Justia Drugs & Biotech Opinion Summaries

The patents at issue are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for NUCYNTA® ER (extended release), a tapentadol hydrochloride tablet. The 364 patent is directed to the Form A polymorph of the chemical compound tapentadol hydrochloride and a method of treating pain and/or urinary incontinence and states that Form A “is very stable at ambient conditions and therefore useful for producing a pharmaceutical composition.” The 130 patent describes a method of using tapentadol and tapentadol hydrochloride for the treatment of polyneuropathic pain, which is caused by damage to multiple nerves. In an infringement suit, stemming from Abbreviated New Drug Application (ANDA) filings seeking to market generic versions of immediate and extended release tapentadol hydrochloride tablets, the Federal Circuit affirmed the district court in finding that the 364 patent is not invalid for obviousness or lack of utility (the defendants had stipulated to infringement) and that the ANDA filings do not infringe the 130 patent, which is not invalid as anticipated. View "Grunenthal GMBH v. Alkem Laboratories Limited" on Justia Law

Endo’s patent, entitled “Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment,” covers a method of using oxymorphone to treat pain in patients with impaired kidney function. Controlled-release dosage forms that maintain optimal levels of pain relief for longer periods are useful to patients and clinicians. Patients’ pain relief levels can be impacted by the way their body processes oxymorphone. The inventor discovered that patients with moderately or severely impaired kidney function need less oxymorphone than usual to achieve a similar level of pain management. The Federal Circuit reversed the district court’s conclusion that the claims were patent-ineligible under 35 U.S.C. 101. The district court incorrectly concluded that the claims at issue are directed to a natural law. The claims prescribe a regimen for specific patients, using a specific compound at specific doses to achieve a specific outcome. Claiming a new treatment for an ailment, albeit using a natural law, is not claiming the natural law. View "Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc." on Justia Law

In this multi-district litigation, plaintiffs brought a series of products liability actions against the makers of Eliquis for injuries they or their decedents suffered while taking the drug. In the multi-district litigation, the district court denied motions to remand many of the actions to state court and then dismissed 64 suits.The Second Circuit affirmed, holding that 28 U.S.C. 1441(b)(2) was no barrier to the removal of the transferred actions at issue. The court held that a home‐state defendant may in limited circumstances remove actions filed in state court on the basis of diversity of citizenship, was authorized by the text of Section 1441(b)(2), and was neither absurd nor fundamentally unfair. The court also affirmed the dismissal of plaintiffs' negligence and strict liability claims as preempted by the Food, Drug, and Cosmetics Act. In this case, plaintiffs' claims consisted of conclusory and vague allegations and did not plausibly allege the existence of newly acquired information. Therefore, plaintiffs' allegations were insufficient to state a claim that was not preempted. View "Gibbons v. Bristol-Myers Squibb Co." on Justia Law

Natural owns patents relating to dietary supplements containing beta-alanine (an amino acid). Together with histidine, another amino acid, beta-alanine can form dipeptides that are involved in the regulation of intracellular pH during muscle contraction and development of fatigue. Variations in dipeptide concentrations affect the anaerobic work capacity of athletes. One dipeptide, carnosine, contributes to hydronium ion buffering. During certain sustained exercise, hydronium ions and lactate can accumulate and severely reduce intracellular pH; reduced pH interferes with the creatine-phosphorylcreatine system, part of the process by which energy is generated in muscle cells. Natural's patents generally relate to the use of beta-alanine in a dietary supplement to “increas[e] the anaerobic working capacity of muscle and other tissue.” The district court applied the Supreme Court’s 2015 two-part “Alice” test and held all of the asserted claims were directed to patent ineligible subject matter (35 U.S.C. 101_ and lacked an inventive concept. The Federal Circuit reversed. Under Natural’s proposed claim constructions, the Method Claims are not directed to an exception to section 101 under the first step of the Alice test, so judgment on the pleadings was inappropriate. The Product Claims contain a dietary supplement limitation, with the same proposed construction, which does not support the idea that this limitation was well-understood, routine, and conventional. The Manufacturing Claims are not directed to the natural law or product of nature, but are an application of the law and new use of that product. View "Natural Alternatives International, Inc.. v. Creative Compunds, LLC" on Justia Law

Drug manufacturers filed Abbreviated New Drug Applications with the Food and Drug Administration seeking to market generic versions of Saphris, a drug product sold by Forest Laboratories. Saphris is a sublingually administered, atypical antipsychotic containing asenapine maleate. Forest sued for patent infringement, asserting that the proposed generic products would infringe claims of its patents. The district court held the generic manufacturers had not established certain claims to be invalid and held Forest had not established infringement of certain claims as to two manufacturers. The Federal Circuit vacated and remanded the validity determination, and for reconsideration infringement under a corrected claim construction. The district court erred in treating “excitation” as being limited to “excitation disorders.” The court rejected claims concerning sufficient written description, obviousness, and the construction of other claims. View "Forest Laboratories, LLC v. Sigmapharm Laboratories, LLC" on Justia Law

Shire manufactured and marketed the lucrative drug Vancocin, which is used to treat a life-threatening gastrointestinal infection. After Shire learned that manufacturers were considering making generic equivalents to Vancocin, it inundated the Food and Drug Administration (FDA) with allegedly meritless filings to delay approval of those generics. The FDA eventually rejected Shire’s filings and approved generic equivalents to Vancocin. The filings resulted in a high cost to consumers. Shire had delayed generic entry for years and reaped hundreds of millions of dollars in profits. Nearly five years later, after Shire had divested itself of Vancocin, the Federal Trade Commission (FTC) filed suit against Shire under Section 13(b) of the Federal Trade Commission Act, 15 U.S.C. 53(b), seeking a permanent injunction and restitution, and alleging that Shire’s petitioning was an unfair method of competition. The district court dismissed, finding that the FTC’s allegations of long-past petitioning activity failed to satisfy Section 13(b)’s requirement that Shire “is violating” or “is about to violate” the law. The Third Circuit affirmed, rejecting “the FTC’s invitation to stretch Section 13(b) beyond its clear text.” The FTC admits that Shire is not currently violating the law and did not allege that Shire is about to violate the law. View "Federal Trade Commission v. Shire ViroPharma Inc" on Justia Law

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

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

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

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