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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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Raising An Argument For The First Time On Appeal Is Fraught With Danger

There is always a danger in raising an argument for the first time on appeal. The Federal Circuit’s recent decision in Boston Scientific Neuromodulation v. Nevro (No. 2019-1584) provides yet another example of this particular peril. 

The case began with Nevro filing an IPR petition challenging the validity of a Boston Scientific patent that claimed an implantable medical device that stopped “listening for” one type of “telemetry” (i.e. a wireless signal to program the device) when the battery level dropped too low, but continued “listening for” a second type of “telemetry” from the medical device’s wireless charging unit. 

In a preliminary response, Boston Scientific proposed a construction of “telemetry” to mean the “transmission of data or information,” which Boston Scientific contended the prior art did not disclose the second type of telemetry—the signal from the external wireless battery charger.

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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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Get to Know Contributing Editors Andrew W. Williams & Gabriel J. McCool

Q: Why did you decide to become an attorney? 

Andrew: When I was an undergraduate at the University of Iowa majoring in Biochemistry, I got involved in student politics in my free time. When I started applying to graduate programs, I was a little jealous of my friends that were taking the LSAT (I know, right?). But for some reason, I always knew that I would end up going to law school at some point. I just didn’t realize at the time that it would be after my PhD and a stint as a post-doc.

Gabe: I was inspired to pursue becoming a patent attorney in the life sciences towards the end of my PhD studies when I filed a patent application on my own research. In addition, I had a few mentors at the time who had already moved from science into patent law, and each of them helped guide me down my new path. Combining my training in science and law is enormously satisfying and rewarding.

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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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Genentech, Inc. v. Hospira, Inc. – Overlapping Temperature Ranges Can Leave a Patentee Out in the Cold

When can a prior art reference that discloses a protein purification step at room temperature render invalid a patent claim with a temperature range from about 10°C to about 18°C? Answer: When that prior art reference defines room temperature to include 18°C (which is about 64.4°F). The Federal Circuit reiterated, in Genentech, Inc. v. Hospira, Inc., that even a small overlap at the extremes of a range can invalidate claims that incorporate that range, absent a showing that the particular range is critical or that the parameter is not a result-effective variable.

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About the Wolf Tracks Life Sciences IP Blog

WOLF TRACKS

The WOLF TRACKS LIFE SCIENCES IP BLOG covers important life sciences news through an intellectual property lens. We discuss legal cases and opinions, breakthrough innovations, and other timely topics impacting the life sciences industry. Our goal is to provide helpful summaries, insightful thoughts and key takeaways on news legal practitioners need to know.

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