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Following all of the latest IP developments in life sciences.

 

One and Done: Federal Circuit Affirms No New Notice Requirement Under BPCIA for Supplement to aBLA That Does Not Alter Biosimilar Structure

(Co-authored by Suresh Rav, Summer Associate)

Overview

On July 6, 2020, the Federal Circuit affirmed denial of Genentech’s motions to enjoin Amgen from marketing MVASI (bevacizumab-awwb), a biosimilar version of Genentech’s AVASTIN® (bevacizumab), an anti-angiogenic agent indicated for treating metastatic colorectal cancer in combination with certain other chemotherapies. The Federal Circuit held that filing a supplement to a previous biosimilar application does not trigger new notice requirements unless the biologic itself has changed. Both the district court and the Federal Circuit focused on the statutory language of the Biologics Price Competition and Innovation Act (“BPCIA”), particularly the relationship between § 262 (l)(8)(A) “Notice of Commercial Marketing” (“subsection (l)(8)(A)”) and § 262 (k) “Licensure” (“subsection (k)”). The Federal Circuit concluded that changes made under subsection (k) that do not alter the biosimilar’s chemical or biological structure do not require new notice under subsection (l)(8)(A).

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Uphill Challenges for Parties Seeking Attorney Fees in Federal Circuit Appeals of PTAB Decisions

As any involved party can confirm, patent litigation is often not the most economical method of resolving a dispute. Typically, the “American Rule” is that each party must pay for its own litigation costs, but 35 U.S.C. § 285 allows for a court to award attorney fees to the prevailing party in “exceptional” cases. The question before the court in Amneal v. Almirall was whether this statute is broad enough to cover those fees incurred by the prevailing party for work done before the PTAB. Under the facts of the case, the Federal Circuit concluded that it is not.

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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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Harmony Brings Discord:  Federal Circuit Affirms Finding that Ariosa Diagnostics’ Harmony® Pre-Natal Test Infringes Illumina and Verinata Health Patents

(Co-authored by Kevin Mosier)

Overview

Cell-free fetal DNA technology was again the centerpiece of a dispute between plaintiffs Illumina and Verinata Health (referred together as Illumina), and defendants Ariosa Diagnostics and Roche Molecular Systems (referred together as Ariosa) in Verinata Health, Inc., et al v. Ariosa Diagnostics, Inc., et al., No. 18-2198 (Fed. Cir. Apr. 24, 2020). At issue in the case was Ariosa’s pre-natal diagnostic test marketed as Harmony®. While Section 101 eligibility was not at issue, the Federal Circuit provided important commentary related to enablement and availability of injunctive relief, affirming a jury determination of validity in view of an enablement challenge, largely based on the referenced prior art and other evidence not strictly tied to the disclosures in the patent itself. Specifically, the jury below found that Harmony® infringed U.S. Patent Nos. 7,955,794 (‘794 patent) and 8,318,430 (‘430 patent), held by Illumina and Verinata Health, respectively. The district court denied Ariosa’s motion for judgment as a matter of law (JMOL) on the validity of the ‘430 and ‘794 patents and its motion for JMOL on infringement of the ‘794 patent. The district court also denied Illumina’s post-trial motions for a permanent injunction and supplemental damages. The parties filed cross-appeals on the denials of these motions, and the Federal Circuit affirmed the district court’s denials. The court also declined to issue an injunction, citing the parties’ respective sales models as evidence that irreparable harm was lacking.

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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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Lessons on Inherency Challenges After Hospira v. Fresenius Kabi USA

The Federal Circuit’s recent decision in Hospira v. Fresenius Kabi USA is the latest to show how the court handles allegations of inherency in life sciences patent litigation. Jonathan Roses dissects the case, addresses whether the court created a new burden-shifting framework for such challenges and summarizes lessons that parties on both sides on an inherency argument can take away from the decision. To read the full article, which was published in Westlaw Journal, click here.

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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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The Purple Book: The FDA Announces Welcome Enhancements

Earlier this week, the FDA announced that it has made enhancements to the Purple Book. These changes improve how information related to biological and biosimilar products is accessed through the use of a simple internet search. For readers unfamiliar with the Purple Book, it is a database of FDA-licensed biological products. However, until these recent updates, the Purple Book only existed as two lists, one from the Center for Biologic Evaluation and Research and one from the Center of Drug Evaluation and Research. Both of these lists contained current licensed biological products with reference to product exclusivity and any biosimilarity or interchangeability evaluations that have occurred. But unlike the Orange Book for FDA-approved small molecule drugs, the Purple Book does not contain a list of patents covering the drug or its use. Instead, the Purple Book includes significant dates for information relevant to the procedures outlined in the Biologics Price Competition and Innovation Act (BPCIA) for the approval and patent-resolution processes for biosimilar versions of approved biologic drugs. These dates and information include the date the product was licensed, and whether the FDA has evaluated it for reference product exclusivity.

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Strategies for Patenting Artificial Intelligence Innovations in the Life Sciences

(Co-authored by Dan Rudoy)

Today, companies are developing artificial intelligence (AI) systems to meaningfully analyze the deluge of biomedical data. A substantial investment in building and deploying machine learning (ML) technology—the most active area of AI technology being developed today—warrants carefully considering how to protect the resulting intellectual property (IP), but there are challenges to doing so. In this post, we explore strategies of protecting IP for ML technology, including what aspects to consider patenting given current and ongoing changes to US patent law, and when to consider trade secret protection.

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