Justia Drugs & Biotech Opinion Summaries

Articles Posted in Drugs & Biotech
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Incept’s 723 and 913 patents relate to improved methods for treating cancer, particularly prostate cancer, using radiation. The patents describe methods of introducing a filler between a radiation target tissue and other tissue to increase the distance between the two and thereby decrease the amount of radiation received by the non-targeted tissue. Palette sought inter partes review challenging the claims of the patents as unpatentable over prior art, including “Wallace,” describes a method for the “rapid formation of a biocompatible gel . . . at a selected site within a patient’s body.”The Federal Circuit affirmed the Patent Trial and Appeal Board in holding that the claims were anticipated or obvious, 35 U.S.C. 102, 103. Wallace discloses each element of claim 1 of the 723 patent, arranged as in that claim. The Board’s findings of motivation to combine are supported by substantial evidence in the form of the references themselves and Palette’s expert’s detailed testimony, which the Board found “persuasive.” With respect to Incept’s argument that the Board improperly dismissed the market share data that Incept provided, the court deferred to the Board’s findings concerning the credibility of expert witnesses. View "Incept LLC v. Palette Life Sciences, Inc." on Justia Law

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Genentech manufactures and sells Rituxan, a drug used to treat leukemia and lymphoma. Rituxan is sold in single-use vials. Williamson was diagnosed with follicular lymphoma and was treated with Rituxan. Williamson later sued Genentech, on behalf of himself and a putative class of similarly situated individuals. He claims that Genentech violates the unfair competition law by selling Rituxan (and three other medications) in excessively large single-use vials; because the appropriate dosage varies based on a patient’s body size, Genentech’s vial sizes are too large for most patients. He argues Genentech should be required to offer smaller vials to reduce the waste of expensive medicine. In addition to injunctive relief, Williamson seeks to recover the amount the class spent on wasted Rituxan (and three other medications). Williamson took only Rituxan, not the other three medications, and paid a $231.15 deductible– the rest of the payments were made by his health insurer.The court of appeal affirmed the dismissal of the case for lack of standing under California’s unfair competition law (Bus. & Prof. Code 17200). Williamson suffered no economic injury caused by the alleged unfair practices and cannot establish standing by borrowing an economic injury from his insurer. The collateral source rule, under which a tortfeasor must fully compensate a victim and cannot subtract compensation the victim may have received from their insurer or another collateral source, does not apply. View "Williamson v. Genentech, Inc." on Justia Law

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Hoping to minimize her risk of suffering serious complications from future blood clots, Johnson underwent surgery to implant a retrievable intravascular filter–a medical device that is placed in the inferior vena cava to prevent blood clots that develop in the lower body from flowing into the heart and lungs. Johnson’s doctor selected the Meridian filter, which was supposed to be temporary and easily removable. Johnson’s filter migrated and fractured, leaving shards embedded in the wall of her heart and elsewhere. Her surgeon was unable to remove the device safely and fully. As a result, Johnson faces an ongoing risk of infection, pain, and other complications.Johnson sued the manufacturers of the Meridian filter (Bard), claiming that they defectively designed the Meridian filter and failed to warn medical providers about the device’s risks, in violation of Wisconsin law. A jury rejected most of Johnson’s theories but returned a $3.3 million verdict in her favor on her strict liability failure-to-warn count. The Seventh Circuit affirmed, stating that its decision “should not be misinterpreted as our endorsement of some of Johnson’s counsel’s trial tactics.” There was no reversible error in instructing the jury or in permitting certain testimony, in alleged violation of expert witness disclosure requirements. View "Johnson v. C. R. Bard, Inc." on Justia Law

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Medtronics’s patents, which share a specification, relate to the transcutaneous (through the skin) charging of implanted medical devices. This charging occurs by inductive coupling, whereby energy is transferred between a primary coil in the external charger and a secondary coil in the implanted device when the two coils are placed in proximity to each other. The patents seek to improve charging efficiency by automatically varying the power output of the external charger based on various measured parameters of the current passing through the implanted device.In two inter partes review (IPR) determinations. The Patent Trial and Appeal Board held that the petitioner had failed to show that claims of the patents were unpatentable as anticipated or obvious. In each decision, the Board adopted a "two-input" claim construction first presented in the patent owner’s response after the institution decision and declined to consider the petitioner’s reply arguments and evidence under the new claim construction, reasoning that the petitioner had not identified anywhere in the petition that the two-input anticipation arguments had been made.The Federal Circuit vacated. The Board’s refusal to consider the new arguments and evidence was erroneous. The court remanded for the Board to consider the merits of Axonics’ responsive arguments and evidence under the new claim construction. View "Axonics, Inc. v. Medtronic, Inc." on Justia Law

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Mylan regularly submitted abbreviated new drug applications (ANDAs) to the FDA, often including Paragraph IV certifications stating that the proposed generic drug at issue would not infringe valid patents. Mylan incurred tens of millions of dollars in legal fees defending itself in about 120 patent infringement suits, 35 U.S.C. 271(e)(2). Mylan incurred additional, much lower legal fees in preparing the notice letters associated with the Paragraph IV certifications. Mylan's fees were $46,158,403, $38,211,911, and $38,618,993 during 2012, 2013, and 2014, respectively, for preparing notice letters and litigating the ANDA suits. In tax filings, Mylan deducted those amounts in the years incurred. The IRS responded that Mylan could not deduct the nearly $130 million of legal expenses incurred from 2012-2014 and that its additional tax liability was about $50 million.The Tax Court considered expert testimony regarding internal FDA processes and the typical course of dealing between an ANDA applicant and the FDA during the submission process for an ANDA with a paragraph IV certification and held that the legal expenses Mylan incurred to prepare notice letters were required to be capitalized because they were necessary to obtain FDA approval of its generic drugs. The Third Circuit affirmed its holding that the legal expenses incurred to defend patent infringement suits were deductible as ordinary and necessary business expenses because the patent litigation was distinct from the FDA approval process. View "Mylan Inc v. Commissioner of Internal Revenue" on Justia Law

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United Therapeutics holds New Drug Application (NDA) 022387 for Tyvaso®, an inhaled solution formulation of treprostinil approved for the treatment of pulmonary hypertension. It is a vasodilator that reduces vasoconstriction in the pulmonary vasculature, thereby decreasing blood pressure. United’s patents are listed in the FDA’s Orange Book for Tyvaso. Liquidia filed NDA 213005 for Yutrepia™ (21 U.S.C. 355(b)(2)), a dry powder inhalation formulation of treprostinil that is not a generic version of any currently marketed drug. United sued Liquidia, alleging infringement. Liquidia filed a petition for inter partes review (IPR); the Board found all claims of the 793 patent unpatentable as obvious. The district court concluded that seven claims of the 793 patent were not invalid and were infringed by Liquidia; several claims of the 066 patent were invalid as anticipated and would have been infringed by Liquidia but for the finding of anticipation; and claim 8 of the 066 patent was not invalid and not infringed.The Federal Circuit affirmed, upholding the district court’s determination that the meaning of “treating pulmonary hypertension” does not require a showing of safety and efficacy; the claims of the 793 patent are adequately enabled and supported by the written description; and Liquida induced infringement of that patent. View "United Therapeutics Corp. v. Liquidia Technologies, Inc." on Justia Law

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Vepuri is the de facto director of KVK-Tech, a generic drug manufacturer. He employed Panchal as its director of quality assurance. KVK-Tech manufactured and sold Hydroxyzine, a prescription generic drug used to treat anxiety and tension. The government alleges that Vepuri, Panchal, and KVK-Tech sourced active ingredient for the Hydroxyzine from a facility (DRL) that was not included in the approvals that they obtained from the FDA and that they misled the FDA about their practices.An indictment charged all three defendants with conspiracy to defraud and to commit offenses against the United States and charged KVK-Tech with an additional count of mail fraud. The district court dismissed the portion of the conspiracy charge that alleges that the three conspired to violate the Food, Drug, and Cosmetic Act (FDCA), which prohibits introducing a “new drug” into interstate commerce unless an FDA approval “is effective with respect to such drug,” 21 U.S.C. 355(a).The Third Circuit affirmed, rejecting an argument that a deviation from the approved drug application means that the approval is no longer effective. The approval ceases being effective only when it has been withdrawn or suspended. The indictment does not include any allegations that the KVK-Tech Hydroxyzine manufactured with active ingredients from DRL had a different composition or labeling than the KVK-Tech Hydroxyzine with the effective approval. View "United States v. Vepuri" on Justia Law

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Medytox’s patent is directed to the use of an animal-protein-free botulinum toxin composition that exhibits a longer-lasting effect compared to an animal protein-containing botulinum toxin composition and purportedly can be used to treat both cosmetic and non-cosmetic conditions. Galderma requested post-grant review of claims 1–10, which the Patent Trial and Appeal Board granted. Medytox filed a non-contingent motion to amend seeking to cancel claims 1–10 and substitute claims 11–18 and requested that the Board issue a Preliminary Guidance. Galderma argued that the claims added new matter because the claims covered compounds with a 16-week responder rate between 50-100% but the specification only disclosed responder rates of up to 62%.Reversing its Preliminary Guidance, the Board found that the substitute claims impermissibly introduced new matter with the inclusion of the responder rate limitation and failed to meet the requirements for revised motions to amend; that the proposed substitute claims were unpatentable for a lack of written description; and that the full scope of the claims was not enabled.The Federal Circuit affirmed, upholding the Board’s claim construction of the responder rate limitation as a range. The Board provided adequate explanation for its enablement finding. The Board’s revision of its claim construction of the responder rate limitation made between its Preliminary Guidance and final decision was not arbitrary and capricious, depriving Medytox of a full and fair opportunity to litigate. View "Medytox, Inc. v. Galderma S.A." on Justia Law

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The pending claims of the 422 application recite methods of increasing prostacyclin release in the systemic blood vessels of a human with essential hypertension to improve vasodilation. Increased prostacyclin release is achieved by co-administering two well-known antihypertensive agents: a GABA-a agonist and an Angiotensin II Receptor Blocker (ARB). Essentially, the claims relate to combatting hypertension with known anti-hypertensive agents and claiming their previously unappreciated mechanism of action. During prosecution, Couvaras conceded that GABA-a agonists and ARBs “have been known as essential hypertension treatments" for decades. The Examiner agreed, citing 10 references establishing that GABA-a agonists and ARBs lower blood pressure; the claimed results of increased prostacyclin release, activation of uninhibited GABA-a receptors, and smooth muscle relaxation were not patentable because they naturally flowed from the claimed administration of the known antihypertensive agents.The Patent Board affirmed the rejection, holding that the claimed result of an increased prostacyclin release was inherent in the obvious administration of the two known antihypertension agents and that Couvaras’s objective indicia arguments did not overcome the prima facie case of obviousness. The Federal Circuit affirmed, rejecting arguments that the Board erred in affirming that a skilled artisan would have had motivation to combine the art; that the claimed mechanism of action was unexpected, and that the Board erred in discounting its patentable weight; and that the Board erred in weighing objective indicia of nonobviousness. View "In Re Couvaras" on Justia Law

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The First Circuit affirmed the decision of the district court granting summary judgment to Vitamin Shoppe and ruling that the Food, Drug, and Cosmetic Act (FDCA) preempted Plaintiffs' state law tort claims, holding that Plaintiffs' state law claims were expressly preempted by the FDCA.Plaintiffs purchased three dietary supplements containing glutamine as a main ingredient. Plaintiffs brought this action against the products' manufacturers claiming that the labels on the supplements contained statements that were false and misleading under state law. The district court granted summary judgment in favor of Vitamin Shoppe, holding that the FDCA preempted Plaintiffs' state law claims. The First Circuit affirmed, holding (1) the statements on Vitamin Shoppe's labels were structure/function claims under 343(r)(6), and Vitamin Shoppe complied with the FDCA's requirements to make such claims; and (2) therefore, Plaintiffs' state law claims challenging the statements about glutamine were expressly preempted by the FDCA. View "Ferrari v. Vitamin Shoppe Industries LLC" on Justia Law