Attorney:
Richard D. Kelly
May 4, 2021
On April 23 President Biden signed into law changes narrowing the scope of eligibility for the non-patent “new chemical entity” (NCE) 5-year exclusivity provisions of 21 U.S.C. §301 et seq. The 5-year exclusivity comprises a 4-year data exclusivity provision during which time a generic applicant cannot rely on the drug application to establish either safety or efficacy which is followed by a 1-year marketing exclusivity. The exclusivity provision found in 21 U.S.C. § 355 (c)(3)(E)(ii) prior to the amendment described the NCE as applying to a drug where “no active ingredient” has been previously approved under § 355. Active ingredient is defined in 21 § 314.3(b) as “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease ….” Some drugs become active only after being metabolized to what is called the active moiety. Prodrugs are an example of this phenomenon. Under the prior definition both a prodrug which metabolized into the active drug and the metabolite might each be capable of receiving separate NCE status.<... Read more
Attorney:
Derek Lightner, Ph.D.
April 26, 2021
In a Patent Trial and Appeal Board (PTAB) decision issued on April 16, 2021, in Ex parte Bhalla, Luthra, Reid I, and Levason (Appeal 2021-001535, USSN 14/373,413), the PTAB was presented with the issue of the obviousness of an imaging agent comprising an 18F-labelled compound of a formula below, with the relevant moieties indicated. The main claim covered a moderate genus of compounds[1], and was rejected over a combination of three references.<... Read more
Attorney:
Richard D. Kelly
April 22, 2021
The USPTO 101 Guidance document has been under a cloud when Judge Brinkema refused to follow the guidance in Cleveland Clinic Found. V. True Health Diagnostics LLC., affirmed at 760 F. App'x. 1013, 1020 (Fed. Cir. 2019). Cleveland Clinic relied on Guidance example 29, claim 1 to assert that its claims were patent eligible since they were drafted in the same manner. The Federal Circuit in rejecting the argument found the 101 Guidance example 29, claim 1 to be "strikingly" similar to claim 1, see760 F. App'x. at 1020, which the Federal Circuit held was patent ineligible. The guidance teaches that example 29, claim 1 is patent eligible. The USPTO has not responded to the Court's criticism and example 29 continues to appear in the Guidance unchanged.... Read more
Attorney:
Grace Kim
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
Attorney:
Daniel J. Pereira, Ph.D.
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
Attorney:
Grace Kim
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
Attorney:
Marina I. Miller, Ph.D.
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
Attorney:
Marina I. Miller, Ph.D.
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
Attorney:
Richard D. Kelly
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
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