The US Supreme Court [official website] heard oral arguments [day call, PDF] Monday in two cases. In Caraco Pharmaceutical Laboratories, Ltd v. Novo Nordisk A/S [transcript, PDF; JURIST report], the court heard arguments on drug patents. When the Food and Drug Administration (FDA) [official website] approves a drug for multiple uses, the Hatch-Waxman Act [text, PDF] allows generic drug makers to avoid contested patent litigation by marketing generic versions of the drug solely for non-patented uses. The FDA lacks the authority and expertise needed to verify the patent information submitted by name-brand drug companies, however, so it defers to their descriptions of the scope of their patents. Such companies can therefore block the approval of generic drugs by submitting overbroad patent descriptions to the FDA, effectively extending their patents to cover non-infringing uses. To combat this problem, the Act allows [21 USC § 355(j)(5)(C)(ii)(I) text] a "counterclaim seeking an order requiring the [patent] holder to correct or delete the patent information submitted by the holder on the ground that the patent does not claim an approved method of using the drug." The US Court of Appeals for the Federal Circuit held [opinion, PDF] that the counterclaim provision effectively authorizes only "delet[ing]" improperly listed patents, but not "correct[ing]" information that misrepresents the scope of the approved uses claimed by a patent. Petitioners claim that ruling expressly invalidates longstanding FDA regulations defining "patent information," which the FDA deems "essential" to administering the Act, without seeking the agency’s views. The question before the court is whether the counterclaim provision applies when (1) there is "an approved method of using the drug" that "the patent does not claim," and (2) the brand submits "patent information" to the FDA that misstates the patent’s scope, requiring "correct[ion]."
In Messerschmidt v. Millender [transcript, PDF], the court heard arguments on whether police officers are entitled to qualified immunity [Cornell LII backgrounder] where they execute search warrants later determined invalid. The US Court of Appeals for the Ninth Circuit ruled [opinion, PDF] that the officers in this case were not entitled to qualified immunity. The Supreme Court has held in United States v. Leon and Malley v. Briggs [opinions] that officers are entitled to qualified immunity, and evidence obtained should not be suppressed, so long as the warrant is not "so lacking in indicia of probable cause as to render official belief in its existence entirely unreasonable." The questions before the court are (1) Under these standards, are officers entitled to qualified immunity where they obtained a facially valid warrant to search for firearms, firearm-related materials, and gang-related items in the residence of a gang member and felon who had threatened to kill his girlfriend and fired a sawed-off shotgun at her, and a district attorney approved the application, no factually on-point case law prohibited the search, and the alleged overbreadth in the warrant did not expand the scope of the search; and (2) Should the Malley/Leon standards be reconsidered or clarified in light of lower courts' inability to apply them in accordance with their purpose of deterring police misconduct, resulting in imposition of liability on officers for good faith conduct and improper exclusion of evidence in criminal cases?