Appeal lost in European Patent Office by Broad Institute; Patents Remain Revoked

Appeal lost in European Patent Office by Broad Institute; Patents Remain Revoked

Nearly a year after the Opposition Division (OD) of the European Patent Office rescinded European Patent No. EP 2771468, the cancellation was confirmed by the Technical Board of Appeal. The European Patent Office published the Board's written ruling over ten months later, providing thorough justification for the proprietors The Broad Institute, MIT and Harvard College. Novozymes A/S, CRISPR Therapeutics GG and many strawmen opposed this patent. The OD cancelled and the Board confirmed the following representative claims:

1) An engineered or non-naturally occurring composition consisting of a Clustered Regularly Interspersed Short Palindromic Repeats (CRISPR)-CRISPR associated (Cas) (CRISPR-Cas) system chimeric RNA (chiRNA) polynucleotide sequence

2) A Clustered Regularly Interspersed Short Palindromic Repeats (CRISPR)-CRISPR associated (Cas) (CRISPR-Cas) vector system consisting of one or more vectors

Using the composition of claim 1 or the vector system of claim 2 or any dependent claim for genome engineering provided that the said use is not a method for surgical or therapeutic treatment of the human or animal body, apart from providing that the said use is not a modification process for the germ line genetic identity of human beings. Using the composition of claim 1 or the vector system of claim 2 or any dependent claim in the production of a non-human transgenic animal or transgenic plant.

The formal opinion of the OD issued on March 26th was consistent with a primary opinion before beckoning the proprietor Broad Institute and the opponents to the oral hearing. Defects were found in certain substantive matters by this opinion while most of the claims were found to lack novelty or inventive step as a result of the OD's decision that EP 2771468 was not entitled to its priority claim. In Europe, under Article 87 EPC and Paragaph IV of the Paris Convention, the prior applicant or his/her successor can validly claim priority to an earlier-filed application. These provisional applications were filed in the name of the inventor in the US and the EPO requires that the invention be assigned on or before a European or PCT application is filed. It was required in this case that both the named applicants i.e. The Broad Institute and Harvard College, and Rockefeller be named as applicants when the application was filed. However, Rockefeller was not named as an applicant.

The formal opinion followed the primary 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." The OD stated, "Neither the requirement of the applicant's identity nor the proof of a valid success in title [had] been fulfilled" for the claimed invention. The OD emphasized 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.

The Board held the Proprietor's position to be directly contrary to Article 87(1)'s requirements In the Enlarged Board of Appeal Decision G 3/92 regarding adequacy of fulfilling Article 60(3) requirements with regard to Article 87(1)'s requirements, the Board did not find a proper analogy. The Board said, "The 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 fulfill such formalities is a feature of the EPC system." That is what happened here but the Board said it was not for it to repair such errors, omissions or deliberate choices of a party. The Board said, "[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 Board noted, "The issue of successor ship in title is not an issue in this case and therefore the appellants' arguments on this point are irrelevant for deciding this case." It said, "[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."

The Board confirmed the OD decision and said that priority had not been validly claimed for certain references. With respect to the Proprietor's request that the Board refer a question to the Enlarged Board of Appeal, the Board stated that it had been able to answer the questions raised beyond doubt and that no referral was required.