Justia Drugs & Biotech Opinion Summaries
Association of American Physicians & Surgeons v. United States Food & Drug Administration
A drug manufacturer cannot distribute a drug in interstate commerce without obtaining the FDA’s approval for the uses listed on the drug’s official label, 21 U.S.C. 355(a). The Act does not prohibit doctors from prescribing FDA-approved drugs for “off-label” use but leaves the regulation of doctors to the states. Hydroxychloroquine is approved to treat malaria, lupus, and arthritis but not to treat COVID-19. In 2020, the FDA relied on then-available data and issued an Emergency Use Authorization, permitting hydroxychloroquine in the federal government’s strategic stockpile to be distributed to treat COVID-19 patients in limited circumstances.The Association, a nonprofit organization with physician members, sued, challenging restrictions barring use of hydroxychloroquine to treat COVID-19 except for hospitalized patients. The Association alleged that these restrictions violated the implied equal-protection guarantee in the Fifth Amendment; violated the First Amendment right to associate by limiting access to medication useful for meeting in groups; and violated the Administrative Procedure Act. The Association alleged an injury to itself: it was considering canceling a conference purportedly due to the restrictions. It also invoked associational standing on behalf of its physician members who could not prescribe hydroxychloroquine for COVID-19.The district court held that none of these injuries plausibly pleaded the Association’s standing to challenge the Authorization. The court dismissed the complaint for lack of subject matter jurisdiction. The Sixth Circuit affirmed. The Associaiton failed to plausibly plead that any member has been injured by the FDA’s actions. View "Association of American Physicians & Surgeons v. United States Food & Drug Administration" on Justia Law
Belcher Pharmaceuticals, LLC v. Hospira, Inc.
Epinephrine (adrenaline), a hormone that has been on the market since approximately 1938, is used for various medical purposes. It degrades by racemization and oxidation. A 1986 publication taught that “there is an optimum pH at which racemization and oxidation can be balanced to minimize loss of intact drug by these two routes.” In 2012, Belcher submitted New Drug Application (NDA) for a 1 mg/mL injectable l-epinephrine formulation. The NDA was literature-based; Belcher did not perform any studies on its epinephrine formulation. Belcher responded to FDA inquiries concerning pH levels and racemization. In 2014, Belcher filed an application entitled “More Potent and Less Toxic Formulations of Epinephrine and Methods of Medical Use,” resulting in the 197. Hospira then submitted an NDA seeking approval of a 0.1 mg/mL injectable l-epinephrine formulation, including a Paragraph IV certification (21 U.S.C. 355(b)(2)(A)(iv)) alleging that the patent’s claims are invalid, unenforceable, and/or not infringed. Belcher sued Hospira for infringement.The Federal Circuit affirmed a finding that the patent was unenforceable for inequitable conduct. Belcher’s Chief Science Officer withheld material information about the pH range and the impurity levels from the Patent and Trademark Office. Belcher’s alleged critical improvement over the prior art was already within the public domain, just not before the examiner. Belcher’s officer acted with intent to deceive. View "Belcher Pharmaceuticals, LLC v. Hospira, Inc." on Justia Law
West Street Associates LLC v. Planning Board of Mansfield
The Supreme Judicial Court held that a previously enacted municipal bylaw that permits only nonprofit entities to operate medical marijuana dispensaries is preempted by a statutory provision specifically eliminating that restriction.In 2012, marijuana was legalized for medical use, and the licensing of medical marijuana dispensaries was limited to nonprofit entities. In 2017, the marijuana laws were amended to allow for-profit entities to dispense medical marijuana. Subsequently, CommCan, Inc., a dispensary, converted from a nonprofit to a for-profit corporation. At issue was what impact the conversion had on CommCan's eligibility for a special permit previously issued by the town of Mansfield planning board. The judge found no error in the board's decision to grant CommCan a special permit and concluded that the town's bylaw requiring medical marijuana dispensaries to be operated by nonprofit entities was preempted by the 2017 act. The Supreme Judicial Court affirmed, holding that the town's bylaw was preempted by state law to the extent it required all medical marijuana dispensaries to be nonprofit organizations. View "West Street Associates LLC v. Planning Board of Mansfield" on Justia Law
Sisley v. United States Drug Enforcement Agency
Zyszkiewicz, a prisoner and a medical cannabis patient, wrote a one-page letter to the DEA, seeking the rescheduling of marijuana under the Controlled Substances Act (CSA), 21 U.S.C. 801, which places federally-regulated substances into one of five schedules depending on “potential for abuse,” “medical use,” “safety,” and the likelihood of “dependence.” The DEA responded that the letter was not in the proper format for a petition but that it welcomed the opportunity to respond to his concerns. The DEA’s letter gave reasons for having denied an earlier rescheduling petition filed by Governors Chafee of Rhode Island and Gregoire of Washington State. Zyszkiewicz treated the DEA’s answer as a denial of his petition and unsuccessfully sought judicial review.Dr. Sisley, her associated institutions, and veterans (Petitioners) sought judicial review of the DEA’s response but did not seek to intervene in Zyszkiewicz’s petition before the DEA, nor have they filed a DEA petition of their own. The arguments Petitioners sought to raise were not made in Zyszkiewicz’s petition.The Ninth Circuit held that the Petitioners satisfy Article III standing requirements, but that they failed to exhaust their administrative remedies under the CSA and dismissed their petition for review. Petitioners alleged direct and particularized harms due to the misclassification of cannabis. Dr. Sisley and her associated institutions contend that the misclassification impedes their research efforts, and the veterans contend that it forecloses their access to medical treatment with cannabis through the VA. View "Sisley v. United States Drug Enforcement Agency" on Justia Law
Juno Therapeutics, Inc v. Kite Pharma, Inc.
T cells, white blood cells that contribute to the immune response, have naturally occurring receptors on their surfaces that facilitate their attack on target cells (such as cancer cells) by recognizing and binding an antigen, i.e., a structure on a target cell’s surface. Chimeric antigen receptor (CAR) T-cell therapy involves isolating a patient’s T cells; reprogramming those T cells to produce a specific, targeted receptor (a CAR) on each T cell’s surface; and infusing the patient with the reprogrammed cells. Juno’s patent relates to a nucleic acid polymer encoding a three-part CAR for a T cell. It claims priority to a provisional application filed in 2002, at “the birth of the CART field.” Kite’s YESCARTA® is a “therapy in which a patient’s T cells are engineered to express a [CAR] to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells.”Juno sued, alleging infringement. The district court held that the claims were not invalid for lack of written description or enablement, the patent’s certificate of correction was not invalid, and Juno was entitled to $1,200,322,551.50 in damages. The Federal Circuit reversed. No reasonable jury could find the patent’s written description sufficiently demonstrates that the inventors possessed the full scope of the claimed invention. View "Juno Therapeutics, Inc v. Kite Pharma, Inc." on Justia Law
United Food & Commercial Workers Local 1776 v. Takeda Pharmaceutical Co.
Defendants in these tandem cases (collectively, "Takeda") are a brand pharmaceutical manufacturer and related entities that began producing and marketing the Type-2 diabetes drug ACTOS in 1999. Purchasers of ACTOS filed suit against Takeda for improperly describing its patents to the FDA, in effect extending the duration of its patent protection over ACTOS and delaying generic competition. The district court denied Takeda's motion to dismiss, concluding that the alleged patent descriptions were incorrect under the Hatch–Waxman Act and pertinent regulations.On this interlocutory appeal, the Second Circuit held that under the "Listing Requirement" of 21 U.S.C. 355(b)(1), a combination patent does not "claim" any of its component drug substances past their individual patent expiration dates. The court also held that the purchasers were not required to allege that Takeda's interpretation of the Listing Requirement was unreasonable in order to plead a monopolization claim under the Sherman Act. Accordingly, the court affirmed the district court's denial of Takeda's motion to dismiss and remanded for further proceedings. View "United Food & Commercial Workers Local 1776 v. Takeda Pharmaceutical Co." on Justia Law
Eli Lilly & Co. v. Teva Pharmaceuticals International GMBH
Teva's patents are directed to methods of using humanized antagonist antibodies that target calcitonin gene-related peptide (CGRP). CGRP is a 37-amino acid peptide that is “a neurotransmitter in the central nervous system and has been shown to be a potent vasodilator in the periphery, where CGRP-containing neurons are closely associated with blood vessels. Dilation of blood vessels was associated with and thought to exacerbate the symptoms of migraine. The challenged patents describe “anti-CGRP antagonist antibodies and methods of using anti-CGRP antagonist antibodies for treating or preventing vasomotor symptoms, such as headaches, such as migraine.” Lilly asserted that each challenged claim would have been obvious over a combination of prior art references.The Patent Trial and Appeal Board first construed the claims, including the preambles and the term “effective amount,” then analyzed prior art, concluding that Lilly failed to prove that the challenged claims would have been obvious over the stated references. The Federal Circuit affirmed, rejecting arguments that the Board erred by reading a result into the constructions of the preambles and the term “effective amount,” which led to erroneously requiring Lilly to prove that a skilled artisan would have expected to achieve results that are unclaimed and that, even if the preambles are limiting and the claims require administration of an antibody with an expectation of results, the Board applied too high a standard in determining whether a skilled artisan would have had a reasonable expectation of success. View "Eli Lilly & Co. v. Teva Pharmaceuticals International GMBH" on Justia Law
Teva Pharmaceuticals International GmbH v. Eli Lily & Co.
Teva’s patents, directed to methods of using humanized antagonist antibodies that target calcitonin gene-related peptide (CGRP), a 37-amino acid peptide that is “a neurotransmitter in the central nervous system, and has been shown to be a potent vasodilator. Dilation of blood vessels was associated with and thought to exacerbate the pain symptoms of migraine. Lilly filed petitions for inter partes review (IPR).In three IPR proceedings, the Board issued a combined final written decision holding that the challenged claims in all three patents are unpatentable as they would have been obvious over various cited references and that a skilled artisan would have been motivated to combine the teachings of the prior art and would have had a reasonable expectation of successfully achieving the claimed invention. The Federal Circuit affirmed, rejecting Teva’s arguments that the Patent Trial and Appeal Board erred as a matter of law in its motivation to combine analysis by deviating from the motivation asserted by Lilly in its IPR petitions, that even under the motivation to combine that the Board did analyze, substantial evidence does not support the Board’s factual findings, and that the Board erred in its analysis of secondary considerations of nonobviousness View "Teva Pharmaceuticals International GmbH v. Eli Lily & Co." on Justia Law
Ignacuinos v. Boehringer Ingelheim Pharmaceuticals Inc.
Plaintiffs, who were prescribed a metered-dose inhaler manufactured by defendant and approved by the FDA to alleviate symptoms of chronic obstructive pulmonary disease, filed suit alleging violations of state law premised on defendant's allegedly deceptive labeling or defective design and manufacture of the metered-dose inhaler.The Second Circuit affirmed the district court's dismissal of the claims as preempted by federal law. The court explained that plaintiffs' state law design and manufacturing defect claims are preempted to the extent that they would require any change listed in 21 C.F.R. 314.70(b)(2). In this case, the modifications that plaintiffs' claims would require under state law constitute "major" changes, and therefore those claims are preempted by federal law. Finally, the complaint failed to state any non-preempted claim and plaintiffs' remaining arguments are without merit. View "Ignacuinos v. Boehringer Ingelheim Pharmaceuticals Inc." on Justia Law
Kennedy v. Novo A/S
Kennedy worked for Novo, promoting a new diabetes drug, Victoza. FDA approval of Victoza included specific conditions concerning a possible risk of thyroid cancer. According to Kennedy, in preparation for Victoza’s commercial launch, she was directed to market the drug in ways inconsistent with those FDA limitations. Kennedy filed a False Claims Act (FCA) complaint, alleging that Novo caused people to submit millions of dollars in false claims for payment under federal health care programs. Several such cases were consolidated in the District of Columbia. The government intervened. Novo, the government, and Kennedy reached a settlement for $46.5 million.The government filed a separate complaint against Novo, under the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301, alleging Victoza was an unlawfully “misbranded” drug. In the FDCA Settlement, Novo admitted that it had trained its employees to undermine the risks and agreed to pay the government $12,150,000. Kennedy was not a party to the FDCA litigation.Kennedy sought a share of the FDCA Settlement, arguing that it was an “alternate remedy” under the FCA, 31 U.S.C. 3730(c)(5). The D.C. Circuit reversed Kennedy’s award. The FCA confines qui tam plaintiffs to recoveries only for claims seeking relief based on fraud or falsehoods covered by that statute. The government’s separate FDCA enforcement action did not involve the type of claim cognizable under the FCA, nor did it allege a false or fraudulent effort to obtain money or property from the government. Kennedy received an agreed-upon FCA payment with knowledge of the separate action and is not entitled to further recovery. View "Kennedy v. Novo A/S" on Justia Law