Justia Drugs & Biotech Opinion Summaries

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

Townsend worked as an Arkansas pharmaceutical sales representative for Bayer, selling Mirena, a contraceptive device. Townsend visited physicians, including Dr. Shrum. Townsend learned Shrum was importing from Canada a version of Mirena that was not FDA-approved, at half the cost of the approved version. Shrum had submitted Medicaid claims at the same rate as the approved version and bragged about $50,000 in extra profit. Townsend sought guidance from his superiors. Bayer told Townsend not get involved. Townsend called the Medicaid Fraud Hotline, although he feared losing his job. Shrum was charged with Medicaid fraud. Meanwhile, Bayer changed its method of reimbursing sales expenses. Not understanding the change, Townsend’s wife spent funds intended for those expenses, causing Townsend’s account to be closed temporarily. Although Townsend's account had been reactivated, Bayer fired him, claiming his closed account prevented him doing his job. Townsend sued, citing anti-retaliation provisions of the False Claims Act, 31 U.S.C. 3730(h).). A jury awarded Townsend back pay, doubled to $642,746, and $568,000 in emotional distress damages. The court denied front pay and ordered Bayer to reinstate Townsend. The Eighth Circuit affirmed on all issues except the emotional distress damage award and remanded to allow Townsend the option of accepting a remittitur of $300,000, or a new trial on emotional distress damages. View "Townsend v. Bayer HealthCare Pharm. Inc." 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

Schumann, as a qui tam relator under the False Claims Act (FCA), 31 U.S.C. 3729, and corresponding state laws, alleged that the drug company defendants improperly induced Medco Health, his employer, to offer certain of defendants’ drugs in its mail-order pharmacies and in health plans it managed; did not include those inducements when calculating the best price for their drugs, and thus submitted inaccurate best price reports to the government; overcharged the government based on those inaccurate best prices; and underpaid rebates owed based on those inaccurate best prices. The district court dismissed, holding that it lacked subject matter jurisdiction over Schumann’s claims because he did not have the requisite direct and independent knowledge to satisfy the original source exception to the FCA’s public disclosure bar. The Third Circuit affirmed. Schumann’s knowledge was not direct because it came from reviewing documents and discussing them with colleagues who participated in the underlying events. View "Schumann v. Astrazeneca Pharm., L.P." on Justia Law

In 2005, in connection with a magnetic resonance imaging procedure (MRI), Decker received a dose of Omniscan, a gadoliniumbased contrast agent manufactured by GEHC. After taking Omniscan, Decker developed Nephrogenic Systemic Fibrosis (NSF). In 2012, the Deckers sued GEHC, as part of a multidistrict litigation (MDL). Before the Deckers’ case, hundreds of similar cases in the MDL involving GEHC had been settled. The Decker case was the first case in the MDL to go to trial. The jury returned a verdict in favor of the Deckers on a failure-to-warn claim, awarding $5 million in damages. The Sixth Circuit affirmed, rejecting claims that the district court judge should have recused himself from the trial and a motion for a new trial; made several erroneous evidentiary rulings, which were applicable to all MDL cases; erroneously denied GEHC’s motion for a new trial because insufficient evidence supported the jury’s verdict regarding the causation element of the Deckers’ failure-to-warn claim; and erroneously failed to issue two proposed jury instructions. View "Decker v. GE Healthcare 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