Justia U.S. Federal Circuit Court of Appeals Opinion Summaries

Articles Posted in Drugs & Biotech
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In this case, the United States Court of Appeals for the Federal Circuit considered whether the defendants' Abbreviated New Drug Applications (ANDAs) infringed two patents owned by the plaintiffs. The patents pertained to the use of the drug vortioxetine in the treatment of patients who had previously taken certain other antidepressant medications and had to cease or reduce use due to sexually related adverse events, and for the treatment of cognitive impairment. The defendants were seeking approval to market vortioxetine for the treatment of Major Depressive Disorder (MDD) in adults, a use not covered by the patents. The plaintiffs sought to block the defendants from marketing a generic version of the drug until after the expiration of the patents.The court held that the defendants' ANDA filings did not infringe the plaintiffs' patents. The court found that the defendants' intended use of the drug, for the treatment of MDD in adults, did not infringe the patents which pertained to other specific uses of the drug.Moreover, the court found no induced or contributory infringement. Regarding induced infringement, the court held that the defendants' proposed labels for the drug did not encourage, recommend, or promote an infringing use. Regarding contributory infringement, the court held that the defendants' sale of the drug would have substantial noninfringing uses, thus there would be no contributory infringement.Additionally, the court rejected Lupin's cross-appeal, which challenged the district court's determination that Lupin infringed a patent concerning a process for manufacturing vortioxetine. The court affirmed the district court's construction of the term "reacting" in the patent and its determination of infringement. View "H. LUNDBECK A/S v. LUPIN LTD. " on Justia Law

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Cloudbreak’s patent discloses compositions and methods for treating pterygium, an eye condition in which a tumor-like growth extends from the nasal or temporal side of the eye to the cornea, by administering multikinase inhibitors to the eye to inhibit specific growth factors that contribute to tumor growth and hyperemia (i.e., eye redness). The patent discloses that nintedanib in particular “may be one of the most powerful multikinase inhibitors for reducing corneal neovascularization.”In inter partes review, the Patent Trial and Appeal Board held that the petitioner, Allgenesis, failed to prove two claims of the patent are unpatentable. The Federal Circuit dismissed an appeal. Allgenesis failed to establish an injury in fact sufficient to confer standing to appeal. Allgenesis identified no concrete plans to develop and bring to market a nintedanib treatment for pterygium and has not shown its activities will create a substantial risk of infringement or will likely cause Cloudbreak to assert a claim of infringement. The court rejected an argument that Allgenesis suffered an injury in fact based on the Board’s priority determination that will have a preclusive effect on the scope of its pending patent application. Allgenesis has not established that the Board’s decision will have preclusive effect. View "Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC" on Justia Law

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Epoprostenol, a naturally occurring substance, useful for treating cardiovascular diseases, was discovered in the early 1980s and was first brought to market under the brand name Flolan® in 1995. Epoprostenol is unstable in water, it was prepared as a freeze-dried, or lyophilized, powder for use in the Flolan composition. Actelion owns two patents directed to improved epoprostenol formulations that can be reconstituted with commercially available IV fluids and do not require refrigeration after reconstitution until use.” The inventor “unexpectedly found that epoprostenol solution in the presence of an alkalinizing agent, and high pH (>11) is very stable compared to Flolan.” Mylan sought approval to manufacture and sell a generic epoprostenol sodium for injection by filing an Abbreviated New Drug Application (ANDA) with the FDA, containing a certification that the Actelion patents’ claims were invalid or would not be infringed by the ANDA product.The Federal Circuit vacated the district court’s claim construction order with respect to the term “a pH of 13 or higher” and its judgment of infringement. The issue involves understanding what the significant digits are for “a pH of 13.” The district court must address extrinsic evidence explaining how a person of ordinary skill in the art would view the significant digits for a pH value. View "Actelion Pharmaceuticals LTD v. Mylan Pharmaceuticals Inc.," on Justia Law

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Elekta’s 648 patent, titled “Method and apparatus for treatment by ionizing radiation,” discloses a device for treating a patient with ionizing radiation for certain types of radiosurgery and radiation therapy. The invention uses a radiation source, e.g., a linear accelerator (linac), mounted on a pair of concentric rings to deliver a beam of ionizing radiation to the targeted area of the patient. ZAP Surgical Systems sought inter partes review (IPR). The Patent Trial and Appeal Board addressed Elekta’s arguments that a skilled artisan would not have been motivated to combine, and would not have had a reasonable expectation of success in combining, one prior art device (Grady) with the linac described in the prior art, Ruchala, and whether a skilled artisan would have been dissuaded from combining the devices because one device was an imaging device, rather than a radiation device, and because the linac’s weight would render the Grady device inoperable, imprecise, and unsuitable for treatment.The Board concluded that a skilled artisan would have been motivated to combine Grady and Ruchala. The Federal Circuit affirmed, finding substantial support for the finding that a person of ordinary skill in the art would have been motivated to make the proposed combination. View "Elekta Ltd. v. ZAP Surgical Systems, Inc." on Justia Law

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In a “key step” of the "coagulation cascade" that forms blood clots, an enzyme (Factor VIIIa) complexes with another enzyme (Factor IXa) to activate Factor X. Hemophilia A is a disorder where the activity of Factor VIII is functionally absent, impeding the body’s ability to effectively form blood clots. Historically, Hemophilia A has been treated by intravenously administering Factor VIII. Approximately 20–30% of Hemophilia A patients cannot benefit from that treatment because they develop Factor VIII inhibitors. Baxalta’s patent provides alternative means to treat Hemophilia A.Baxalta sued, alleging Genentech’s Hemlibra® (emicizumab) product infringes the patent. Emicizumab is a humanized bispecific antibody that binds to Factor IXa with one arm and Factor X with the other arm, mimicking the function of Factor VIIIa. Following the district court’s construction of the claim terms “antibody” and “antibody fragment” to exclude bispecific antibodies, the Federal Circuit held the proper construction of “antibody” was “an immunoglobulin molecule having a specific amino acid sequence comprising two heavy chains (H chains) and two light chains (L chains),” and the proper construction of “antibody fragment” was “a portion of an antibody” and remanded. On remand, Genentech successfully moved for summary judgment of invalidity of multiple claims for lack of enablement. The Federal Circuit affirmed. The patent fails to teach skilled artisans how to make and use the full scope of claimed antibodies without unreasonable experimentation. View "Baxalta Inc. v. Genentech, Inc." on Justia Law

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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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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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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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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