Posts Tagged: "Amgen v. Sanofi"

The U.S. Supreme Court granted petitions for certiorari in two intellectual property cases Friday, one dealing with the limits of extraterritorial application of the Lanham Act and another asking the High Court to weigh in on whether “enablement” means a specification must enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation.

As the pharmaceutical industry continues to shift toward biologic-based drugs, including monoclonal antibodies, protecting the underlying technology has been and continues to be a priority for companies. As with any drug, patenting therapeutic monoclonal antibodies as early as possible in the drug development process is crucial to protect the underlying invention. In the early days of antibody discovery for therapeutic development, protection could be obtained with minimal disclosure of the actual antibody. But as the art and case law have evolved, companies now need far more data to obtain the broadest scope of protection. For that reason, it has become more of a challenge to determine the best time to file with the U.S. Patent and Trademark Office (USPTO). After the America Invents Act (AIA), it is a race to the USPTO to be the first to claim your invention, but you may lack the requisite data to enable you to obtain patent protection in the end.

The Amgen v. Sanofi decision put most functional antibody claims into question, including epitope and competitive binding claims, as well as antibody claims based on a newly characterized antigen. After Amgen v. Sanofi, non-sequence based antibody claims may become more difficult to obtain before the USPTO from a written description standpoint.  Yet, to fully protect the essence of the invention and avoid design-arounds, such claims are extremely valuable to patent owners. To obtain antibody genus claims beyond those defined by sequences, the patent applicant will need to make and test a sufficient number of representative antibodies across the claimed genus, or establish a clear structure/function relationship among the members of the genus.  Patent applicants should carefully assess the amount of data they have acquired, in comparison to the scope of claims that they wish to obtain, before rushing to the Patent Office.

The memorandum points to Amgen for stating that the “newly characterized antigen” test could not stand because it contradicted the quid pro quo of the patent system whereby in order to obtain a patent one must describe an invention (the antibody, not the antigen recognized by the antibody). The memorandum states that in view of Amgen, “adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional.”

May a court rely on post-priority-date evidence offered to show that a patent lacks written description support even though written description is judged based on the state of the art as of the priority date?  Yes, at least when the evidence relates to whether or not a claimed genus discloses a representative number of species.  Amgen v. Sanofi No. 2017-1480 slip op. Fed. Cir. Oct. 5, 2017 (“Amgen”).   Such evidence, the Federal Circuit observed, is likely to postdate the priority date, because were it to predate, it might be anticipatory.  To consider such evidence is therefore a matter of “common-sense,” the Court added.

In what appears to be a clear departure from the past, in Amgen, the Federal Circuit has rejected the test, basing its rejection on the ground that it effectively eliminates the written description requirement.  Amgen at 15, 16.  According to the Court, where a functional genus claim to antibodies to a newly characterized antigen is concerned, the underlying science is not so advanced as to establish that “make and use” is equivalent to the required description of the claimed antibodies.  Id. at 16.  Drawing such equivalence, the Court said would amount to declaring a contested scientific proposition to be so settled as to be entitled to judicial notice, which the Court was not prepared to do.  Id.

In the case, Amgen v. Sanofi, the Court vacated an injunction Amgen obtained against a competing drug to its new PCSK9-inhibitor.  The Court’s decision turned on a finding that the jury was improperly instructed on the criteria for invalidating a patent directed to an antibody for lack of written description.  Thus, will the precedent recently established in Amgen’s PCSK9 case doom the validity of its patents covering Enbrel®?  There are likely two ways that the decision in Amgen v. Sanofi made a validity challenge to Enbrel®’s patents easier.