Justia Drugs & Biotech Opinion Summaries

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

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

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

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

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

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

LDL cholesterol can lead to cardiovascular disease, heart attacks, and strokes. PCSK9 is a naturally occurring protein that degrades LDL receptors responsible for extracting LDL cholesterol from the bloodstream. In 2011, Amgen and Sanofi each obtained a patent for the antibody employed in a PCSK9-inhibiting drug, describing the relevant antibody by its unique amino acid sequence. Amgen obtained two additional patents in 2014 that relate back to its 2011 patent and purport to claim “the entire genus” of antibodies that “bind to specific amino acid residues on PCSK9,” and “block PCSK9 from binding.” Amgen identified the amino acid sequences of 26 antibodies that perform those functions and described “roadmap” and “conservative substitution” methods for making other antibodies that perform the described functions.Amgen sued Sanofi for infringement. Sanofi argued that Amgen’s relevant claims were invalid under the “enablement” requirement, which requires a patent applicant to describe the invention “in such full, clear, concise, and exact terms as to enable any person skilled in the art” to make and use the invention,” 35 U.S.C. 112(a), characterizing the methods Amgen outlined for generating additional antibodies as a trial-and-error process.The district court, the Federal Circuit, and the Supreme Court sided with Sanofi. If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, its specification must enable a person skilled in the art to make and use the entire class. The claimed class of antibodies does not include just the 26 that Amgen described by their amino acid sequences, but many additional antibodies. The “roadmap” and “conservative substitution” approaches are little more than research assignments. View "Amgen Inc. v. Sanofi" on Justia Law

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

A group consisting primarily of union health and welfare insurance plans claims that Abbvie, the manufacturer of the drug Niaspan, paid off a potential manufacturer of a generic version of the drug to delay the generic’s launch. This putative class action was brought to recover damages based on the allegedly inflated prices charged by Abbvie in violation of state antitrust and consumer protection laws. The district court denied a motion for class certification, finding that the class was not ascertainable.The Third Circuit affirmed, declining to reconsider its “ascertainability” requirement. The court rejected an argument that the district court’s factual findings were clearly erroneous because the court misunderstood their proposed methodology, overstated the prevalence of intermediaries in the pharmacy benefit managers’ data, and failed to consider the use of affidavits as a means of identifying class members. The court further noted that the new suggestion concerning affidavits was not properly put before the district court. The district court properly concluded that the proposed data matching technique is unreliable. View "In Re: Niaspan Antitrust Litigation" on Justia Law

The 2005 Medicare amendment, launching prescription drug coverage, raised concerns that patient assistance plans could violate the Anti-Kickback Statute, 42 U.S.C. 1320a-7b, and the False Claims Act, 31 U.S.C. 3729, by effectively rewarding doctors and patients for choosing particular drugs. Astellas subsequently launched Xtandi, used to treat metastatic prostate cancer. Priced at $7,800 per month, Xtandi prescriptions were covered by Medicare up to about $6,000 per month. Astellas made contributions to two patient assistance plans. An Astellas marketing executive encouraged both plans to create special funds to provide co-pay assistance for only androgen receptor inhibitors like Xtandi and a few other medications. Astellas donated to the new funds but stopped after contributing about $27 million. Astellas continued contributing to broader prostate cancer funds.The Department of Justice began investigating; the Astellas marketing executive acknowledged that he had “hoped” and “expected” that the contributions would produce financial benefits for Astellas but that Astellas had made no efforts to calculate “a return on investment.” Astellas settled with the government for $100 million--$50 million for “restitution” to the government. Astellas sought indemnification from liability insurers, including Federal, which denied coverage.The Seventh Circuit affirmed summary judgment for Astellas. Under Illinois law, a party may not obtain liability insurance for genuine restitution it owes the victim of its intentional wrongdoing, but a party may obtain insurance for compensatory damages. In cases of ambiguity, Illinois favors settlements and freedom of contract. Federal wrote its insurance policy to try to extend coverage to the limit of what Illinois law would allow. Federal did not carry its burden of showing that the portion of the settlement payment for which Astellas seeks coverage is uninsurable restitution. View "Astellas US Holding, Inc. v. Federal Insurance Co." on Justia Law