Last January 17th, the Opposition Division (OD) of the European Patent Office revoked in its entirety European Patent No. EP 2771468, which named as Proprietors The Broad Institute, MIT, and Harvard College and had been opposed by Novozymes A/S, CRISPR Therapeutics GG, and several strawmen). Almost one year later to the day, 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).
To recap, representative claims revoked by the OD 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, an
(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 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 U.S. 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 named Zhang, Cong, Hsu, Ran, Habib, Cox, Lin and Maraffini as inventors
• U.S. 61/748,427 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 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 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. Rockefeller was not named as an applicant. Accordingly, the OD determined that the named Proprietors could only validly claim priority to the third provisional application, 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.
The Broad made three arguments, all of which the OD rejected:
I. The EPO should have no power to assess legal entitlement to the right of priority.
II. In case of joint/multiple applicants in a first application, the meaning of the term "any person" under Article 87 EPC should be interpreted to mean "one or some indiscriminately" of the co-applicants.
III. The meaning of "any person who has duly filed" should be interpreted according to national law, in this case U.S. law.
The formal opinion noted that "[t]hese perspectives were not fully addressed by the OD's preliminary opinion, as they were submitted at a later stage," and the Technical Board of Appeal (TBoA) considered (and rejected) these arguments.
With regard to the first argument, the Broad contended that the OD (and the TBoA) should reconsider established practice and case law regarding the requirements for priority. The formal opinion set forth in this regard the status of the European Patent Convention as a "special agreement" as contemplated by Article 19 of the Paris Convention (PC), and thus the EPC cannot contravene the provisions of the PC. The purpose of the PC, according to the opinion, was to "provide a mechanism as simple as possible and appropriate for applicants to obtain international protection for their invention, as well as for patent offices to assess the validity of priority claims." The Broad challenged the EPO's competence to make priority determinations, which it contended were within the purview of the jurisdictions of the national courts of each member state. In their view, the EPO should presume that priority is properly claimed, and should be reviewed only on the basis that the priority document discloses the same invention claimed in any application filed under the EPC. The jurisdictional argument was based on the assertion that the EPO was never intended to have jurisdiction over whether a party was entitled to ownership of the property right to a priority document. If the EPO were to have such jurisdiction, it would need to be empowered to apply the national laws regarding ownership in each contracting state, according to the Broad. Also, under most legal systems, only a person alleging to be the rightful owner has a right to challenge ownership of a priority right. Finally, the proper portion of the EPC to be applied is Article 60(1) regarding determination of ownership of an EPC application, which is left to the national courts.
The OD rejected this approach, based in part on its refusal to follow a non-binding opinion of the Board in T239/16, in which the Board did not address the issue as a basis for revoking the patent in that proceeding. According to the OD, "the aforementioned established practice . . . has never been questioned to the extent of the EPO's power to assess legal entitlement to priority." The OD stressed that "[t]he assessment of the formal requirements does not determine the rightful owner of the priority right; rather it establishes whether the priority was validly claimed by those named as applicants in the later application (applicant's status), irrespective of their actual entitlement." The issue is not assessment of the substantive right of priority (i.e., inventorship) but the procedural point that the Applicant must have title to the priority right to properly have an application filed in its name (whether by assignment from the inventors or as successors in that title). This requirement is the basis for the EPO to be able to properly identify the prior art, which depends (as it did here) on the priority date to which an Applicant is entitled. If not, the EPO would be put in the position of granting patents without a reliable state of the art and, thus, invalid. The policy implications considered to be determinative by the OD were that "[l]egal certainty and the protection of the interests of the public (against the granting of invalid patents) require that priority is validly claimed, since this is relevant for defining the effective date of a claimed invention and for determining the relevant state of the art." The OD also rejected the Broad's argument that Article 60 was the proper basis for making the procedural priority determination, inter alia, because the Broad had not demonstrated that there was a deficiency in Articles 87-89 that needed supplementation or correction. Also, the OD views the two provisions to serve different purposes: Article 87 "serves to set the relevant date for the state of the art and ultimately affects the patentability of the invention" whereas Article 60 does not.
Accordingly, the OD rejected the Broad's first line of argument, stating that "the EPO has the task to assess the identity of the applicant, as well as the validity of its succession in title."
Regarding the Broad's second argument, that the meaning of the term "any person" under Article 87 EPC should be interpreted to mean "one or some indiscriminately" of the co-applicants, the OD considered the Broad's semantic argument (in French, no less) regarding the meaning of the language of the PC. In the Broad's view these semantics were consistent with an intent under the PC for "a more permissive notion of who is allowed to claim priority" in contrast with who would be permitted to file a divisional application from a prior EPC application, for example. The Broad further contended that as to third parties their interests would be protected by the "same invention" requirement for a valid priority claim. Finally, the Broad's interpretation of the requirement is consistent with how the PC has been implemented in the U.S., all arguments supported by expert legal opinions proffered to the OD.
Once again, the OD refused to "deviate from established practice" regarding the procedural priority requirements. The OD did not find "an exclusive indication as to whether the later application must be filed by 'all applicants' of the first or by 'any one' of them" in the language of 87 EPC. Commentaries on the EPC have been consistent with the current interpretation, according to the OD, as has EPO practice and case law including national case law, citing specific examples from several EPC member states. The OD further considered how the "all applicants" approach has been consistently applied in Boards of Appeal decisions and has been used as the "starting point [for] decisions concerning . . . valid assignment of the priority right" ("Stressing the fact that the right to claim priority originates from the applicant of the first application, so that, in principle, the applicant has to be the same for the first and the subsequent applications, the Boards concluded that where the first application has been filed jointly by two or more applicants, the right of priority belongs to them jointly.")
However, while the OD recognizes justifications in theory for permitting each of joint applicants to file EPC applications without the other, as a practical matter "allowing each joint applicant, separately or in different combinations with other co-applicants, to file a patent application claiming priority from the first application would lead to a multiplication of proceedings with identical content." The "logical consequences" of permitting this state of affairs would "run counter to the interests of patent offices and the public both in terms of procedural inefficiencies and of avoiding multiplication of protections for the same subject-matter, having different patent owners." Nor did the OD see any basis for giving U.S. provisional applications any special status and treatment.
Accordingly, the OD rejected the Broad's suggestion "to consider priority as validly claimed even when any one of the joint applicants of the first application is applicant of the later application would protect the legitimate interest of a joint applicant wishing to keep a priority right valid even when the co-operation of the other joint applicants is missing" because this approach "would have far reaching consequences, in particular the risk of multiple patenting."
Finally, with regard to the Broad's third argument that the meaning of "any person who has duly filed" should be interpreted according to national law, the OD rejected the conclusion that this was a "special case" involving U.S. priority documents disclosed several inventions and that the invention by excluded inventors and Applicant were not within the scope of the granted claims. The OD held that the meaning of the term "any person who has duly filed" is limited to according a filing date. Adopting a different approach according to the OD "would be contrary to the scope of simplification of proceedings, as intended by the EPC legislator when choosing to focus solely on the status of an applicant in the EPC system both in Article 87(1) and in Article 60(3)." (The OD also notes in this regard that adopting the Broad's approach would have the effect of having U.S. law take precedence over the EPC, an outcome the OD could not accept.) In addition, this approach would increase complexity by requiring analysis under U.S. law. "Since this approach would disregard the wording and the scope of Article 4PC and Article 87 EPC, the OD sees no reason to depart from the established interpretation given by the BOAs that substantive entitlement is not a basis for the right of priority," the OD held and thus rejected the Broad's third argument.
Consequently, the OD further held that, in the absence of their priority claim all claims of EP 2771468 were invalid for lack of novelty and inventive step.
The TBoA does not immediately publish the basis for their decision, which will be the subject of a later post when it becomes available. For the Broad, the decision by the TBoA is final and thus the Broad has lost exclusive rights in Europe under this patent (and, presumably the nine related patents in Europe). Which may be one reason that the Broad issued a press release, suggesting that patent holders on CRISPR technology "move beyond litigation" and work together to ensure open and widespread access to CRISPR.