Justia Intellectual Property Opinion Summaries

Articles Posted in U.S. Supreme Court
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Once the FDA has approved a brand manufacturer's drug, another company could seek permission to market a generic version pursuant to legislation known as the Hatch-Waxman Amendments. See Drug Price Competition and Patent Term Restoration Act of 1984, 98 Stat. 1585. The relevant statute at issue in this case provided that a generic company "may assert a counterclaim seeking an order requiring the [brand manufacturer] to correct or delete the patent information [it] submitted... under [two statutory subsections] on the ground that the patent does not claim... an approved method of using the drug." 117 Stat. 2452, 21 U.S.C. 355(j)(5)(C)(ii)(I). At issue in this case was whether Congress had authorized a generic company to challenge a use code's accuracy by bringing a counterclaim against the brand manufacturer in a patent infringement suit. The Court held that a generic manufacturer could employ this provision to force correction of a use code that inaccurately described the brand's patent as covering a particular method of using the drug in question. Therefore, the Court reversed the judgment of the Federal Circuit. View "Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S" on Justia Law

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The patent claims at issue covered processes that help doctors who use thiopurine drugs to treat patients with autoimmune diseases determine whether a given dosage level was too low or too high. The claims purported to apply natural laws describing the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that the drug dosage would be ineffective or induce harmful side-effects. At issue was whether the claimed processes have transformed these unpatentable natural laws into patent-eligible applications of those laws. The Court concluded that they have not done so and that therefore the processes were not patentable. The steps in the claimed processes involved well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries. Therefore, the Court reversed the judgment of the Federal Circuit. View "Mayo Collaborative Services v. Prometheus Laboratories, Inc." on Justia Law

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Petitioners are orchestra conductors, musicians, publishers, and others who formerly enjoyed free access to literary and artistic works section 514 of the Uruguay Round Agreements Act (URAA), 17 U.S.C. 104A, 109(a), removed from the public domain. Petitioners maintained that Congress, in passing section 514, exceeded its authority under the Constitution's Copyright and Patent Clause and violated the First Amendment rights of anyone who previously had access to such works. The Tenth Circuit ruled that section 514 was narrowly tailored to fit the important government aim of protecting U.S. copyright holders' interests abroad. In accord with the judgment of the Tenth Circuit, the Court concluded that section 514 did not transgress constitutional limitations on Congress' authority. The Court held that neither the text of the Copyright and Patent Clause, historical practice, or the Court's precedent excluded application of copyright protection to works in the public domain. The Court also held that nothing in the historical record, subsequent congressional practice, or the Court's jurisprudence warranted exceptional First Amendment solicitude for copyrighted works that were once in the public domain. View "Golan v. Holder" on Justia Law

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Respondents (collectively, "i4i"), holding a patent which claimed an improved method for editing computer documents, sued petitioner, Microsoft Corp. ("Microsoft"), for willful infringement of the patent. Microsoft counterclaimed and sought a declaration that the patent was invalid pursuant to the on-sale bar under Section 102(b) of the Patent Act of 1952 ("Act"), 35 U.S.C. 102(b), which precluded patent protection for any "invention" that was "on sale in this country" more than one year prior to the filing of a patent application. At issue was whether Section 282 of the Act required an invalidity defense to be proved by clear and convincing evidence. The Court rejected Microsoft's contention that a defendant need only persuade the jury of a patent invalidity defense by a preponderance of the evidence and also rejected Microsoft's argument that a preponderance standard must at least apply where the evidence before the factfinder was not before the Patent and Trademark Office during the examination process. Accordingly, the Court held that Section 282 required an invalidity defense to be proved by clear and convincing evidence. The Court also added that it was in no position to judge the comparative force of the parties' policy arguments as to the wisdom of the clear and convincing standard that Congress adopted where any recalibration of the standard of proof remained in Congress' hands.

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The Board of Trustees of Stanford University filed suit against Roche Molecular Systems ("Roche") claiming that their HIV test kits infringed upon Stanford's patents. The suit stemmed from Stanford's employment of a research fellow who was arranged by his supervisor to work at Cetus, a research company developing methods to quantify blood-borne levels of HIV. The research fellow subsequently devised a PCR-based procedure for measuring the amount of HIV in a patient's blood while working with Cetus employees. The research fellow had entered into an agreement to assign to Stanford his "right, title and interest in" inventions resulting from his employment there and subsequently signed a similar agreement at Cetus. Stanford secured three patents to the measurement process. Roche acquired Cetus's PCR-related assets and commercialized the procedure into HIV test kits. At issue was whether the University and Small Business Patent Procedures Act of 1980, 35 U.S.C. 200 et seq., commonly referred to as the Bayh-Dole Act ("Act"), displaced the basic principle that rights in an invention belonged to the inventor and automatically vested title to federally funded inventions in federal contractors. The Court held that the Act did not automatically vest title to federally funded inventions in federal contractors or authorize contractors to unilaterally take title to such inventions and therefore, affirmed the judgment of the Court of Appeals for the Federal Circuit, which held that the research fellow's agreement with Cetus assigned his rights to Cetus, and subsequently to Roche; that the Act did not automatically void an inventor's rights in federally funded inventions; and thus, the Act did not extinguish Roche's ownership interest in the invention and Stanford was deprived of standing.

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This case concerned a patent for an innovative deep fryer designed by respondent SEB S.A. ("SEB"), a French maker of home appliances. SEB sued Pentalpha Enterprises, Ltd. ("Pentalpha"), a Hong Kong home appliance maker and wholly owned subsidiary of petitioner Global-Tech Appliances, Inc., asserting that it had contravened 35 U.S.C. 271(b) by actively inducing Sunbeam Products, Inc. ("Sunbeam") and the other purchasers of Pentalpha fryers to sell or offer to sell them in violation of SEB's patent rights. At issue was whether a party who "actively induces infringement of a patent" under section 271(b) must show that the induced acts constituted patent infringement. The Court held that induced infringement under section 271(b) required knowledge that the induced acts constituted patent infringement and that deliberate indifference to a known risk that a patent existed did not satisfy the knowledge required by section 271(b). The Court, nevertheless, affirmed the judgment of the Court of Appeals because the evidence in this case was plainly sufficient for a jury to find that Pentalpha subjectively believed there was a high probability that SEB's fryer was patented, that Pentalpha took deliberate steps to avoid knowing that fact, and that it therefore, willfully blinded itself to the infringing nature of Sunbeam's sales.