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Following all of the latest IP developments in life sciences.

 

Gabe McCool

Gabe McCool
Gabe McCool has over 17 years of experience advising clients in the life science industry on intellectual property matters, particularly in the areas of patent preparation, prosecution, and strategic counseling.

Recent Posts

Not a Fragment of the Imagination: Federal Circuit Decides in Favor of Antibody Patent Owner in Hemlibra® Dispute

Overview

On August 27, 2020, the Federal Circuit vacated the district court’s determination that Genentech’s Hemlibra® (emicizumab-kxwh) product for treating hemophilia did not infringe Baxalta’s US Patent No. 7,033,590 (the ‘590 patent) because it found the lower court had erred in its claim construction of “antibody” and “antibody fragment.”

Background and Issue Presented

Hemophilia is a rare blood clotting disorder characterized by an underlying malfunction in the coagulation cascade. A critical step in the cascade is the formation of a complex between activated factor IX (FIXa) and activated factor VIII (FVIIIa) which then goes on to activate factor X (FX). Hemophilia develops when this complex is unable to form, due in many cases to the development of self-antibodies that inhibit FVIIIa, thereby blocking the activation of FX. The disclosed and claimed invention in the ‘590 patent relates to antibodies against FIXa that take the place of FVIIIa and result in the activation of factor X by FIXa even in the absence of FVIIIa. Thus, rapid blood coagulation may be achieved in hemophiliacs with FVIIIa inhibitors by administering the claimed anti-FIXa antibodies.

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The Eagle has Landed: Federal Circuit Affirms Disclosure-Dedication Doctrine Barring Doctrine of Equivalents in Eagle Pharmaceuticals v. Slayback Pharma LLC

Overview

The Federal Circuit upheld the US District Court for the District of Delaware’s decision that generic Slayback Pharma did not infringe Eagle Pharmaceutical’s patents covering its anti-cancer drug, BELRAPZO®, because Eagle was barred from applying the doctrine of equivalents under the disclosure-dedication doctrine to capture Slayback’s generic product, which included ethanol instead of the claimed propylene glycol (PG). The court found that Eagle disclosed ethanol as an alternative solvent to PG, but failed to claim it, thereby dedicating ethanol to the public. The court also determined that the application of the disclosure-dedication doctrine was permitted at the pleadings stage.

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Illuminating Section 101: The Federal Circuit Upholds Diagnostic-Related Patent In Illumina, Inc. v. Ariosa Diagnostics, Inc.

Overview

On March 17, 2020, the Federal Circuit reversed the district court’s finding that two patents relating to diagnostic methods involving cell-free fetal DNA were invalid for lacking subject matter eligibility under 35 U.S.C. § 101. The court reached its decision entirely on analyzing step one of the two-part Alice/Mayo test, finding that “the claims are not directed to a patent-ineligible concept” and consequently did not need to reach the second step of the test. This decision adds clarity to the metes and bounds of patent eligibility jurisprudence because it suggests that a claimed method relating to a natural phenomenon may be patent eligible so long as concrete processing steps that go beyond merely observing the natural phenomenon are recited in the claim. Also, while the decision does not go as far as requiring a physical transformation or the production of non-naturally occurring material as a result of such processing steps, it may be instructive to consider whether a material not existing in nature results from performing the steps of the claim.

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Hospira Requests En Banc Review as to its Entitlement to Safe Harbor Protections for Manufacturing its Epogen® Biosimilar

Overview

On January 15, 2020, Hospira, Inc. filed a petition for rehearing en banc of the Federal Circuit’s December 16, 2019 panel decision in Amgen, Inc. v. Hospira, Inc., Nos. 2019-1067, 2019-1102 (Fed.Cir. 2019) in which Hospira lost on the issue of whether its EPO biosimilar manufacturing activities are entitled to Safe Harbor protections. The petition requested review on the question of “[w]hether 35 U.S.C. § 271(e)(1) provides a safe harbor against infringement of patents claiming a method of manufacture, when the product manufactured is used to generate information for submission to the Food and Drug Administration (‘FDA’) in order to seek approval of a biosimilar drug.” Petition, page 1.  Hospira also alleges that the panel decision is contrary to the Safe Harbor precedent of the US Supreme Court and the Federal Circuit, as well as erring in its claim construction by improperly “reading out a claim limitation” relating to the meaning of “mixture…of isoforms.” The Federal Circuit has yet to decide on the petition.

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Galderma Prevails At The Federal Circuit, Forcing Case Back To The District Court To Consider Teva’s Additional Invalidity Theories

Overview

On January 29, 2020, the Federal Circuit reversed and remanded an August 21, 2019 decision (Galderma v. Teva, 390 F.Supp.3d 582 (2019)) handed down by the United States District Court for the District of Delaware in the patent infringement dispute between Galderma Laboratories and generic manufacturer, Teva Pharmaceuticals, relating to Teva’s Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of Galderma’s Soolantra® (1% ivermectin cream for topical use) for treating inflammatory lesions of rosacea. Galderma Laboratories, L.P. et al. v. Teva Pharmaceuticals USA, Inc., Nos. 2019-2396, 2020-1213 (Jan 29, 2020). Each of the asserted claims recite administering a 1% ivermectin formulation together with the appearance of one or more functional efficacy metrics. In siding with Galderma, the Federal Circuit reversed the district court’s finding that Galderma’s asserted claims were anticipated based on two references (McDaniel-U.S. Patent No. 5,952,372 and Manetta-US Patent No. 7,550,440), contrary to the axiom that “a patent claim can only be invalid for anticipation if a single reference discloses each and every limitation of the claimed invention.” According to the Federal Circuit, the district court erred in two ways.

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