interlocutory decision of 31/05/2012 in case T1242/06:
(1) Can the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC have a negative effect on the allowability of a product claim directed to plants or plant material such as a fruit?
(2) In particular, is a claim directed to plants or plant material other than a plant variety allowable even if the only method available at the filing date for generating the claimed subject-matter is an essentially biological process for the production of plants disclosed in the patent application?
(3) Is it of relevance in the context of questions 1 and 2 that the protection conferred by the product claim encompasses the generation of the claimed product by means of an essentially biological process for the production of plants excluded as such under Article 53(b) EPC?
Amicus curiae briefs may be filed by third parties until the end of November 2012.
This case (also known as the Wrinkly Tomato case) carries a long history. It relates to EP 1 211 926, in name of the State of Israel—Ministry of Agriculture. There was a first referral to the Enlarged Board of Appeal (consolidated cases G2/07 and G1/08, see OJ EPO 3/2012 p. 130) which dealt with the patentability of essentially biological methods (Art. 53(b) EPC). In December 2010, the EBA set out clear boundaries for patenting methods encompassing steps of crossing and selection making use of the natural phenomenon of meiosis (G 1/08). In their decision the EBA concluded that methods “containing or consisting of” sexually crossing the whole genomes of plants are excluded from patentability. We reported on the patentability of essentially biological processes in detail in our newsletter of May 2011.
An oral hearing of the parties took place in T 1242/06 regarding the patent at stake on 8 November 2011 before the TBA, and this has led to an interlocutory decision of TBA 3.3.04 of 31 May 2012 which led to the present referral to the Enlarged Board of Appeal (in fact the 2nd referral to the EBA in the same case). The referral was based on objections under Art. 53(b) raised by the Opponent against the remaining claims to tomato fruit (after the claims to a method for breeding tomato plants were cancelled in view of G1/08).
The questions referred to the EBA in G2/12 (see above) relate amongst others to the patentability of product claims on conventionally bred (non-GMO) plants and the products directly derived from the non-allowed method claims (including also for instance product-by-process claims).
Procedurally, the referral is a bit exceptional as Unilever, the sole opponent in this case, has withdrawn its opposition. Therefore the Patentee is at this moment the sole Appellant. On November 9, 2012, the Patentee has filed new submissions in which they defend the position that this amounts to reformatio in peius.
The decision of the EBA in G2/12 (if it would continue) will be very important for practice, as it will have an important impact on the patentability of breeded (non-GMO) plants and seeds or fruits thereof. It will also be interesting to follow the developments in the Taste of Nature vs Cresco case in the Netherlands. In that case, the Judge considered Article 53(b) EPC to exclude not only essentially biological methods from patent protection, but also products directly obtained by using such methods.
The EBA will have to decide now if the case can be continued after the Patentee's last submissions of November 9, 2012.
The Broccoli case at the EPO
The hearing before the TBA in T 83/05 after the publication of G1/08 and G2/07 in December 2010 on the broccoli patent (EP patent 1 069 819 in name of Plant Bioscience Ltd which also contains claims to breeded plants and was opposed by Syngenta and Groupe Limagrain Holding), scheduled for 26 October 2011, was cancelled. The Opponent requested end November 2011 for a stay of the proceedings by referring to the alleged similar Tomato case discussed above. Since the questions have now been referred to the EBA in G2/12, the Board now wishes to hold oral proceedings to hear the parties. The Board in this case is the same one as in the Tomato case discussed above. Public Oral proceedings are scheduled for 1 March 2013 before the TBA 3.3.04. It will be important to follow up this case.
The Melon case at the EPO
Another remarkable case at the EPO which is to be followed is Monsanto’s EP patent 1 962 578 granted on 4 May 2011 relating to melon plants resistant to a virus - cucurbit yellow stunting disorder virus (CYSDV) - that attacks melons, turning them yellow and reducing fruit yield. The plants are made resistant by the introduction of a gene from another melon plant by way of a conventional breeding method involving the use of a genetic marker ("marker-assisted breeding"). The gene which is responsible for the resistance was first found in a melon plant in India and catalogued in 1961. It has been publicly available since 1966.
The patent covers the modified plant, parts of the plant and its fruits and seeds, but not the breeding process for obtaining the plant. Nunhems has opposed the patent on technical grounds, including lack of novelty and inventiveness of the patented plants. A further opponent is from a coalition of NGOs acting under the heading "No patents on seeds", who, in addition to technical arguments, voice their concerns over the protection of products obtained by conventional breeding methods.
On October 29th, the Patentee submitted new requests and an oral proceedings may be expected to take place somewhere next year. If the Wrinkly tomato case would not be able to proceed to the EBA, this case could instead.
Conclusion
In the area of plants, most patent applications relate to genetically engineered (GM) plants. However, there is no requirement under patent law for a plant to be modified by genetic engineering techniques for it to be patentable. In recent years, therefore, the EPO has also received a number of patent applications relating to plants obtained by new breeding techniques, such as marker-assisted breeding. This point is expected to be further clarified hopefully in G2/12 as discussed above as well as in the other two plant cases referred to above hanging before the Boards of Appeal. Amicus briefs may be filed by the end of November 2012 in G2/12. There is some doubt though if this case will continue or not.
We will report on the further developments in these plant cases and any other emerging plant patent cases. As the team of De Clercq & Partners contains several European and national patent attorneys specialized in the field of plant molecular biology we expect to be in the forefront of these debates and are available for any questions you may have on these issues.
5. Brussels Court completely overturns first instance decision on Lundbeck’s Escitalopram SPC and grants injunction against generics
The national validations of European patent EP 0347 066 and the corresponding SPCs requested for escitalopram have been the subject of quite some European litigation between the patent owner Lundbeck and different generic companies, such as, for Belgium, Tiefenbacher, Ratiopharm, Teva Pharma and Eurogenerics NV. The issues raised in this case being quite complex, different appeal courts have revised their first instance decision. This is also the case for Belgium.
In a first instance decision issued on October 3rd, 2011, the Brussels Commercial court had revoked Lundbecks’s Belgian escitalopram SPC, based on the position that the requirements of Articles 3(c) and 3(d) of the SPC Regulation had not been met. In view of this assessment the court had not found it necessary to consider the validity of the patent, despite the extensive report provided by the experts on this matter.
The decision of September 17, 2012 of the Court of Appeal however now not only acknowledges the validity of the SPC but also confirms the validity of the basic patent, thereby effectively overturning the first instance decision in its entirety.
The issue of the validity of the SPC hinged on whether the S-enantiomer escitalopram should be considered the same product as the racemate citalopram, such that the market authorisation for escitalopram could not be considered the “first” market authorization (in view of the earlier MA for citalopram) as required under Article 3(d). The court of Appeal however considered that the generics failed to demonstrate “strict identity” between the two products. Indeed, no conclusive proof had been submitted that the S-enantiomer was the only active substance in the racemate. The fact that both the racemate and the purified S-enantiomer product perform equally as such does not unequivocably prove that the R-enantiomer is completely inactive. On the contrary, the evidence submitted suggested that the R-enantiomer did have some effect on the activity of the racemate. Also, arguments to the effect that the R-enantiomer should be considered a derivative or an impurity were not found convincing. Thus the requirements of Articles 3(c) and 3(d) of the SPC Regulation were considered met and the SPC was considered valid.
Turning now to the validity of the underlying patent, the Court of Appeal decision addresses the different arguments presented by the generics.
In their assessment of whether or not a claim to an enantiomer can be considered patentable over the disclosure of the racemate, reference is made to the caselaw of the EPO. Indeed, different decisions of the technical boards of appeal deal with this specific situation. Based on T297/87(Hoechst) and T1048/92(Pfizer) the court argued that novelty could only be denied for a claim to the enantiomer (hic escitalopram) if it could be demonstrated that the prior art documents disclosing the racemate (hic citalopram) allowed the skilled person to obtain the enantiomer in individualized form, which was not considered to be the case. Thus the claim to the S-enantiomer escitalopram was considered novel.
With regard to inventive step, it was considered that the case-law of the EPO indicated that if the product could not previously be produced and the method disclosed for producing the product was inventive, the product per se could also be considered to involve an inventive step (reference to T595/90).
Starting from the closest prior art, which was considered to be the disclosure of the racemate (as it was developed for the same purpose of treating depression), the court considered the technical problem was the identification of an alternative composition for the treatment of depression. Indeed, while the defendants had argued that the technical problem should be formulated as “how to separate an enantiomer from the racemate”, the Court of Appeal considered that such a formulation was based on hindsight, i.e. knowledge of the solution of the problem.
The court then went on to evaluate whether the skilled person would have been motivated to separate the racemate into enantiomers and, if so, if he would have reasonable expectation of success of achieving this.
With regard whether or not the skilled person would have expected to obtain an improved therapeutic by separating the enantiomers, the court referred to different expert testimonies submitted by Lundbeck, which indicated that the skilled person would not be motivated to separate the enantiomers of citalopram, in view of the envisaged difficulties and uncertainties about the activity of the enantiomers. The court then also looked at whether or not methods for separating the enantiomers with reasonable expectation of succes were in fact available from the state of the art. In this regard, it was considered that the testimonies provided by Ratiopharm and Teva in support of the fact that the separation of enantiomers was being carried out routinely in industry at the time in fact were not conclusive to suggest that separation of the enantiomers of citalopram would also have been straightforward. Based also on European case law decision T857/04, the Court of Appeal considered that the difficulty for obtaining enantiomers from a racemate should be considered on a case by case basis.
With regard to the assessment of whether or not the skilled person would have been able to obtain the S-enantiomer in an obvious way based on the prior art, the Court emphasizes that this was a highly technical discussion which had been taken into consideration by independent experts appointed to the court and which had been discussed with both parties (a reference to the expert report and the questions submitted by both parties is made in the judgement – item 46).
The court further points out that the experts extensively considered all possible methods for obtaining enantiomers from the racemate citalopram available in the art at the filing date of the patent. It is considered by the court that the expert report conclusively demonstrates that the skilled person would not have had reasonable expectation of success to obtain the enantiomers from citalopram without undue burden. In this regard it is considered that all documents raised by either party were extensively addressed or at least taken into consideration by the experts. The court then goes on to comment on a document which was not submitted to the experts, but considers that insufficient proof is provided by the defendants that this document could counter the arguments provided by the experts.
Thus the Court concludes that the claim to the method for obtaining the purified S-enantiomer from the citalopram racemate is novel and inventive. Based thereon, and in light of the above arguments, the Court also concludes that product claim 1 to the S-enantiomer is also novel and inventive, in view of the fact that methods for obtaining the enantiomer from citalopram in a straightforward way were not available in the art and the disclosed method involved an inventive step.
In view of the validity of both the patent and the SPC, the injunction requested by Lundbeck is granted.
The present decision illustrates that the Court of Appeal of Brussels does not shy away from quite difficult technical cases and can present a fully reasoned decision based on an independent assessment of the information provided by all parties. Irrespective of the outcome of the present case, this is good news for everyone envisaging potential litigation in Belgium.
The Brussels Court of Appeal herewith brings the position of the Belgian Court in line with the earlier decision of the German Bundesgerichtshof of 10 September 2009 (which held the SPC valid), the Dutch Court of appeal decision of 24 January 2012 and the French Supreme Court decision of 30 September 2010 which upheld Lundbeck’s SPC in those respective countries.
6. The Judge in the Netherlands has ordered a Dutch company in summary proceedings to stop promoting and/or facilitating infringement of patent rights in Portugal
In the case of Boehringer Ingelheim Pharma GmbH versus the corporate group Teva Pharma, the Dutch judge ruled in summary proceedings of August 15, 2012 that Teva Pharma, based in the Netherlands, has violated the principle of due care by contributing to, or at least not preventing, the infringement by its Portuguese affiliate of patent rights owned by Boehringer Ingelheim.
Background
Boehringer Ingelheim Pharma GmbH, holds a European patent (EP 0 429 987) as well as a national Portuguese patent (PT 95919) relating to diazepines and their use in the prevention or treatment of HIV infection. The Portuguese national patent as well as its corresponding supplementary protection certificate protect the pharmaceutically active ingredient nevirapine, obtained by a specifically claimed preparation process.
A Dutch affiliate of the Teva Pharma Group holds a European market authorization for drugs comprising nevirapine as the active ingredient. On the basis of this market authorization, pharmaceuticals comprising nevirapine are commercialized by a Teva affiliate in Portugal.
Boehringer Ingelheim initiated proceedings in Portugal to stop the infringement of its patent rights by Teva. In addition, Boehringer Ingelheim has sought an injunction in summary proceedings in the Netherlands to withhold the Dutch Teva Pharma (holding a market authorization for nevirapine) from committing unlawful acts by promoting and/or facilitating the infringement of the Portuguese rights of Boehringer Ingelheim. Teva argued in its defense that the Dutch court does not have jurisdiction to rule a case involving the infringement of patent rights valid abroad and furthermore stated that the Portuguese patent and supplementary protection certificate were invalid.
Jurisdiction of the Dutch court
The District Court of The Hague considered that it did have jurisdiction to decide in respect of this case, based on Article 31 of the Brussels Regulation (EC 44/2001), providing that national courts may order provisional and protective measures, notwithstanding the jurisdiction of another court, and in line with the recent decision of the European Court of Justice (CJ-EU) of 12 July 2012, C-616/10, Solvay/Honeywell.
In the latter, the CJ-EU confirmed the admissibility of interim cross-border injunctions in patent disputes under limited conditions, by clarifying the provisions of the Brussels Regulation (EC 44/2001) on the jurisdiction and the recognition and enforcement of judgments in civil and commercial matters, in particular Article 6 (1), Article 22 (4) and Article 31 EC44/2001. According to Article 6 (1) EC44/2001, co-defendants from different jurisdictions can be sued together, if the claims are connected so closely that it is expedient to assess them together with the aim of preventing irreconcilable judgments.
In the past however, the practice to centralize infringement proceedings by asking the court to rule on infringement of other national parts of a European patent based on the Brussels Regulation had been cut back substantially by two earlier landmark decisions of the CJ-EU, namely Gat/Luk (CJ-EU C-4/03) and Roche/Primus (CJ-EU C-539/03). Nevertheless, in Solvay/Honeywell the CJ-EU revisits these previous decisions, ruling that Article 6(1) EC44/2001 can be used where each of the defendants infringe in relation to the same product, the same national part of a European patent. The court in this context reasoned that in separate proceedings, there is a risk of irreconcilable judgments of different national courts and considered this sufficient to allow cases being heard before one single court.
In addition, the CJ-EU interpreted Article 22 (4) EC44/2001, which provides for exclusive jurisdiction of the national courts of registration in matters concerning the validity of patents or other IP rights.
The CJ-EU established in this regard that despite the limitations for cross-border injunction in main proceedings as set out in its earlier case law (i.e. Gat/Luk), the situation is different in the case where preliminary relief is sought. Preliminary measures indeed do not prevent the national courts in other member states from arriving at a different decision with regard to validity with effect for their territory. Accordingly, the ECJ has decided that there is no risk of conflicting decisions when a national court deals with the prima facie invalidity of a patent in interim proceedings, provided that such proceedings do not have a final effect on the merits of the case which will be decided upon by the national court of the state where the patent is registered.
Based thereon, the Dutch judge in the present case declared his competence to provide a provisional judgment on the ground of European law since there was a sufficiently real connection with the Dutch territory. The judge further asserted the absence of the chance of creating a conflicting decision with the decision of the Portuguese judge on the merits, as he would not be giving a final, but rather a preliminary decision on the validity of the Portuguese national patent.
Assessment of validity of the Portuguese patent by the Dutch court
After having decided to be competent to hear the case, the Dutch judge also considered the validity of the patent under Portuguese law and provisionally ruled the patent to be valid. In particular, with regard to inventive step, an earlier Boehringer patent, disclosing a compound analogous to nevirapin but with certain variations in its chemical structure, was selected as presenting the closest prior art.
The judge in essence ruled that small differences in chemical structure could result in major changes in functionality or reactivity. Since Teva was not able to find other prior art providing an incentive to amend the chemical structure of the prior art compound to nevirapin with a reasonable expectation of success of obtaining an improved effect, the claimed compound was considered to involve an inventive step.
Assessment of unlawful act by the Dutch court
With regard to the assessment of whether or not the Dutch Teva Pharma violated the standard of due care by not preventing the infringement acts of its Portuguese affiliate, the judge considered that since the Portuguese registration is in the name of the Dutch affiliate of Teva Pharma, this company was deemed to be aware of the rights of Boehringer Ingelheim in Portugal. Therefore, the judge held that the Dutch company Teva Pharma, by allowing marketing of Nevirapine by its affiliate in Portugal, thereby facilitating or not preventing infringing acts, acted unlawfully vis-à-vis Boehringer Ingelheim.
Conclusion
This case is the first example, after the recent CJ-EU Solvay/Honeywell case on the same subject, which clearly demonstrates the collaboration of the Dutch court in cross-border infringement proceedings in Europe. In the future, this could evolve towards more possibilities for patent owners to successfully prevent infringement by Dutch companies based on patent rights valid abroad.
7. Inherency – just as beauty, “disclosure” is in the eye of the beholder
For a prior art reference to destroy the novelty of a claim it must in principle disclose all features recited in the claim. However, situations arise where a claimed feature, while not mentioned in the prior art document, is in fact present in the product or method of the prior art. Whether or not such a feature is in such a case to be considered “disclosed” and thus should be taken into account in the novelty analysis is a question which is approached differently by different patent offices. This article focuses on recent decisions from the different patent offices involving claims to therapeutic indications and considers the potential relevance of the evaluation particularly of inherency for the emerging field of personalized medicine.
The EPO: a careful approach to Inherency
Where a claim is directed to a known product, the reference in a claim to a single feature not recited in a prior art document which discloses all other features of the claimed product will be looked at skeptically during prosecution by most patent offices. A difference in this regard can be made between implicit features (which would be recognized to be present in the prior art without knowledge of the invention) and inherent features (which would only be recognized to be present in the prior art product based on the invention).
In order to avoid that a prior art product is claimed, most patent examiners will in both cases assume that the feature not previously described is in fact ( either implicitly or inherently) present in the prior art product, and the burden of proof will be with the applicant to demonstrate that this is not the case. In biotech cases, where the product is often biological material and the feature a result of a biological process, such as the expression of a marker protein, the applicant will have difficulties proving the absence of the claimed feature as the prior art material is typically not available to him. Consequently, the product claims often have to be limited in another way (e.g. demonstrating a selection over the generic disclosure of the prior art) or abandoned.
The issue of inherency may also arise with regard to claims directed to a new use of a prior art product, more particularly when the technical effect claimed, though not recognized as such, would also have been present in the known uses of the prior art product. Here the European patent office tends to take a strict view on novelty. Indeed, the Enlarged Board of Appeal explained the allowability of claims to a new use of a known product in its decision G02/88, where it was emphasized that “under Article 54(2) EPC the question to be decided is what has been "made available" to the public: the question is not what may have been "inherent" in what was made available”. It was made clear that only what was clearly disclosed could be considered as prior art and that “the question of "inherency" does not arise as such under Article 54 EPC” (G02/88, item 8.1).
As an example, for the technical case T231/85 under consideration, this meant that the prior art use of a compound on a plant to regulate its growth, was not considered to anticipate a claim to the use of that compound on a plant to control fungus, even if this effect had inherently been present upon application of the compound as a growth regulator to the plant. It was considered by the Board that the technical feature of the claim “to control fungus” and the corresponding use was in fact not "made available" to the public.
This view was confirmed in recent decision T1859/08 (June 2012) with regard to a claim to a second medical indication. In this case, the position of the Examining division had been that the therapeutic effect claimed for a specified combination of agents would have been inherently present during clinical trials which were described in the cited prior art document as “currently being explored”. This decision was overruled in that the Technical Board of Appeal considered that neither in vitro experiments demonstrating effectiveness of the claimed combination nor the reference to envisaged clinical trials could be considered to anticipate a claim which specified the combination therapy to have “clinical efficacy as measured by determining time to disease progression and reduced myocardial dysfunction”.
Moreover, the position of the board on anticipation of the claimed medical indication is taken even further than T158/96. In T158/96, the Board considered that the announcement of clinical trials phase II could not be considered to disclose a therapeutic application, in view of the fact that the skilled person could not deduce therefrom unambiguously that the therapeutic effect had already been shown or proven during phase I trials or during the pre-clinical experimentation. In the reasons for the decision, this evaluation had been strongly tied to the complex nature of the disease under consideration, obsessive compulsive disorder (OCD). In T1859/08, the board argued that based on a reference to a planned or ongoing phase III clinical trial based on “positive results” in phase II, the skilled person could not, in the absence of an actual report on the outcome, directly and unambiguously derive that a therapeutic effect was indeed obtained. This was a fortiori the case for the specific effect (increased time to disease progression) claimed.
Inherency in the US patent system
The US Patent and Trademark Office and the US courts take a somewhat different approach to inherency. Indeed, the US ‘doctrine of inherency’ as established in the Manual of Patent Examination Practice (MPEP), not only determines that a prior art document may anticipate a claim if an apparently missing element of the claim is inherently present in that prior art product or method, but further specifies that the inherent feature need not be recognized at the time of the invention (MPEP § 2112).
In line therewith, in Schering Corp. v. Geneva Pharmaceuticals, Inc. (2003), it was considered that a claim to a metabolite of a known drug was anticipated by the prior art disclosure of the therapeutic application of the drug itself, because the metabolite was inherently formed in the body upon administration of the drug (and the claimed therapeutic effect of the metabolite had thus inherently taken place). Thus, even though the prior art reference did not recognize or disclose the structure of the metabolite, a claim to the metabolite was considered anticipated.
The more established practice in the US of establishing disclosure by inherency is again demonstrated in In Re Montgomery (2012), where the Federal circuit considered claims to the use of a class of compounds in a method for the treatment or prevention of stroke anticipated by a prior art reference describing the design of a clinical trial for testing one such compound for its effect on the prevention of stroke (the HOPE study). While the HOPE study ultimately found that patients receiving the agent falling within the scope of the claim had a statistically significant reduction in the risk of stroke, these data were not disclosed in the prior art document at issue. The Federal circuit however considered the HOPE study as being “clearly enabled to treat patients” with stroke with a compound falling within the scope of the claims such that it inherently anticipated the claimed method. While of course the facts of the case differ somewhat from those in the Board of Appeal case T1859/08 discussed above, this does reflect the underlying difference in the approach to inherency between the US and Europe.
Inherency a threat to personalized medicine?
It can be considered to what extent the issue of inherency may become relevant in the pursuit of claims to methods in the field of personalized medicine, i.e. whereby a treatment is linked to the presence of genetic or non-genetic markers in the patient.
A typical claim in this field may refer to determining, in a sample of the patient, whether or not biomarker A is present, “wherein the presence of biomarker A is indicative of susceptibility of the patient of treatment with compound x”. It can be questioned to what extent the wherein clause is an effective limitation as it can be considered to describe an inherent property that was always present when analyzing patient samples, though not recognized. Thus, more particularly when the biomarker is assessed by well-established methods, carefull wording of the claims will be required to avoid inherent anticipation by the prior art.
Moreover, the question arises whether a claim to the treatment of a specific group of patients having a particular biomarker A with drug x for condition y, will be considered novel over a prior art reference generally describing the use of drug x for the treatment of condition y, when it is clear that at least some of the patients previously treated in the prior art carried the (previously unidentified) biomarker.
A priori, the patentability of a claim to a known therapeutic indication identifying a new and inventive patient group is well-established and has been confirmed in G02/08. While in the earlier case law of the EPO (such as T233/96) the criteria for recognizing a patient group as novel and inventive were quite strict (no overlap with the known population and an effect of the biomarker was required), in later decisions of the Technical Boards of Appeal (such as T1399/04) it was found that a substantial overlap with the known patient group did not compromise patentability, even when this implied that most of the patients of the newly identified group of patients would also have been treated using the prior art method. Based thereon, the patentability of claims to methods involving biomarkers would not be expected to encounter major difficulties in Europe. It moreover appears that where an issue of novelty would be raised based on the argument that the patients treated by the prior art methods are likely to also have carried the specified marker, it may be possible to overcome such an objection by including the step of identification of the marker in the claim.
Conclusions & Practical implications
In the past the EPO has been very careful in the application of anticipation by inherency and recent decisions of the Technical Board of Appeal suggest that this is still the standard. However, as prior art may be interpreted more liberally against a corresponding application in the US, and the EPO is also struggling with prior art interpretation in particular fields, such as methods involving biomarkers, the danger of inherent anticipation by a prior art disclosure should not be underestimated.
It appears that both in the US and in Europe, rejection of a claim based on inherent anticipation by a prior art document can in many cases be overcome by specifying a technical effect, more particularly when that technical effect, though potentially present, is not inevitably (i.e. necessarily always) inherent to the prior art product or method. More particularly, for applications directed to therapeutic indications, this implies that a further characteristics of the therapeutic outcome should be envisaged and described in the application, such that if necessary, they can be introduced into the claims. In the field of personalized medicine, this may involve combining detection and treatment steps and/or specifying envisaged effects of assessing the biomarker, such as improvements in efficacy or safety, or effects related to dosage of the compound. Such biomarker patents emphasizing safety and efficacy may moreover provide added value as the methods they protect are attractive to regulatory authorities looking for ways to assess efficacy and safety and thus will generate an additional hurdle for generics to circumvent.
8. G1/10: Inadmissibility of requests under Rule 140 EPC to correct the text of a granted patent
On July 23, 2012 the Enlarged Board of Appeal (EBA) of the EPO issued the decision G 1/10 concerning the admissibility of requests under Rule 140 EPC to correct the text of a patent. Rule 140 EPC prescribes: “In decisions of the European Patent Office, only linguistic errors, errors of transcription and obvious mistakes may be corrected.”
Answering the question referred to it by the Technical Board of Appeal 3.5.03:
“Is a patent proprietor's request for correction of the grant decision under Rule 140 EPC which was filed after the initiation of opposition proceedings admissible? In particular, should the absence of a time limit in Rule 140 EPC be interpreted such that a correction under Rule 140 EPC of errors in decisions can be made at any time?”,
the EBA decides:
“Since Rule 140 EPC is not available to correct the text of a patent, a patent proprietor's request for such a correction is inadmissible whenever made, including after the initiation of opposition proceedings.”
The situation underlying the referral can be outlined as follows. An opposition was filed against a European patent based on the sole ground of added subject-matter (Article 100(c) EPC). In particular, the opponent argued that the feature “means for initiating (56) a command related to a position of the device data” in the granted claim 1 was not disclosed in the application as filed. The proprietor explained that this feature resulted from a typographical error made during the examination proceedings and that the correct phrase should have read “means for initiating (56) a command related to a portion of the device data”. The proprietor therefore requested that the opposition proceedings be stayed and that the case be remanded to the examination division for reissuance of the granted patent after correction under Rule 89 EPC 1973 (corresponding to Rule 140 EPC 2000). When the opposition division took the interlocutory decision to stay opposition proceedings and to remit the case to the examining division, the opponent appealed against this decision. The Technical Board of Appeal 3.5.03 decided to refer the aforementioned question to the EBA.
Before analysing the case, the EBA first carefully delineates the circumstances to which its decision will apply. In particular, the EBA emphasises that its decision is not concerned with corrections of any other decisions than grant decisions. Moreover, even in the context of corrections of grant decisions, the EBA decision is confined to corrections of the description, claims and drawings, and is not concerned with corrections of bibliographic data (including corrections of priority claims). In this connection, the EBA notes that under Rule 71(3) EPC as amended from 1 April 2012 the bibliographic data is now also sent to the applicant for verification. Yet, the EBA confirms that under the amended rule the bibliographic data still does not form part of the text of the patent.
Turning to the reasons for its decision, the EBA first observes that legal certainty and the prevention of adverse effects on third parties are the reasons for the narrow ambit of allowable corrections under Rule 140 EPC, and postulates that legal certainty is served by the grant decision establishing a definitive text of a patent for the purposes of any subsequent proceedings, whether at national or EPO level.
The EBA explains that adverse effects on third parties including potential opponents are avoided if there is no possibility to use Rule 140 EPC to correct the text of patents. Hence, there will be no delay in opposition proceedings caused by requests under Rule 140 EPC and no decisions on corrections which are not appealable by an opponent. There will be no adverse effects on third parties who, relying on a patent as granted, undertake activities which later infringe a patent as corrected. There will be no would-be opponents who, relying on the granted claims, decide not to file an opposition only to find that, after correction, they are threatened by the patent but deprived of the possibility of opposition. And there will be no question of denying the principle of equal treatment of parties through the possibility for a patentee to turn inter partes proceedings before the Opposition Division into ex parte proceedings before the Examining Division on an issue – the content of the patent – which is decisive for an opposition.
On the other hand, the EBA believes that the absence of the possibility to correct the patent text under Rule 140 EPC should not prejudice patent proprietors. The reasoning is that if a correction is obvious, then the patent should be read by all concerned as if corrected and an actual correction should not be necessary. If a correction is less than immediately obvious, then it should not be allowed under Rule 140 EPC anyway.
The EBA then emphasises that a patent applicant has ample opportunities to ensure that his patent is granted in the exact form as he wants it to be, since mistakes can be corrected before grant under Rule 139 EPC on request. Moreover, a patent applicant is obliged to approve the text in which the Examining Division intends to grant his patent, and may request amendments or corrections to that text (‘Druckexemplar’). Given the applicant’s opportunity to check the patent text before approving it, the EBA decisively puts the responsibility for any errors remaining in that text solely with the applicant, irrespective of who made or introduced the errors – the applicant himself or the Examining Division. Consequently, the EBA also explicitly disapproves of the practice, whereby applicants turn to Rule 140 EPC to request the correction of obvious errors when this is no longer possible under Rule 139 EPC.
For situations where the mistake is effectively imputable to the Examining Division, the EBA explains that if the Examining Division issues a decision to grant which contains an error subsequently made by it, so that the granted text is not that approved by the proprietor, then the proprietor is adversely affected by that decision and is entitled to appeal. In view of the Examining Division's mistake the appeal should succeed by allowing interlocutory revision and reimbursement of the appeal fee.
Finally, the EBA notes that although it considers Rule 140 EPC as not available for correcting patents, including during opposition or limitation proceedings, a patent proprietor may of course seek to amend his patent during opposition or limitation proceedings and such an amendment could remove a perceived error. Such an amendment would have to satisfy all the legal requirements for amendments including those of Article 123 EPC.
Based on all its considerations, the EBA answers the referring Board’s question as set forth above, deciding that Rule 140 EPC is not available to correct the text of a patent, and a patent proprietor’s request for such a correction is inadmissible.
The lesson from this decision is clear – the applicant must thoroughly check the text in which the Examining Division intends to grant the patent (Communication under Rule 71(3) EPC) to ensure its accuracy before approving it. Although this EBA decision does not concern corrections of the bibliographic data, the latter should also be carefully scrutinised by the applicant.
9. European Applicants and Prior Art under the AIA
On March 16, 2013, the United States Patent and Trademark Office will transition to a first-to-file or the "First-Inventor-to-File" system as it is named in the America Invents Act (AIA). Thus, an applicant seeking protection in the US can no longer invoke the date of the invention to establish entitlement to an invention if another applicant files the same invention first.
Additionally, the location of a previous disclosure, which under the current system can prevent a prior disclosure from being prejudicial, will no longer be relevant. In other words, geographical boundaries that previously prevented certain disclosures from being considered as prior art will be lifted.
European applicants who have long been familiar with a first-to-file system before the EPO and National offices, might reap some benefit. Priority applications filed by European applicants are typically EP or national filings. Under the new system, the date of this non-US priority application will serve as the date from which the later US application (i.e. PCT entering the US or US direct application claiming priority of the non-US priority application) will be considered prior art before the US PTO. With the current rules, only a US-filed priority application can bestow the earlier date. The playing field will be leveled in the future, foreign priorities being recognized for this purpose. Dispensing with the geographical requirements will alleviate the need for European applicants to file simultaneously a US-provisional application to obtain what is currently known as a “102(e) date”.
The recognition of the foreign priority will mainly cause the earlier redating of “intermediate prior art” which is an application filed before but published after the filing of the application in prosecution. Both the EPO and US PTO recognize only applications filed under their respective systems as such art. The EPO system still remains less severe for intermediate art insofar as it is citable only for novelty under Article 54(3) EPC. In the US, such art may also be used to support an obviousness rejection.
The downside for all applicants is that more prior art may be invoked against applications pursued before the US PTO at least for the reasons above. Other activities, previously exempted, will also be considered as prior art, such as public use and commercial activities that occur outside the U.S. i.e. there will be an expansion of the prior art, hence the general advice originating from US commentators to file US applications prior to March 16, 2013.
With the new changes, interference proceedings will be avoided. However, for cases of entitlement, the AIA will introduce “Derivation proceedings” that allow a first applicant with a later filing date to present evidence that an inventor with an earlier filing date derived his claimed invention from the first inventor.
The AIA continues to provide applicants with a one-year grace period to decide whether to pursue patent protection in the US after public disclosure of the invention by the inventor. In order for an inventor’s prior disclosure to disqualify as applicable prior art, a US application must be filed by the inventor less than a year after the inventor’s disclosure. Publications and patent applications by others within the grace period may be removed as prior art if they are dated after the publication by the inventor.
As noted, the first-to-file system will be in force from March 16, 2013 for a PCT application designating the US or a US direct application, having an effective filing date on or after March 16, 2013.
10. T1680/08 – Artificial ventilation
The European Patent Convention under Article 53(c) EPC provides an exception to patentability for certain activities including methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body. As has been stated in past case law of the Boards of Appeal, the supposed freedom of a medical or veterinary practitioner from being hampered by patents and thus, social-ethical considerations, have emerged as the policy underpinning the original article. While the European Patent Office does afford protection for these applications by the so-called “second medical use” claim formulations for the compositions developed for use in these methods, inventions which relate to a particular sequence of method steps and/or involve devices rather than compositions can often not be protected in this way. Thus, the exact criteria to determine what constitutes a method of therapy, surgery or diagnosis remains the subject of much debate.
The Enlarged Board of Appeal issued its decision G1/04 on December 16, 2005 discussing diagnostic methods in detail. Subsequent Enlarged Board of Appeal decision G1/07 explored treatment by surgery in some depth; in a previous edition of this newsletter, we looked at two decisions of the Technical Board of Appeal post-G1/07 that took divergent views.
In this article, we examine decision T1680/08 issued by the Technical Board of Appeal (TBA) on June 8, 2011 concerning the excepted treatment by therapy of the human and animal body.
The Applicant appealed against the decision of the Examining Division posted on April 3, 2008 to refuse European patent application No. 04007355.3 (EP 1 579 882), mainly because the subject-matter of claim 1 was considered to be a method for treatment of the human body by therapy excluded from patentability pursuant to Article 53(c) EPC.
Claim 1 of the main request before the Board read:
1. Method for determining airway pressure levels at which certain lung conditions of a lung ventilated by an artificial ventilator occur, comprising the steps of:
- obtaining data samples of the CO2 concentration of the expired gas over a single breath,
- selecting a plurality of data samples from said obtained data samples,
- calculating a mean tracing value being sensitive to changes of alveolar dead space on the basis of said selected data samples,
- repeating steps a), b) and c) for obtaining a plurality of mean tracing values, and
- changing the airway pressure of the artificial ventilator, wherein from the observation of the resulting course of the plurality of calculated mean tracing values the airway pressure level at which alveolar opening or lung over distension or lung open condition or alveolar closing occurs is detected.
The TBA eventually regarded the method claim as falling under the exception, raising and confirming some noteworthy points in its decision:
Step aimed at maintenance of life is therapeutic
The claimed method requires the patient to be connected to the artificial ventilator in order to apply pressure to its lungs and to measure the concentration of CO2 in the expired gas. The pressure level is applied to the lungs of the patient by the artificial ventilator; when the airway pressure is changed it is not in any way superimposed on a "normal" ventilation pressure, but is the only pressure actually applied to the patient's lungs. In other words, the method is not applied on top of any normal artificial ventilation of the patient but during the ventilation phase in which the method is carried out; it is the only artificial ventilation effectively applied to the patient. Therefore, this “testing phase” is just as vital for the survival of the patient as any other normal artificial ventilation, according to the TBA. It follows that the ventilation phase during which the method is executed cannot be distinguished from the normal artificial ventilation applied to the patient.
Further, the step of changing (increasing or decreasing) the airway pressure of the artificial ventilator in order to determine the relevant pressure levels cannot be distinguished from what a medical doctor would do in order to adapt an artificial ventilation to a given patient.
According to the TBA, there is a functional and indissociable link between the claimed method and any artificial ventilation practised on a connected patient. It is indisputable that artificial ventilation is a therapeutic method because it aims at keeping the patient alive.
While the appellant submitted that the method did not cure any particular disease, and therefore did not qualify as therapy, the TBA disagreed because the method could not be distinguished from normal artificial ventilation, the very first aim of which is to keep an anesthetised patient alive, which clearly must be considered as a therapeutic treatment since it avoids the death of the patient by artificially maintaining respiration.
Presence of a single therapeutic step
The TBA admitted that while the primary intention of the appellant was not to protect a method for treatment but a method for determining the relevant pressure levels, it regarded this fact as little relevance, citing G1/07 and applying its decision, namely that the presence of a single therapeutic or surgical step is sufficient to exclude the method from patentability:
"... in the EPC revision the European legislator deliberately maintained the exclusions under Article 52(4) EPC 1973 in the now Article 53 c) EPC. Thereby the principle has been confirmed that medical and veterinary practitioners' freedom to use the best available treatments to the benefit of their patients uninhibited by any worry that some treatment might be covered by a patent is protected by excluding these activities from patentability. Excluding from patentability also multi-step methods which comprise or encompass a therapeutic or a surgical step serves to give full effect to that legislative purpose. Therefore, the principle developed in the jurisprudence that the presence of one therapeutic or surgical step in a multi-step method excludes that method from patentability is not only formally justified by the fact that the exclusion under Article 53 c) EPC does not contain any limitation as to the defined methods being excluded only when claimed as such. More importantly, it is also justified as to substance, i.e. it serves to enable achieving the legislative purpose served by the exclusion." (emphasis added).
Freedom of a medical or veterinary practitioner is no prerequisite for exclusion
The appellant submitted that a medical doctor would never be hampered by the claimed method, as it was executed by a computer. However, the TBA confirmed that the EPC excludes from patentability any methods of treatment by therapy in general. It recited G 1/07 point 3.2.3.2:
"...There is, however, no term in Article 53 c) EPC which would allow concluding that hampering of the practitioner’s freedom is a prerequisite for the exclusion to apply in the individual case considered. The only condition defined in Article 53 c) EPC for a claim to be excluded from patentability is that it contains subject-matter being a method for treatment of the human or animal body by surgery or therapy or a diagnostic method. If so, it is excluded from patentability and it is then irrelevant whether in the individual situation under consideration a medical practitioner would or could infringe the claim." (emphasis added).
The main request was rejected. However, the case was remitted to the Examining Division, based on auxiliary request 2, which was directed only towards an apparatus.
Conclusion
In this decision, the TBA has interpreted the exception of patentability generously to encompass methods which as such do not have a therapeutic effect but analyse and potentially influence a therapeutic method. The continued referencing of G1/07 that primarily concerns questions of treatment by surgery rather than by therapy, indicates the breadth and influence of that decision.
11. Extending limitation: Article 123 (3) EPC - a hidden risk
In recent decisions by the EPO Boards of Appeal intriguing insights were provided regarding the risks associated with amending claims drafted using numerical ranges in combination with open-ended claim language. While such a claim amendment may seem as a limitation of the subject matter at first sight, it is in fact often an extension of the scope of protection conferred by the claims.
The article in the EPC relevant for these decisions is Article 123 of the EPC as it indicates that:
(1) The European patent application or European patent may be amended in proceedings before the European Patent Office, in accordance with the Implementing Regulations. In any event, the applicant shall be given at least one opportunity to amend the application of his own volition.
(2) The European patent application or European patent may not be amended in such a way that it contains subject-matter which extends beyond the content of the application as filed.
(3) The European patent may not be amended in such a way as to extend the protection it confers.
The underlying principle with Art 123(2) EPC, is that an applicant is not allowed to improve his position by adding features not disclosed in the application as filed, because this would provide him an unjustifiable advantage which could be detrimental for the legal certainty of third parties. Art 123(3) EPC, on the other hand, aims to protect the interests of third parties by prohibiting any broadening of the claims after grant beyond the scope of the granted patent, even if there would be a basis for such broadening in the application as filed.
An Art 123 (2) - (3) trap may arise where a granted European patent contains a feature which was not disclosed in the application as originally filed, thereby contravening Art. 123(2) EPC. In subsequent opposition proceedings, the patentee may be required to remove the non-disclosed feature from the claims, but removal thereof typically extends the scope of protection beyond the scope conferred by the patent as granted. An inescapable trap situation is thus created where during the opposition proceedings the patent claims cannot be maintained in unamended form without contravening Art 123(2) EPC and deleting the added subject matter from the claims would contravene Art 123(3) EPC. In such cases, the patent will therefore be revoked, unless an alternative limitation is found which finds basis in the application as originally filed and thus can be introduced into the claims without contravening either Art 123(2) EPC or Art 123(3) EPC.
The wording playing a crucial role in these recent decisions is the term “comprising”. The term “comprising” is an open-ended term which means that the claim encompasses all the elements listed, but may also include additional, unnamed elements. For example, if a claim refers to a composition comprising elements "A" and "B", this wording means that the composition comprises “A” and “B”, but may also comprise an additional element e.g. “C”. A close-ended term such as the term “consisting of” on the contrary in this context means that the composition has only the recited elements and nothing more.
Whereas in most cases the application of Article 123(3) EPC may seem rather straightforward, the following cases dealt with by the Boards of Appeal are proof of the contrary. Indeed, in claims with an open-ended wording, particular amendments which at first sight may appear to imply a limitation of the claim may in fact actually lead to an extension of the scope of protection conferred by the claim.
T2017/07
In T2017/07 a granted patent was maintained during opposition proceedings with the following amendments (amendments indicated):
A hair dye composition comprising:
(A) an acid dye, and
(B) an alkylene carbonate having 3-5 carbon atoms in total,
said composition exhibiting a pH of 2-6, and having a buffer capacity of 0.007-0.5 gram equivalent/L, wherein the content of the alkylene carbonate having 3-5 carbon atoms in total is 0.5-50% by weight, the alkylene carbonate being propylene carbonate, and wherein the composition contains neither benzyloxyethanol nor benzyl alcohol.
The Boards of Appeal overruled this decision by the opposition division. The claim uses a numerical range to determine the presence of a component in the composition. Such a range however also implicitly excludes the presence of that component in an amount outside of the set range.
In the present case, the granted claim related to a hair dye composition requiring alkylene carbonate having 3-5 carbon atoms in amount from 0.5 to 50 % by weight. Accordingly, the amount of alkylene carbonate having 3-5 carbon atoms in the composition may not exceed 50% by weight.
The amendment to the claim during the opposition proceedings was made with the intention to limit the claim by specifying a particular C3 alkylene carbonate, namely propylene carbonate. By selecting this particular alkylene carbonate, the requirement that the content of alkylene carbonate having 3 to 5 carbon atoms is between 0.5-5% was removed. The hair dye is however characterized by the use of the open-ended term “comprising”, and therefore the composition of amended claim 1 may comprise, in addition to an acid dye and 0.5-50% by weight propylene carbonate, other components including other alkylene carbonates having 3 to 5 carbon atoms, in any amount. Thus, the upper limit of 50% by weight of alkylene carbonate having 3 to 5 carbon atoms as specified in the granted claim may be exceeded.
The Board therefore concluded that the claim had been amended in such a way as to extend the protection beyond that conferred by the granted patent, thereby contravening Art 123(3) EPC.
T9/10
In T9/10 a similar situation arose as the following amendments were made and considered allowable in the opposition proceedings (amendments indicated):
A skin cleansing composition comprising
(A) 3 to 80 wt.% of an oil component,
(B) 1 to 45 wt.% of a hydrophilic nonionic surfactant, having an HLB value of more than 8 and having a hydrophilic group with 8 or more carbon atoms,
(C) 1 to 45 wt.% of a lipophilic amphiphile, selected from nonionic surfactants having an HLB value of 8 or less, fatty alcohols having 8 to 25 carbon atoms, fatty acids having 8 to 25 carbon atoms and monoalkylphosphoric acids having 8 to 25 carbon atoms,
(D) 3 to 80 wt.% of a water-soluble solvent, and
(E) 3 to 80 wt.% of water,
and having an isotropic liquid phase exhibiting a bicontinuous structure.
Here again, the use of the term "comprising" in connection with a numerical range defining the amount of a components implicitly implies that the protection conferred by the claim does not extend to compositions containing the components in amounts outside the defined range.
Accordingly, while the original claim excluded any hydrophilic nonionic surfactant in an amount less than 1 and more than 45 wt.%, the claim as amended allows the presence in undefined amounts of any other hydrophilic nonionic surfactants than those having the specific HLB values and/or the number of carbon atoms in the hydrophobic group. Therefore the protection conferred by the amended claim was extended in comparison with the protection conferred by the original claim, contrary to the requirement of Art 123(3) EPC.
A remarkable issue is that in neither of the above-mentioned cases, the application provided explicit basis for compositions characterized as "consisting of" the listed ingredients as a particular embodiment of the term "comprising". Thus, such an amendment was also not possible, as this would contravene Art 123(2) EPC.
On the other hand, in T9/10, the Board held that the following request (amendments with regard to the earlier request) was allowable and not contrary to Art 123(3) EPC.
A skin cleansing composition comprising
(A) 3 to 80 wt.% of an oil component,
(B) 1 to 45 wt.% of a hydrophilic nonionic surfactant,
(C) 1 to 45 wt.% of a lipophilic amphiphile,
(D) 3 to 80 wt.% of a water soluble solvent, and
(E) 3 to 80 wt.% of water, and having an isotropic liquid phase exhibiting a bicontinuous structure,
wherein the hydrophilic nonionic surfactant (B) has an HLB value of more than 8 and has a hydrophobic group with 8 or more carbon atoms, and wherein the lipophilic amphiphile (C) is selected from nonionic surfactants having an HLB value of 8 or less, fatty alcohols having 8 to 25 carbon atoms, fatty acids having 8 to 25 carbon atoms and monoalkylphosphoric acids having 8 to 25 carbon atoms.
Conclusion
It can be learned from the above discussion that several measures should be taken when drafting the text of the description of a patent application to ensure that situations as described above will not occur or that at least an alternative option for limitation is provided for. This can be for instance the inclusion of a general statement that the term "consisting of" is considered to be a particular embodiment of the term "comprising". However, in some cases a general statement may not be sufficient. Fact is that an amended feature must, explicitly or implicitly, be directly and unambiguously disclosed to the skilled person using common general knowledge in the application as originally filed in order to be allowable under Art 123(2) EPC. The latter meaning that it will be the teaching of the application in general which will decide if an amendment from “comprising” to “consisting” will actually be allowable. Therefore, it is always advisable to provide, wherever available, the explicit wording “comprising”, “consisting of” and also “consisting essentially of”, the latter being an intermediate wording meaning that beside the indicated ingredient(s) also other compounds may be present in amounts that do not materially affect the essential characteristics of the composition (T 472/88).
It is furthermore essential to realize that when a claim indicates that the composition contains a generic compound class in a certain amount defined by a numerical range, this implicitly excludes the presence of all members of the compound class in an amount outside of that range. The use of the term "comprising" in such a claim on the other hand opens the claim to the presence of any further components other than those “limited” by the numerical range. Thus, where the numerical range is applied only to specific compounds of the generic class, this typically implies that all other members of the generic class can be present as other components, without the numerical range limitation. Thus, for such compositions, the impact of specifying the numerical range for either the generic class or specific compound(s) within the class should be carefully considered.
Again, these cases demonstrate that a thoroughly drafted detailed specification including multiple fallback positions is essential for ensuring adequate patent protection, without having to worry about issues with Art 123(2) EPC or Art 123(3) EPC.
12. Submitting your Third Party Observations (TPO) for a PCT application
It is long established practice before the EPO that third parties can submit their comments on the patentability of claims of pending patent applications, by way of Third Party Observations (Article 115 EPC). However, many applications enter Europe only after regional phase conversion of an international application filed through the PCT route.
Thus, until recently, a third party confronted with “questionable” claims in the international phase, had to wait until the application became a European application to submit their comments.
For Euro-PCT applications, this had the disadvantage that for applications for which the international examination was positive, the Examiner may have been tempted not to give such observations (filed after EP entry) much weight, and to proceed with the allowance to grant of the EP patent application.
Recently, the World Intellectual Property Office (WIPO) has introduced a similar procedure which enables the submission of Third Party Observations (TPO) on International patent applications.
It is therefore now possible for a third party to submit, free of charge and either anonymously or otherwise, observations regarding the patentability (i.e. novelty and inventive step) of the claims of a PCT application.
Such Third Party Observations should be submitted online (through the Patentscope website) and may be submitted as from the International publication date (18 months after the priority date) until 28 months after the priority date.
These Third Party Observations – when filed - are always notified to the applicant. It should be noted, however, that the applicant is permitted but not obliged to respond. The response can be filed until 30 months after the priority date. The observations and any responses by the applicant are made public and may be taken into consideration during the examination in the national and regional phases by the individual Offices.
This may be of interest to any third party who is in the possession of a prior art document which is particularly relevant to the patentability of a pending PCT application.
It should be noted however, that the downside of the current system is that it allows for the submission of only 500 characters, such that only very limited arguments can be included. Also, the number of prior art documents that can be submitted is limited to 10, and in principle a person may make only one submission per application. Similar to filing a Third Party Observation at the EPO, the third party filing the observations is not further involved in the proceedings.
By filing prior art at the international stage, a third party can put these documents on the record such that they will come to the attention of the examiners of each of the patent offices where the patent application enters the national or regional phase after PCT. However, where the relevance of the prior art is not self-evident, it can be questionable to what extent this procedure will be sufficiently effective to convince Examiners to consider the submitted prior art.
If you are considering taking action against a pending application, De Clercq and Partners will be happy to assist you in determining whether the filing of third party observations can be of interest in your specific case.
13. Belgian Patent Tax Deduction: Requirements for R&D department more flexible
Introduction
In 2007, the Belgian Government instated a tax deduction regimen for patent-related income of Belgium-based companies, in order to stimulate R&D in Belgium.
In short, this enables companies to reduce the tax regimen on profit obtained from Patents, from 34 percent to only 6.8 percent (20% of 34%).
The main requirements for benefiting from said deduction are in fact quite simple:
- A granted patent is required, a pending application is not sufficient,
- The granted patent needs to be valid and in force in the country of production or commercialization,
- In case the patent is acquired from a third party, the company must have developed the product in-house or have done some kind of improvement to the protected product or method,
- The company must have a separate R&D department.
Although the requirement to have a separate R&D department is not a problem for big companies, it seemed to be a hurdle for many S(M)E's since they often have a limited number of people doing R&D, within the general company structure, rather than having a real separate department with own decision making capacity and own financial means.
Requirements on R&D department rendered more flexible
The Ruling commission (Dienst voor Voorafgaande Beslissingen in fiscale zaken), which can be asked to issue a Ruling on any application for tax deduction on patent related income however has been granting tax deductions also to SMEs having no separate R&D structure, if they could at least prove that there were skilled people and specific resources for doing R&D.
This unspoken rule now has been confirmed by the Belgian Federal Government (responsible for taxation) in July 2012 in an agreement to further stimulate R&D and economy in general (Relancestrategie juli 2012).
Translated, the agreement says: "One of the current requirements for the tax deduction, namely the existence of a separate R&D department, is abolished. The access to the tax deduction on patent income will be simplified for most SME's, and even more for starters, for whom this requirement formed a hurdle."
This is an important simplification of the rules, since it now clearly opens the way for all companies to benefit from the tax deduction on patent income. The main requirements will be to provide proof that the company indeed has a (lasting) budget for R&D and has qualified personnel. Keeping a good track record of what has been done and of staff qualifications seem to be important in view of the decision of the Ruling Commission.
Important to know is that requesting a Ruling is very important, since if your application for tax deduction is accepted by the Ruling Commission, the local tax office has to obey said decision. "Forewarned is for armed" hence seems appropriate here.
De Clercq and Partners would be most happy to address your questions regarding this topic as well as regarding the Innovation Box in the Netherlands for SME’s.
14. News from our firm
It is with great pleasure that we can announce the arrival of Dr. Minna M. Alarcon and Dr. Verónica Rojas de la Parra, to further strengthen our Chemical Patents team of Attorneys and Advisors. Minna has a PhD in Organic Chemistry, is Finnish and has obtained her patent training at Procter & Gamble in Belgium. Minna speaks English and Finnish. Verónica has a PhD in Medicinal Chemistry, is Mexican and worked for several years in the patent department of Remynd in Belgium. Véronica speaks English, Dutch and Spanish. We welcome Minna and Verónica very heartily within our firm.
De Clercq & Partners is honored to have received an impressive ranking amongst Belgium's top ranking Patent Practitioners in IAM Patents 1000 - The World's Leading Patent Practitioners 2012, a guide prepared by the renowned magazine, Intellectual Asset Management (IAM). The guide states that "The firm is held in the utmost regard for prosecution of biotechnology and life sciences-related patents, and sustains a loyal and appreciative client base. The IAM Patents 1000 guide is based on almost 1000 interviews with patent experts around the globe, and is compiled yearly by Intellectual Asset Management, published by the IP Media Group.
De Clercq & Partners is also pleased to announce that it has once again been ranked among top tier IP law firms for patent prosecution in Belgium by the Managing Intellectual Property (MIP) Survey, a leading global resource for IP related news and analysis. MIP annually conducts its authoritative global survey which ranks the leading IP law firms in tiers based on extensive research among professional peers and clients. According to MIP, “the tiers reflect the perception of the leading firms in each market, with the top tier listing those firms regarded as having the strongest practices in each category.” The survey results and methodology can be found at www.managingip.com.
Dr. De Clercq and Dr. Paemen of the firm have also obtained the label of officially recognized SME service providers (“officiële KMO diensterverleners in pijlers advies en strategisch advies”) in Flanders (Belgium). Our firm is now able to provide its services in the domain of “advice” and “strategic advice” in Flanders in a way that SME’s are able to benefit from the existing governmental subsidies. We are happy to inform you more about these measures in case of interest.
Finally we are proud to inform our readers that the firm has now also invested in professional videoconferencing equipment which allows our branches to communicate with clients and the EPO in a safe manner and allows our professionals to perform Oral Proceedings by Video Conference, a service which has been made available and is being promoted by the EPO. This makes holding of Oral Proceedings in Examination cheap and very efficient for our clients.
We wish you a good end of 2012 and hope you will have read our newsletter with great interest. We are available for answering any questions you may have at info@dcp-ip.com.