Justia Drugs & Biotech Opinion Summaries

Bayer’s patent concerns genetically modifying plants to confer resistance to a common herbicide (2,4-D) by inserting a particular DNA segment into plant cells, which reproduce to create new cells that contain that gene. Those cells produce an enzyme that catalyzes a biochemical reaction with 2,4-D in which the herbicide is broken down into something harmless to the plant. A plant with the gene survives 2,4-D application while surrounding weeds do not. At the time of the patent application, the inventors had sequenced one gene coding for one enzyme, using a test supposedly capable of finding other, similar genes. In writing the application, they claimed a broad category based on the function of the particular enzyme, defining the category by using a term with established scientific meaning. Years before the patent issued, experiments showed that the term did not apply to the particular enzyme whose gene was sequenced, but Bayer did not change its claim language. When Bayer sued Dow for infringement, Bayer recognized that the term’s established scientific meaning, did not cover the accused product, which was, itself, different from the enzyme whose gene Bayer’s inventors had sequenced. Bayer argued for broad functional claim construction. The district court entered summary judgment of noninfringement, citing particularly the great breadth of the asserted functional construction. The Federal Circuit affirmed. View "Bayer CropScience AG v. Dow AgroSciences, LLC" on Justia Law

SkinMedica owns the 494 and 746 patents, which relate to methods for producing pharmaceutical compositions containing “novel conditioned cell culture medium compositions ... [and] uses for the[m].” Skinmedica filed a patent infringement suit against Histogen for producing dermatological products according to methods covered by the claims of those patents. The district court entered summary judgment of noninfringement after construing the phrase “culturing ... cells in three-dimensions” as “growing ... cells in three dimensions (excluding growing in monolayers or on microcarrier beads).” The Federal Circuit affirmed. View "SkinMedica Inc v. Histogen Inc" on Justia Law

Prior art concerning treatment of the skin disease, psoriasis, discloses a combination treatment of a vitamin D analog and a corticosteroid. Leo’s patent calls for simultaneous treatment with vitamin D and corticosteroids to heal psoriasis faster and more effectively; a storage-stable combination of vitamin D and corticosteroids in a single formulation did not exist in prior art because vitamin D and corticosteroids have different pH requirements for optimum stability. Because of the storage-stability problem, doctors had to prescribe a regimen that required patients to apply one drug in the morning and another at night, which caused patient compliance issues. Leo discovered that a new set of solvents, including polyoxypropylene 15 stearyl ether, solved the storage stability problem by allowing the vitamin D analog and corticosteroid to coexist in a single pharmaceutical product. The Board of Patent Appeals rejected several claims. The Federal Circuit reversed. The Board incorrectly construed the term “storage stable,” incorrectly found the claimed invention would have been obvious in view of prior art, and incorrectly weighed the objective indicia of nonobviousness. View "Leo Pharm. Prods., Ltd. v. Kappos" on Justia Law

Conventional tests for prenatal abnormalities caused by genetic abnormalities have relied on invasive and potentially risky techniques like amniocentesis to obtain fetal cells. As an alternative, scientists developed methods of analyzing DNA extracted from fetal cells floating in maternal blood to determine fetal abnormalities and other fetal traits. These methods require separating fluids from the cells and then discarding the fluids, either plasma or serum, and then separating fetal cells from the much more common maternal cells. The 540 patent discloses methods to identify fetal genetic defects by analyzing the fluid that had commonly been discarded as medical waste: maternal plasma or serum. The new tests presented fewer risks and a better rate of abnormality detection. Ariosa sought a declaratory judgment that it could use its Harmony test without infringing the 540 patent. The district court denied the patent holder’s motion for summary judgment. The Federal Circuit vacated and remanded, finding that the district court incorrectly interpreted the asserted claim terms “amplifying” and “paternally inherited nucleic acid” and improperly balanced factors regarding issuance of a preliminary injunction. View "Aria Diagnostics, Inc. v. Sequenom, Inc." on Justia Law

Rembrandt’s patent relates to contact lenses that have a highly wettable surface and are permeable to oxygen. The patent discloses a soft gas permeable lens with an acrylic layer on the surface of the lens body that increases the wettability and comfort of the contact lens. The district court held that Johnson & Johnson did not infringe the patent. The Federal Circuit affirmed. View "Rembrandt Vision Techs., L.P. v. Johnson & Johnson Vision Care, Inc." on Justia Law

Generic manufacturers submitted Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market generic versions of Copaxone®, a drug used in treating multiple sclerosis. Teva, which markets Copaxone®, sued the generic manufacturers for patent infringement under 35 U.S.C. 271(e)(2)(A). The patents at issue share a common specification and are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) entry for Copaxone®. The patents include claims reciting a product called copolymer-1 and recite two methods of making copolymer-1: one using statistical average measures and the other describing how many molecules in a polymer sample have molecular weights that fall within an arbitrarily set range. The district court found that various claims of the nine patents by Teva are infringed, based on holdings regarding indefiniteness, nonenablement, and obviousness. The Federal Circuit affirmed in part and reversed in part, holding that Group I claims are invalid for indefiniteness, but that Group II claims were not proven indefinite. The district court did not err in finding that the claims are infringed, and that the generic manufacturers failed to prove that the claims would have been obvious and are not enabled. View "Teva Pharm. USA, Inc. v. Sandoz, Inc." on Justia Law

The patent at issue concerns methods for preventing bovine mastitis, the inflammation of udder tissue in cows, and is entitled “Antiinfective free intramammary veterinary composition.” The summary of the invention describes how the composition employs a physical barrier within the teat canal to block introduction of mastitis-causing organisms without requiring use of antiinfectives such as antibiotics. A patent examiner rejected certain claims introduced in the context of ex parte reexamination. The Patent Trial and Appeal Board and Federal Circuit affirmed, finding that substantial evidence supported the Board’s finding that one claim failed the written description requirement because the disclosure did not “describe[] a formulation excluding a specific species of the anti-infective genus, while permitting others to be present.” View "In re: Bimeda Research & Dev. Ltd." on Justia Law

The Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act), 21 U.S.C. 355(j)(2)(A)(vii)(IV) established procedures for identifying and resolving patent disputes between brand-name and generic drug manufacturers. One procedure requires a prospective generic manufacturer to certify to the FDA that any listed, relevant patent is invalid or will not be infringed by the manufacture, use, or sale of the generic drug (paragraph IV). Generic manufacturers filed paragraph IV applications for generic drugs modeled after Solvay’s FDA-approved, patented drug AndroGel. Solvay claimed patent infringement, 35 U.S.C. 271(e)(2)(A). The FDA approved the generic product, but the generic companies entered into “reverse payment” settlements, agreeing not to bring the generic to market for a number of years and to promote AndroGel to doctors in exchange for millions of dollars. The FTC sued, alleging violation of section 5 of the Federal Trade Commission Act by agreeing to abandon patent challenges, to refrain from launching low-cost generic drugs, and to share in Solvay’s monopoly profits. The district court dismissed. The Eleventh Circuit affirmed. The Supreme Court reversed and remanded, calling for application of a “rule of reason” approach rather than a “quick look.” Although the anti-competitive effects of the reverse settlement might fall within the exclusionary potential of Solvay’s patent, the agreement is not immune from antitrust attack. It would be incongruous to determine antitrust legality by looking only at patent law policy, and not at antitrust policies. The Court noted the Hatch-Waxman Act’s general pro-competitive thrust, facilitating challenges to a patent’s validity and requiring parties to a paragraph IV dispute to report settlement terms to antitrust regulators. Payment for staying out of the market keeps prices at patentee-set levels and divides the benefit between the patentee and the challenger, while the consumer loses. That a large, unjustified reverse payment risks antitrust liability does not prevent parties from settling their lawsuits; they may settle in other ways, e.g., by allowing the generic to enter the market before the patent expires without payment to stay out prior to that point. View "Fed. Trade Comm'n v. Actavis, Inc." on Justia Law

Myriad obtained patents after discovering the precise location and sequence of the BRCA1 and BRCA2 genes, mutations of which can dramatically increase the risk of breast and ovarian cancer. The discovery enabled Myriad to develop medical tests for detecting mutations for assessing cancer risk. Myriad’s patents would give it the exclusive rights to isolate an individual’s BRCA1 and BRCA2 genes and to synthetically create BRCA composite DNA. The district court entered summary judgment, finding the patents invalid under 35 U.S.C. 101 because they covered products of nature. On remand following the Supreme Court’s decision, Mayo Collaborative Servs. v. Prometheus Labs, Inc., the Federal Circuit found both isolated DNA and composite DNA patent-eligible. The Supreme Court affirmed in part and reversed in part, noting that the case did not involve “method claims” for new applications of knowledge about the genes or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. A naturally-occurring DNA segment is not patent-eligible merely because it has been isolated, but composite DNA is patent-eligible because it is not naturally-occurring. Myriad did not create or alter the genetic information encoded in the genes or the genetic structure of the DNA. Even brilliant discovery does not alone satisfy the section 101 inquiry. Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs chemical bonds that bind gene molecules together. The claims are not expressed in terms of chemical composition, nor do they rely on the chemical changes resulting from the isolation of a particular DNA section. Composite DNA, however, is not a “product of nature;” a lab technician unquestionably creates something new when introns are removed from a DNA sequence to make composite DNA. View "Assoc. for Molecular Pathology v. Myriad Genetics, Inc." on Justia Law

Once the FDA has approved a brand manufacturer's drug, another company could seek permission to market a generic version pursuant to legislation known as the Hatch-Waxman Amendments. See Drug Price Competition and Patent Term Restoration Act of 1984, 98 Stat. 1585. The relevant statute at issue in this case provided that a generic company "may assert a counterclaim seeking an order requiring the [brand manufacturer] to correct or delete the patent information [it] submitted... under [two statutory subsections] on the ground that the patent does not claim... an approved method of using the drug." 117 Stat. 2452, 21 U.S.C. 355(j)(5)(C)(ii)(I). At issue in this case was whether Congress had authorized a generic company to challenge a use code's accuracy by bringing a counterclaim against the brand manufacturer in a patent infringement suit. The Court held that a generic manufacturer could employ this provision to force correction of a use code that inaccurately described the brand's patent as covering a particular method of using the drug in question. Therefore, the Court reversed the judgment of the Federal Circuit. View "Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S" on Justia Law