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The Bristol-Myers Squibb (BMS) patent, entitled “Stable Protein Formulations,” describes and claims specific fluid formulations an immunosuppressive agent used in the treatment of immune system disorders such as rheumatoid arthritis. The product has the common name “abatacept” and the brand name Orencia®. Momenta sought Inter Partes Review of the Patent under the America Invents Act, 35 U.S.C. 311. Momenta was attempting to develop a biosimilar counterpart of Orencia®. The Patent Trial and Appeal Board sustained patentability of the patent claims. Momenta filed an appeal under 35 U.S.C. 319. BMS moved to dismiss for lack of standing because Momenta’s proposed product had failed its Phase 1 clinical trials and had been withdrawn. Momenta responded that it had not abandoned its intent to produce a counterpart of the Orencia® product and filed various exhibits concerning its intentions, ultimately submitting a form that was filed with the Securities and Exchange Commission in December 2018, indicating termination of Momenta’s collaboration agreement with respect to the development of a proposed biosimilar to ORENCIA®. Momenta did not withdraw its appeal. The Federal Circuit dismissed the appeal for lack of standing as moot. The cessation of potential infringement means that Momenta no longer has the potential for injury, thereby mooting the inquiry. View "Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co." on Justia Law

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Athena Diagnostics is the exclusive licensee of the 820 patent, covering methods for diagnosing neurological disorders by detecting antibodies to a protein called muscle-specific tyrosine kinase (MuSK), which is associated with Myasthenia gravis (MG), a neurological disorder where patients experience muscle weakness and symptoms including drooping eyelids, double vision, and slurred speech. Athena markets a test (FMUSK) that functions by evaluating those antibodies. After Mayo developed two competing tests, Athena accused Mayo of infringing its patent. The Federal Circuit affirmed that the asserted claims of the 820 patent are invalid under 35 U.S.C. 101, for claiming ineligible subject matter. The claims at issue are directed to a natural law and lack an inventive concept. View "Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC" on Justia Law

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Plaintiff filed a personal injury action against Merck after she suffered cardiovascular injuries allegedly from taking a medication called Vioxx. The Eighth Circuit reversed the district court's dismissal of plaintiff's claims. The district court held that plaintiff's claims accrued prior to September 2001 and thus her September 29, 2006 suit was time-barred. In Missouri, the statute of limitations for personal injury claims is five years after the cause of action accrues. The court held that there was a genuine issue of fact as to whether the evidence was such that a reasonably prudent person was on notice of a potentially actionable injury before September 29, 2001. The court predicted that the state supreme court would conclude that mere knowledge in the medical community of a possible link between Vioxx and heart problems did not, as a matter of law, place a reasonably prudent person in plaintiff's position on notice of a potentially actionable injury. View "Levitt v. Merck & Co." on Justia Law

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RCT owns the 551 patent, which discloses and claims enantiomeric compounds and pharmaceutical compositions useful in the treatment of epilepsy and other central nervous system disorders. The Patent and Trademark Office Patent Trial and Appeal Board, in an inter partes review, concluded that claims 1–13 of the patent are not unpatentable. The Federal Circuit affirmed, rejecting an argument that an ordinary artisan would have recognized the methoxyamino group in compound 3l (disclosed in a prior reference) to be uncommon and to have potential synthetic and stability problems and that a person of skill in the art would then have been motivated to modify compound 3l by replacing the amine of its methoxyamino group with a methylene link to yield a more stable, synthetically accessible, pharmaceutically common and acceptable moiety. The Board’s findings are supported by substantial evidence. Even if a person of skill in the art would have been motivated to modify compound 3l, the evidence suggests that compounds without a methoxyamino or nitrogen-containing group at the αcarbon had reduced activity. View "Mylan Pharmaceuticals Inc. v. Research Corporation Technologies, Inc." on Justia Law

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In these consolidated appeals arising out of two “off-label” prescription drug marketing cases aggregated for pretrial proceedings in the district court by order of a multidistrict litigation panel, the First Circuit reversed the dismissal of claims brought by two of the four plaintiffs, vacated the denial of Plaintiffs’ motion to compel the production of additional documents, and otherwise affirmed the district court's rulings. In their complaint, Plaintiffs claimed that Defendants, Forest Pharmaceuticals, Inc. and Forest Laboratories, Inc., engaged in an off-label marketing scheme aimed at fraudulently inducing doctors to write pediatric prescriptions of their antidepressant drugs when the FDA had not approved the use of these medications for minors. After discovery, the district court entered summary judgment for Defendant on Plaintiffs’ Racketeer Influenced and Corrupt Organizations Act (RICO), 18 U.S.C. 1962(c)-(d), claims and dismissed Plaintiffs’ state-based allegations as deriving from their noncognizable RICO claims. The First Circuit (1) reversed the district court’s entry of summary judgment on certain plaintiffs’ RICO and state-law claims and on another plaintiff’s RICO and unjust-enrichment claims on the basis that the evidence was insufficient on these claims; (2) vacated the denial of Plaintiffs’ motion to compel; (3) affirmed the denial of class certification; and (4) otherwise affirmed. View "Painters & Allied Trades District Council 82 Health Care Fund v. Forest Pharmaceuticals, Inc." on Justia Law

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Dr. Barry’s patents, entitled “System and Method for Aligning Vertebrae in the Amelioration of Aberrant Spinal Column Deviation Conditions,” claim methods and systems for correcting spinal column anomalies, such as those due to scoliosis, by applying force to multiple vertebrae at once. Dr. Barry sued Medtronic, alleging that Medtronic induced surgeons to infringe the patents. The jury found infringement of method claims 4 and 5 of the 358 patent and system claims 2, 3, and 4 of the 121 patent, rejected Medtronic’s several invalidity defenses, and awarded damages. In post-trial rulings on the jury issues, the district court upheld the verdict, rejecting challenges as to induced infringement and associated damages for domestic conduct, invalidity of the asserted 358 patent claims under the public-use and on-sale bars, and invalidity of all asserted claims due to another’s prior invention. The district court then rejected Medtronic’s inequitable-conduct challenge and enhanced damages by 20 percent while denying attorney’s fees to Dr. Barry, The Federal Circuit affirmed, rejecting several arguments by Medtronics, principally concerning the public-use and on-sale statutory bars, but also concerning prior invention, inequitable conduct, and induced infringement and associated damages. View "Barry v. Medtronic, Inc." on Justia Law

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Bard manufactures a surgical patch, consisting of two pieces of mesh that surround a flexible plastic ring. During a hernia repair, the patch is folded to fit through a small incision, then the plastic ring springs back into its original shape and flattens the mesh against the abdominal wall. Bard recalled several versions of the patch in 2005-2006 following reports that the plastic ring was defective. Sometimes the ring broke, exposing a sharp edge that could perforate the patient’s intestines. Other times the ring caused the patch to bend and warp, exposing the patch’s adhesive to a patient’s viscera. Before the recall, Bowersock underwent hernia repair surgery, involving a Bard patch. Roughly one year later, she died of complications arising from an abdominal-wall abscess. Her estate sued. Unlike defective patches in other injured patients, Bowersock’s patch did not adhere to her bowel or perforate her organs. Plaintiff's expert tried to present a new theory of causation: the patch had “buckled,” forming a stiff edge that rubbed against and imperceptibly perforated her internal organs. The court excluded that testimony, finding the “buckling” theory not sufficiently reliable. The Seventh Circuit affirmed summary judgment for the defense. The novel theory of causation was not peer-reviewed, professionally presented, consistent with Bowersock’s medical records or autopsy, or substantiated by other cases. View "Robinson v. Davol, Inc." on Justia Law

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Helsinn makes a treatment for chemotherapy-induced nausea using the chemical palonosetron. While developing that product, Helsinn granted another company the right to market a 0.25 mg dose of palonosetron in the United States; that company was required to keep proprietary information confidential. Nearly two years later, in 2003, Helsinn filed a provisional patent application covering a 0.25 mg dose of palonosetron. Helsinn filed four patent applications that claimed priority to the 2003 date. Helsinn’s fourth application, filed in 2013 (the 219 patent), is covered by the Leahy-Smith America Invents Act (AIA). In 2011, Teva sought approval to market a generic 0.25 mg palonosetron product. Helsinn sued for infringement. Teva countered that the 219 patent was invalid under the “on sale” provision of the AIA, which precludes a person from obtaining a patent on an invention that was “in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention,” 35 U.S.C. 102(a)(1), arguing the 0.25 mg dose was “on sale” more than one year before Helsinn filed the 2003 application. The Federal Circuit held, and the Supreme Court unanimously agreed, that the sale was publicly disclosed, regardless of whether the details of the invention were publicly disclosed in the agreements. A commercial sale to a third party who is required to keep the invention confidential may place the invention “on sale” under section 102(a). The patent statute in force immediately before the AIA included an on-sale bar. Supreme Court and Federal Circuit precedent interpreting that provision indicated that a sale or offer of sale need not make an invention available to the public to constitute invalidating prior art. The Court applied the presumption that when Congress reenacted the “on sale” language in the AIA, it adopted earlier judicial constructions. View "Helsinn Healthcare S. A. v. Teva Pharmaceuticals USA, Inc." on Justia Law

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The Ninth Circuit affirmed the district court's grant of summary judgment for defendants, makers of vitamin E supplements, in an action alleging that the labels on the supplements violated California laws against false advertising. The panel held that section 343-1(a)(5) of the Federal Food, Drug, and Cosmetic Act (FDCA) expressly preempts state law requirements for claims about dietary supplements that differ from the FDCA's requirements. In this case, the panel held that section 343-1(a)(5) preempted most of plaintiff's claims. The panel held that because the FDCA and California law have the same labeling requirement with respect to failing to disclose an increased risk of death, section 343-1(a)(5) did not preempt this part of plaintiff's action. The panel held that the record lacked evidence that vitamin E supplements were actually harmful, as opposed to simply useless at reducing all-cause mortality (which they did not claim to reduce). Therefore, there was no genuine issue of material fact as to whether defendants' immune-health structure/function claim was misleading. View "Dachauer v. NBTY, Inc." on Justia Law

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Plaintiff filed suit against pharmaceutical companies, alleging that they were liable for substantial gambling and other financial losses that resulted from obsessive compulsive behavior, a side effect of taking a dopamine agonist called Mirapex for his Parkinson's disease. The Eighth Circuit affirmed the district court's grant of summary judgment dismissing all claims as barred by the applicable California statute of limitations. The court rejected plaintiff's contention that the statute should be tolled because he was insane when the cause of action accrued; rejected plaintiff's contention that each ingestion of the drug gave rise to a separate and distinct claim under the continuing violations doctrine; and held that the district court did not abuse its discretion in denying a motion to stay defendants' motion for summary judgment. View "Mancini v. Boehringer Ingelheim Pharmaceuticals" on Justia Law