Justia Drugs & Biotech Opinion Summaries

UCB sought a declaration that its Cimzia® brand antibody does not infringe Yeda’s 923 Patent and that the 923 Patent was invalid. Yeda counterclaimed for infringement. The district court granted summary judgment of non-infringement, holding that, based on the specification and prosecution history, the monoclonal antibodies claimed in the 923 patent are not infringed by the chimeric or humanized antibodies of the Cimzia® product. The Federal Circuit affirmed, finding that the district court correctly applied the law and that Yeda is estopped from including chimeric and humanized antibodies within the scope of the monoclonal antibodies claimed in the 923 Patent. View "UCB, Inc. v. Yeda Research & Dev. Co., Ltd." on Justia Law

The 997 patent relates to spinal surgery that “insert[s] an artificial implant between two adjacent vertebrae” from a patient’s side and discloses “instrumentation and methods of performing surgical procedures on the human thoracic and lumbar spine along the lateral aspect [(i.e., side)] of the spine” to correct “thoracic and lumbar disc disease and spinal deformities where concomitant fusion is desired.” The lateral approach to spinal surgery seeks to avoid complications that may arise when the surgery is performed from the patient’s front or back. Based on petitions filed by NuVasive, the Patent Trial and Appeal Board instituted inter partes review and found claims 1–8 and 17–23 obvious and therefore invalid. The Federal Circuit affirmed in part. Substantial evidence supported findings of obviousness in light of prior art and concerning motivation to combine prior art. The court vacated with respect to a limitation in one specific claim. View "In re: Warsaw Orthopedic, Inc." on Justia Law

TMC owns patents relating to bivalirudin, a synthetic peptide anti-coagulant. TMC sells the drug for injection under the Angiomax® brand and, from 1997 to 2006, purchased pharmaceutical batches from BV. In 2005, BV created batches of bivalirudin with levels of impurity above the FDA-approved maximum. TMC’s consultant discovered that certain methods of adding a pH-adjusting solution during compounding minimize the impurity. In 2008, TMC filed patent applications, describing this discovery. A year earlier, TMC had hired BV to prepare batches using the patented method. Each was released for commercial packaging. In 2010, TMC sued, alleging infringement by Hospira’s ANDA filings. The district court found the patents not infringed and not invalid as obvious, indefinite, or under the on-sale bar (35 U.S.C. 102(b)), which applies when, before the critical date, the claimed invention was the subject of a commercial offer for sale and was ready for patenting. The court found that the claimed invention was ready for patenting but not commercially offered for sale. The Federal Circuit initially reversed, but affirmed on reconsideration. To be “on sale” a product must be the subject of a commercial sale or offer for sale; a commercial sale bears the general hallmarks of a sale pursuant to Section 2-106 of the Uniform Commercial Code. No such invalidating commercial sale occurred in this case. View "Medicines Co. v. Hospira, Inc." on Justia Law

Hepatocytes, a type of liver cell, are useful for testing, diagnostic, and treatment purposes. Fresh hepatocytes can only be obtained from liver resections or non-transplantable livers of organ donors; their lifespan is short. Supply is erratic. Before the 929 patent, scientists developed “cryopreservation” techniques, but the process could damage the hepatocytes and was unsuitable for multi-donor hepatocyte pools. Prevailing wisdom was that hepatocytes could be frozen only once before being used or discarded. The 929 parent's inventors discovered that some hepatocytes can survive multiple freeze-thaw cycles and developed an improved process: subjecting thawed cells to density gradient fractionation to separate viable from non-viable cells; recovering the viable cells; and refreezing the viable cells. After refreezing only the viable cells, the preserved hepatocyte preparations can be thawed and used later without unacceptable loss of viability. Hepatocyte samples from single donors can be pooled into a composite preparation that can be refrozen for later use. In an infringement suit, the court found the patent invalid under 35 U.S.C. 101, as directed to a patent-ineligible law of nature—that hepatocytes can survive multiple freeze-thaw cycles—and that the patented process lacks the requisite inventive concept. The Federal Circuit vacated. That each of the individual steps (freezing, thawing, and separating) were known independently in the art does not make the claim unpatentable; patent-eligibility does not turn on ease of execution or obviousness of application. View "Rapid Litig. Mgmt. v. Cellzdirect, Inc." on Justia Law

Apotex applied to the FDA, under the Biologics Price Competition and Innovation Act of 2009, for permission to begin marketing a product allegedly “biosimilar” to Amgen’s FDA-approved Neulasta®. Apotex and Amgen proceeded under the Act’s process for exchanging information and channeling litigation about patents relevant to the application. In this suit, Amgen alleged that Apotex’s proposed marketing would infringe an Amgen patent. On Amgen’s motion, the district court preliminarily enjoined Apotex from entering the market unless it has given Amgen notice after receiving the requested FDA license and then waited 180 days, pursuant to 42 U.S.C. 262(l)(8)(A). The Federal Circuit affirmed. The Act’s commercial-marketing provision is mandatory, with the 180-day period beginning only upon post-licensure notice, and an injunction was proper to enforce the provision against even a biosimilar product​ applicant that did engage in the statutory process for exchanging patent information and channeling patent litigation. View "Amgen Inc. v. Apotex Inc." on Justia Law

Pompe’s disease is a genetic condition associated with a deficiency or absence of the lysosomal enzyme acid α-glucosidase (GAA), which breaks down glycogen, a larger molecule, into glucose. In a person with Pompe’s disease, glycogen accumulates in the heart and muscles, causing progressive muscle weakness and respiratory symptoms, and, in early-onset cases, cardiac symptoms. Early efforts at enzyme replacement therapy failed because the injected enzyme was predominantly taken up by the patient’s liver. By 1997, research had progressed and the FDA approved Duke University’s application for Orphan Drug Designation for a new therapy, involving injection of a recombinant form of GAA. In 2013, Biomarin sought inter partes review of Genzyme’s patents, directed to treating Pompe’s disease with injections of GAA, asserting that claims were obvious, given the Duke press release and prior references. Genzyme argued that because all references described in vitro experiments, a person of ordinary skill would not find those experiments predictive of results in a human patient. The Federal Circuit affirmed the Patent Board’s conclusion that “a person of ordinary skill in the art would have had a reasonable expectation of success at the time the invention was made,” and “no more than routine processes were needed” to achieve the results recited in the disputed claims. View "Genzyme Therapeutic Prods., Ltd. P'ship v. Biomarin Pharma., Inc." on Justia Law

Finacea® Gel contains azelaic acid as the therapeutically active ingredient in a concentration of 15% by weight and is indicated for the topical treatment of rosacea. Finacea® is manufactured as a “hydrogel,” which the court construed to mean “a semisolid dosage form that contains water and a gelling agent to form a gel, which may contain dispersed particles and/or insoluble liquids.” The FDA Orange Book lists the 070 patent as covering Finacea® Gel. The 070 patent, entitled “Composition with Azelaic Acid,” issued in 2003 and claims priority to a 1998 provisional application. Glenmark submitted an Abbreviated New Drug Application to the FDA seeking to market a generic version of Finacea®, including a paragraph IV certification (21 U.S.C. 355(j)(2)(A)(vii)(IV)) that the patent was invalid and not infringed. Unlike Finacea®, the proposed generic product substituted isopropyl myristate for the claimed triglyceride and lecithin. The court held that certain claims were infringed under the doctrine of equivalents and not invalid. The court concluded that the isopropyl myristate in Glenmark’s generic product met the claim elements triglyceride and lecithin under the doctrine of equivalents, relying on the function-way-result test. The court rejected arguments that infringement under the doctrine of equivalents would encompass the prior art and was barred by prosecution history estoppel. The Federal Circuit affirmed, agreeing that the asserted claims would not have been obvious. View "Intendis GMBH v. Glenmark Pharma., Inc." on Justia Law

In 1997, Merck and Weider considered jointly introducing, into the U.S., dietary supplements with Merck ingredients, including crystalline calcium salt of a tetrahydrofolic acid (MTHF), agreeing that, until a definitive agreement was signed, neither party was under any legal obligation. Weider later notified Merck that it was no longer interested in a joint venture, but would like to purchase two kilograms of MTHF. Merck quoted a price of $25,000 per kg. After extensive correspondence, in October 1998, Merck sent confirmation of the “first order.” Merck then met with a Weider competitor. Merck contacted Weider in January 1999, asking whether its purchase order was still “active.” Weider sent confirmation that the parties had mutually cancelled Weider’s “existing order for [MTHF].” Merck filed its 168 patent application, including claim 4 (MTHF), in 2000; the patent issued in 2002. In a 2013 infringement suit concerning Abbreviated New Drug Applications, the court held that claim 4 was not anticipated, obvious, or invalid for lack of adequate written description and was not invalid under the on-sale bar. Although the court determined that MTHF was ready for patenting by September 1998, it concluded that there had been no invalidating commercial offer for sale or sale, because Merck’s fax did not include “important safety and liability terms.” The Federal Circuit reversed. Merck’s September 1998, offer to sell MTHF was a premature commercial exploitation of its invention. View "Merck & Cie v. Watson Labs., Inc." on Justia Law

Stryker’s 243 patent concerns a socket assembly used in prosthetic hip implants. The patent addresses three major components involved: a shell member and a bearing member, which together replace the socket (technically the acetabulum) part of the pelvis bone, and the femoral component, the ball-shaped end of the thigh bone that marries with the socket. The district court granted summary judgment of noninfringement following claim construction. The Federal Circuit upheld the construction of “relative location” claim language to require that “the recess is essentially midway along the taper such that the effectiveness of each is not compromised” and to require that “the internal taper of the shell mates with the external taper of a metallic securing member (i.e. sleeve) secured to and separate from the bearing member,” essentially requiring the presence of a sleeve in between the shell and the bearing, for the taper type of securement. The district court did not abuse its discretion in applying its local rules to preclude Stryker from arguing infringement under the doctrine of equivalents. View "Howmedica Osteonics Corp. v. Zimmer, Inc." on Justia Law

GTG’s 179 patent claims methods of analyzing sequences of genomic deoxyribonucleic acid (DNA) for decoding genetic variations. The Federal Circuit affirmed dismissal of GTG’s infringement suit, finding certain claims ineligible for patenting under 35 U.S.C. 101. The court stated that GTG’s attempts to distinguish its position on the ground that the method of the claim is useful “have no basis in case law or in logic.” The claim ineligible for claiming unpatentable subject matter, not for lack of utility; even valuable contributions can fall short of statutory patentable subject matter. View "Genetic Techs. Ltd. v. Merial L.L.C." on Justia Law