CRISPR EP Update: Berkeley EP patent application close to grant

EPO by sporst

While the CRISPR-cas9 patent fight between the Broad Institute (“Team Zhang”) and the UC Berkeley (“Team Doudna”) in the US saw its first hearing at the USPTO´s Patent Trial and Appeal Board on December 5, the UC Berkeley has only a few days later received good news from the European Patent Office. An Office Action from December 8, 2016 indicated allowability of broad claims for its European patent application (publication number EP 2 800 811). Claim 1 reads as follows:

 

1. A method of modifying a target DNA, the method comprising contacting the target DNA with a complex comprising:
(a) a Cas9 polypeptide and
(b) a single-molecule DNA-targeting RNA comprising:
(i) a DNA-targeting segment comprising a nucleotide sequence that is complementary to a sequence in the target DNA, and
(ii) a protein-binding segment that interacts with said Cas9 polypeptide, wherein
the protein-binding segment comprises two complementary stretches of nucleotides that
hybridize to form a double stranded RNA (dsRNA) duplex,
wherein said two complementary stretches of nucleotides are covalently linked
by intervening nucleotides,
wherein said contacting is in vitro or in a cell ex vivo; and
wherein said modifying is cleavage of the target DNA.

A restriction to either eukaryotic or procaryotic cells seems not to be present. The contacting of the target DNA to be modyfied by the method, however, according to the claim has to take place in vitro or in a cell ex vivo. 

A notice of allowance from the EPO (communication under Rule 71(3) EPC) can be expected soon.

 

Disclaimer: Neither I myself nor the patent firm Betten & Resch, of which I am a partner, is involved in any patent cases relating to CRISPR-cas9 technology.

(picture by sporst)

Amicus curiae brief in the case G1/15 of the Enlarged Board of Appeal of the EPO

I herewith publish my amicus curiae brief, which I filed on February 27, 2016 in the case G1/15 of the Enlarged Board of Appeal of the EPO relating to the issue of so-called “poisonous divisionals” under the EPC (photograph by sporst):  

 

This amicus curiae brief is submitted in accordance with Art. 10 of the Rules of Procedure of the Enlarged Board of Appeal providing observations on question 5 of the questions referred to the Enlarged Board of Appeal by the Technical Board of Appeal 3.3.06 in the case T 0557/13, pending as G1/15. The opinions expressed in the brief are my own and do not necessarily reflect the views of Betten & Resch or any of its clients.

1.Introduction

The case G1/15 relates to the issue of self-collision between parent and divisional applications as mutual prior art documents under Art. 54(3) EPC, a situation which became notorious as “toxic divisional” or “poisonous divisional” problem. Surprisingly, this issue has come up for the first time only in September 2012 with the still singular Appeal Board decision T 1496/11, despite the large number of divisional applications pending or having been granted under the EPC since it coming into force in 1978.

The “toxic” situation occurs when of two related European patent applications EP1, EP2 (either parent or divisional) both claiming the same priority date P of an earlier application (either national or European) one application (e.g. EP1) comprises a patent claim containing a generalization with respect to the priority application such that the claim of EP1 as a whole cannot validly claim the priority date P of the earlier application and at the same time EP2 comprises a specific embodiment which can validly claim the priority date P. The specific embodiment of EP2 validly claiming priority P thus is novelty-destroying prior art under Art. 54(3) for the generalized claim of EP1 not enjoying priority P.

In the case T 1496/11 (referring decision T 0557/13, Reasons 15.1.7) claim 1 of the parent patent was directed to a security document including a security device which comprised a functionally defined “feature (10) which can be inspected, enhanced or optically varied by the optical lens when …“. The priority document disclosed only a “printed or embossed” feature for this purpose. The board concluded (Reasons, 2.1) that the claimed subject-matter had been generalized by omitting the more specific indication and thus encompassed security devices including features produced by other means. Hence, it did not constitute the same invention as that set out in the priority document (Article 87(1) EPC). Consequently, the subject-matter of claim 1 was found to be only entitled to the filing date of the parent application upon which the patent had been granted. The board went on to conclude that the subject-matter of claim 1 lacked novelty under Article 54(3) EPC over an embodiment disclosed in its published European divisional application. This embodiment was identically disclosed in the priority document and was hence entitled to the claimed priority date. Therefore it anticipated the subject-matter of claim 1 of the parent patent, which was not entitled to the priority.

As the situation that a priority application contains one or multiple specific embodiments and relatively narrow claims and a later European or PCT patent application has broader claims is rather common for users of the patent system due to continuous improvements of the claimed invention, the conclusion is obvious that poisonous parent or divisional applications “killing” their relatives are rather common and threaten a substantial number of European patents, in particular if national invalidity courts would follow T 1496/11 in applying Art. 54(3) EPC to parent/divisional applications.

One possibility to avoid this highly undesirable situation for patent owners is to entitle the generalized claim partial priorities such that those parts of the claimed scope which are disclosed in the priority document can enjoy its priority and the remainder of the claimed scope enjoys the priority of the filing date. The specific example enjoying the earlier priority date thus anticipates only those parts of the generalized claim which validly claims the same priority, thus not forming novelty-destroying prior art under Art. 54(3) EPC. Or, in the words used in the referring decision T 0557/13, a “generic OR-claim” encompassing alternative subject-matter by virtue of one or more generic expressions or otherwise may be entitled to partial priority. This solution to the toxic divisional problem is dealt with in questions 1 – 4 of G1/15. The present amicus curiae brief, however, focuses exclusively on the general question of whether or not parent and divisional applications can be mutual prior art under Art. 54(3) EPC at all, that is, question 5 of G1/15, which reads as follows:

5. If an affirmative answer is given to question 1, may subject-matter disclosed in a parent or divisional application of a European patent application be cited as state of the art under Article 54(3) EPC against subject-matter disclosed in the priority document and encompassed as an alternative in a generic “OR”-claim of the said European patent application or of the patent granted thereon?

In my view, question 5 should be answered independent from the answers to questions 1 – 4, and it should be answered in the negative. Both issues – partial priorities and the application of Art. 54(3) to parent/divisional applications – are very important as such, but not necessarily dependent on each other. Allowing partial priorities under the “conceptual approach“ suggested in T 1127/00 to distinguishing “a limited number of clearly defined subject-matters” as required by decision G2/98 is essential not only to establish novelty of an EP application having a generic “OR”-claim over a specific embodiment contained in its divisional or parent application, but also over such specific embodiment contained in its national or European priority application. The eligibility to partial priorities under the “conceptual approach“ is therefore to be affirmed. Conversely, the eligibility of divisional/parent applications or patents as prior art under Art. 54(3) EPC is a fundamental question of patent law under the EPC, which should be clarified by the Enlarged Board of the Appeal, also in order to serve as precedence for national invalidity courts in Europe.

2. Applying Art. 54(3) EPC to parent/divisional applications is inconsistent with the right to file divisional applications

According to Art. 76(1) EPC

(1)    A European divisional application shall be filed directly with the European Patent Office in accordance with the Implementing Regulations. It may be filed only in respect of subject-matter which does not extend beyond the content of the earlier application as filed; in so far as this requirement is complied with, the divisional application shall be deemed to have been filed on the date of filing of the earlier application and shall enjoy any right of priority.

This provision prescribes the right of the applicant of a European patent application to file a divisional application, which shall enjoy any right of priority of the parent application. Likewise, under Art. 4G of the Paris Convention

(1) If the examination reveals that an application for a patent contains more than one invention, the applicant may divide the application into a certain number of divisional applications and preserve as the date of each the date of the initial application and the benefit of the right of priority, if any.

(2) The applicant may also, on his own initiative, divide a patent application and preserve as the date of each divisional application the date of the initial application and the benefit of the right of priority, if any. Each country of the Union shall have the right to determine the conditions under which such division shall be authorized.

an applicant has the explicit right to a divisional application, either according to paragraph (1) in response to a non-unity objection of the patent examiner or according to paragraph (2) in his/her own right. The EPC constitutes, according to its preamble, a “special agreement within the meaning of Article 19 of the Paris Convention“. Hence, it shall not contravene the basic principles concerning priority laid down in the Paris Convention (Referring decision T 0557/13, Reasons 12.1; G 2/98, Reasons, 3).

It is very clear that a specific example or embodiment in the description of a European patent application cannot be cited as prior art under Art. 54(3) for a generalized claim (generic-OR-claim) in the very same application, even if the specific example can validly claim an earlier priority date as the generalized claim. Art. 76 (1) EPC as well as Art. 4G of the Paris Convention give the applicant the right to file a divisional application under the same conditions (same filing date, dame priority date) as the parent application. If the act of making use of this right through filing a divisional application retroactively creates prior art not present before and posing a high risk of invalidating not only the divisional but also the patent application, the applicant cannot properly enjoy this right to a divisional application but is at least partly deprived of the right to a patent for his/her invention disclosed to the public. The applicant should with respect to novelty over the prior art of the invention disclosed in the patent application not be in a worse position after filing the divisional application than before filing it. Applying Art. 54(3) EPC to parent/divisional applications is thus inconsistent with the right of the applicant to file divisional applications according to Art. 76 EPC as well as Art. 4G of the Paris Convention and therefore could in my view not have been the intention of the drafters of the EPC.

3. Applying Art. 54(3) EPC to parent/divisional applications is inconsistent with the purpose of Art. 54(3) EPC

Art. 54 EPC defines the prior art when assessing novelty and inventive step of European patent applications:

Article 54 EPC (Novelty)

(2) The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application.

(3) Additionally, the content of European patent applications as filed, the dates of filing of which are prior to the date referred to in paragraph 2 and which were published on or after that date, shall be considered as comprised in the state of the art.

It recites two types of prior art, namely prepublished prior art according to Art. 54(2) EPC and fictional prior art (“shall be considered as comprised in the state of the art”) according to Art. 54(3) EPC. The latter is only relevant for the establishment of novelty but irrelevant for judging inventive step (Art. 56 EPC).

From the wording of the provision (“the content of European patent applications”) it is not clear, whether or not parent or divisional applications of a European patent application under consideration should be regarded as part of that fictional prior art.

The purpose of Art. 54(3) EPC is to avoid double patenting, that is to ensure that only the first applicant filing an application directed to the same subject-matter will be granted a patent. This can be directly seen from the travaux préparatoires to both the EPC 1973 and the EPC 2000 (detailed discussion and references enclosed in the amicus curiae brief of Vossius & Partner dated November 17, 2015, pages 4 – 7):

The Chairman then summarized the discussion stressing that the basic idea was that only one patent could be granted for one invention.” (Travaux préparatoires to the EPC 1973, document 9081/IV/63-E-Final, page 69, fifth paragraph)

Article 54(3) EPC contains a legal fiction (…). The purpose of this provision is to include European prior rights into the state of the art in order to preclude double patenting.” (Travaux préparatoires to the EPC 2000, document CA/PL 17/99 e, page 1, items 1 to 2).

This was also confirmed by Enlarged Board of Appeal in its decisions G 1/03 (Reasons, 2.2.2) of April 8, 2004 and in G 2/98 (Reasons, 8.1) of May 31, 2001.

One should keep in mind, however, that with the formulation of Art. 54(3) EPC the “prior claim approach” to double patenting (which was e.g. applied in German patent law before the introduction of the EPC and the accompanying harmonization of substantive European patent law) was replaced by the “whole content approach”, which excludes from patent protection everything which was disclosed in an earlier filed, later published EP application. Therefore only the first inventor to file a patent application has the right to the patent to the disclosure in this application and later applicants are precluded from obtaining a patent therefor.

Applying Art. 54(3) to parent or divisional applications is contrary to the purpose of avoiding double patenting also according to the “whole content approach” for the following reasons:

(i) Double patenting in parent/divisional applications is handled in the examination proceedings at the EPO by refusing a divisional application if it claims the same subject-matter as a pending parent application or a granted parent patent, as confirmed by the Enlarged Board of Appeal in its decision G 1/05 (Reasons, 13.4):

“The Board accepts that the principle of prohibition of double patenting exists on the basis that an applicant has no legitimate interest in proceedings leading to the grant of a second patent for the same subject-matter if he already possesses one granted patent therefor. Therefore, the Enlarged Board finds nothing objectionable in the established practice of the EPO that amendments to a divisional application are objected to and refused when the amended divisional application claims the same subject-matter as a pending parent application or a granted parent patent.”

That is, to avoid double patenting between parent/divisional applications, the later examined application is refused based on the principle of avoiding double patenting applying the “prior claim approach”, but not through the application of Art. 54(3) EPC.

(ii) The effect of applying Art. 54(3) to parent/divisional applications does not serve the purpose of preventing double patenting. Four different cases can be distinguished:

(1)    The parent/divisional applications EP1, EP2 do not claim earlier priority dates such that the effective filing date of both applications is the actual filing date, which is by definition identical for both applications. They therefore cannot form prior art to each other under Art. 54(3) EPC, requiring an earlier date of one application, even if the claimed subject-matter is identical. In this case double patenting would be possible even when applying Art. 54(3) EPC to parent/divisional applications.

(2)    Both parent/divisional applications EP1, EP2 claim earlier priority date P. The claims of both applications are identical and both can validly claim priority P. Again, the applications cannot form prior art to each other under Art. 54(3) EPC, even though the claimed subject-matter is identical. Therefore double patenting likewise cannot be prevented by application of Art. 54(3) EPC to parent/divisional applications.

(3)    Both parent/divisional applications EP1, EP2 claim earlier priority date P. The claims of both applications are identical, but generalized with respect to priority application P such that both EP1 and EP2 cannot validly claim priority P but only the respective filing dates EP1 = EP2. Assuming that both applications EP1 and EP2 contain the same embodiment validly claiming priority P (the typical situation), then both applications form prior art to each other under Art. 54(3) EPC and none of it survives, even if the applicant would withdraw one of the applications after its publication. Again, not double patenting would be prevented by application of Art. 54(3) EPC, but both applications would be invalidated even if the applicant would itself avoid double protection by withdrawing one of the applications.

(4)    Both parent/divisional applications EP1, EP2 claim earlier priority date P. The claims of both applications are not identical, EP1 being generalized with respect to priority application P such that EP1 cannot validly claim priority P, but EP2 can. Then EP2 would form prior art under Art. 54(3) EPC with respect to EP1, but not vice versa. Therefore EP2 would survive, but not EP1. Thus, one application would be eliminated, but because the claims are different. The effect again is contrary to avoiding double patenting.

In conclusion, the application of Art. 54(3) to parent/divisional applications of the European patent application under consideration is in clear contradiction to the purpose of this provision to avoid double patenting.

4. Self-collision between parent and divisional applications in other jurisdictions

1) USA:

According to 35 U.S.C. § 102 (a) (2) an earlier filed and later published patent application (prior application) directed to the same invention is only to be regarded as prior art, if it names another inventor. Therefore, self-collision between parent and divisional applications is explicitly excluded (Report of the Tegernsee experts group: Treatment of conflicting applications; September 24, 2012, paragraphs 64 – 65, enclosed to this brief)

2) Japan:

According to Article 29-2 of the Japanese Patent Act an earlier filed and later published patent application (prior application) directed to the same invention (using the “whole content approach”) as the invention under consideration is regarded as novelty-destroying prior art with the explicit exceptions that the inventor or applicant (at the time of filing) are identical. Therefore, parent and divisional applications are excluded from the prior art effect of earlier filed and later published applications (Report of the Tegernsee experts group, paragraphs 39 – 48)

3) Germany:

The provision of § 3 (2) German Patent Act (PatG) is worded as Art. 54(3) EPC, thus leaving it open whether or not parent/divisional applications can form novelty-destroying prior art. There are to date no FCJ decisions in which divisional applications have been cited as prior art for parent applications/patents or vice versa. According to § 39 German Patent Act (PatG) the division of a pending patent application into a parent application and a divisional application (the latter pending at the same stage of the procedure as the parent application) is regarded primarily as a procedural act dividing one application procedure into two separate procedures (“Schulte”, PatG, 9th edition, § 39, No. 10 – 13). § 39 (3) German Patent Act also speaks of a “declaration of division”, indicating the focus on the procedural aspect of a divisional application.

This focus on the procedural aspect gives rise to the following considerations: As in all jurisdictions, in German (as in European) patent law a specific example or embodiment in the description of a patent application cannot be cited as prior art for a generalized claim (generic-OR-claim) in the very same application, even if the specific example can validly claim an earlier priority date and the generalized claim cannot. If the filing of a divisional application is mainly a procedural act dividing one application procedure into two separate procedures, the declaration of division should not change the prior art status of the content of the original (combined) patent application. It would be a surprising result at least that new prior art should be created retroactively by the act of dividing one application procedure into two procedures. Based on these considerations, parent and divisional applications should not be regarded as prior art with respect to each other under German Patent Act.

5. Conclusion

In summary, parent and divisional applications should not be regarded as prior art under Art. 54(3) EPC to each other, independent from the practice of entitlement to partial priorities.

Applying Art. 54(3) EPC to parent and divisional applications of the patent application under consideration is not consistent with the purpose of Art. 4 G of the Paris Convention and Art. 76(1) EPC giving the applicant the right to divisional applications. If this right carries the risk that the parent application is invalidated by the divisional application or vice versa, the provisions are not appropriate and sufficient to provide the applicant this right.

Applying Art. 54(3) EPC to parent and divisional applications is also not consistent with the purpose of Art. 54(3), i.e. to avoid double patenting in the sense that only the first inventor to disclose an invention has the right to the patent.

As the intensive discussion about “poisonous” or “toxic” divisionals has shown, the application of Art. 54(3) EPC to parent and divisional applications exposes applicants and patentees under the EPC to a considerable invalidity risk. Conversely, no purpose or positive effect thereof can be recognized. Question 5 of the referral should therefore be answered in the negative.

Alexander Esslinger

Enclosure:    Report of the Tegernsee experts group: Treatment of conflicting applications; September 24, 2012