Justia Drugs & Biotech Opinion SummariesArticles Posted in Drugs & Biotech
Amgen Inc. v. Sanofi
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
Posted in: Drugs & Biotech, Intellectual Property, Patents, US Supreme Court
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
In Re: Niaspan Antitrust Litigation
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
Astellas US Holding, Inc. v. Federal Insurance Co.
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
Bridges v. Blackstone, Inc.
Bridges and Cunningham filed a putative class action, alleging that Blackstone (the owner of Ancestry.com) violated Section 30 of Illinois’s 1998 Genetic Information Privacy Act, which provides that no person or company “may disclose or be compelled to disclose the identity of any person upon whom a genetic test is performed or the results of a genetic test in a manner that permits identification of the subject of the test,” 410 ILCS 513/30(a). Both plaintiffs had purchased DNA testing products from Ancestry and submitted saliva samples for genetic sequencing years earlier. Blackstone subsequently purchased Ancestry in a “control acquisition”— an all-stock transaction. Because Ancestry had allegedly paired the plaintiffs’ genetic tests with personally identifiable information—including names, emails, and home addresses—Bridges and Cunningham maintained that Blackstone, as part of acquiring Ancestry, had compelled the disclosure of their genetic identities in violation of Section 30.The Seventh Circuit affirmed the dismissal of the suit for failure to state a claim. The complaint focusing exclusively on Blackstone’s acquisition of Ancestry did not adequately allege any compulsory disclosure. View "Bridges v. Blackstone, Inc." on Justia Law
Onglyza Product Cases
In 2008, as part of the defendants’ application for approval of Onglyza and Kombiglyze XR, two diabetes drugs with saxagliptin as the active ingredient, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee required that defendant AstraZeneca perform a cardiovascular outcomes study. “SAVOR” was a randomized, double-blind, placebo-controlled study that consisted of 16,492 patients with type 2 diabetes who were at high risk of cardiovascular disease. The study concluded that saxagliptin did not increase or decrease the risk of these occurrences but noted a higher risk of hospitalization. Following SAVOR, the FDA required warning labels for medications containing saxagliptin, referring to the potential increased risk of heart failure. Researchers conducted additional studies and did not find an association between saxagliptin and an increased risk of hospitalization for heart failure.Patients who took drugs with saxagliptin filed approximately 250 related cases. Most of these cases were filed in federal court and consolidated into federal multidistrict litigation. A Judicial Council coordination proceeding (JCCP) was established for the California state court cases. The court of appeal affirmed summary judgment in favor of the defendants. The court upheld the exclusion of the plaintiffs’ general causation expert, who opined that saxagliptin can cause heart failure. View "Onglyza Product Cases" 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
KYM PARDINI, ET AL V. UNILEVER UNITED STATES, INC.
The Butter! Spray is a butter-flavored vegetable oil dispensed in pump-action squirt bottles with a spray mechanism. The front label on the product states that the Butter! Spray has 0 calories and 0 grams of fat per serving. Plaintiffs are a class of consumers who brought their lawsuit against the then-manufacturer, Unilever United States, Inc., contending that the product’s label makes misrepresentations about fat and calorie content based on artificially low serving sizes. The district court found that Plaintiffs failed to plausibly allege that Butter! Spray was not a “spray type” fat or oil under Food and Drug Administration (FDA) regulations. The district court further held that the FDCA preempted plaintiffs’ serving size claims. The Ninth Circuit affirmed the district court’s Fed. R. Civ. P. 12(b)(6) dismissal. The panel held that, as a matter of legal classification, Butter! Spray was a “spray.” In common parlance, a “spray” refers to liquid dispensed in the form of droplets, emitted from a mechanism that allows the product to be applied in that manner. In addition, the notion that Butter! Spray could be housed under the FDA’s legal classification for “butter” is implausible. The panel also rejected Plaintiffs’ argument that Butter! Spray is a “butter substitute” based on how it is marketed so it should be treated as “butter” for serving size purposes, too. The court explained that because Plaintiffs’ challenge to the Butter! Spray serving sizes would “directly or indirectly establish” a requirement for food labeling that is “not identical” to federal requirements, the FDCA preempts their serving size claims. View "KYM PARDINI, ET AL V. UNILEVER UNITED STATES, INC." on Justia Law
Alliance Hippocratic Medicine v. FDA
The Food and Drug Administration (“FDA”) approved mifepristone to be marketed with the brand name Mifeprex under Subpart H (the “2000 Approval”). In January 2023, FDA approved a modified REMS for mifepristone, lifting the in-person dispensing requirement. Plaintiffs (physicians and physician organizations) filed a suit against FDA, HHS, and a several agency heads in the official capacities. Plaintiffs challenged FDA’s 2000 Approval of the drug and also requested multiple grounds of alternative relief for FDA’s subsequent actions. Plaintiffs moved for a preliminary injunction ordering FDA to withdraw or suspend (1) FDA’s 2000 Approval and 2019 Generic Approval, (2) FDA’s 2016 Major REMS Changes, and (3) FDA’s 2021 Mail-Order Decision and its 2021 Petition Denial of the 2019 Citizen Petition. The district court entered an order staying the effective date of the 2000 Approval and each of the subsequent challenged actions. The Fifth Circuit granted Defendants’ motions for a stay pending appeal. The court wrote that at this preliminary stage, and based on the court’s necessarily abbreviated review, it appears that the statute of limitations bars Plaintiffs’ challenges to the Food and Drug Administration’s approval of mifepristone in 2000. However, Plaintiffs brought a series of alternative arguments regarding FDA’s actions in 2016 and subsequent years. And the district court emphasized that its order separately applied to prohibit FDA’s actions in and after 2016 in accordance with Plaintiffs’ alternative arguments. As to those alternative arguments, Plaintiffs’ claims are timely. Defendants have not shown that Plaintiffs are unlikely to succeed on the merits of their timely challenges. For that reason, Defendants’ motions for a stay pending appeal are denied in part. View "Alliance Hippocratic Medicine v. FDA" on Justia Law
UCB, Inc. v. Actavis Laboratories UT, Inc.
Rotigotine is used to treat Parkinson’s disease, which causes difficulty swallowing and slow transit times through intestines, which can frustrate oral treatments. Transdermal therapeutic systems deliver drugs through the patient’s skin and avoid those complications. In 2007, UCB invented and marketed Neupro®, the first FDA-approved patch treatment for Parkinson’s disease. Original Neupro® is covered by several UCB patents, including the Muller patents, which claim priority to an application filed in 1999. The Muller patents are listed in the FDA’s “Orange Book,” as covering reformulated Neupro®.In 2013, Actavis submitted an Abbreviated New Drug Application (ANDA) for FDA approval of a generic transdermal rotigotine patch. UCB sued for infringement. The district court granted UCB an injunction preventing approval of Actavis’s ANDA until March 2021, when the Muller patent expired. In 2018 UCB filed the patent application that matured into the 589 patent, claiming priority from a provisional application filed in 2009, entitled “Polyvinylpyrrolidone for the Stabilization of a Solid Dispersion of the Non-Crystalline Form of Rotigotine.” UCB again filed suit, asserting the 589 patent, to delay FDA approval of a generic for nine additional years.The district court found that the Muller patents anticipate all asserted claims and that the asserted claims would have been obvious in view of multiple prior art references, including the Muller patents. The Federal Circuit affirmed the judgment of invalidity of the 589 patent. The district court’s fact findings on overlapping ranges, teaching away, unexpected results, and commercial success are not clearly erroneous, View "UCB, Inc. v. Actavis Laboratories UT, Inc." on Justia Law