NHK-Fintiv Rule - APA Violation?

April 21, 2021

I recently wrote an article (NHK-Fintiv Rule Challenges Look Futile at Federal Circuit) about a Federal Circuit decision that dismissed Mylan’s appeal of a PTAB decision that denied institution of an IPR. The Federal Circuit concluded that although judicial review is available by petition for mandamus and the Federal Circuit may consider Mylan’s request for mandamus, “there is no reviewability of the Director’s exercise of his discretion to deny institution except for colorable constitutional claims.” Mylan Laboratories Ltd. v. Janssen Pharmaceutica. N.V., No. 2021-1071, slip op. at 12 (Fed. Cir. March 12, 2021) (precedential).<... Read more

Indefiniteness: Bad Translation/Lack of Definition Redux

April 15, 2021

            I previously wrote about a Federal Circuit Opinion that affirmed a lower court ruling that the term “half-liquid” was indefinite despite the apparent mis-translation of the original Italian term “semiliquido” https://www.lifesciencesipblog.com/indefiniteness-bad-translation-lack-of-definition-or-both. On March 1, 2021, the losing party (IBSA Institut Biochimique, S.A., Altergon, S.A., IBSA Pharma Inc.) filed a petition for writ of certiorari in the U.S. Supreme Court and so I thought it would be interesting to take another look at this case. Indeed, the petitioner presented a novel question for review of the lower courts’ decision of indefiniteness of the term at issue. The question presented in the petition is:<... Read more

NHK-Fintiv Rule Challenges Look Futile at Federal Circuit

April 6, 2021

The NHK-Fintiv rule allows the Patent Trial and Appeal Board (PTAB) to deny institution of an inter partes review petition based on the progress of a parallel U.S. district court proceeding of the same patent. The rule was established under former USPTO director Andrei Iancu in 2018, in NHK Spring v. Intri-Plex., No. IPR2018-00752, Paper 8 (PTAB Sept. 12, 2018) (precedential). As a result of the restrictions opposed by the NHK-Fintiv Rule, many petitioners have been facing increasing challenges in seeking review at the PTAB for patents where there is a parallel district court proceeding.<... Read more

Claims Directed to Computerized Statistical Methods for Determining Haplotype Phase Are Patent Ineligible

April 6, 2021

The Board of Trustees of the Leland Stanford Junior University (“Stanford”) appeals the final rejection of patent claims in its patent Application No. 13/486,982. The patent examiner rejected the claims as involving patent ineligible subject matter. The PTAB affirmed the examiner’s rejection. On appeal, the Federal Circuit affirmed the decision of the PTAB that the rejected claims were drawn to abstract mathematical calculations and statistical modeling, and similar subject matter that is not patent eligible.<... Read more

Invalidation of Chemical Compound Claims

March 8, 2021

Torrent Pharmaceuticals and Indoco Remedies Ltd. (Defendant-Appellant) appealed from the district court’s final judgment on Takeda’s (Plaintiffs-Appellees) invalidity challenges to claims 4 and 12 of U.S. Patent No. 7,807,689, owned by Takeda. In a non-precedential opinion, the Federal Circuit (“the Court”) affirmed the district court’s final judgment that Torrent and Indoco had failed to prove that the claims asserted by Takeda were invalid for statutory obviousness or non-statutory obviousness-type double patenting.<... Read more

GlaxoSmithKline v. Teva - Not a Skinny Label?

March 1, 2021

The decision in GlaxoSmithKline LLC. V Teva Pharms. (976 F.3d 1347 (Fed. Cir. 2020) has caused panic in the generic industry because it has been interpreted as killing the “skinny label” approach to generic drug approval. A “skinny label” allows a generic company where there are multiple approved indications for a drug and some are protected by patent and others are not, to omit the patented indications from its label and avoid the need for a paragraph (iv) certification and 35 U.S.C. 217(e)(2) litigation. During the oral argument on February 23, 2021, on remand to the original panel, it became clear that the skinny label exception is not under attack although you wouldn’t know it from the Federal Circuit’s decision or the press reports.<... Read more

Supreme Court Declines to Hear Idenix Case: Dispute Surrounding the Enablement Standard for Biotechnology Patents Continues

February 12, 2021

On January 19, 2021, the Supreme Court denied a petition for certiorari to hear the Idenix Pharmaceuticals LLC v. Gilead Sciences Inc. case (941 F.3d 1149 (Fed. Cir. 2019)). In the underlying district court litigation, the jury found the Idenix patents were infringed, awarding it $2.5 billion in damages. But, the district court overturned the verdict and granted judgement as a matter of law finding the patents invalid for lack of enablement, and the Federal Circuit affirmed. To revive its damages claim, Idenix filed a petition to reverse the Federal Circuit's decision. The petition addressed whether a genus claim is not enabled if it encompasses a large number of compounds or whether, as the Supreme Court has previously recognized, enablement is a context-specific jury question (as well as a related written description issue that will not be discussed further).... Read more

The "Skinny Label" - The Federal Circuit Has Second Thoughts

February 10, 2021

On Tuesday the Federal Circuit vacated its decision in GlaxoSmithKline LLC. V. Teva Parma., USA, Inc., 976 F.3d 1347 (Fed. Cir. 2020) in response to GSK’s request for rehearing en banc. In vacating the decision and deciding to rehear the case, the panel limited the rehearing to Teva’s question in its en banc petition as “whether there was substantial evidence to support the jury’s verdict of induced infringement.”<... Read more

Two-Step Eligibility for Genomic Analysis Systems

February 4, 2021

For practitioners at the USPTO, the reversal of a 101 rejection in Ex parte Patil (PTAB January 7, 2021), APJs Grimes, Scneider and Valek, in Appeal 2020-002775 should be interesting if not provide some light on the dance floor for doing the two-step with the USPTO.

The invention focused on assessing genetic variability with a system including databases and processors and as recited in Claim 27 U.S. 15/169,498:<... Read more

USPTO: Proposed Changes to Terminal Disclaimer Practice in Joint Research Agreement Situations

February 1, 2021

The USPTO proposes to modify the rules of practice when certain types of patent applicants and patentees may obtain or enforce a second patent for an invention that is similar (i.e., patentably indistinct) to a first patent. Generally, an application for a second patent covering a similar invention would be rejected. The proposed rule change is limited to the situation where owners of the first and second patents or patent applications are different but have an agreement to conduct research together (i.e., a joint research agreement or JRA). The proposed rule change would increase the ability to file a terminal disclaimer (TD) that ties the rights of a second patent to the first patent. The proposed rule change intends to expand when a TD can be filed in the JRA situation by eliminating the requirement that the second patent or patent application be filed later than the first patent or patent application. The USPTO also proposes to amend the rules to explicitly state existing practices in the rules regarding when certain affidavits and declarations, as well as TDs, may be filed.<... Read more