Articles Posted in US Court of Appeals for the Federal Circuit

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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

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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

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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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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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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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Acorda’s patents claim the administration of a medication containing the active ingredient 4- aminopyridine (4-AP) to improve walking in individuals with multiple sclerosis. Acorda holds an FDA-approved New Drug Application and markets, under the name “Ampyra®,” 10 milligram 4-AP sustained-release tablets for twice-daily oral administration and holds an exclusive license to the earlier, broader “Elan patent,” which is listed in the FDA Orange Book for Ampyra with the Acorda patents, and claims methods of treating patients having certain conditions, including multiple sclerosis, by administering a drug containing a sustained-release formulation of any of certain agents, including 4-AP. Defendants sought FDA approval to market generic versions of Ampyra. In Acorda's infringement suit, the district court held that the asserted claims in the Acorda patents are invalid for obviousness but upheld the Elan patent and enjoined infringement of that patent until it expired in July 2018. The Federal Circuit affirmed that the asserted Acorda patent claims are invalid, discounting the weight of Acorda’s evidence of commercial success, failure of others, and long-felt but unmet need. The court noted the Elan patent issued in 1996 and was licensed exclusively to Acorda in 1997 for spinal cord injury and in 1998 for multiple sclerosis treatment, which blocked others from domestic marketing without risk of infringement and deterred other entities from investing in research whose reward depended on marketing a drug like Ampyra. View "Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc." on Justia Law

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Orexo’s 330 Patent, entitled “Abuse-Resistant Pharmaceutical Composition for the Treatment of Opioid Dependence,” claims a product having the brand name Zubsolv®, approved by the FDA for treatment of opioid dependence. Actavis filed an Abbreviated New Drug Application for a generic counterpart of Zubsolv, accompanied by a Paragraph IV certification, leading to Hatch-Waxman litigation under 21 U.S.C. 355(j) and 35 U.S.C. 271(e)(2)(A). The Federal Circuit reversed a finding of obviousness. The question is not whether the references separately taught components of the 330 Patent formulation, but whether the prior art suggested the selection and combination achieved by the 330 inventors. The district court erred in discounting the enhanced bioavailability in the 330 patent’s formulation as “a ‘difference in degree,’ not a difference in ‘kind.’” The clinical studies reported in the 330 Patent show 66% improved bioavailability. In the context of this invention, this is more than a trivial “degree.” View "Orexo AB v. Actavis Elizabeth, LLC" on Justia Law

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The Jazz patents relate to a drug distribution system for tracking prescriptions of a “sensitive drug.” “A sensitive drug is one which can be abused, or has addiction properties or other properties that render the drug sensitive.” One such sensitive drug is Xyrem®. Jazz exclusively markets Xyrem®, which the FDA has approved to treat symptoms associated with narcolepsy. The active ingredient in Xyrem®, gamma-hydroxybutyrate (GHB), may also be illicitly used as a “date-rape drug.” Under the Controlled Substances Act any approved drug product containing GHB is classified as a Schedule III depressant, so the FDA approved Xyrem® under “restricted distribution regulations contained in [21 C.F.R. 314.500] (Subpart H) to assure safe use of the product.” On inter partes review, the Patent Board found certain claims invalid as obvious. The Federal Circuit affirmed, upholding a conclusion that implementing prior art, consisting of background materials and the meeting minutes, transcript, and slides on the FDA website, on multiple computers “would have been a predictable use of a known distributed data system according to its established function.” View "Jazz Pharmaceuticals, Inc.. v. Amneal Pharmaceuticals, LLC" on Justia Law

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Endo holds the approved New Drug Application for Aveed®, a testosterone undecanoate intramuscular injection. Bayer owns the 640 and 395 patents listed in the Orange Book for Aveed®. Custopharm’s predecessor submitted an Abbreviated New Drug Application (ANDA) to the FDA for approval to produce and market a generic version of Aveed® and made a Paragraph IV certification and gave notice of the certification to Endo and Bayer in October 2014. Endo and Bayer brought an action alleging infringement of the 640 and 395 patents. Custopharm stipulated to infringement; Endo and Bayer limited their asserted claims to claim 2 of the 640 patent and claim 18 of the 395 patent. After a bench trial on invalidity, the district court concluded that Custopharm had not proven that the claims were invalid under 35 U.S.C. 103. The Federal Circuit affirmed. Custopharm failed to meet its burden of showing that a skilled artisan would combine a lowered dose with the injection schedule in the manner claimed. View "Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc." on Justia Law