Our 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.
Join De Clercq and Partners at upcoming events
De Clercq & Partners is organizing, or will be present at the following events the coming months:
Knowledge for Growth: The Ninth edition of FlandersBio’s annual life sciences convention will be held in Ghent on May 30, 2013. Do not hesitate to visit our booth 35. It is the meeting place for everyone interested in Biotech, and is Europe's largest regional biotech event. For more info: visit http://knowledgeforgrowth.be.
Half-day Seminar: “Patenting Inventions In Life Sciences: Do’s and Don’ts”: De Clercq & Partners has the pleasure to invite you to a seminar held on June 14, 2013, jointly organized with the Réseau LIEU which bundles the tech transfer offices of the Walloon and Brussels Universities and Colleges of Higher Education and provides an easy access towards industry. The seminar provides an excellent opportunity to become familiar with Intellectual Property Rights used to protect biotech and pharma research results and the Knowledge Transfer process which may lead to their commercial exploitation. You will gain insight into the requirements for obtaining a patent in life sciences and have the opportunity to exchange ideas and experiences with other participants as well as with the panel of speakers including tech transfer officers, industrials, patent examiners and patent attorneys. The seminar is free of charge and starts at 12 o’clock with a networking lunch and will be held at the Agro-Biotech Campus in Gembloux. Please refer to our website for more information, as registration is required.
Yearly Seminar of De Clercq & Partners in the Auberge du Pecheur in Sint-Martens-Latem (Belgium) on November 22, 2013. Reserve your place for this year’s very promising edition with contributions from speakers of the EPO and renowned law and industry firms. It is the place to be for every practitioner in patenting and litigation in Biotech, Pharma and beyond.
The schizophrenic Brüstle case on patenting human embryonic stem cells: German Federal Court says yes, EPO says no…
Introduction
The Brüstle case on patenting human embryonic stem cells (hESCs) has been in every DCP Newsletter of the past two years, and we fear this edition is not going to be different. We’ve had two recent developments in the case: Firstly, the German Federal Court (Bundesgerichtshof), who initially referred questions on patenting hESCs to the Court of Justice of the European Union (CJ-EU) decided to uphold the patent of Professor Brüstle in amended form, and a few months later, the European Patent Office (EPO) revoked the parallel European patent EP 1 040 185 in Opposition Proceedings. Both decisions will be briefly discussed here.
First a little background on the case to refresh your memory. German Patent 197 56 864, was applied for by Professor Brüstle on 19 December 1997 and relates to isolated and purified neural precursor cells, methods for manufacturing these from embryonic stem cells and use of the neural precursor cells for treatment of neural defects.
Claim 1 of the patent read:
"Isolated, purified precursor cells with neuronal or glial properties from embryonic stem cells, comprising at most about 15% primitive embryonic and non-neutral [meant is: non-neural] cells, obtainable by the following steps:
a) cultivating ES cells into embryoid bodies,
b) cultivating the embryoid bodies into neutral precursor cells,
c) proliferating the neural precursor cells in a growth factor-containing serum-free medium,
d) proliferating the neural precursor cells of step c) in a further growth factor-containing serum-free medium and isolating the purified neutral precursor cells and
e) proliferating the neutral precursor cells of step d) in a further growth factor-containing serum-free medium and isolating the purified precursor cells with neuronal or glial properties,
or
a') cultivating of ES cells into embryoid bodies,
b') cultivating of the embryoid bodies into neutral precursor cells,
c') proliferating the neutral precursor cells in a growth factor-containing serum-free medium,
d') proliferating the neural precursor cells of step c') in a further growth factor-containing serum-free medium into spheroids with neuronal and glial differentiation potential and isolating the neural spheroids and
e') proliferating the neutral sphere of step d') in a further growth factor-containing serum-free medium up to the formation of a cell layer consisting of glial precursor cells and isolating the purified precursor cells with glial properties."
Claim 8 relates to cells of the aforementioned type, isolated from mice, rats, hamsters, pigs, cattle, primates or humans. Claims 12 and 16 relate to methods for manufacturing purified precursor cells with neuronal or glial properties, with claim 12 containing steps a to e set out in claim 1 and claim 16 containing steps a’ to e’ set out in claim 1.
The plaintiff, Greenpeace, requested that the patent be revoked since claims 1, 12 and 16 contain precursor cells that are derived from human embryonic stem cells. In addition, they requested for revocation of the patent because claim 8, which indirectly refers back to claim 1, included human cells. Reasoning was that the technical teaching of the disputed patent is excluded from patentability under Section 2 of the German Patent Act.
The patent was revoked by the German Patent Court. Professor Brüstle appealed said decision at the German Federal Court of Justice and requested the decision to be set aside. As an auxiliary request, Professor Brüstle requested the patent to be upheld with the following alternative wording:
In claims 1, 12 and 6, “from cell lines” is to be inserted after “ES cells” in the paragraphs beginning with “a)” and “a’)”;
In claim 1, “with the inclusion of no isolated purified precursor cells from human embryonic stem cells whose derivation involved the destruction of embryos” is to be inserted at the end;
In claims 12 and 16, “with the use of no human embryonic stem cells whose derivation involved the destruction of embryos” is to be inserted at the end.
Being unable to decide, the German Federal Court referred several questions (cf. Xa ZR 58/07) to the CJ-EU in order to interpret the Biotech Directive (Directive 98/44/EC). Below, we have reproduced the answers (cf. CJ-EU decision C-34/10):
“1. Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions must be interpreted as meaning that:
- any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’.
- it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a 'human embryo' within the meaning of Article 6(2)(c) of Directive 98/44.2. The exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of Directive 98/44 also covers the use of human embryos for purposes of scientific research, only use for therapeutic or diagnostic purposes which is applied to the human embryo and is useful to it being patentable.
2. The exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of Directive 98/44 also covers the use of human embryos for purposes of scientific research, only use for therapeutic or diagnostic purposes which is applied to the human embryo and is useful to it being patentable.
3. Article 6(2)(c) of Directive 98/44 excludes an invention from patentability where the technical teaching which is the subject matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.”
Point three was considered to have quite an impact on hESC patenting, since the decision made it very clear that also cell-lines that had been established years ago from an embryonic stem cell obtained through destruction of a human embryo and inventions requiring the use of such cells were excluded from patentability.
Based on this decision of the CJ-EU, the EPO decided to apply a more restrictive approach in its own examination of applications in that all subject-matter relating to hESCs for which it could be determined that they could only be obtained through the destruction of a human embryo should be excluded, irrespective of the time point at which said destruction had been performed (cf. Guidelines for Examination 2012, G, Chapter II, 5.3 (iii)). The previous policy of using a cut-off date of May 2003, the date at which hESC-lines were considered to be available was cancelled.
The EPO examiners however were provided by practitioners with several publications showing that from at least 2008 onwards (and possibly even from 2006 onwards), techniques existed that enabled the isolation of hESCs from human embryos, without destroying the embryo. Based thereon, a new cut-off date of January 10, 2008 was introduced, the date at which the publication of the single blastomere biopsy process (SBB) took place (cf. Chung et al., 2008, Cell Stem Cell. 2:113–117). Applications claiming hESCs filed after January 2008 might hence be allowable, because then applicants can argue that they did not need to destroy an embryo because of the SBB technique.
German Federal Court upholds patent in amended form
In its recent decision of, November 27, 2012 the German Federal Court upheld the German patent from Professor Brüstle in amended form (cf. Auxiliary request above) arguing that the claimed subject-matter, did not contravene morality, since the claims now explicitly excluded hESCs derived from human embryos through embryo destruction.
According to the Federal Court of Justice, the subject matter of claims 1, 8, 12 and 18 in the version of auxiliary request I is not excluded from patentability according to Section 2(2) sentence 1 no. 3 of the German Patent Act, because cells and manufacturing methods are only excluded from patent protection insofar as the precursor cells are derived from embryonic stem cells of human embryos. According to the German Federal Court, the partial revocation does not extend to alternative methods in which the human stem cells used to manufacture the precursor cells are manufactured without using an embryo and bypassing the totipotency stage, or to methods in which the stem cells are derived from primordial germ cells that have been isolated from several-week-old aborted human foetuses.
According to the German Federal Court, the claim with the proviso excluding embryonic stem cells obtained by destruction of human embryo’s is also disclosed in the patent specification in such a way that a person skilled in the art can execute it, since it is stated that embryonic stem cells could also be obtained from embryonic germ cells. It follows from these statements that such cells are also to be regarded as embryonic stem cells under the disputed patent. A person skilled in the art is thus shown at least one way in which the stem cells required to execute the invention can be derived without the destruction of human embryos. The fact that the disputed patent in the version defended with auxiliary request I is not solely limited to this way and that other ways of deriving embryonic stem cells without the destruction of human embryos are not set out in the patent specification is no barrier to admissibility of the defended version.
The Court further states that the clarification in the claims made in auxiliary request I is sufficient to remove methods excluded from patentability from the subject matter of the disputed patent. It can be left open here whether practicable ways of deriving stem cells from embryos without destroying them are available to a person skilled in the art. If such ways are available, they are covered by patent protection for the aforementioned reasons even if they are not disclosed in the patent specification. If such methods are not available, the execution of methods for which protection is sought with auxiliary request I can in any case not lead to a use of human embryos that is excluded from patentability.
In essence, the German Federal Court hence decided to allow claims pertaining to hESCs, if some sort of limitation (or disclaimer) is introduced into the claims that makes clear that no human embryo’s have to be destroyed in order to obtain said hESCs, i.e. as long as the specification gives the skilled person one possible way of obtaining hESCs without embryo destruction.
EPO revokes the European patent
Professor Brüstle also has a corresponding European patent EP 1 040 185, which was opposed by Geron Corporation. At the Oral Proceedings which took place on April 11, 2013, the EPO Opposition Division decided to revoke the patent for reasons of insufficiency of disclosure. Upon finalizing this Newsletter we did not yet have access to the minutes or decision yet, so we have to rely on witness reports. The main problem identified by the Opposition Division apparently lies in a conflict between morality and ethics that lead to the formulation of the disclaimer on the one hand, and the admissibility of said disclaimer on the other hand.
The opposition division (OD) stated that the non-disclaimed part of the claimed subject-matter was not sufficiently disclosed in the application in an enabling manner, and could not have been carried out by a skilled person at the filing date of the patent. Although one publication, Shamblott et al. published in November 1998, is about establishment of embryonic germ (EG) cell lines without destroying human embryos, it does not disclose the use of this technique for establishing ES cells. Contrary to the German Supreme Court, the OD did not acknowledge EG cells to correspond to a definition of ES cells to be applied here, and therefore one could not rely on this prior art publication to support enablement of obtaining hESCs without the destruction of an embryo (despite some broader definitions provided in the patent and similar in literature, e.g. Resnick et al., 1992, abstract: “embryonic germ cells resemble embryonic stem cells”).
A further critical point related thereto was the question of allowability of the disclaimer under Article 123(2) EPC. In view of G1/03, the OD did not consider the disclaimer allowable. Apparently, the OD was of the view that as the introduction of the disclaimer introduced issues under the enablement criterion for the non-disclaimed subject matter as described above, the disclaimer should not be allowable.
Although the grounds and reasons used by the OD to revoke the patent appear to raise some questions, the actual written decision which is still awaited may provide some insight.
And what about the UK?
The position of the UK Intellectual Property Office (UKIPO) on patenting hESCs is also briefly commented on. Recently, two patent applications were rejected by the UKIPO because they related to the use of human embryos for industrial or commercial purposes, which was considered to be excluded from patentability under UK patent law. Both applications were directed to methods for producing human stem cells/tissues that use parthenogenesis to activate the oocyte. Whether or not an activated oocyte produced by the claimed methods falls within the definition of a 'human embryo', and hence would be excluded from patentability was one of the main issues. The UK examiner's position was that the activated oocytes fell within the definition of a 'human embryo', which was later on confirmed by the CJ-EU decision. Although activated oocytes are not fertilized, they are capable of commencing the process of development of a human being, due to the effect of the technique used to obtain them. The applicant provided information proving that activated oocytes are not capable of developing into a human being. On this basis, and in line with established case law, the applicant argued that the CJ-EU's decision should not be binding on the UK IPO. The UK IPO agreed that the activated oocytes could not develop into a human being due to inherent biological limitations. However, they noted the distinction that the CJ-EU's decision merely indicated that they were “capable of commencing this developmental process”, rather than “completing this process”. Therefore, the UKIPO reached the decision that the CJ-EU's decision could not be ignored and refused the two applications.
The case has been appealed to the UK High Court, so also this strand of the story is to be continued…
What’s to come?
It is rather likely that the decision of the EPO Opposition Division revoking the patent for lack of enabling disclosure will be appealed and hence the Boards of Appeal will have to take a position in this matter. Whether this is good or bad news depends on whether you are in favor of patenting hESCs or not. Given the nature of this case, we might expect the Boards of Appeal to thoroughly analyze the underlying legal issues, and to arrive at a detailed and considered decision.
The policy currently proposed and used by EPO examiners in the Biotech field for the assessment of claims involving hESCs would thus also be evaluated by the Boards of Appeal, which should provide more legal certainty.
Finally, we would like to inform you of a new possible referral of questions from the UK High Court to the CJ-EU regarding the patentability of Stem Cells obtained from unfertilized human eggs through Parthenogenesis. In the case of International Stem Cell Corp. (ISCC) vs. the Comptroller General of Patents (UKIPO), the decision to refuse the patent application claiming was appealed bay the Applicant.
Residing Judge, the Honorable Henry Carr QC, expressed his preliminary views on the issue as follows: “Since I have reached a view on the issue to be referred, it may be helpful if I express it. I agree with ISCC that if the process of development is incapable of leading to a human being, as the Hearing Officer has found to be the case in relation to parthenotes, then it should not be excluded from patentability as a 'human embryo'.
Like the Advocate General in Brüstle, I consider that totipotent cells should be excluded from patentability, whereas pluripotent cells should not. I note that totipotent cells are expressly referred to in recital 38 as an example of cells which are obviously excluded from patentability. This would seem surprising, if the intention of the legislation is to exclude pluripotent cells as well.
Stem cells have the potential to revolutionise the treatment of human disease. Because of their capacity to differentiate into almost any type of adult cell, human stem cells open the door to a wide variety of new therapies and other medical applications. For instance, cardiac muscle cells could be used to alleviate ischaemic heart disease, pancreatic islet cells for treatment of diabetes, liver cells for hepatitis and neural cells for degenerative brain diseases such as Parkinson's. Other potential applications include the treatment of burns, strokes, eye disease, spinal cord injuries and certain forms of cancer.
The recitals to the Biotech Directive show that a part of its purpose is to encourage research in the field of biotechnology by means of the patent system. The balance between this objective and the need to respect the fundamental principles safeguarding the dignity and integrity of the person may properly be struck by excluding from patentability processes of development which are capable of leading to a human being. However, to exclude processes of development which are incapable of leading to a human being does not, in my view, strike a balance at all. This is particularly so in the case of parthenotes, which are not the same as fertilised ova at any stage. It is more akin to a total exclusion from patent protection of the fruits of stem cell research, to the detriment of European industry and public health.”
Nonetheless, Judge Carr suggested to refer the following questions to the CJ-EU:
“Are unfertilised human ova whose division and further development have been stimulated by parthenogenesis, and which, in contrast to fertilised ova, contain only pluripotent cells and are incapable of developing into human beings, included in the term "human embryos" in Article 6(2)(c) of Directive 98/44/EC on the legal protection of biotechnological inventions?“
We will of course keep you informed of future developments.
Patenting Diagnostics in the US after Prometheus: Hopes are up again!
The diagnostic industry has been shaking a bit over the last few years with the USPTO blindly following the Supreme Court decision in Mayo vs. Prometheus regarding the non-patentability of diagnostic methods due to the so-called preemption of natural laws or phenomena. In essence, the view of the Supreme Court was that a diagnostic method is nothing but the registration of a naturally occurring process in a patient, whether it is in response to a treatment or to a disease. Since a naturally occurring process is not “man-made”, it should according to the Supreme Court not be seen as holding patent-eligible subject-matter.
Although everyone was worried to see this decision enter into practice, no one actually anticipated the full force of its effects at the USPTO. In their Interim Guidelines issued in July 2012, the USPTO however made it very clear that diagnostic methods as such were to be held non-patentable, unless some very strict criteria were fulfilled. In essence, the USPTO has indicated that it wants to prevent the “preemption of a natural law or phenomenon”. This has implied in practice that claims to diagnostic methods merely specifying the interaction of a patient sample with a reagent were no longer patentable. Where applicable, the use of a newly developed reagent or test (i.e. down to e.g. a specific antibody) can be included in the claim to overcome the objection, but this generally leads to a highly limited scope of protection.
In working together with our US associates, we have now found that the Prometheus rejection can be overcome using specific wording. For instance, by reformulating a diagnostic method claim into a method of treatment wording, including the diagnostic method as a decision-making step, we have been able to obtain a notice of allowance from the USPTO on a claim relating to an invention purely based on the diagnostic assessment of the level of a biomarker in a blood sample.
We have also received indications from our US associates that diagnostic method claims directed to the use of multiple marker panels are being considered allowable, even without having to limit them to a specific assay or test.
It thus appears that the USPTO examiners are still willing to grant claims on inventions relating to diagnosis and are open to identify wording that does not contravene Prometheus.
So indeed, as the title suggests, hopes are up again in the patenting of diagnostic methods in the US!
Together with our US associates specialized in Biotech and Pharma, we have been fighting at the forefront on this issue since the decision and interim guidelines came out in order to ensure our clients in the field of diagnosis can still get adequate protection for their inventions. Please do not hesitate to contact us in case you think we could help you out with one of your cases.
Danger ahead: When divisionals turn against their own parents
Article 54 of the European patent convention defines the principle of novelty: the invention claimed in an application must be new, meaning that it does not form part of the “state of the art” (Art. 54 (1)), the latter being defined as “everything that has been made available to the public before the filing date of the application” (Art. 54(2)). Article 54(3) EPC further includes as state of the art those European applications that have a filing date before that of the application describing the invention under consideration, but have been published on or after that filing date.
Up until recently, the question of whether or not a divisional application could become prior art for its own parent application (under Art. 54(3)EPC) had been the subject of mostly academic debate, due to the limited case law on this topic. Decision T1496/11 (published online on 15.10.2012) however, relates to this very topic and has re-awakened this discussion. Indeed, its outcome, if followed by the EPO, could have a significant impact on the validity of quite a number of divisional applications and patents granted thereon.
In the T1496/11 case, the Opponent argued that the subject-matter of claim 1 of the parent application was not entitled to the claimed priority date. Indeed it was considered that the scope of the claim had been broadened compared to what was described in the priority application, by omission of a feature which characterized all embodiments described in the priority application. The divisional application, similar to the parent application, disclosed in its description the particular embodiments of claim 1 described in the priority document. Since the divisional application is validly entitled to the claimed priority for these embodiments, the disclosure of these embodiments becomes novelty destroying prior art under Art. 54(3) EPC for the subject-matter of claim 1 in the parent application. The Technical Board of Appeal agreed with this argument, and considered that as claim 1 of the parent application is only entitled to the filing date, the subject-matter of claim 1 lacks novelty with respect to its own divisional application.
According to current EPO practice, divisional applications are not cited as prior art under Article 54(3) EPC during examination. In practice it is noted that often divisionals are filed only during prosecution of the parent application, thus, probably they would not have been picked up in the search carried out at the start of examination. But should they indeed be considered under Article 54(3) EPC?
Many practitioners will argue that an application and its divisional(s) should in fact be considered as one and the same application. According to this reasoning a parent and its divisional application should not have a different effect from e.g. one single application which includes both claims which are entitled to priority and claims that are not. As a divisional application does not confer any specific advantages to the applicant with regard to the subject matter claimed (i.e. both the filing date and the term remain identical to those of the parent application), it appears unclear why the legislators would have intended to confer specific disadvantages onto the applicant.
The newly issued technical board of appeal case is however not the first of its kind. Indeed, in T307/03, which related to the reverse situation, the Board decided in the same way. In this case, the main claim of the divisional application, though supported by the text of the (parent) application as filed, was broader than, and thus not entitled to, the claimed priority. This was considered to automatically turn the parent application into novelty-destroying prior art under Art. 54(3) EPC for the divisional application.
The underlying situation in both these cases is not exceptional. Indeed, it is common practice to extend the description at the end of the priority year to include additional embodiments. The entitlement of a claim to priority may not be the subject of much concern if there is no intervening prior art.Since the novelty-destroying prior art is cited under Art. 54(3) EPC, one would be tempted to try to remedy the situation by the introduction of a disclaimer. Indeed, G 1/03 confirmed the established practice of the EPO of allowing the introduction of an undisclosed disclaimer to overcome prior art cited only for novelty under Article 54(3) EPC. However, the issue of disclaimers has also more recently become the subject of quite some debate. Indeed, Enlarged Board of Appeal decision G2/10 states that G1/03 does not relate to the disclaiming of subject matter which is disclosed as part of the invention in the application as filed (which is typically the case when discussing divisional applications). At the same time, G2/10 emphasizes that, even if the disclaimer itself does not contravene Article 123(2) EPC, the remaining subject matter must also comply with Article 123(2) EPC. Similarly recent Technical Board of Appeal decision T0748/09 emphasized that the overriding consideration to determine the allowability of an undisclosed disclaimer to overcome prior art cited under Article 54(3) EPC should still be whether or not the remaining subject matter is directly and unambiguously disclosed in the application as originally filed. Indeed, the disclaimer may result in a specific limitation (in case T0748/09 it was a new range), which was as such not envisaged in the application as filed. Thus, introduction of a disclaimer may not always be a safe option.
Unfortunately, where this situation occurs, it may be difficult to remedy after the divisional has been filed. Indeed, as the prior art effect is effective upon publication and not affected by the pendency of the application, withdrawal of the anticipating (parent or divisional) application at a later stage will not help. It is however always possible to address this issue by a claim amendment (either during pendency or by use of the newly implemented limitation procedure), e.g. by limiting to subject matter which is entitled to priority.
It is clear that, while the option of filing a divisional applications can be of interest in the development of a patent portfolio, in practice there are quite some potential issues related to the filing of divisional applications under the EPC, such that this option can not be fully exploited. Indeed, the issue of double patenting between a parent and a divisional application (with partially or completely overlapping claims) has also been the subject of some controversy in the case law and to date has not been officially clarified by the EPO. The limitation on the timing of filing divisional applications introduced in 2010 has further complicated matters for applicants of European applications. Indeed, the fact that a divisional can no longer be filed after the expiry of 24 months from the first communication from the Examining division on a parent application implies that often a decision has to be taken on whether or not to file a divisional application before information on the scope of the claims which can be obtained for the parent application is available. As a result thereof, applicants are tempted to file ‘precautionary’ divisionals, often filed without serious consideration of the scope of the claims or the overall impact. However, until further case-law questions this decision, T1496/11 should remind everyone of the fact that the filing of a divisional application should be considered carefully.
It is noted that the EPO has recently launched a public enquiry as to the impact of the 24 month deadline for filing divisional applications. While the public statements issued by the EPO tend to declare that there has been no impact of the timeline on the filing of divisional applications with the EPO, there is hope that either the economic crisis and/or the understanding of difficulties faced by applicants will motivate the European patent office to do away with the imposed time limit.
De Clercq and Partners will be glad to assist you in any specific questions you may have with regard to the filing of divisional applications and how this can affect the strategy for the parent application.
Patentability of plants again under fire at European Patent Office
Under Article 52 of the European Patent Convention (EPC), patent protection is in principle available to inventions in all areas of technology. This includes inventions in the field of agriculture and horticulture, which while excluded under some national laws prior to 1973, were purposely not excluded from patentability under the EPC.
Nevertheless, Article 53(b) EPC excludes from patent protection “plant and animal varieties and essentially biological processes for the production of plants and animals”. The interpretation of this provision by the European patent office has over the years brought some concern both to opponents and supporters of the patent system.
In G1/98, the Enlarged Board of Appeal of the European patent office considered whether a claim to a plant should be objected to under Article 53(b) EPC because it necessarily encompassed plant varieties. The underlying cases referring this question of law related to the genetic modification of plants by introduction of a gene to increase insect tolerance. The claim language under consideration referred to a (any) plant comprising the transgene integrated in its genome and it was argued by the patentee that such a claim did not read on an individual plant variety. The Enlarged board of appeal agreed in G1/98 and stated that a claim should not be excluded based on the fact that it embraces plant varieties if it is not limited to a plant variety. This paved the way for many claims to plants with traits introduced by genetic modification.
More recently in consolidated cases G2/07 and G1/08 the interpretation of “essentially biological processes” referred to in Article 53(b) EPC was considered by the Enlarged board of appeal. This time, the underlying “tomato” and “broccoli” cases related to methods for the production of plants with non-GMO traits, whereby the traits were introduced into the plant by steps of crossing and selection. The Enlarged board of appeal had different arguments to take into consideration in the determination of whether or not such methods should fall under the exclusion of Article 53(b) EPC.
The Technical boards of appeal of the European Patent Office had previously considered the meaning of “essentially biological processes” in T320/85 and had come to the conclusion that whether or not a process was to be considered as “essentially biological” was dependent on whether or not the contribution of the invention represented a substantial human intervention into the process of crossing and selection and whether the technical contribution was significantly different from conventional breeding methods. Such an evaluation process in which the meaning of a term was made dependent on comparison with the state of the art was however considered necessarily flawed by the Enlarged Board of Appeal.
In the meantime, in 2000, the implementation of the Biotech Directive 98/44/ec had led to the introduction of a number of definitions into the Implementing regulations of the EPC. More particularly, what is now Rule 26(5) EPC, corresponding to Article 2.2 of the Directive, specifies that an essentially biological process is a process consisting entirely of natural phenomena such as crossing and selection. However, based on the historical records of this provision, the Enlarged Board of Appeal in G2/07-G1/08 considered that this wording did not reflect the intention of the legislators and should thus not be given much weight.
Finally, the Enlarged Board of Appeal turned to the historical documents which led to the texts of the EPC and the plant variety protection under UPOV. From the different documents considered it was concluded that the legislators intended to exclude from patent protection conventional breeding methods for plant varieties. However, a lot of weight was also given to the fact that the wording was changed during the different exchanges from “purely” biological to “essentially” biological, which to the Enlarged Board was a clear indication that it was the intention of the legislators to extend the exclusion to cover methods which for the process of crossing and selection made use of technical features.
Based thereon the decision in G2/07-G1/08 stated that “a non-microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is in principle excluded from patentability as being "essentially biological" within the meaning of Article 53(b) EPC. It is further specified that “such a process does not escape the exclusion of Article 53(b) EPC merely because it contains a step of a technical nature.”
In practice this has implied that since the publication of this decision, any claim reciting steps of crossing and selection is objected to under Article 53(b) EPC, irrespective of whether the claim recites technical features in other steps. In the underlying “broccoli” and “tomato” cases, the patentees have abandoned the process claims in light of the decision of the Enlarged Board of Appeal and have entered new requests with claims to plants only, whereby the plants are either characterized by the envisaged trait or worded as product-by-process claims. While in the broccoli case, the plant claims were not opposed under Article 53(b), the opponent in the tomato case strongly argued against the patentability of claims to products (i.e. plants) which were obtained and/or (only) obtainable by methods which were found to be excluded from patentability. The board in this case agreed to refer a new set of questions to the Enlarged board of appeal, relating to the influence of G2/07-G1/08 on the patentability of claims to plants obtainable by such excluded methods. More particularly, the referred questions in G2/12 are:
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?
Interestingly, the opponent in the “tomato” case has withdrawn its appeal so it is questionable to what extent the plant claims, that were maintained by the opposition division, can still be challenged in this case, because the referral would have no legal ground. However, the Enlarged Board of Appeal has indicated that it feels entitled and will consider the referral of G2/12. The numerous amicus curiae briefs filed encouraging the Enlarged Board of Appeal to clarify this issue may have played a role in this regard. In the meantime the patentee in the broccoli case has also agreed to allow the introduction of a new ground of opposition, i.e. the consideration of the plant claims under Article 53(b) EPC, provided this issue would indeed be taken up by the EBA. Thus, it appears that once again both cases will be consolidated in G2/12. It is as yet unclear however, whether the EBA will accept additional questions to those referred by the parties in the “tomato” case.
The amicus curiae briefs filed in G2/12 by the European seed association and German plant breeders association align with those originally brought in by the opponent, i.e. that allowing claims to plants which are obtained or obtainable only by excluded methods would go against the intention of G2/07-G1/08, as a product claim in fact governs the methods of production of the product and thus exclusion of the method claim under Article 53(b) would be pointless if overriding product protection can still be obtained. This argument is also brought forward in the amicus curiae briefs of NGO’s such as “no patents on seeds”.
It is further argued that G1/98 which acknowledged the patentability of claims to plants which are not limited to a plant variety should be read in light of the underlying cases which related to GMO plants and thus should apply only to GMO plants. Finally, the fact that Article 53(b) does not explicitly acknowledge the patentability of plants obtained by essentially biological processes (as is the case for products obtained by microbiological processes) is considered to be evidence of the fact that the legislators intended the exclusion to extend to plants obtained by the excluded process.
On the other side, the Amicus curiae briefs in favor of claims to plants (such as those filed by the industry organization of the plant science industries (CropLife International) and the Chartered institute of Patent Attorneys) bring forward the argument that there is no legal basis for the exclusion from patentability of product claims to plants and that an opposite decision would be in direct conflict with G1/98. It has also been argued that it would be against the principles of the EPC to allow the patentability of a product claim to depend on the method by which the product was made.
It appears that again the Enlarged Board of Appeal will have to consider the intention of the legislators in drafting the exclusion under Article 53(b) EPC. If it is considered that the intention was primarily to avoid overlap with the protection available for plant varieties under UPOV, the current practice of allowing claims to plants which are not limited to a plant variety could be confirmed. However, if, as suggested in G2/07-G1/08 the intention of the legislator was to avoid protection “for conventional breeding methods for obtaining plant varieties”, it appears that allowing protection for plants obtainable only by such excluded methods would indeed defy this purpose.
The decision to interpret the exclusion under Article 53(b) EPC to read on plants obtained or obtainable (only) by processes which are considered “essentially biological” based on G2/07-G1/08 would however imply the exclusion from patent protection of a specific sector of industry, for reasons which can only be interpreted as political. One can question whether this is the role of the European Patent Office or whether this question should in fact be discussed at the national (or community) level, in the context of a breeder’s exemption. On the other hand, it would appear that issues can arise with these claims under the standard criteria of inventive step and enablement (reproducibility over the entire scope of the claim). Indeed, in a number of cases (and many consider the “broccoli” and “tomato” cases as exemplary in this regard) a correct application of these criteria would preclude protection for plants which are obtained by methods which involve only crossing of whole genomes and selection based on a feature of interest.
The agbiotech industry awaits with great interest the outcome of G2/12. A decision by the Enlarged Board of Appeal is however not expected before the fall of 2013.
Finally we also wish to report briefly on the very recent decision of the District Court of the Hague (NL) of 8 May 2013 in Taste of Nature vs Cresco confirming the patentability of plants obtained from essentially biological processes. The District Court reversed the earlier provisional summary proceedings decision on which we reported in our Newsletter of May 2012. Plant claims formulated as “product by process” claims referring to essentially biological (classical breeding) methods have now been pronounced to be patentable in this case under Art 53(b) EPC. The same questions had to be answered as in G2/12. The Court gave its decision without awaiting the outcome of G2/12 as both Parties to the case had requested an early judgment. This represents the first European Case law on plants obtained through breeding and throws a positive light on the patentability of plant inventions.
Unitary Patent and Unitary Patent Court
After almost 40 years of discussions, the EU Parliament and Council approved regulations to create a Unitary Patent system. The package that has been approved comprises a new unitary patent and a unified patent court. It is the intention of this legislation to simplify procedures and decrease the costs for applicants. More particularly, it is the objective to make the European patent system more attractive for inventors from all over the world, but also more accessible, especially for small to medium enterprises (SME)s.
Currently, once a European patent is granted by the EPO, it has to be validated in each EPC member state for which the patent proprietor seeks patent protection. Currently there are 38 EPC contracting states and two EPC extension states. Upon validation the majority of the member states require a translation of at least part of the patent transcript into their official language(s). Instead of this multitude of validations, the Unitary Patent system will only require a single validation throughout the territory of the 25 participating EU member states. In the remaining EPC contracting states, separate validation will remain necessary.
The recent decisions made by the EU Parliament and Council will majorly affect the procedure after grant (post-grant phase) where the patent proprietor has to make a decision concerning the validation of the patent. To render it more complex, in the initial stage where only a limited number of countries have agreed to participate, the patent proprietor may need to combine both schemes and validate in a number of countries not yet participating in the Unitary Patent system and validate a unitary patent for the already participating countries.
Before going into detail, it is generally believed that in the end, the Unitary Patent will simplify validation by limiting the translation and renewal fee requirements. Furthermore, the introduction of a central European patent court is believed to bring down patent litigation costs and increase legal certainty.
Unitary Patent
The EU regulations on a unitary patent for Europe comprise two parts, the first concerns unitary patent protection, and the second sets out the translation arrangements for such protection. These regulations were accepted under the EU's legislative procedure of "enhanced co-operation": With the exception of Italy and Spain, 25 EU member states have embarked on enhanced co-operation with a view to creating unitary patent protection for their territories.
Here are some of the main aspects that are included in the regulations.
Time periods
After grant of a European patent application the patent proprietor can either choose between the already existing validation in a number of individual designated states (individual territorial coverage) or opt for a European patent having a unitary effect (Unitary Patent) in all participating states (general territorial coverage). This choice needs to be made in a period no later than one month after the mention of the grant in the European Patent Bulletin. It will be the EPO who will perform the administration for unitary patents.
Translations
While a European patent application may be filed in any language, a translation into one of the official EPO languages (English, French or German) is required. Currently, applicants filing patent applications at the EPO in one of the official languages of the Union that is not an official language of the EPO can benefit from reductions of filing fee, examination fee, opposition fee, appeal fee, fee for petition for review or limitation and revocation fee. With the new regulations a compensation scheme for the reimbursement of translation costs up to a ceiling will be set in place only for natural persons, non-profit organizations, and universities or public research institutions having their residence or principal place of business within a member state. It is unclear if this compensation scheme will be added to the already existing fee reductions or replace them.
It is further the intention of the new regulation to evolve to a system where after grant, machine translations are used to translate the patent specification into all official languages of the Union. However, at this moment the quality of machine translations is not adequate and in the transitional period required for developing high quality machine translations, human translations will remain required upon request for unitary effect. Where the language of the proceedings before the EPO is French or German a full translation of the specification of the patent into English must be supplied by the patentee. Where the language of the proceedings before the EPO is English a translation into any official language of the Union must be supplied. The transitional period has a duration of minimally 6 years and maximally 12 years. An independent expert committee will regularly carry out an objective evaluation of the availability of high quality machine translations of patent applications and specifications and decide on the duration of the transitional period.
Human translations will remain necessary in case of disputes, requiring a full translation into the official language of the member state where an alleged infringement took place. Also, when legal proceedings are commenced, the Unitary Patent Court (UPC) can impose a full translation of the patent specification into the language of the proceedings.
Renewal fees
Renewal fees for Unitary Patents will be paid to the EPO. While the exact amount of the fee is not yet available, it is the intention that the level of renewal fees for the Unitary patent will be “equivalent to the level of the renewal fee to be paid for the average geographical coverage of current European patents”, which is currently about five member states on average.
Reductions of the renewal fees may be attributed to small and medium-sized enterprises (still to be decided) and also a reduction may be awarded when the patent proprietor publically offers it to be licensed in return for appropriate consideration (using a statement towards the EPO).
Transfers and licenses
A Unitary Patent shall have a unitary character. It will provide uniform protection and it may only be limited, transferred, revoked, or lapse, in respect of all the participating Member States. Licenses are possible for the whole or part of the territories of the participating Member States.
When it comes to questions of property in unitary patents (entitlement issues, assignments, licenses and transactions) national laws will apply. The applicable national law is determined by the, at the time of filing, applicant’s place of business or residency. Where at the time of filing the applicant has no principal place of business or residency in a Member State, then the law governing the property in the unitary patent will be the law of the Member state where the applicant had a place of business at the time of filing. Where at the time of filing the applicant has no place of business within Europe then the default position will be that the law governing the property in the unitary patent or patent application, will be that of the state where the EPO has its headquarters namely, Germany.
Territorial patent landscape
While it may be the purpose of the legislator to provide more simplified and straightforward procedures, the patent landscape in Europe will become more complex due to the introduction of the Unitary Patent. At this moment the European patent landscape comprises either national patents or nationally validated European patents. As there is no obligation to choose for a Unitary Patent, this will add to the already existing types of patents. Moreover, as the new regulation is only applicable for EU member states, national validations still need to occur for non-participating member states (Spain and Italy) and EPC member states which are not EU member states (Albania, Croatia, Former Yugoslav Republic of Macedonia, Iceland, Norway, Serbia, Switzerland, and Turkey).
Moreover, in the initial stage where the Unitary Patent system is in force but some EU member states have not yet ratified it, also a national validation in these not yet participating states would be possible, leading to a more complex patent landscape.
Unitary Patent Court (UPC)
The second part of the new regulations provide the establishment of a Unitary Patent Court (UPC), set up to create a single enforcement forum for all European patents.
Currently, decisions regarding the infringement and validity of European patents are taken on a national level. In practice, this means that when a patent proprietor wishes to enforce a European patent, or when a third party seeks the revocation of a European patent, national courts are competent in these matters. This gives rise to a number of difficulties including high costs, risk of diverging decisions and lack of legal certainty due to the different court proceedings in various countries.
The Agreement on the UPC creates a specialized patent court competent for litigation relating to European patents and European patents with unitary effect. The UPC comprises a Court of First Instance, a Court of Appeal (in Luxembourg) and a Registry. The Court of First Instance will be composed of a central division (with seat in Paris and two sections in London and Munich) and of several local and/or regional divisions in the Contracting Member States to the Agreement. In this context it may be useful to lobby with the regulating authorities for a national division of the patent court in Belgium to ensure that Belgian enterprises are not forced to go to neighboring countries to commence court proceedings.
While it is the intention of the UPC to provide a single forum for patent litigation thereby rendering litigation proceedings more efficient and consistent, the UPC is only competent to decide on matters concerning European patents with unitary effect. National litigation systems will remain competent when it concerns national patents or classical European patents. Consequently, there remains a split jurisdiction, which allows room for diverging decisions before different courts. Additionally, the UPC agreement provides a rather liberal transitional scheme consisting of a transitional period of seven to fourteen years where actions for infringement or revocation may still be brought before national courts. There is also an opting-out and opting-in mechanism where proprietors of EP patents with unitary effect can opt-out from the exclusive competence of the UPC during the transitional period and opt back in at a later stage.
The UPC will be competent to decide on matters of among others infringement and validity. Disputes regarding the entitlement of a European patent (notwithstanding its unitary nature) is not within the competence of the UPC and remains the competence of national courts. The UPC agreement indicates in Articles 25 and 26 the acts of infringement and in Article 27 the limitations thereof. Important for companies with research facilities located in Belgium is that Art. 27(b) indicates that the rights conferred by a patent shall not extend to any acts done for experimental purposes relating “to” the subject matter of the patented invention. This is slightly different from the broader research exemption in Belgium. More particularly, Article 28(1) of the Belgian Patent Act states that the rights conferred by the patent shall not extend to ... (b) acts done for scientific purposes “on and/or with” the subject matter of the patented invention. The UPC agreements accordingly provides a more strict research exemption, an aspect which may influence strategies for companies with research facilities located in Belgium, especially if they make use of the research exemption for some of their activities.
Entry into force
The regulations on a unitary patent entered into force on 20 January 2013. However, they will only apply from January 1, 2014 or the date of entry into force of the Agreement on a Unified Patent Court, whichever is the later.
The Agreement on the UPC was signed by 25 EU Member States on 19 February 2013. However, the signing initiates a ratification process by the individual Member States. In order for the Agreement to enter into force at least 13 states, including France, Germany and the United Kingdom need to ratify the agreement.
While it was first expected that the agreement would be ratified by April 2014, it is very unlikely that this will be the case, especially when considering that the ratification process will be tampered by Spain which has initiated two actions before the Court of Justice of the EU (Cases C-146/13 and C-147/13 respectively) against the Regulations implementing enhanced cooperation and against the applicable translation arrangements. While the Spanish pleas in law are not yet accessible, it is believed that these procedures will at least delay the ratification process to some extent resulting in a system that will be in place by the end of 2014, early 2015 or even later.
Conclusions
If these regulations will eventually come into force, the question remains whether these will fulfill their objectives. The cost reduction is based on an assumption that users want a pan EU protection, while at this moment this might only be true for a minority of the cases. Furthermore, it remains to be seen what the strategic choices will be of the different enterprises. For small and medium size enterprises the unitary patent offers a pan EU protection with limited translation and administration costs, but these enterprises only manufacture or market products in a handful of EU states. On the other hand, large entities with high value patents (e.g. pharmaceutical companies), are likely to continue their current strategy to spread litigation risks across several jurisdictions, and not to put all eggs in one basket.
In general, while these new regulations do have some potential flaws, it is a long awaited step forward. However, it remains to be seen how enterprises will react to these new regulations once they enter into force.