Justia Drugs & Biotech Opinion Summaries

Senju sued defendants for infringement of the reexamined 045 patent, alleging constructive infringement under the Hatch-Waxman Act, 98 Stat. 1585. Defendants counterclaimed seeking a declaratory judgment of noninfringement and invalidity. The patent relates to gatifloxacin, an aqueous liquid pharmaceutical eye drop composition, with added disodium edetate. Seven prior art patents were alleged as the basis for the obviousness determination, each containing some of the same chemistry as the claimed invention. There are several prior patent infringement suits involving the same chemistry and the same 045 patent. The district court adjudged the claims infringed but invalid for obviousness. The Federal Circuit affirmed. The district court properly applied a presumption of validity, considering both the evidence of obviousness and the evidence of unexpected results, to find clear and convincing evidence of invalidity; it was not clear error for the court to conclude that the unexpected results evidence that Senju relied upon during reexamination did not withstand scrutiny by Lupin’s experts and the court. View "Senju Pharma. Co. v. Lupin, Ltd." on Justia Law

Warsaw owns the 973 patent, which claims oversized spinal implants, and the 933 patent, which claims methods and devices for retracting tissue to create a working channel for minimally invasive spinal surgery. NuVasive owns the 236 patent, which relates to neuromonitoring during surgery. Warsaw sued NuVasive, alleging infringement; NuVasive counterclaimed, asserting infringement. A jury found that the asserted claims of the 973 patent were not invalid (infringement was not in dispute), that the asserted claims of the 933 patent were infringed under the doctrine of equivalents (validity was not in dispute), and that the asserted claims of the 236 patent were infringed (validity was not in dispute), and awarded damages for each. The district court denied motions for JMOL or a new trial; denied Warsaw’s requests for supplemental damages and a permanent injunction; and set ongoing royalty rates. The Federal Circuit affirmed with respect to invalidity and infringement of all three patents, but remanded for a new trial on damages with respect to the 973 and 933 patents. On remand, Warsaw will be limited to a reasonable royalty and cannot recover lost profits. View "Warsaw Orthopedic, Inc. v Nuvasiive, Inc." on Justia Law

The application from which the 135 patent issued (28 years later) was filed in 1974. The patent relates to prosthetic vascular grafts made of highly-expanded polytetrafluoroethylene (ePTFE), consisting of solid nodes of PTFE connected by thin PTFE fibrils. The graft formed by ePFTE is homogeneously porous: a structure that allows uniform cell regrowth to establish a firm integration of the graft into the body. The different claims of the patent are directed to grafts made of ePTFE with varying intermodal distances, which are also called fibril lengths. It is sold by Gore under as “Gore-Tex.” In 2003, BPV and Dr. Goldfarb sued Gore for infringement. A jury found the patent valid and that Gore willfully infringed. The Federal Circuit affirmed in 2012, but granted rehearing and vacated for the limited purpose of addressing willfulness, enhanced damages and attorneys’ fees. On remand, the district court again found that Gore, as a “reasonable litigant,” could not have realistically expected its defenses to succeed. The Federal Circuit affirmed, rejecting a claim that neither BPV nor Goldfarb had standing to sue for infringement and holding that Gore’s position was not susceptible to a reasonable conclusion that the patent was invalid on inventorship grounds. View "Bard Peripheral Vascular, Inc. v. W.L. Gore & Assocs., Inc." on Justia Law

Plaintiffs own patents relating to the BRCA1 and BRCA2 genes, mutations of which are linked to hereditary breast and ovarian cancers. In prior litigation, the Supreme Court held that claims of one of the patents were drawn to patent-ineligible subject matter because the isolated DNA strands were natural phenomena. Generic competitors entered the market for kits to test for susceptibility to particular kinds of cancer. Plaintiffs sought a preliminary injunction, alleging infringement of 66 claims across 15 patents. The district court denied a preliminary injunction. The four composition of matter claims on appeal are directed to primers, which are “short, synthetic, single-stranded DNA molecule[s] that bind[] specifically to . . . intended target nucleotide sequence[s].” The court held these were likely patent ineligible because they claim “products of nature.” The method claims on appeal involve comparisons between the wild-type BRCA sequences with the patient’s BRCA sequences. The court reasoned that these were likely ineligible because the only “inventive concepts” are the patent-ineligible naturally occurring BRCA1 and BRCA2 sequences themselves; the other steps are conventional activities, uniformly employed by those working with DNA. The Federal Circuit affirmed, finding that the claims are directed to ineligible subject matter under 35 U.S.C. 101. View "Univ. of Ut. Research Found. v. Ambry Genetics Corp." on Justia Law

The patents at issue relate DNA testing, specifically to multiplex amplification of short tandem repeat (STR) loci and claim methods or kits for simultaneously determining the alleles present in a set of STR loci from DNA samples, comprising: obtaining a DNA sample; selecting a set of loci of the DNA sample to amplify, including at least the specific loci recited in the claim; co-amplifying the selected loci in a multiplex amplification reaction; and evaluating the amplified alleles to determine the number of STR present at each loci. The district court entered judgment that the asserted claims were not invalid for lack of enablement and obviousness and that certain accused products did not infringe either the Promega patents the Tautz patent, vacating a verdict of damages and willful infringement. The Federal Circuit held that LifeTech was not licensed for all uses of the asserted patents under an agreement with Promega and, therefore, reversed with respect to infringement (under 35 U.S.C. 271(a) and 35 U.S.C. 271(f)(1)), and remanded for determination of damages. The Federal Circuit held that the asserted claims of the Promega patents are invalid for lack of enablement. View "Promega Corp. v. Life Tech. Corp." on Justia Law

Sandoz sought a declaratory judgment that two patents, exclusively licensed to Amgen, were invalid and unenforceable and would not be infringed if Sandoz uses, offers to sell or sells, or imports a drug product “biosimilar” to Amgen’s Enbrel®, which is a drug used for treatment of rheumatoid arthritis. Sandoz has not yet filed an application for approval of its contemplated product by the FDA and had only begun certain testing required for its contemplated FDA filing. The district court dismissed the case, determining that no Article III controversy (yet) existed between the parties and also that the suit was barred by the Biologics Price Competition and Innovation Act of 2009 (BPCIA), 42 U.S.C. 262. The Federal Circuit affirmed, concluding that Sandoz did not allege an injury of sufficient immediacy and reality to create subject matter jurisdiction. The court did not address interpretation of the BPCIA. View "Sandoz, Inc. v. Amgen, Inc." on Justia Law

Tyco sued alleging that Ethicon’s ultrasonic cutting and coagulating surgical devices infringed certain claims in three of its patents. The district court held that certain claims of those patents would not have been obvious under 35 U.S.C. 103, but that the other asserted claims are anticipated under 35 U.S.C. 102(g). The Federal Circuit upheld the section102(g) findings, but held that the section 103 determination was improper, including the court’s decision to exclude the section 102(g) prior art from the obviousness analysis. View "Tyco Healthcare Grp., LP v. Ethicon Endo-Surgery, Inc." on Justia Law

Megestrol was used to treat wasting in cancer patients. In 1993, Squibb marketed an oral suspension of micronized megestrol, Megace OS, for treatment of anorexia and cachexia in AIDS patients. Other manufacturers submitted Abbreviated New Drug Applications to market generic versions of Megace OS. Par received approval, but continued to experiment and eventually formulated nanosized megestrol. Patients taking Megace OS with a meal showed a significantly higher rate and extent of absorption compared with patients in a fasting state. The nanosized formulation showed a greatly reduced food effect, especially vital for patients with reduced appetites. The Patent Office rejected Par’s claims covering methods for nanosized megestrol formulations as obvious in light of prior art. Par amended to address the lack of a food effect in the nanosized formulation. The FDA approved Par’s New Drug Application for its nanoparticle formulation, Megace ES, which has generated more than $600M in net sales since 2005. Par pled guilty to marketing Megace ES without FDA approval as an effective weight-gain method for geriatric patients and as having superior clinical efficacy over Megace OS despite lack of clinical studies. TWi filed an ANDA for a generic nanosized megestrol, asserting that the Par patent was invalid or would not be infringed. Par sued under 35 U.S.C. 271(e)(2)(A). The Federal Circuit vacated the district court finding of invalidity; that court incorrectly applied the law on inherency in the context of obviousness. View "Par Pharma., Inc. v TWi Pharma., Inc." on Justia Law

Antares’s 015 patent, entitled “needle assisted jet injector,” discloses a system in which a needle punctures the skin before forcefully expelling a medication. With typical injectors the medication itself ruptures the outer layers of skin. During prosecution, the applicants distinguished prior art by emphasizing the “jet injector” limitation. The originally issued claims all contained the “jet injection” limitation. Antares later sought reissue under 35 U.S.C. 251, stating that the patentee claimed “more or less than he had a right to claim.” The 846 reissue patent was granted. Specification and claims 1–22 were unaltered; claims 23–37 were added. The original claims recite embodiments of a jet injection device and specify, for example, the exact plunge depth of the needle assist. The reissue claims are not restricted to jet-injection devices, but concern safety features; they recite a different invention than originally claimed. Defendants submitted an FDA new drug application for pre-filled methotrexate syringes. Antares sought a preliminary injunction. Defendants counterclaimed for invalidity, arguing that the reissue claims were invalid for violating the recapture rule and failing the original patent requirement. The district court denied a preliminary injunction. The Federal Circuit affirmed; the reissue claims are invalid under section 251’s “original patent” requirement. View "Antares Pharma, Inc. v. Medac Pharma, Inc." on Justia Law

AntiCancer, Inc. owns patents for technology related to the imaging of gene expression using a green fluorescent protein linked to a gene promoter. The fluorescent protein is derived from a species of green-glowing jellyfish, Aequorea victoria. The patented inventions are described as useful for drug discovery and evaluation in cancer control and treatment. The district court entered summary judgment of noninfringement, not on the substantive merits of any issue, but on a procedural aspect at the threshold of the litigation arising from application of the Patent Local Rules of the Southern District of California. The court imposed a fee-shifting sanction as a condition of permitting AntiCancer to supplement the Preliminary Infringement Contentions that found to be defective under Patent Local Rule 3.1. The Federal Circuit vacated the condition and remanded. Considering the language and purposes of the Local Rule, and the record of what Anti-Cancer disclosed in its Contentions and the limited, specific criticisms of the Contentions’ sufficiency, there was no reasonable basis for making the finding of bad faith that would be required to sustain the fees sanction. View "Anticancer Inc. v. Pfizer, Inc." on Justia Law