Posts Tagged: "written description requirement"

On November 7, the U.S. Supreme Court issued an order list showing that it had denied the petition for writ of certiorari filed in Juno Therapeutics, Inc. v. Kite Pharma, Inc. In denying the petition, the Court refused yet again to clarify the Federal Circuit’s questionable interpretation of U.S. patent code, this time within the context of the written description requirement of 35 U.S.C. § 112, and leaves in place an appellate court ruling that many believe will be very damaging to the United States’ life sciences innovation sector.

Earlier today, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. granting a petition for rehearing from appellant HEC Pharm Co., Ltd. In granting HEC’s petition, the panel majority of Chief Judge Kimberly Moore, who authored the decision, and Circuit Judge Todd Hughes vacated a previous January ruling by the Federal Circuit, which had affirmed the District of Delaware’s final judgment that Novartis patent claims covering its Gilenya treatment for multiple sclerosis were not invalid for failing to satisfy the written description requirement under 35 U.S.C. § 112. Senior Circuit Judge Richard Linn authored a dissent arguing that the panel majority had improperly adopted a heightened written description standard and failed to take into account expert testimony from Novartis regarding a negative claim limitation that the district court found was supported by ample evidence.

Juno Therapeutics last week petitioned the U.S. Supreme Court, asking it to review an August 2021 decision of the U.S. Court of Appeals for the Federal Circuit (CAFC) that reversed a jury verdict for Juno and Sloan Kettering Institute for Cancer Research, wiping out a $1.2 billion judgment for the entities. The CAFC found that the jury’s verdict with respect to written description was not supported by substantial evidence.

The U.S. Court of Appeals for the Federal Circuit (CAFC) earlier today affirmed a district court ruling that Biogen International’s patent for a method of treating multiple sclerosis (MS) was invalid for lack of written description. Judge O’Malley dissented, arguing that the district court clearly erred in its finding that Biogen was judicially estopped from drawing a distinction between clinical and therapeutic effect, and that the entire analysis “might well change” if the case was remanded “for reconsideration of the record with the understanding that the patent is not about clinical efficacy” but therapeutic effect.

Several weeks ago, in a non-precedential opinion, the Court of Appeals for the Federal Circuit issued a decision in In re: David Tropp, which vacated and remanded a decision of the Patent Trial and Appeal Board (PTAB). The PTAB decision had affirmed an examiner’s rejection of a patent application covering a luggage inspection technology. The Federal Circuit panel of Chief Judge Sharon Prost and Circuit Judges Raymond Clevenger and Kimberly Moore determined the PTAB erred in its written description analysis by failing to consider all of the language of the specification as filed when determining whether there was sufficient support for the claimed invention. “Even if it is new matter, the language in the ’233 application as filed is relevant to assessing compliance with the written description requirement,” Judge Moore wrote. “The Board’s failure to consider this language was erroneous.”

The Federal Circuit upheld the district court’s damages award of approximately $140 million for Sprint after Time Warner was found to infringe claims of five patents covering technologies related to methods for linking circuit-switched and packet-switched networks within a telecommunications system. Despite the nonprecedential designation, Circuit Judge Haldane Mayer issued a dissenting opinion reflecting his views that the damages award should be vacated and the asserted patent claims found invalid for failing the written description requirement… The Federal Circuit majority also disagreed with Time Warner that the references to the 25 percent rule of thumb in the 2007 Vonage verdict made it inadmissible as evidence to the jury in district court.

Writing a patent application is not as easy as many think. Indeed, the concept of usefully describing the invention, which on its face seems easy enough to understand, is not as straight forward as it might seem, and why you cannot simply file an abbreviate description of an invention and think that suffices to protect anything really. This article looks at the most common parts of a patent application, and provides discussion about what each section needs to include.

On Friday, June 1st, the Court of Appeals for the Federal Circuit issued a decision in In re: Durance striking down a decision by the Patent Trial and Appeal Board (PTAB) that affirmed a patent examiner’s obviousness rejection of a microwave vacuum-drying apparatus and associated method. The Federal Circuit panel consisting of Judges Alan Lourie, Jimmie Reyna and Raymond Chen…

Disclosure of one way to attach or position a roof assembly (a species) did not provide an adequate written description of other ways to attach or position the assembly (a genus or different species). Boilerplate language that a patent covers all modifications, permutations, additions, and sub-combinations of the disclosed invention that a POSA would recognize as within the language of the claims is not sufficient to show possession of a specifically claimed combination.

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.

Appellant General Hospital Corp. (“GHC”) appealed the Board’s dismissal of an interference because the claims of its involved patent application lacked sufficient written description. The disclosure of a wide range with exemplary values does not provide written description support for a narrower claimed range, absent something to indicate the claimed range was considered critical or that inventor was in possession of the specific claimed embodiments. The Board cannot reject a motion to add a new claim to a patent application involved in an interference without explaining its findings.

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.”