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Following all of the latest IP developments in life sciences.

 

Expert Declarations in Inter Partes Review Proceedings Must Do More Than Create Noise:  PTAB Silences Challenge to Patented Method for Cleaning “Noisy” Genetic Data

Overview

On December 11, 2020, the PTAB issued a Final Written Decision in Illumina, Inc. v. Natera, Inc., IPR2019-01201, upholding the validity of Natera Inc.’s patent for determining genetic data from fragmentary DNA. Illumina, Inc. (“Illumina”) filed its petition, challenging claims 1-27 of Natera Inc.’s (“Natera” or “Patent Owner”) U.S. Patent No. 8,682,592 B2 (“’592”). The PTAB instituted inter partes review of all the challenged claims on obviousness grounds. While Illumina carried its burden at the institution stage, it failed to prove the unpatentability of the challenged claims by a preponderance of the evidence as required by 35 U.S.C. § 316(e). The PTAB determined that the challenged claims were not unpatentable, and also denied Illumina’s Motion to Exclude Evidence. Central to the PTAB’s decision were the expert declarations submitted by the parties, and the noted failure by Illumina to include all of its expert’s declarations in its petition.

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Targeting Indefinite Claims: Horizon Pharma, Inc. v. Dr. Reddy’s Laboratories, Inc.

Summary

Agreeing with the district court’s decision to invalidate two drug patents for indefiniteness, the Federal Circuit reasoned that two terms (“target” versus “produce”) used in the alternative in similar specification contexts were not implicitly interchangeable in meaning, affirmed a district court’s judgment that the claims were indefinite, and affirmed that conclusory, non-factual expert testimony was not persuasive either in construing the claims during a Markman hearing or in establishing an issue of fact to prevent summary judgment.

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Economic Considerations in Granting Injunctive Relief: Federal Circuit Partially Reverses Injunctive Relief in a Case of Willful Infringement

(Co-authored by Eric Greenwald)

Overview

On August 3, 2020, the United States Court of Appeals for the Federal Circuit partially reversed a District Court’s decision for a permanent injunction against 10X Genomics. Bio-Rad Laboratories had sued 10X Genomics (“10X”) for infringing three patents directed to a microfluidic system that enables researchers to encapsulate biological materials in oil partitions, or plugs, for high-throughput biochemical reactions and genomics. During trial in the District Court for the District of Delaware, a jury found the patents-in-suit to be valid and willfully infringed and awarded Bio-Rad $24 million in damages based on 10X’s sale of five product lines. After denying 10X’s motion for judgment as a matter of law to overturn the verdict, the district court granted Bio-Rad’s motion for a permanent injunction prohibiting 10X from selling the five infringing product lines. 10X appealed these decisions.

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Unqualified Antitrust Immunity: the In re Humira Decision

(Co-authored by Chelsea Loughran)

Scores of lawyers and stakeholders in the biologics industry had been eagerly awaiting guidance from a federal district court in the In re Humira (Adalimumab) Antitrust Litigation, which was filed in March 2019 by indirect purchasers of Humira® alleging anticompetitive behavior on the part of Humira® manufacturer, AbbVie Inc. (AbbVie). On June 10, 2020, Northern District of Illinois Judge Manish Shah granted AbbVie’s motion to dismiss the complaint, finding that the plaintiffs’ antitrust allegations were too speculative and therefore insufficient to state a claim upon which relief could be granted. The decision suggests that patent “evergreening” practices akin to those the plaintiffs allege AbbVie has exercised will still be available to innovators who wish to find ways to increase patent term on their marketed reference biologics and maintain a dominant position in the market.

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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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