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Indivior markets and holds the New Drug Application (NDA) for Suboxone® sublingual film, an opioid addiction treatment that combines two active ingredients: the opioid buprenorphine and the opioid antagonist naloxone. Suboxone Film is applied below a patient’s tongue, where it then rapidly dissolves to release the active ingredients. In 2010, the FDA approved Indivior’s film product, the first such product to gain FDA approval. Previously, Indivior sold buprenorphine/naloxone only in a tablet form. These appeals involve issues of infringement and invalidity of four patents covering pharmaceutical films and methods of making them, particularly two patents that claim pharmaceutical films and are listed in the Orange Book2 as covering Suboxone Film. The district court concluded that the asserted claims of three patents are not invalid as obvious; that one patent is not invalid as indefinite and that Watson infringes that patent; and that DRL and Alvogen do not infringe either of two patents. The court found certain claims in a fourth patent invalid. The Federal Circuit vacated, as moot, the holding that those claims were invalid as obvious but otherwise affirmed. In a parallel inter partes review proceeding, the Patent Trial and Appeal Board had held the claims unpatentable as anticipated and obvious, and the Federal Circuit affirmed. View "Indivior Inc. v. Dr. Reddy's Laboratories, S.A." on Justia Law

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UCB’s 434 patent, entitled “Transdermal therapeutic system which contains a d2 agonist and which is provided for treating Parkinsonism, and a method for the production thereof,” claims a polymorph of rotigotine. UCB’s 414 patent is entitled “Polymorphic form of rotigotine and process for production.” UCB has been selling the FDA-approved product, Neupro, since 2007. The district court concluded that Actavis’s generic products infringed the patent under the doctrine of equivalents and upheld the 434 patent's validity over obviousness and anticipation challenges. The court invalidated the 414 patent under 35 U.S.C. 102(a) as known and used by others in the U.S. before the date of invention. The Federal Circuit affirmed. There is not enough evidence to conclude that UCB surrendered polyisobutylene as a possible equivalent; UCB’s claiming of acrylates and silicates does not bar treating polyisobutylenes as an equivalent for infringement purposes and vitiation does not bar application of the doctrine of equivalents here. Actavis offers no examples of prior art that would be ensnared by the addition of polyisobutylene to the claim, in contrast to the claim as is. The court upheld fact findings as to polyisobutylene’s characteristics as compared to silicates and acrylates and as to what a skilled artisan would have known about the interchangeability of polyisobutylene-based adhesives and silicone-based adhesives and the conclusion that the accused products infringe the claims under the doctrine of equivalents. View "UCB, Inc. v. Watson Laboratories Inc." on Justia Law

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Mayne’s 745 patent discloses and claims pharmaceutical compositions of azole antifungal drugs that are practically insoluble in aqueous media. The patent explains that insoluble drugs are difficult to formulate into dosage forms because of their low absorption and poor bioavailability and purports to provide a pharmaceutical composition addressing these shortcomings. On MSD’s petition, the Patent Trial and Appeal Board initiated inter partes review and found several claims unpatentable as anticipated or obvious, 35 U.S.C. 103 The Federal Circuit affirmed, upholding the Board’s decision to permit MSD’s amendment, finding no indication of intentional concealment, no bad faith on MSD’s part, no attempt to circumvent the estoppel rules, or any other material benefit to it in its delay in naming MCI as a real party in interest. The Board did not err in its constructions of either “pharmaceutical composition” or the “wherein” clauses; under the Board’s constructions, the claims are obvious or anticipated View "Mayne Pharma International Pty. Ltd. v. Merck Sharp & Dohme Corp." on Justia Law

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About 1,300 public entities sued manufacturers, distributors, and retailers of prescription opiate drugs to recover the costs of health problems caused by the opioid crisis. Plaintiffs subpoenaed the U.S. Drug Enforcement Agency’s ARCOS database, a “comprehensive drug reporting system which monitors the flow of DEA controlled substances from their point of manufacture through commercial distribution channels to point of sale or distribution at the dispensing/retail level.” The district court noted that the ARCOS data “are not pure investigatory records compiled for law enforcement purposes, [but] simply business records of defendants; . . . the database does not include any additional DEA analysis or work-product” and concluded that Plaintiffs’ request was reasonable. The court permitted pleadings and other documents to be filed under seal or with redactions, refused a request to disclose the ARCOS data to the media, and entered a protective order. The Sixth Circuit vacated. The district court never made a finding that Defendants or the DEA made “a particular and specific demonstration of fact” justifying the Protective Order. The court expressed concern that the district court may have wanted the threat of public disclosure to motivate settlement discussions. On remand, the court may consider why pieces of ARCOS data related to specific ongoing investigations should not be disclosed but cannot enter a blanket, wholesale ban on disclosure pursuant to state public records requests. No modified protective order may specify that the ARCOS data be destroyed or returned to the DEA at the conclusion of litigation. The court must reconsider each pleading filed under seal or with redactions and make specific determinations as to the necessity of nondisclosure. View "In re National Prescription Opiate Litigation" on Justia Law

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T.L. consulted Dr. Jack Goldberg for a blood condition. In October 2010, Dr. Goldberg told T.L. about a new medication, Pegasys. After taking Pegasys, T.L. experienced a number of symptoms, but Dr. Goldberg advised that T.L. should continue taking Pegasys. T.L. began experiencing severe pain in her neck and both arms, requiring hospitalization and rehabilitation. T.L. was diagnosed with inflammation of the spinal cord and experienced partial paralysis on her right side. T.L. brought suit against Dr. Goldberg and his employer, Penn Medicine Cherry Hill. T.L. claimed that Dr. Goldberg deviated from accepted standards of care by prescribing Pegasys to her because she was diagnosed with, and took medication for, chronic depression. During Dr. Goldberg’s deposition, when asked whether he was aware of any studies in the Journal of Clinical Oncology pertaining to the use of Pegasys to treat patients with T.L.’s condition, Dr. Goldberg answered “no.” On T.L.’s motion, the court barred Dr. Goldberg from using any medical literature at trial that was not produced during the course of discovery. At trial, Dr. Goldberg testified that he prescribed Pegasys to T.L. because he relied upon a clinical trial, published in the Journal of Clinical Oncology in 2009, that included patients with a history of depression. T.L.’s counsel did not object. The jury found that Dr. Goldberg did not deviate from the applicable standard of care. T.L. was granted a new trial on grounds that Dr. Goldberg’s discussion of the 2009 publication constituted reversible error. Dr. Goldberg appealed as of right based on a dissenting justice in the Appellate Division's reversal of the trial court. The New Jersey Supreme Court reversed, finding there was no demonstration that the changed testimony caused prejudice to T.L., and the plain error standard did not compel reversal, "especially because counsel’s failure to object was likely strategic." Under the circumstances, T.L. was not entitled to a new trial. View "T.L. v. Goldberg" on Justia Law

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Plaintiff filed suit on behalf of his mother's estate against WellDyne and Exactus, asserting claims for negligence, negligence per se and breach of the implied warranty of fitness for a particular purpose against both defendants. Plaintiff also alleged Exactus was vicariously liable for the actions of WellDyne under agency and joint venture theories. In this case, plaintiff's mother died shortly after a hospital stay stemming from her ingestion of prescription medications that were erroneously mailed to her by WellDyne. The district court granted summary judgment in favor of WellDyne and Exactus as to all counts, finding that plaintiff's mother was contributorily negligent as a matter of law which completely barred her recovery in North Carolina. The court reversed the district court's judgment insofar as it granted summary judgment on the basis of contributory negligence and causation, remanding for the district judge to conduct a Daubert analysis of the expert opinions proffered by plaintiff to determine whether taking some of the misdirected medications was the cause of the mother's injuries and death. The court affirmed summary judgment to Exactus; affirmed summary judgment to WellDyne as to the claim for implied warranty of a particular purpose; and remanded. View "Small v. Welldyne, Inc." on Justia Law

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Merck’s drug Fosamax treats and prevents osteoporosis in postmenopausal women. When the FDA approved Fosamax in 1995 (21 U.S.C. 355(d)), its label did not warn of the then-speculative risk of atypical femoral fractures associated with the drug. Stronger evidence connecting Fosamax to such fractures developed later. The FDA ordered Merck to add a warning to the Fosamax label in 2011. Individuals who took Fosamax and suffered atypical femoral fractures sued, claiming that state law imposed upon Merck a legal duty to warn. Merck asserted that the FDA would have rejected any attempt to change the label. The district court agreed with Merck’s pre-emption argument and granted Merck summary judgment. The Third Circuit vacated. The Supreme Court remanded. The Third Circuit incorrectly treated the pre-emption question as one of fact. A state-law failure-to-warn claim is pre-empted where there is “clear evidence” that the FDA would not have approved a change to the label. “Clear evidence” shows the court that the manufacturer fully informed the FDA of the justifications for the warning and that the FDA would not approve a label change to include that warning. FDA regulations permit drug manufacturers to change a label to “reflect newly acquired information” if the changes “add or strengthen a . . . warning” for which there is “evidence of a causal association.” The pre-emption question can only be determined by agency actions taken pursuant to the FDA’s congressionally delegated authority. The question of agency disapproval is primarily one of law for a judge to decide. Judges, rather than juries, are better equipped to evaluate an agency’s determination and to understand and interpret agency decisions in the statutory and regulatory context. While contested facts will sometimes prove relevant, they are subsumed within a tightly-circumscribed legal analysis and do not warrant submission to a jury. View "Merck Sharp & Dohme Corp. v. Albrecht" on Justia Law

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Non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin and naproxen, control pain but have undesirable side effects, including gastrointestinal problem. Some practitioners began prescribing acid inhibitors, including PPIs, to reduce the acidity in the gastrointestinal tract. The combination therapy had complications. Stomach acid degraded the PPI before it could reach the small intestine. To address those complications, Dr. Plachetka invented a drug (Vimovo®.) that coordinated the release of an acid inhibitor and an NSAID in a single tablet with a core of an NSAID, an enteric coating around the NSAID that prevents its release before the pH increases to a certain desired level, and an acid inhibitor like PPI around the outside of the enteric coating that actively works to increase the pH to the desired level. Plachetka’s invention contemplates using some uncoated PPI for immediate release. Manufacturers, wanting to market a generic version of Vimovo®, submitted Abbreviated New Drug Applications to the FDA. They stipulated to infringement, except with respect to one ANDA product and alleged that the Vimovo® patents were invalid as obvious over prior art, 35 U.S.C. 103 and for lack of enablement and adequate written description, 35 U.S.C. 112. The Federal Circuit reversed a holding that the Vimovo® patents were valid. The specification provides nothing more than a claim that uncoated PPI might work, even though persons of ordinary skill in the art would not have thought so, and does not satisfy the written description requirement. View "Nuvo Pharmaceuticals, Inc. v. Dr. Reddy's Laboratories Inc." on Justia Law

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BTG’s 438 Patent, entitled “Methods and Compositions for Treating Cancer,” discloses the administration of a therapeutically effective amount of a CYP17 inhibitor, such as abiraterone acetate, in combination with at least one additional therapeutic agent such as an anti-cancer agent or a steroid. The patent defines an “anti-cancer agent” as “any therapeutic agent that directly or indirectly kills cancer cells or directly or indirectly prohibits[,] stops[,] or reduces the proliferation of cancer cells.” BTG sued Amneal, asserting that its Abbreviated New Drug Applications (ANDA) for the generic version of BTG’s abiraterone product ZYTIGA® infringed the patent. On inter partes review, the Patent Trial and Appeal Board found that the patent’s claims would have been obvious under 35 U.S.C. 103. The district court affirmed, accepting the Board’s claim construction and the same combination of prior art. The Federal Circuit affirmed. The Board correctly concluded that the claims cover a therapy in which abiraterone has an anticancer effect, while prednisone either has its own anti-cancer effect or has a palliative/side-effect reduction effect, and that the “prior art provides a reasonable expectation that prednisone could be used as a therapeutic agent in the treatment of prostate cancer.” View "BTG International Ltd. v. Amneal Pharmaceuticals LLC" on Justia Law

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The Novartis 131 patent claims methods of using the compound everolimus to treat advanced renal cell carcinoma (RCC). Advanced RCC is a cancer of the kidneys that has spread to other parts of the body. Everolimus is the active ingredient in Novartis’s Afinitor product. West-Ward’s predecessor filed an Abbreviated New Drug Application (ANDA) seeking to manufacture and sell generic versions of Afinitor. Novartis filed an infringement suit in response. The district court ruled that West-Ward failed to prove by clear and convincing evidence that claims 1–3 of the 131 patent are invalid as obvious in light of prior art, 35 U.S.C. 103(a). The Federal Circuit affirmed. While the district court erred in its analysis of whether there was a motivation to combine, a person of ordinary skill would not have reasonably expected success in using everolimus to treat advanced RCC as of February 2001. View "Novartis Pharmaceuticals Corp v. West-Ward Pharmaceuticals International, Ltd." on Justia Law