Justia Drugs & Biotech Opinion SummariesArticles Posted in Patents
Amgen Inc. v. Sanofi
LDL cholesterol can lead to cardiovascular disease, heart attacks, and strokes. PCSK9 is a naturally occurring protein that degrades LDL receptors responsible for extracting LDL cholesterol from the bloodstream. In 2011, Amgen and Sanofi each obtained a patent for the antibody employed in a PCSK9-inhibiting drug, describing the relevant antibody by its unique amino acid sequence. Amgen obtained two additional patents in 2014 that relate back to its 2011 patent and purport to claim “the entire genus” of antibodies that “bind to specific amino acid residues on PCSK9,” and “block PCSK9 from binding.” Amgen identified the amino acid sequences of 26 antibodies that perform those functions and described “roadmap” and “conservative substitution” methods for making other antibodies that perform the described functions.Amgen sued Sanofi for infringement. Sanofi argued that Amgen’s relevant claims were invalid under the “enablement” requirement, which requires a patent applicant to describe the invention “in such full, clear, concise, and exact terms as to enable any person skilled in the art” to make and use the invention,” 35 U.S.C. 112(a), characterizing the methods Amgen outlined for generating additional antibodies as a trial-and-error process.The district court, the Federal Circuit, and the Supreme Court sided with Sanofi. If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, its specification must enable a person skilled in the art to make and use the entire class. The claimed class of antibodies does not include just the 26 that Amgen described by their amino acid sequences, but many additional antibodies. The “roadmap” and “conservative substitution” approaches are little more than research assignments. View "Amgen Inc. v. Sanofi" on Justia Law
Posted in: Drugs & Biotech, Intellectual Property, Patents, US Supreme Court
Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc.
Sanofi-Aventis’s 614 patent, entitled “Drug Delivery Device and Method of Manufacturing a Drug Delivery Device,” relates to a “drug delivery device” that can be “configured to allow setting of different dose sizes.” Mylan petitioned the Patent Trial and Appeal Board for inter partes review of claims 1–18, citing a combination of three prior art references: Burren, Venezia, and de Gennes. Mylan relied on Burren—cited as prior art within the 614 patent—to teach the use of springs within a drug-delivery device and sought to combine Burren with Venezia to teach the use of spring washers within drug-delivery devices and de Gennes to add “snap-fit engagement grips” to secure the spring washer. Mylan argued that “De Gennes, while concerned with a clutch bearing [in automobiles], addresses a problem analogous to that addressed in Burren (axially [sic] fixation and support of two components relative to one another).”The Board found all challenged claims unpatentable as obvious. The Federal Circuit reversed. Mylan failed to argue that de Gennes constitutes analogous art to the 614 patent and instead compared de Gennes to another prior art reference. Mylan did not meet its burden to establish obviousness premised on de Gennes. The Board’s factual findings regarding analogousness are not supported by substantial evidence. View "Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc." on Justia Law
Amgen Inc. v. Sandoz Inc.
Amgen produces apremilast and markets it as a phosphodiesterase-4 (PDE4) inhibitor, which is used for treating psoriasis and related conditions, under the brand name Otezla®. The 638, 101, and 541 patents cover Otezla. Sandoz submitted an Abbreviated New Drug Application (ANDA) seeking FDA approval to market a generic version of apremilast. Amgen’s predecessor brought a Hatch-Waxman suit, asserting that Sandoz’s generic product would infringe the patents.The Federal Circuit affirmed holdings that claims 3 and 6 of Amgen’s 638 patent and claims 1 and 15 of Amgen’s 101 patent had not been shown to be invalid as obvious and that claims 2, 19, and 21 of its 541 patent”) were shown to be invalid as obvious in light of prior art. The court noted that varying a dose in response to the occurrence of side effects is a well-known, standard medical practice that may well lead to a finding of obviousness. View "Amgen Inc. v. Sandoz Inc." on Justia Law
UCB, Inc. v. Actavis Laboratories UT, Inc.
Rotigotine is used to treat Parkinson’s disease, which causes difficulty swallowing and slow transit times through intestines, which can frustrate oral treatments. Transdermal therapeutic systems deliver drugs through the patient’s skin and avoid those complications. In 2007, UCB invented and marketed Neupro®, the first FDA-approved patch treatment for Parkinson’s disease. Original Neupro® is covered by several UCB patents, including the Muller patents, which claim priority to an application filed in 1999. The Muller patents are listed in the FDA’s “Orange Book,” as covering reformulated Neupro®.In 2013, Actavis submitted an Abbreviated New Drug Application (ANDA) for FDA approval of a generic transdermal rotigotine patch. UCB sued for infringement. The district court granted UCB an injunction preventing approval of Actavis’s ANDA until March 2021, when the Muller patent expired. In 2018 UCB filed the patent application that matured into the 589 patent, claiming priority from a provisional application filed in 2009, entitled “Polyvinylpyrrolidone for the Stabilization of a Solid Dispersion of the Non-Crystalline Form of Rotigotine.” UCB again filed suit, asserting the 589 patent, to delay FDA approval of a generic for nine additional years.The district court found that the Muller patents anticipate all asserted claims and that the asserted claims would have been obvious in view of multiple prior art references, including the Muller patents. The Federal Circuit affirmed the judgment of invalidity of the 589 patent. The district court’s fact findings on overlapping ranges, teaching away, unexpected results, and commercial success are not clearly erroneous, View "UCB, Inc. v. Actavis Laboratories UT, Inc." on Justia Law
Regents of the University of Minnesota v. Gilead Sciences, Inc.
Gilead filed an inter partes review (IPR) petition challenging claims of the University of Minnesota’s 830 patent, directed to phosphoramidate prodrugs of nucleoside derivatives that prevent viruses from reproducing or cancerous tumors from growing. The U.S. Patent and Trademark Office Patent Trial and Appeal Board found certain claims unpatentable as anticipated by the asserted prior art.The Federal Circuit affirmed. There is no “ipsis verbis” written description disclosure sufficient to support the patent’s claims, 35 U.S.C. 112. The court referred to “a compendium of common organic chemical functional groups, yielding a laundry list disclosure of different moieties for every possible side chain or functional group. Indeed, the listings of possibilities are so long, and so interwoven, that it is quite unclear how many compounds actually fall within the described genera and subgenera.” The court found no violations of the Administrative Procedures Act and rejected the University argument that sovereign immunity barred IPR proceedings against it. View "Regents of the University of Minnesota v. Gilead Sciences, Inc." on Justia Law
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, Inc
Jazz holds an approved New Drug Application (NDA) for the narcolepsy drug Xyrem®, with the active ingredient, GHB, which exerts a heavily sedating effect and is prone to misuse; it is known as a date rape drug. The FDA conditioned approval of Jazz’s NDA upon the development of Risk Evaluation and Mitigation Strategies (REMS). The 963 patent relates to Jazz’s distribution system, which controls access to the drug through a central pharmacy and computer database, tracking prescriptions, patients, and prescribers. Jazz listed the 963 patent in the Orange Book as covering a method of using Xyrem. The patent’s claims expired in 2022. In 2020, Avadel submitted an NDA for the GHB-based drug FT218. Unlike Xyrem, FT218 is dosed once nightly. FT218’s REMS describe multiple pharmacies and databases for ensuring proper drug handling. Although Avadel had filed an NDA, not an Abbreviated NDA, the FDA required Avadel to file a certification that to the best of its knowledge, the 963 patent’s single-pharmacy system was invalid, unenforceable, or would not be infringed by its product.Jazz sued Avadel for infringement. Avadel sued the FDA for requiring certification; the suit was dismissed because 21 U.S.C. 355(c)(3)(D)(ii)(I) provided Avadel with a separate adequate remedy. Avadel responded to Jazz’s infringement assertions, seeking de-listing of the 963 patent. The Federal Circuit affirmed the district court order that Jazz request de-listing. The 963 patent claims a system and does not claim an approved method of use. View "Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, Inc" on Justia Law
ChromaDex, Inc. v. Elysium Health, Inc.
ChromaDex’s 807 patent is directed to dietary supplements containing isolated nicotinamide riboside (NR), a form of vitamin B3 naturally present—in non-isolated form—in cow’s milk and other products. Animal cells convert ingested NR into the coenzyme nicotinamide adenine dinucleotide, or NAD+. NAD+ deficiencies can cause diseases in both animals and humans. ChromaDex sued Elysium, a former ChromaDex customer, for patent infringement.The district court construed several claim terms, finding “isolated [NR]” to mean “[NR] that is separated or substantially free from at least some other components associated with the source of [NR].” The district court granted Elysium summary judgment, finding that the asserted claims were invalid under 35 U.S.C. 101. The Federal Circuit affirmed. The asserted claims concern a product of nature and are not patent eligible. They do not have characteristics markedly different from milk; both “increase NAD+ biosynthesis upon oral administration.” Recognizing the utility of NR is nothing more than recognizing a natural phenomenon, which is not inventive. The act of isolating the NR by itself, “no matter how difficult or brilliant it may have been” does not turn an otherwise patent-ineligible product of nature into a patentable invention. View "ChromaDex, Inc. v. Elysium Health, Inc." on Justia Law
Genentech, Inc. v. Sandoz Inc.
Pirfenidone is a drug used to treat idiopathic pulmonary fibrosis (IPF), a chronic, irreversible lung disease. There is no cure for IPF. Patients living with the disease face an average survival of two-five years. The FDA has approved two drugs for the treatment of IPF, pirfenidone, and nintedanib; differences center on side effects and metabolism. Pirfenidone was first studied as an investigational new drug in 1973. In 2004, the FDA granted pirfenidone orphan drug status for treatment of IPF. In 2014, pirfenidone was approved to treat IPF in the U.S. as Esbriet®, sold by Genentech. Sandoz submitted two Abbreviated New Drug Applications, seeking FDA approval to market a generic version of pirfenidone. Genentech then brought this Hatch-Waxman suit, asserting that Sandoz’s generic product would induce the infringement of its patents. The asserted patents do not claim pirfenidone itself, or the use of pirfenidone to treat IPF but claim methods for managing side effects when using pirfenidone to treat IPF.The Federal Circuit affirmed district court holdings that the claims of Genentech’s Liver Function Test patents are unpatentable as obvious, sales of Sandoz’s generic product would not induce infringement of the LFT patents, and sale of Sandoz’s generic product would not directly infringe Genentech’s Drug-Drug Interaction patents. View "Genentech, Inc. v. Sandoz Inc." on Justia Law
Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.,
Merck’s 708 patent describes sitagliptin dihydrogen phosphate (sitagliptin DHP), which belongs to the class of dipeptidyl peptidase-IV (DP-IV) inhibitors that can be used for treating non-insulin-dependent (Type 2) diabetes. Mylan petitioned for inter partes review, arguing that claims 1–3, 17, 19, and 21–23 were anticipated by the Merck-owned 489 publication, and the equivalent 871 patent (collectively, Edmondson) Edmondson is directed to compounds that are DP-IV inhibitors, useful in the treatment or prevention of diseases in which the dipeptidyl peptidase-IV enzyme is involved, such as diabetes and particularly type 2 diabetes. Mylan also argued that claims 1–4, 17, 19, and 21–23 would have been obvious over Edmondson and two additional publications.The Federal Circuit affirmed the Patent and Trademark Office Patent Trial and Appeal Board holding that Mylan failed to show that claims 1–4, 17, 19, and 21–23 were anticipated or would have been obvious over the cited prior art at the time the alleged invention was made. Merck reduced to practice more than what is shown in Edmondson for the claimed subject matter. View "Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.," on Justia Law
Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc.
Since 2014 Par has manufactured and sold Vasostrict®, an FDA-approved vasopressin injection product used to treat patients with critically low blood pressure. The Orange Book identifies Par’s 785 and 209 patents as encompassing Vasostrict®. Both patents require the vasopressin composition to have a rounded pH between 3.7–3.9. In 2018, Eagle filed an abbreviated new drug application (ANDA) to manufacture and sell a generic version of Vasostrict® before those patents expired. Eagle represented in its release specification that the pH range would be between 3.4–3.6. Eagle’s ANDA also contained 35 U.S.C. 355(j)(2)(A)(vii)(IV) certification that Par’s patents are invalid or will not be infringed by Eagle’s proposed product.Par sued for infringement under 35 U.S.C. 271(e)(2). Eagle stipulated that its proposed product would meet all asserted claim limitations except the claimed pH range. Par argued that “real-world” evidence shows the pH of Eagle’s product drifts up over time and that Eagle sought authority to release products into the marketplace with a pH of 3.64, just 0.01 beneath the infringing range. The Federal Circuit affirmed the rejection of those arguments. Minor fluctuations in pH value identified by Par did not reveal any discernible trend and the stability specification imposed an additional constraint that Eagle’s proposed product maintain a pH between 3.4–3.6 from the time of its distribution through its entire shelf life. View "Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc." on Justia Law