Justia Drugs & Biotech Opinion Summaries

Teva’s patents, directed to methods of using humanized antagonist antibodies that target calcitonin gene-related peptide (CGRP), a 37-amino acid peptide that is “a neurotransmitter in the central nervous system, and has been shown to be a potent vasodilator. Dilation of blood vessels was associated with and thought to exacerbate the pain symptoms of migraine. Lilly filed petitions for inter partes review (IPR).In three IPR proceedings, the Board issued a combined final written decision holding that the challenged claims in all three patents are unpatentable as they would have been obvious over various cited references and that a skilled artisan would have been motivated to combine the teachings of the prior art and would have had a reasonable expectation of successfully achieving the claimed invention. The Federal Circuit affirmed, rejecting Teva’s arguments that the Patent Trial and Appeal Board erred as a matter of law in its motivation to combine analysis by deviating from the motivation asserted by Lilly in its IPR petitions, that even under the motivation to combine that the Board did analyze, substantial evidence does not support the Board’s factual findings, and that the Board erred in its analysis of secondary considerations of nonobviousness View "Teva Pharmaceuticals International GmbH v. Eli Lily & Co." on Justia Law

Teva's patents are directed to methods of using humanized antagonist antibodies that target calcitonin gene-related peptide (CGRP). CGRP is a 37-amino acid peptide that is “a neurotransmitter in the central nervous system and has been shown to be a potent vasodilator in the periphery, where CGRP-containing neurons are closely associated with blood vessels. Dilation of blood vessels was associated with and thought to exacerbate the symptoms of migraine. The challenged patents describe “anti-CGRP antagonist antibodies and methods of using anti-CGRP antagonist antibodies for treating or preventing vasomotor symptoms, such as headaches, such as migraine.” Lilly asserted that each challenged claim would have been obvious over a combination of prior art references.The Patent Trial and Appeal Board first construed the claims, including the preambles and the term “effective amount,” then analyzed prior art, concluding that Lilly failed to prove that the challenged claims would have been obvious over the stated references. The Federal Circuit affirmed, rejecting arguments that the Board erred by reading a result into the constructions of the preambles and the term “effective amount,” which led to erroneously requiring Lilly to prove that a skilled artisan would have expected to achieve results that are unclaimed and that, even if the preambles are limiting and the claims require administration of an antibody with an expectation of results, the Board applied too high a standard in determining whether a skilled artisan would have had a reasonable expectation of success. View "Eli Lilly & Co. v. Teva Pharmaceuticals International GMBH" on Justia Law

Oakwood hired Dr. Thanoo in 1997. As Oakwood's Senior Scientist, he signed confidentiality agreements. Thanoo designed Oakwood’s microsphere process technology. Oakwood invested more than $130 million and two decades in its Microsphere Project and developed the “Leuprolide Products,” which are bioequivalent to Lupron Depot®. Aurobindo contacted Oakwood to discuss collaboration. Some of Oakwood’s trade secret information was shared under a confidentiality agreement. Negotiations failed. Aurobindo hired Thanoo six months later and began developing microsphere-based injectable products that Oakwood alleges are “substantially similar to and competitive with Oakwood’s Microsphere Project." Oakwood asserts that the product could not have been developed within the rapid timeframe without Thanoo’s assistance and the use of Oakwood’s trade secret information.The Third Circuit vacated the dismissal of Oakwood's suit, asserting trade secret misappropriation, breach of contract, and tortious interference with contractual relations. Under the Defend Trade Secrets Act, 18 U.S.C. 1836(b), Oakwood sufficiently identified its trade secrets and sufficiently alleged that the defendants misappropriated those trade secrets. The “use” of a trade secret encompasses all the ways one can take advantage of trade secret information to obtain an economic benefit, competitive advantage, or other commercial value, or for an exploitative purpose, such as research or development. A trade secret plaintiff need not allege that its information was the only source by which a defendant might develop its product. Aurobindo's avoidance of substantial research and development costs that Oakwood has invested is recognized as "harm" in the DTSA. View "Oakwood Laboratories LLC v. Thanoo" on Justia Law

PacBio’s patents describe methods for sequencing a nucleic acid, such as DNA, using nanopore technology. PacBio sued Oxford for infringement. Before trial, the district court granted PacBio’s motion “to prevent [Oxford] from using ‘pejorative’ terms (such as ‘non-practicing entity,’ ‘NPE,’ and ‘paper patents’), stating “it would be inappropriate to put before the jury evidence or argument about the potential impact of a verdict in favor of PacBio— such as higher prices or slower medical research.”A jury found all asserted claims infringed but also determined that they are invalid under 35 U.S.C. 112 for lack of enablement. The district court upheld the verdict on enablement and denied PacBio’s request for a new trial because of Oxford’s improper opening remarks that included references to the potential applications of its accused products to the then-emerging global COVID-19 crisis. The Federal Circuit affirmed. The record supports the legal conclusion that the disclosures of the patents, even combined with the knowledge of relevant artisans, required undue experimentation to enable the full scope of the relevant claims. The court reasonably denied a new trial, given PacBio’s own conduct and references to COVID-19, and its successful request for no more than curative instructions. View "Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Inc." on Justia Law

Stanford’s 925 application is directed to methods and computing systems for determining haplotype phase--an indication of the parent from whom a gene has been inherited. Improved haplotype phasing techniques “promise[] to revolutionize personalized health care by tailoring risk modification, medications, and health surveillance to patients’ individual genetic backgrounds.” Achieving the understanding necessary to accomplish those goals requires “interpretation of massive amounts of genetic data produced with each genome sequence.” The 925 application describes a method for receiving genotype and pedigree data and processing the data by performing mathematical calculations and statistical modeling to arrive at a haplotype phase determination.The Federal Circuit affirmed the Patent Trial and Appeal Board in rejecting the claims as patent-ineligible under 35 U.S.C. 101 because they are drawn to abstract mathematical calculations and statistical modeling, and similar subject matter that is not patent-eligible. Claim 1 recites no steps that practically apply the claimed mathematical algorithm; instead, claim 1 ends at storing the haplotype phase and “providing” it “in response to a request.” Simply storing information and providing it upon request does not alone transform the abstract idea into patent-eligible subject matter. View "In Re Board of Trustees of the Leland Stanford Junior University" on Justia Law

Bayer’s patent is directed to recombinant forms of human factor VIII (FVIII), a protein that is produced, and released into the bloodstream, by the liver. In Bayer’s suit, alleging that Baxalta’s biologic product Adynovate® infringes certain claims of the patent, a jury found that the asserted claims were enabled and infringed, and that Bayer was entitled to reasonable-royalty damages. The district court did not send the question of willful infringement to the jury, holding as a matter of law that Baxalta’s conduct did not meet the requirements for willfulness.The Federal Circuit affirmed, rejecting Baxalta’s challenges to the district court’s construction of the claim term “at the B-domain” and its interpretation of the word “random” in its construction of the claim term “an isolated polypeptide conjugate.” The court upheld the district court’s judgments of infringement and enablement as supported by substantial evidence, along with the court’s awards of damages and pre-verdict supplemental damages. Even accepting Bayer’s evidence as true and weighing all inferences in Bayer’s favor, the record is insufficient to establish that Baxalta’s “conduct rose to the level of wanton, malicious, and bad-faith behavior required for willful infringement.” View "Bayer HealthCare LLC v. Baxalta Inc." on Justia Law

Elevated LDL cholesterol is linked to heart disease. LDL receptors remove LDL cholesterol from the bloodstream; the PCSK9 enzyme regulates LDL receptor degradation. Amgen’s 165 and 741 patents describe antibodies that purportedly bind to the PCSK9 protein and lower LDL levels by blocking PCSK9 from binding to LDL receptors. Amgen sued Sanofi, alleging infringement of multiple patents, including the 165 and 741 patents. Amgen and Sanofi stipulated to infringement of selected claims and tried issues of validity to a jury.The court granted judgment as a matter of law (JMOL) of nonobviousness and of no willful infringement. Following remand, a jury again found that Sanofi failed to prove that the asserted claims were invalid for lack of written description and enablement. The district court granted Sanofi’s Motion for JMOL for lack of enablement and denied the motion for lack of written description. The Federal Circuit affirmed. Undue experimentation would be required to practice the full scope of these claims, which encompasses millions of candidates claimed with respect to multiple specific functions. It would be necessary to first generate and then screen each candidate antibody to determine whether it meets the double-function claim limitations. View "Amgen Inc. v. Sanofi, Aventisub LLC" on Justia Law

AndroGel, a testosterone replacement therapy, generated billions of dollars in sales, The Federal Trade Commission sued the owners of an AndroGel patent under Section 13(b) of the Federal Trade Commission Act, 21 U.S.C. 301, alleging that they filed sham patent infringement suits against Teva and Perrigo and entered into an anticompetitive reverse-payment agreement with Teva. The FTC accused the defendants of trying to monopolize and restrain trade over AndroGel. The District Court dismissed the FTC’s claims to the extent they relied on a reverse-payment theory but found the defendants liable for monopolization on the sham-litigation theory. The court ordered the defendants to disgorge $448 million in profits but denied the FTC’s request for an injunction.The Third Circuit reversed in part. The district court erred by rejecting the reverse-payment theory and in concluding that the defendants’ litigation against Teva was a sham. The court did not err in concluding the Perrigo litigation was a sham and that the defendants had monopoly power in the relevant market. The FTC has not shown that monopolization entitles it to any remedy. The court did not abuse its discretion in denying injunctive relief. The court erred by ordering disgorgement because that remedy is unavailable under Section 13(b). View "Federal Trade Commission v. AbbVie Inc" on Justia Law

Vectura sued GSK in 2016, alleging direct infringement of claim 3 of the 991 patent, which concerns the production of “composite active particles” for use in pulmonary administration, such as in dry-powder inhalers. The composite active particles described in the patent consist of additive material that is adhered to particles of the active ingredient. The active ingredient produces the desired chemical or biological effect, while the additive particles promote the dispersion and delivery of the active ingredient into the lungs when the inhaler is activated.The Federal Circuit affirmed holdings that the patent was infringed and not invalid. The court rejected arguments that Vectura failed to present substantial evidence that the accused inhalers use additive material that “promotes the dispersion” of the active material, that the district court’s construction of the term “composite active particles” was erroneous, that there were flaws in the calculation of the royalty proposed by Vectura’s damages expert, and that Vectura made prejudicial references to GSK’s sales and advanced an improper “pennies on the dollar” argument in comparing Vectura’s royalty request to GSK’s sales. View "Vectura Ltd. v. GlaxoSmithKline, LLC" on Justia Law

Fein was a consultant for Ferring Pharmaceuticals, involved in a project involving desmopressin, a synthetic analog of the naturally occurring hormone arginine vasopressin, which regulates the body’s retention of water. Fein suggested administration as a waterless orodispersible form to improve the bioavailability of the desmopressin. In 2002, Ferring filed a Great Britain Patent Application, covering an orodispersible desmopressin formulation but did not list any inventors. When Ferring experienced production delays, it undertook another clinical study with an intravenous desmopressin formulation. Fein was selected to oversee the U.S. study and suggested certain changes. After Ferring terminated Fein’s consulting agreement, both parties continued to test various formulations. Both Ferring and Fein filed patent applications. Fein’s company sold the right to commercialize a low-dose desmopressin intranasal spray.Ferring unsuccessfully requested reexamination of Fein’s patent, then filed a complaint asserting state law claims and claims for correction of inventorship of the Fein patents under 35 U.S.C. 256. The district court granted the defendants summary judgment, finding that conduct occurring before the issuance of Fein's patents could give rise to equitable estoppel of claims for correction of inventorship. The court noted Ferring’s inaction for over seven years following letters from Fein’s attorney. On counterclaims for correction of inventorship of Ferring’s patents, the court granted Ferring judgment. The Federal Circuit vacated and remanded for further development of the record, noting the fact-laden equitable issue and the need to avoid a rush to judgment. View "Ferring B.V. v. Allergan, Inc." on Justia Law