Justia Drugs & Biotech Opinion Summaries

Methicillin-resistant Staphylococcus aureus (MRSA), and other Gram-positive bacteria that have developed resistance to antibiotics cause health problems, particularly in the hospital environment. TheUniversity of Strathclyde’s 706 patent addresses problems resulting from the “availability of few effective sterili[z]ation methods for environmental decontamination” of air and surfaces and discloses photoinactivation as a method that has emerged for killing harmful bacteria like MRSA and describes a method for photo-inactivating antibiotic-resistant bacteria like MRSA without using a photosensitizing agent.In inter partes review, the Patent Trial and Appeal Board found claims 1–4 of the 706 patent unpatentable as obvious, 35 U.S.C. 103. The Federal Circuit reversed. Neither the Board’s finding that the prior art disclosed all claim limitations nor its finding of a reasonable expectation of success is supported by substantial evidence. No reasonable factfinder could have found that the combination of the prior art discloses inactivating one or more Gram-positive bacteria without using a photosensitizer. In this case, where the prior art establishes only failures to achieve that at which the inventors succeeded, no reasonable factfinder could find an expectation of success based on the teachings of that same prior art. View "University of Strathclyde v. Clear-Vu Lighting, LLC" on Justia Law

Celgene markets pomalidomide as a multiple-myeloma drug under the brand name Pomalyst. Many drug companies questioned the validity or applicability of Celgene's patents and sought to bring generic pomalidomide to market. The defendants submitted an abbreviated new drug application (ANDA) to the FDA. Celgene filed suit in New Jersey. Celgene is headquartered there, but no defendant is. MPI is based in West Virginia, Mylan Inc. in Pennsylvania, and Mylan N.V. in Pennsylvania and the Netherlands. The district court dismissed the case for improper venue (MPI; Mylan Inc.) and for failure to state a claim (as to Mylan N.V.).The Federal Circuit affirmed. Under the Hatch-Waxman Act, 21 U.S.C. 355(j)(5)(B)(iii), venue was improper in New Jersey for the domestic corporation defendants, MPI and Mylan Inc. Celgene did not show that those defendants committed acts of infringement in New Jersey and have a regular and established place of business there. The court rejected Celgene’s argument that receipt of the ANDA notice letter is an infringing act in New Jersey. Under section 271(e)(2), submitting an ANDA is the act of infringement; although the ANDA applicant must later send a notice letter that happens after the infringing submission. As to the foreign-corporation defendant, Mylan N.V., Celgene’s pleadings failed to state a claim upon which relief could be granted. View "Celgene Corp. v. Mylan Pharmaceuticals Inc." on Justia Law

OptiNose AS and OptiNose, Inc. (collectively, OptiNose) agreed to license its Exhalation Delivery Systems (“EDS”) technology to Currax Pharmaceuticals, LLC. The parties limited the License Agreement to a product which used a powder EDS device to deliver the migraine treatment drug sumatriptan into the nasal cavity. The product covered by the license, a powder EDS device and sumatriptan together, was trade-named ONZETRA(R) XSAIL(R). Currax had a limited right to sell the sumatriptan powder EDS device (the “Product”) in Canada, the United States, and Mexico. OptiNose retained the right to sell EDS devices: (1) with powders and liquids other than sumatriptan around the world; and (2) EDS devices with sumatriptan in every area other than those three countries. OptiNose also gave Currax the “first right” to “prosecute and maintain” certain patents related to the Product, listed in the License Agreement as the Product Patents. During Currax’s prosecution of the ’009 Patent Application, the U.S. Patent and Trademark Office (“USPTO”) rejected claims because they were not “patentably distinct” from the claims in another Product Patent. To overcome the patent office rejection, Currax needed to file a terminal disclaimer over the issued Product Patent. Currax needed a power of attorney from OptiNose to file a terminal disclaimer. OptiNose refused to provide it. Currax filed suit against OptiNose in the Court of Chancery, seeking an order of specific performance requiring OptiNose to grant it a power of attorney. OptiNose counterclaimed for a declaration that the License Agreement did not require it to provide a power of attorney. According to OptiNose, Currax’s right to prosecute Product Patents did not include a power of attorney, and, in any event, Currax could not file a terminal disclaimer without OptiNose’s advance approval, which it had not given. The Court of Chancery granted Currax’s motion for judgment on the pleadings, finding the License Agreement OptiNose to provide a power of attorney to prosecute the ’009 Application. On appeal, the parties focused primarily on OptiNose’s advance approval right, and whether a terminal disclaimer “relate[s] to or characterize[s] the Device component of the Patent or other OptiNose intellectual property.” The Delaware Supreme Court affirmed the Court of Chancery’s judgment that filing a terminal disclaimer in the ’009 Application prosecution was included in the rights OptiNose gave to Currax under the License Agreement. View "Optinose AS v. Currax Pharmaceuticals, LLC" on Justia Law

Epinephrine (adrenaline), a hormone that has been on the market since approximately 1938, is used for various medical purposes. It degrades by racemization and oxidation. A 1986 publication taught that “there is an optimum pH at which racemization and oxidation can be balanced to minimize loss of intact drug by these two routes.” In 2012, Belcher submitted New Drug Application (NDA) for a 1 mg/mL injectable l-epinephrine formulation. The NDA was literature-based; Belcher did not perform any studies on its epinephrine formulation. Belcher responded to FDA inquiries concerning pH levels and racemization. In 2014, Belcher filed an application entitled “More Potent and Less Toxic Formulations of Epinephrine and Methods of Medical Use,” resulting in the 197. Hospira then submitted an NDA seeking approval of a 0.1 mg/mL injectable l-epinephrine formulation, including a Paragraph IV certification (21 U.S.C. 355(b)(2)(A)(iv)) alleging that the patent’s claims are invalid, unenforceable, and/or not infringed. Belcher sued Hospira for infringement.The Federal Circuit affirmed a finding that the patent was unenforceable for inequitable conduct. Belcher’s Chief Science Officer withheld material information about the pH range and the impurity levels from the Patent and Trademark Office. Belcher’s alleged critical improvement over the prior art was already within the public domain, just not before the examiner. Belcher’s officer acted with intent to deceive. View "Belcher Pharmaceuticals, LLC v. Hospira, Inc." on Justia Law

T cells, white blood cells that contribute to the immune response, have naturally occurring receptors on their surfaces that facilitate their attack on target cells (such as cancer cells) by recognizing and binding an antigen, i.e., a structure on a target cell’s surface. Chimeric antigen receptor (CAR) T-cell therapy involves isolating a patient’s T cells; reprogramming those T cells to produce a specific, targeted receptor (a CAR) on each T cell’s surface; and infusing the patient with the reprogrammed cells. Juno’s patent relates to a nucleic acid polymer encoding a three-part CAR for a T cell. It claims priority to a provisional application filed in 2002, at “the birth of the CART field.” Kite’s YESCARTA® is a “therapy in which a patient’s T cells are engineered to express a [CAR] to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells.”Juno sued, alleging infringement. The district court held that the claims were not invalid for lack of written description or enablement, the patent’s certificate of correction was not invalid, and Juno was entitled to $1,200,322,551.50 in damages. The Federal Circuit reversed. No reasonable jury could find the patent’s written description sufficiently demonstrates that the inventors possessed the full scope of the claimed invention. View "Juno Therapeutics, Inc v. Kite Pharma, Inc." on Justia Law

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