Justia U.S. Federal Circuit Court of Appeals Opinion SummariesArticles Posted in Drugs & Biotech
Elekta Ltd. v. ZAP Surgical Systems, Inc.
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
Baxalta Inc. v. Genentech, Inc.
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
Incept LLC v. Palette Life Sciences, Inc.
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
Axonics, Inc. v. Medtronic, Inc.
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
United Therapeutics Corp. v. Liquidia Technologies, Inc.
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
Medytox, Inc. v. Galderma S.A.
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
In Re Couvaras
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
Medtronic, Inc. v. Teleflex Innovations S.à.r.l.
For decades, cardiologists have used guide catheters to deliver interventional cardiology devices (e.g., guidewires, stents, balloon catheters) designed to alleviate stenoses. These procedures involved certain challenges and risks. Telex’s patents sought to address these problems by using a coaxial extension catheter insertable into standard guide catheters that offered increased backup support and the ability to deep seat without the attendant drawbacks of traditional systems.Medtronic petitioned for inter partes review (IPR), alleging the challenged claims would have been obvious over prior art. The Patent Trial and Appeal Board found certain claims unpatentable. The Federal Circuit affirmed. The Board did not err in determining Medtronic failed to carry its burden to show that certain claims would have been obvious, and substantial evidence supports its underlying findings of fact. The court also upheld the Board’s determination that Telex's proposed Substitute Claims had adequate written description support and would not have been obvious over Medtronic’s asserted grounds. View "Medtronic, Inc. v. Teleflex Innovations S.à.r.l." on Justia Law
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