Justia Health Law Opinion Summaries

Regeneron Pharmaceuticals, Inc. holds a Biologics License Application (BLA) for EYLEA®, a therapeutic product containing aflibercept, a VEGF antagonist used to treat angiogenic eye diseases. Regeneron also owns U.S. Patent No. 11,084,865, which covers VEGF-trap formulations suitable for intravitreal injection. Several companies, including Samsung Bioepis Co., Ltd. (SB), filed abbreviated Biologics License Applications (aBLAs) seeking approval to market EYLEA® biosimilars. Regeneron sued these companies, including SB, for patent infringement in the Northern District of West Virginia.The district court consolidated the cases and granted Regeneron’s motion for a preliminary injunction against SB, enjoining it from marketing its biosimilar product in the U.S. without a license from Regeneron. The court found it had personal jurisdiction over SB based on SB’s aBLA filing and its distribution agreement with Biogen, which indicated plans for nationwide marketing, including West Virginia. The court also found that Regeneron was likely to succeed on the merits, as SB had not raised a substantial question of invalidity of the ’865 patent for obviousness-type double patenting or lack of written description.The United States Court of Appeals for the Federal Circuit reviewed the case and affirmed the district court’s decision. The appellate court agreed that the district court had personal jurisdiction over SB, as SB’s actions indicated plans to market its biosimilar nationwide. The court also upheld the district court’s findings that SB had not raised a substantial question of invalidity for the ’865 patent. The court found that the patent’s specific stability and glycosylation requirements were patentably distinct from the reference patent and adequately supported by the specification. The court also agreed that Regeneron had established a causal nexus between SB’s infringement and the irreparable harm it would suffer without an injunction. View "REGENERON PHARMACEUTICALS, INC. v. MYLAN PHARMACEUTICALS INC. " on Justia Law

In 2003, following a physical examination, Contreras, 13 years old, received the Tetanus-Diphtheria and Hepatitis B vaccines. About 24 hours later, he was diagnosed with atypical Guillain-Barre Syndrome (GBS), a peripheral nervous system disease that causes descending paralysis. Three months later, Contreras was discharged from the hospital with a diagnosis of Transverse Myelitis (TM), an inflammatory disease of the spinal cord. His petition for compensation under the Vaccine Act, accompanied by an expert report indicating that he developed both conditions as a result of the vaccines, was denied, on the basis that the time interval between the administration of Contreras’s vaccines and the onset of TM was too short to establish causation. Contreras submitted the expert report of pediatric neurologist concerning his rapid adverse immunological response. In 2012, a Special Master concluded that Contreras failed to establish that the TM arose within a “medically appropriate” timeframe. Following a remand from the Claims Court, the government disclosed that the medical license of its expert (Sladsky) was suspended during the time that he had provided witness services in this case. The Special Master again denied compensation, stating that Sladky’s opinion “retain[ed] some value” and that Contreras did not suffer from GBS—a violation of the court’s instruction to refrain from diagnosing Contreras. The Claims Court again remanded, with instructions to address Sladky’s credibility in light of his misrepresentations and to issue an alternative ruling that disregards Sladky’s testimony. The Special Master denied compensation. The Claims Court denied review based on the time interval. The Federal Circuit vacated. The Special Master improperly diagnosed Contreras and failed to consider evidence relevant to his GBS. View "Contreras v. Secretary of Health & Human Services" on Justia Law

Eilise was born in 1996 and had problems with gross motor skills and language development. After therapy, Eilise showed dramatic improvement. In 2001, Eilise received three vaccinations, including her second dose of the measles, mumps, and rubella vaccine. Five days later, Eilise’s brother witnessed her arching her back, thrusting her head back, rolling her eyes, and jerking. He did not know what was happening. Her parents, who did not witness the seizure, noted that Eilise was feverish and lethargic. Eilise had a grand mal seizure at school. She was taken to a hospital. She had another seizure there. Eilise’s MRI results were generally normal, but her EEG results were “consistent with a clinical diagnosis of epilepsy.” She continued to suffer seizures until she started a ketogenic diet. Her parents filed suit under the National Childhood Vaccine Injury Compensation Program, 42 U.S.C. 300aa, alleging that Eilise suffered from autism as a result of her vaccinations; they later amended to allege, instead, that Eilise suffered from a “seizure disorder and encephalopathy.” The Claims Court affirmed denial of her petition. The Federal Circuit vacated: in certain cases, a petitioner can prove a logical sequence of cause and effect between a vaccination and the injury with a physician’s opinion where the petitioner has proved that the vaccination can cause the injury and that the vaccination and injury have a close temporal proximity. View "Moriarty v. Sec'y of Health & Human Servs." on Justia Law