Justia Drugs & Biotech Opinion Summaries

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

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 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’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

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

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

The First Circuit affirmed the judgment of the district court dismissing Amyndas Pharmaceuticals, S.A.'s claims against Zealand Pharma A/S and vacated the dismissal of Amyndas's claims against Zealand Pharma U.S., Inc., holding that the district court erred in dismissing Amyndas's claims against Zealand Pharma U.S.When Amyndas was considering separate joint ventures with Zealand Pharma and Alexion Pharmaceuticals, Inc. it shared trade secrets before understanding that neither of the joint ventures would materialize. Zealand Pharma and Zealand US, its newly established affiliate, subsequently announced a partnership with Alexion Pharmaceuticals, Inc. Amyndas sued for misappropriation of trade secrets and other confidential information. The district court (1) dismissed Amyndas's claims against Zealand Pharma on the ground that Amyndas was required to litigate those claims in Denmark; and (2) dismissed Amyndas's claims against Zealand US for failure to state a claim. The First Circuit vacated in part and remanded the case for further proceedings, holding that the district court (1) correctly dismissed Amyndas's claims against Zealand Pharma; and (2) erred in concluding that Amyndas's claims against Zealand US were futile. View "Amyndas Pharmaceuticals, S.A. v. Zealand Pharma A/S" on Justia Law

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

After the district court granted summary judgment in favor of two government agencies and a pharmaceutical company in this Freedom of Information Act ("FOIA") case. Plaintiff, a science writer and journalism professor, sought records from the government agencies relating to the pharmaceutical company's successful application for accelerated approval of a drug for the treatment of a neuromuscular disease. The agencies produced over 45,000 pages of documents, some of which were redacted under Exemption 4 of FOIA. The district court granted summary judgment for the agencies and the pharmaceutical company on the basis that the redacted information fell within Exemption 4 and publication would either cause foreseeable harm to the interests protected by Exemption 4 or was prohibited by law.Plaintiff appealed and the Second Circuit affirmed the district court’s ruling. The court held that the interests protected by Exemption 4 are the submitter's commercial or financial interests in the information that is of a type held in confidence and not disclosed to any member of the public by the person to whom it belongs. Defendants' declarations show that the release of the information Plaintiff seeks would foreseeably harm the pharmaceutical company’s interests and Plaintiff does not raise a genuine dispute as to that showing. View "Seife v. FDA, et al." on Justia Law

The patents share the same specification and are entitled “Non-Invasive Diagnosis of Graft Rejection in Organ Transplant Patients.” They discuss diagnosing or predicting organ transplant status by using methods to detect a donor’s cell-free DNA (cfDNA). When an organ transplant is rejected, the recipient’s body, through its natural immune response, destroys the donor cells, releasing cfDNA from the donated organ’s dying cells into the blood. These increased levels of donor cfDNA—which occur naturally as the organ’s condition deteriorates—can be detected and then used to diagnose the likelihood of an organ transplant rejection.In an infringement action, the district court found the patents ineligible under 35 U.S.C. 101. The Federal Circuit affirmed. The court applied the Supreme Court’s two-part “Alice” test to determine whether the claims were patent-eligible applications of laws of nature and natural phenomena or claims that impermissibly tie up such laws and phenomena. The claims boil down to collecting a bodily sample, analyzing the cfDNA using conventional techniques, including PCR, identifying naturally occurring DNA from the donor organ, and then using the natural correlation between heightened cfDNA levels and transplant health to identify a potential rejection, none of which was inventive. This is not a case involving a method of preparation or a new measurement technique. View "CareDx, Inc. v. Natera, Inc" on Justia Law