Broad Institute Loses Appeal in European Patent Office, Patents Remain Revoked

McDonnell Boehnen Hulbert & Berghoff LLP

McDonnell Boehnen Hulbert & Berghoff LLP

Earlier this year, and almost one year to the day (January 17, 2019) that the Opposition Division (OD) of the European Patent Office revoked in its entirety European Patent No. EP 2771468, the Technical Board of Appeal affirmed the revocation (after suggesting it would refer some of the Broad's questions and challenges to the OD's decision to the Enlarged Board of Appeal). A little more than ten months later, the written decision of the Board was published by the European Patent Office, offering cold comfort but at least some detailed explanation for the Proprietors The Broad Institute, MIT, and Harvard College.

To recap, this patent was opposed by Novozymes A/S, CRISPR Therapeutics GG, and several strawmen. Representative claims revoked by the OD and affirmed by the Board are as follows:

1. A non-naturally occurring or engineered composition comprising:
a Clustered Regularly Interspersed Short Palindromic Repeats (CRISPR)-CRISPR associated (Cas) (CRISPR-Cas) system chimeric RNA (chiRNA) polynucleotide sequence, wherein the polynucleotide sequence comprises
(a) a guide sequence of between 10 - 30 nucleotides in length, capable of hybridizing to a target sequence in a eukaryotic cell,
(b) a tracr mate sequence, and
(c) a tracrRNA sequence
wherein (a), (b) and (c) are arranged in a 5' to 3' orientation,
wherein when transcribed, the tracr mate sequence hybridizes to the tracrRNA sequence and the guide sequence directs sequence-specific binding of a CRISPR complex to the target sequence,
wherein the CRISPR complex comprises a Type II Cas9 protein complexed with (1) the guide sequence that is hybridized to the target sequence, and (2) the tracr mate sequence that is hybridized to the tracrRNA sequence,
wherein the tracrRNA sequence is 50 or more nucleotides in length.

2. A Clustered Regularly Interspersed Short Palindromic Repeats (CRISPR)-CRISPR associated (Cas) (CRISPR-Cas) vector system comprising one or more vectors comprising
I. a first regulatory element operably linked to a nucleotide sequence encoding a CRISPR-Cas system chimeric RNA (chiRNA) polynucleotide sequence as defined in claim 1, and
II. a second regulatory element operably linked to a nucleotide sequence encoding a Type II Cas9 protein comprising one or more nuclear localization sequences, of sufficient strength to drive accumulation of said Cas9 protein in a detectable amount in the nucleus of a eukaryotic cell;
wherein components I and II are located on the same or different vectors of the system.

12. Use of the composition of claim 1, or the vector system of claim 2 or any claim dependent thereon for genome engineering, provided that said use is not a method for treatment of the human or animal body by surgery or therapy, and provided that said use is not a process for modifying the germline genetic identity of human beings.

17. Use of the composition of claim 1, or the vector system of claim 2 or any claim dependent thereon, in the production of a non-human transgenic animal or transgenic plant.

The OD had issued its formal opinion on March 26th, which was consistent with a preliminary opinion prior to summoning Proprietor Broad Institute and the opponents to oral hearing. While this opinion found defects in certain substantive matters (such as claims 1, 2, 14, and 15 not satisfying Article 123(2) EPC), the majority of the claims were found to lack novelty (claims 1-6 and 9-17) or inventive step (claims 7 and 8) as a consequence of the OD's decision that EP 2771468 was not entitled to its priority claim.

The priority issue was raised based on the earliest two provisional applications (U.S. Provisional Application Nos. 61/736,527 and 61/748,427), as well as U.S. Provisional Application Nos. 61/791,409 and 61/835,931, which named Luciano Marraffini as an inventor, and which were owned by Rockefeller University. The priority documents and their named inventors are as follows:

• U.S. 61/736,527 (P1) named Zhang, Cong, Hsu, Ran, Habib, Cox, Lin and Maraffini as inventors
• U.S. 61/748,427 (P2) named Zhang, Cong, Hsu, Ran, Habib, Cox, Lin and Maraffini as inventors
• U.S. 61/758,468 named Zhang, Cong, Hsu, and Ran as inventors
• U.S. 61/769,046 named Zhang, Cong, Hsu, and Ran as inventors
• U.S. 61/791,409 (P5) named Zhang, Cong, Hsu, Ran, Habib, Cox, Lin and Maraffini, Bikard and Jian as inventors
• U.S. 61/802,174 named Zhang, Cong, Hsu, Ran, and Platt as inventors
• U.S. 61/806,375 named Zhang, Cong, Hsu, Ran, and Platt as inventors
• U.S. 61/814,263 named Zhang, Cong, Hsu, Ran, and Platt as inventors
• U.S. 61/819,803 named Zhang, Cong, Hsu, Ran, and Platt as inventors
• U.S. 61/828,130 named Zhang, Cong, Hsu, Ran, and Platt as inventors
• U.S. 61/835,931 (P11) named Zhang, Cong, Hsu, Ran, Cox, Lin, Maraffini, Platt, Santjana, Bikard and Jian as inventors
• U.S. 61/836,127 named Zhang, Cong, Hsu, and Ran as inventors

In Europe, under Article 87 EPC and Paragraph IV of the Paris Convention, priority to an earlier-filed application can be validly claimed by the prior applicant or by her successor in interest. In either case, the applicant must be someone having the right to claim priority. In the U.S., these provisional applications were filed in the name of the inventor and the EPO requires that there be an assignment of the invention on or before a European or PCT application is filed. (Of course, a PCT application can always be filed naming the inventors as applicants.) In this case, proper application of the applicable rules required both the named applicants (The Broad Institute, MIT and Harvard College) and Rockefeller to have been named as applicants when the application was filed.

But Rockefeller was not named as an applicant. Accordingly, the OD determined that the named Proprietors could not validly claim priority to provisional applications P1, P2, P5, and P11; the third provisional application thus provided the earliest effective filing date, and by the filing date of that application there had published prior art that invalidated the granted claims. In this regard, the formal opinion followed the earlier preliminary opinion in stating that "[i]n both the EPC and the Paris convention systems the decisive fact for a valid claim of priority is the status of applicant, rather than the substantial requirement . . . to the subject matter of the first application" (emphasis in opinion). The OD determined that "neither the requirement of the applicant's identity nor the proof of a valid success in title [had] been fulfilled" for the claimed invention, and stressed that these were requirements to promote legal certainty that would protect third parties' interests, and that these requirements were not subject to the national law of the priority document. Nor, according to the preliminary opinion, could the granted European patent properly claim priority to U.S. 61/758,468 because that document failed to disclose the length of the guide sequence as claimed.

On appeal, the Board set forth the following as the issue before them:

"A and B are applicants for the priority application. A alone is the applicant for the subsequent application. Is a priority claim valid even without any assignment of priority right from B to A?"

The appellants say that the answer is "yes" and the respondents that the answer is "no".

The Broad made arguments regarding three questions, none of which were persuasive:

1) Should entitlement to priority be assessed by the EPO?

2) How is the expression "any person" in Article 87(1) EPC to be interpreted?

3) Does national law (in this case US law) govern the determination of "any person" who has "duly filed" in Article 87(1) EPC?

And the remedy Appellants requested (and the Board denied) was as follows:

1. The decision of the Opposition Division dated 26 March 2018 be set aside.
2. …
3. Entitlement to priority of the Patent to P1, P2, P5 and P11 is acknowledged as validly claimed.
4. Questions are referred to the Enlarged Board of Appeal if the Board is minded not to decide that entitlement to priority of the Patent to P1, P2, P5 and P11 was validly claimed, as set out at pages 70-72 of the grounds of appeal;
5. ….
6. The case is remitted to the Opposition Division for further prosecution if the Board decides that entitlement to priority of the Patent to P1, P2, P5 and P11 was validly claimed;
7. ….
8. In case the Board decides not to remit the case to the Opposition Division, to reject the oppositions and maintain the Patent as granted or, alternatively, in the form of any of Auxiliary Requests 1-64.

(where grounds 2, 5, and 7 were not pursued in this appeal).

With regard to Question 1, the Board characterized the Proprietor's (Broad's) position to be that for a property right devolving from national law the EPO should leave priority challenges to the national courts of each country in which rights are pursued by the Proprietor. This would be consistent with Article 60(3) EPC, wherein the EPO does not adjudicate patent ownership disputes. This argument comes down to matters of jurisdiction and competence according to the Board, which the Proprietor contended were adequately policed by Article 88 EPC and Rules 52 and 53 EPC. The "same invention" requirement is sufficient to ensure legal certainty for third parties according to the Proprietor's argument. And this principle would be applied to technical deficiencies in a priority claim, something the Proprietor argues is within their area of expertise. Finally, this would not be a challenge that could be raised in opposition proceedings.

The Board understood that the Proprietor contended in these arguments that the EPO should not consider the portion of Article 87(1) relating to "any person" and set forth the Article to illustrate their decision to the contrary:

Article 87 Priority right

(1) Any person who has duly filed, in or for (a) any State party to the Paris Convention for the Protection of Industrial Property or (b) any Member of the World Trade Organization, an application for a patent, a utility model or a utility certificate, or his successor in title, shall enjoy, for the purpose of filing a European patent application in respect of the same invention, a right of priority during a period of twelve months from the date of filing of the first application.

(2) Every filing that is equivalent to a regular national filing under the national law of the State where it was made or under bilateral or multilateral agreements, including this Convention, shall be recognised as giving rise to a right of priority.

(3) A regular national filing shall mean any filing that is sufficient to establish the date on which the application was filed, whatever the outcome of the application may be.

(The Board noted that this Article has the identical wording as Article 4A of the Paris Convention).

The Board distilled the requirements of this Article as requiring proper identification by an Applicant of "who," "where," "what," and "when" an invention was made. Clearly, "who" is the only question before the Board in this appeal.

The Board held Proprietor's position to be directly contrary to the requirements of Article 87(1), saying that "Article 87(1) EPC does not require that the 'any person' who has filed the patent application is actually legally entitled to do so, merely that they have done so." The EPO's assessment is thus not of substantive ownership but of the formality of whether the proper who has actually filed the application. And the Board did not find a proper analogy in Enlarged Board of Appeal Decision G 3/92 regarding the adequacy of fulfilling Article 60(3) requirements with regard to the requirements of Article 87(1).

The Board agreed with Proprietor that failure to satisfy these formalities requirements as Proprietor has been determined not to can result in loss of rights, but responded by reminding the Proprietor that "EPC sets out many formal requirements for obtaining a patent, relating to such things as payment of fees, time limits for carrying out certain actions etc." and "[t]he loss of a patent or a patent application due to failure to fulfil such formalities is a feature of the EPC system." That is certainly what happened here, but the opinion states that "[i]t is not for the Board to repair such errors, omissions or deliberate choices of a party."

Further, the opinion states that "[t]he Board can see no basis in Article 88 EPC and Rules 52 and 53 EPC for disregarding the 'any person' requirement of Article 87 EPC," [because] "none of these provisions relieve the EPO from the obligation to formally assess who has performed the act of filing the patent application as required by Article 87(1) EPC."

The opinion then turned to the relevance of successors in title, which the Proprietor argued is inconsistently applied but the Board stated is "merely a supporting argument for the appellants' view that a substantive legal assessment of the right to a priority claim should not be carried out." And the Board noted that "the issue of successorship in title is not an issue in this case and therefore the appellants' arguments on this point are irrelevant for deciding this case." Nor was the Board persuaded by the Proprietor's arguments regarding Article 54(3) EPC because "[t]he EPO does not perform a substantial assessment of the legal entitlement to claim priority, but only a formal assessment of who has performed the act of filing the patent application."

Regarding Question 1, the Board thus held that "the Board concludes that the instances of the EPO are empowered and obliged to assess the validity of a priority right claim as required by Article 87(1) EPC."

Turning to Question 2 regarding how the term "any person" in Article 87(1) should be interpreted, the opinion rejected the Proprietor's view that this term should be interpreted to mean that any of a number of applicants having a valid priority claim can file on behalf all of them and that the EPO's contrary requirement that all applicants be properly named on filing is in contravention of the Paris convention. The Proprietor made semantic/textual arguments (that the use of "any person" does not mean "all," as well as others), and argument that the Paris Convention governs how ambiguous terms must be interpreted "in light of their object and purpose" which is to "assist the applicant in obtaining international protection for his invention" (something that interpretation of Article 87(1) does not achieve, inter alia, by imposing additional priority requirements). The Proprietor further argued that national court decisions support their position that how the EPO is applying Article 87(1) was in error, and that there has never been a clear examination of this application on the merits (summarizing this aspect of the Proprietor's argument as contending "[i]t was irrelevant whether a practice was well-established. If it was wrong, it was always possible to change such a practice . . ."). Finally, the Proprietor contended that the EPO's interpretation and application of Article 87(1) was intended to prevent multiple proceedings by individual applicants, that could lead to multiple patents.

The Board agreed that the interpretation of "any person" in Article 87(1) EPC was based on Article 4A of the Paris Convention as interpreted using principles set forth in the Vienna Convention, specifically Article 31(1):

A treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose.

Under this rubric, the Board agreed with respondents that the term "any person" is "restrictive in meaning and requires strict identity of the applicants." However, the Board also admitted that "the ordinary meaning of this term in all the language versions is ambiguous" and thus turned to the "object and purpose" of the Paris Convention upon which this requirement is based (this linguistic genealogy being undisputed between the parties). For this determination the Board turned to Technical Board of Appeal Decision T 0015/01 (cited by the Proprietor) to be to "assist the applicant in obtaining international protection for his invention" (remembering that the Proprietor cited this language from this decision to illustrate that the EPO's interpretation was contravening this purpose, at least in this case). In the Board's view, on the contrary, the question was rather "who is the 'applicant' whose interests are being safeguarded" under these objects and purposes. Turning to the introductory hypothetical, the Board noted that:

So if A and B file the first patent application together, the appellants' interpretation of "any person" would allow A alone to file and own another patent application in another country claiming the same invention without involving B. This could of course result from an agreement between A and B, it could however equally result from more sinister circumstances, such as A trying to deprive B of its rights to a patent in another country. This second scenario can hardly be thought of as one that the law should seek to protect, and neither safeguards the interests of all of the patent applicants, nor assists the applicants in obtaining international protection.

This cannot be the object and purpose of the Paris Convention as understood by the Board.

The Board took something of a detour in this section of the opinion in considering the Proprietor's argument that the EPO's application of the priority rule at issue in these proceedings is in violation of the European Convention on Human Rights. But the detour was not extensive or time-consuming; the Board asserted that it found the argument "circular: it assumes that the established EPO interpretation of the Paris Convention is wrong, without bringing any supplementary arguments as to why this is the case, and then concludes that, being wrong, the European Convention on Human Rights is violated."

With regard to proper interpretation of Article 87(1) the opinion states that its consideration of the language, object, and purpose of the Paris Convention was not dispositive either (although the opinion attests that the Board finds respondents arguments to be more persuasive). And the Board readily admitted that there is no informative case law on the question (the opinion distinguishing the UK and Swiss cases cited by the Proprietor as supporting their position on the proper interpretation of the Article on the basis that these cases involved successorship in title).

In such an instance, the Board asserted that "[u]sers of the international patent system are thus faced with an established practice, the continued application of which can be seen as an aspect of legal certainty. In general, the bar for overturning long established case law and practice should be a high one because of the disruptive effects a change may have."

The opinion also addressed what can be considered an equitable principle at play here that made them disinclined to soften the applicant identity requirements:

The Board notes that in the present case it does not appear to have been a mistake of inadvertence that one of the applicants for the Priority Application was excluded from the Subsequent Application, but rather a deliberate choice of the appellants. Moreover, a formal requirement cannot be merely disregarded or ignored if, as the consequence of its non-compliance, it results in the revocation of the patent. It is not appropriate to "soften" any requirement - be it formal or substantive - for patenting on the sole basis that its non-compliance may result in the revocation of a patent.

The Board set forth its conclusion on Question 2 by stating

The ordinary meaning of the term "any person" in Article 87(1) EPC is ambiguous [due, inter alia, to differences in the languages of the underlying treaties]. The "all applicants" approach is certainly a plausible interpretation of this term from the ordinary meaning perspective and appears to be the one consistently applied by several member states of the EPC, over the last hundred years. . . . The bar to overturning long established case law and practice should be very high because of the disruptive effects a change may have. The continuation of such long standing and rationally based practices can be considered as an aspect of legal certainty. In the light of these considerations the Board finds that the words "any person" in Article 87(1) EPC require that all applicants for the priority application, or their successors in title, are applicants for the subsequent application.

The final question was whether national law (in this case, U.S. law) should govern the meaning of the term "any person" in Article 87(1). In particular, this interpretation is apt for answering the question why one inventor was "left off" the application and their assignee not identified as a co-applicant (which in this case was that the (U.S.) attorneys had determined that the omitted inventor was not an inventor as the application was filed.

But this situation raised the issue of how the EPO could determine proper inventorship in EP applications claiming priority, as this one does, to U.S. provisional applications that "do not need claims; . . . are never examined; . . . never proceed to grant; [whose] sole purpose is to obtain a filing date; . . . may contain multiple inventions; [and] need not name (an) inventor(s) or applicant(s)."

The Board responded to this situation by stating that the U.S, as a signatory to the Paris Convention, is bound by its terms, including Article 4A with regard to who falls under the description as "any person" as discussed by the Board in this case. And the Proprietor's arguments regarding the relevance of the "special characteristics" of U.S. provisional applications were not relevant to the Board's decision here.

The Board rendered its decision, that the OD decision is affirmed and that priority has not been validly claimed for the P1, P2, P5, and P11 references.

The Board made one more decision in its opinion, regarding the Proprietor's request that the Board refer a question to the Enlarged Board of Appeal. Specifically, the Board stated that it believed it has been able to answer the questions raised "beyond doubt" and that no referral was necessary.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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