Justia Health Law Opinion Summaries

Incyte Corporation and Incyte Holdings Corporation (collectively, Incyte) own U.S. Patent No. 9,662,335, which claims deuterated versions of ruxolitinib, a Janus kinase (JAK) modulator used to treat autoimmune disorders. Sun Pharmaceutical Industries, Ltd. and Sun Pharmaceutical Industries, Inc. (collectively, Sun) secured FDA approval for an oral deuterated ruxolitinib product, branded as Leqselvi, to treat alopecia areata (AA) and planned to launch it in October 2024. Incyte sued Sun for allegedly infringing the ’335 patent and moved for a preliminary injunction to prevent Sun from launching Leqselvi.The United States District Court for the District of New Jersey granted Incyte’s motion for a preliminary injunction, finding that Incyte would suffer irreparable harm if Sun launched Leqselvi. The district court based its decision on the theory that Sun’s launch would give it an unjust head start in the AA market, diminishing the value of Incyte’s investments in developing its own topical deuterated ruxolitinib product.Sun appealed the district court’s decision to the United States Court of Appeals for the Federal Circuit. The Federal Circuit reviewed the grant of the preliminary injunction for an abuse of discretion, focusing on whether the district court made a clear error in its irreparable harm analysis. The Federal Circuit found that the district court clearly erred in its finding of irreparable harm, as it was based on the incorrect assumption that Incyte would be first to market if the injunction were granted. The court noted that Sun’s multi-year head start was inevitable regardless of the injunction, as Incyte’s product would not launch until several years after the ’335 patent expired.The Federal Circuit reversed the district court’s order granting the preliminary injunction, concluding that Incyte failed to provide non-speculative evidence of irreparable harm. View "INCYTE CORPORATION v. SUN PHARMACEUTICAL INDUSTRIES, LTD. " on Justia Law

Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited (collectively, "Jazz") manufacture and sell sodium oxybate products, Xyrem and Xywav, for treating narcolepsy and idiopathic hypersomnia (IH). Avadel CNS Pharmaceuticals, LLC ("Avadel") sought FDA approval for Lumryz, a sodium oxybate product, for treating narcolepsy. Jazz sued Avadel, alleging that Avadel's FDA submission infringed Jazz's U.S. Patent 11,147,782. The district court found in favor of Jazz, issuing a permanent injunction against Avadel from seeking FDA approval for Lumryz for IH and from marketing Lumryz for that indication.The U.S. District Court for the District of Delaware initially ruled that Avadel's submission of its New Drug Application (NDA) constituted infringement under 35 U.S.C. § 271(e)(2). The court issued a permanent injunction prohibiting Avadel from seeking FDA approval for Lumryz for IH, offering open-label extensions (OLEs) to clinical trial participants, and initiating new clinical trials. Avadel appealed, arguing that the injunction was overly broad and that certain activities were protected under the safe-harbor provision of 35 U.S.C. § 271(e)(1).The United States Court of Appeals for the Federal Circuit reviewed the case. The court reversed the injunction prohibiting Avadel from initiating new clinical trials and offering OLEs, finding these activities to be protected under the safe-harbor provision. The court vacated the injunction preventing Avadel from seeking FDA approval for new indications of Lumryz, remanding the issue to the district court for further consideration. The court instructed the district court to determine whether Avadel's submission of a paper NDA for additional indications would constitute an act of infringement under 35 U.S.C. § 271(e)(2) and to reassess the eBay factors if necessary. View "JAZZ PHARMACEUTICALS, INC. v. AVADEL CNS PHARMACEUTICALS, LLC " on Justia Law

The veteran served in the U.S. Army from March 1944 to May 1945 and was diagnosed with Hodgkin’s lymphoma in 1978. He received radiation therapy at a VA facility, which successfully treated the lymphoma but led to his death in early 1979 due to pulmonary complications. The veteran’s wife, Hatfield, filed a claim for dependency and indemnity benefits, which was denied by the Regional Office (RO) for lack of service connection. Hatfield appealed to the Board of Veterans’ Appeals (the Board), asserting that the veteran’s death was due to negligent VA medical care. In 1980, the Board denied the appeal, finding the VA provided adequate care and the veteran’s reaction was a recognized complication of radiation therapy.Hatfield later filed an application to reopen her claim in 2010, arguing entitlement to compensation under a 2004 regulation requiring informed consent for VA-administered medical care. The Board denied the application, but the Veterans Court reversed, granting benefits from August 1, 2010, due to the VA’s failure to obtain informed consent. In 2020, Hatfield filed a motion to revise the 1980 Board decision, claiming clear and unmistakable error (CUE) for not considering informed consent under 38 U.S.C. § 4131. The Board denied the motion, and the Veterans Court affirmed, stating there was no indication in 1980 that failure to obtain informed consent amounted to a compensable negligence claim.The United States Court of Appeals for the Federal Circuit reviewed the case and affirmed the Veterans Court’s decision. The court held that Hatfield did not demonstrate that the 1980 Board committed CUE, as there was no undebatable error in the application of the law at that time. The court found no evidence that the failure to obtain informed consent under 38 U.S.C. § 4131 was considered a compensable negligence claim under 38 U.S.C. § 351 in 1980. View "HATFIELD v. COLLINS " on Justia Law

Daniel R. Smith, who is currently blind, underwent medical examinations upon entering military service in August 1964 and upon leaving in June 1965. Both examinations noted poor night and color vision, with vision correctable in both eyes. After his discharge, Smith filed several claims with the U.S. Department of Veterans Affairs (VA) for benefits based on retinitis pigmentosa, an eye disease causing vision loss. An ophthalmologist opined that Smith's condition preexisted his service and did not worsen during service. The VA denied his claim, and the Board of Veterans’ Appeals agreed, finding clear and unmistakable evidence rebutting the presumption of sound health upon entry into service. The Court of Appeals for Veterans Claims affirmed this decision.The United States Court of Appeals for Veterans Claims reviewed the case and affirmed the Board's decision, finding that Dr. Wilson's opinion constituted clear and unmistakable evidence that Smith's retinitis pigmentosa did not increase in severity during service. Smith appealed, arguing that Dr. Wilson's opinion did not meet the clear and unmistakable evidence standard and that it improperly relied on the absence of evidence.The United States Court of Appeals for the Federal Circuit reviewed the case and dismissed Smith's appeal. The court held that it lacked jurisdiction to review the factual determination that Dr. Wilson's opinion met the clear and unmistakable evidence standard. The court also found that the Veterans Court did not rely on an absence of evidence but rather on affirmative evidence comparing Smith's vision tests at entry and separation from service. Therefore, the Federal Circuit concluded that it could not address Smith's legal contention regarding the sufficiency of the evidence. View "SMITH v. COLLINS " on Justia Law

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