Justia Drugs & Biotech Opinion Summaries

XY sued Trans Ova for infringement of seven patents relating to technology for sex selection of non-human mammals. Its 559 patent is titled “Enhancing Flow Cytometry Discrimination with Geometric Transformation.” Flow cytometers can be used as “high-speed jet-in-air sorters to discriminate particles and cells that are only subtly different.” The patent relates to “apparatus and methods for real-time discrimination of particles while being sorted by flow cytometry . . . resulting in enhanced discrimination between populations of particles” and “can be used to separate X from Y bearing sperm,” an application useful in animal husbandry to “guarantee[] the sex of offspring.”The district court found asserted claims 1–23 of the 559 patent-ineligible under 35 U.S.C. 101 and that XY’s patent-infringement allegations with respect to certain claims of other patents were claim-precluded based on a prior lawsuit filed by XY against Trans Ova. The Federal Circuit reversed. The asserted claims of the patent are directed to a patent-eligible improvement to a method of sorting particles using flow cytometry technology, not to an abstract idea. The district court did not apply the proper legal standard to its claim-preclusion analysis. The court vacated the claim-preclusion judgment. View "XY, LLC v. Trans Ova Genetics, LC" on Justia Law

Reckitt developed Suboxone tablets, a prescription drug used to treat opioid addiction. Toward the end of its seven-year period of exclusivity in which other manufacturers could not introduce generic versions, Reckitt developed an under-the-tongue film version of Suboxone, which would enjoy its own exclusivity period. Generic versions of Suboxone tablets would not be rated as equivalent to the name-brand Suboxone film, so state substitution laws would not require pharmacists to substitute generic Suboxone tablets if a patient were prescribed Suboxone film.Purchasers filed suit, alleging that Reckitt’s transition to Suboxone film was coupled with efforts to eliminate the demand for Suboxone tablets and to coerce prescribers to prefer film in order to maintain monopoly power, in violation of the Sherman Act, 15 U.S.C. 2. The Purchasers submitted an expert report indicating that, due to Reckitt’s allegedly-anticompetitive conduct, the proposed class paid more for brand Suboxone products. The district court certified a class of “[a]ll persons or entities . . . who purchased branded Suboxone tablets directly from Reckitt” during a specified period. The Third Circuit affirmed. Common evidence exists to prove the Purchasers’ antitrust theory and the resulting injury. Although allocating the damages among class members may be necessary after judgment, such individual questions do not ordinarily preclude the use of the class action device; the court correctly found that common issues predominate. View "In re: Suboxone Antitrust Litigation" on Justia Law

The Fifth Circuit affirmed the district court's dismissal of plaintiff's complaint alleging that she used defendants' prescription chemotherapy drug and now suffers from permanent hair loss. As a plaintiff in this multidistrict litigation (MDL), plaintiff was required to serve defendants with a completed fact sheet disclosing details of her personal and medical history soon after filing her short form complaint. She failed to do so in this case.The court applied the Deepwater Horizon two-factor test to the district court's dismissal of plaintiff's case and held that the district court was not required to make specific factual findings on each of the Deepwater Horizon prongs before dismissing plaintiff's case. The court explained that plaintiff exhibited a clear record of delay sufficient to meet the first prong in the Deepwater Horizon test, and lesser sanctions would not have served the best interests of justice. The court also held that the district court did not abuse its discretion in denying plaintiff's motion for reconsideration. View "Kuykendall v. Accord Healthcare, Inc." on Justia Law

Each patent at issue claims a method of treating cancer by administering antibodies targeting specific receptor-ligand interactions on T cells, which are responsible for processing information to develop an immune response in the body using receptors on their surfaces. The named inventor Dr. Honjo, a professor at Kyoto University, had shared information with Drs. Wood and Freeman until about 2001. In 2002, Honjo filed his patent application in Japan. Each patent at issue case claims priority from that patent application; none include Freeman and Wood as inventors.The Federal Circuit affirmed that Drs. Freeman and Wood should be deemed inventors of the subject matter of the patents alongside Dr. Honjo, 35 U.S.C. 116(a). The inventorship of a complex invention may depend on partial contributions to conception over time, and there is no principled reason to discount genuine contributions made by collaborators because portions of that work were published prior to conception for the benefit of the public. Earlier publication of an invention is obviously a potential hazard to patentability, but the publication of a portion of a complex invention does not necessarily defeat joint inventorship of that invention. View "Dana-Farber Cancer Institute v. Ono Pharmaceutical Co., Ltd." on Justia Law

Plaintiffs filed a class action under S.E.C. Rule 10b-5, 17 C.F.R. 240.10b-5, following the failure of NewLink's Phase 3 clinical trial for a novel pancreatic cancer drug and the resulting decline in the market value of NewLink shares.The Second Circuit held that defendants' statements about the efficacy of their pancreatic cancer drug were puffery, not material misrepresentations. However, the court held that plaintiffs plausibly pled material misrepresentation and loss causation for defendants' statements about the scientific literature and the design of their clinical trial. Therefore, the court affirmed the district court's dismissal in part regarding the 2013-2016 Assessments; vacated the dismissal in part regarding the September, March, and Enrollment statements; and remanded for further proceedings. View "Nguyen v. NewLink" on Justia Law

The First Circuit affirmed both of Defendant's federal racketeering-related convictions but vacated and remanded the prison sentence, forfeiture order, and restitution order, holding that the district court erred in several respects.Defendant was convicted of racketeering, racketeering conspiracy, federal mail fraud, and violating the Federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. 331(a), 333(a). The district court sentenced Defendant to ninety-six months' imprisonment, issued a forfeiture order in the amount of $175,000, and ordered restitution. On appeal, Defendant challenged his convictions for racketeering and racketeering conspiracy and his sentence. The First Circuit remanded the case, holding (1) the convictions were supported by sufficient evidence; (2) the district court erred in its reasoning declining to apply certain enhancements; (3) neither of the two reasons the district court gave for limiting the forfeiture order was sustainable; and (4) the district court too narrowly construed who counts as a "victim" under the Mandatory Victims Restitution Act. View "United States v. Chin" on Justia Law

Plaintiffs, three cigar and pipe tobacco industry associations, filed suit challenging various provisions of the FDA's Deeming Rule, which subjects newly regulated tobacco products, including cigars and pipe tobacco, to requirements akin to those previously imposed by statute on cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Plaintiffs contend that the warning requirements for cigars and pipe tobacco violate the Tobacco Control Act and the Administrative Procedure Act because the FDA did not adequately consider how the warnings would affect smoking. Plaintiffs also argued that the warning requirements violate the First Amendment.The DC Circuit held that Congress required the FDA to consider whether any regulation under section 906(d)(1) of the Federal Food, Drug, and Cosmetic Act would likely affect the number of tobacco users. In promulgating the warning requirements for cigars and pipe tobacco, the court held that the FDA failed to satisfy that obligation. Therefore, the court reversed the district court's grant of summary judgment to the FDA and the denial of summary judgment to plaintiffs. The court dismissed as moot plaintiffs' appeal from the denial of their motion for a preliminary injunction. Finally, the court remanded for further proceedings. View "Cigar Association of America v. Food and Drug Administration" on Justia Law

Genentech manufactures and sells bevacizumab, a biological product used to treat certain types of cancer, under the name Avastin. Amgen filed a biologics license application, 42 U.S.C. 262(k) to market a biosimilar version of Avastin—Mvasi. Mvasi received FDA approval effective September 2017. In October, Amgen notified Genentech of its intent to commercially market Mvasi starting no earlier than 180 days from the date of the letter. In August 2018, Amgen filed a third supplement to its Mvasi application to add a manufacturing facility and a fourth supplement to change its drug label. By July 2019, Amgen decided it would commercially launch Mvasi, intending to market it immediately. Genentech filed motions, seeking to preclude Amgen from commercially marketing Mvasi until Amgen “provides notice of its intent to commercially market such product” pursuant to 42 U.S.C. 262(l)(8) and 180 days have elapsed,” arguing that Amgen’s third and fourth supplements resulted in new and distinct applications that require new notices. The Federal Circuit affirmed the denial of the motions, reasoning that Amgen’s October 2017 commercial marketing notice for Mvasi satisfied Section 262(l)(8)(A)’s notice requirements. View "Genentech, Inc. v. Immunex Rhode Island Corp." on Justia Law

Plaintiffs filed suit against Mentor, alleging causes of action for negligence and negligence per se based on Mentor's negligent failure to warn and negligent manufacturing of breast implants, strict products liability for failure to warn, and strict products liability for manufacturing defects.The Court of Appeal reversed the trial court's judgment and entered an order overruling the demurrer to the third amended complaint. The court held that the tort claims in this case survive preemption because they are premised on conduct that both violates the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetics Act and would give rise to a recovery under state law even in the absence of the MDA. The court also held that plaintiffs pleaded the requisite causal connection between their injuries and Mentor's tortious acts to survive a demurrer. Finally, the trial court erroneously sustained Mentor's demurrer to the loss of consortium claim because it was derivative of the other claims. View "Mize v. Mentor Worldwide LLC" on Justia Law

In July 2010, L.M. was born at full-term and developed normally for six months. In February 2011, L.M. received childhood vaccines, including the diphtheria-tetanus-acellular pertussis vaccination. By that evening, L.M. had a fever, was lethargic, had poor muscle tone, and would not eat., Any disturbance caused L.M. to scream. L.M. began to have several seizures a day. At seven years of age, L.M. could crawl and walk with the assistance of a walker. She had a poorly coordinated grasp, suffered cortical visual impairments, and was nonverbal, though she could use a few signs to express ideas such as “yes,” and “no.” Testing revealed that L.M. had a genetic mutation.In a claim under the National Vaccine Injury Compensation Program, L.M. alleged that the vaccinations administered to L.M. in February 2011, significantly aggravated L.M.’s pre-existing condition under two alternative theories. The Special Master denied the petition, finding that L.M.’s genetic mutation was “the most compelling explanation for her predisposition to develop a seizure disorder.” The Federal Circuit affirmed the denial of an “on-table” claim, finding no support for an argument that most encephalopathies do not become acute until after vaccination. The court vacated and remanded the denial of an “off-table” claim, which requires determining whether the child’s receipt of vaccinations significantly aggravated her seizure disorder in the face of an underlying genetic mutation. View "Sharpe v. Secretary of Health and Human Services" on Justia Law