Justia Intellectual Property Opinion Summaries

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

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

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

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. View "Microsoft Corp. v. i4i Limited Partnership" on Justia Law

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. View "Board of Trustees of the Leland Stanford Junior Univ. v. Roche Molecular Systems, Inc." on Justia Law

A patent specification must “conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as [the] invention,” 35 U.S.C. 112. The 753 patent involves a heart-rate monitor used with exercise equipment; it asserts that prior monitors were often inaccurate in measuring the electrical signals accompanying each heartbeat (ECG signals) because of the presence of other electrical signals generated by the user’s skeletal muscles that can impede ECG signal detection. The invention claims to improve on prior art by detecting and processing ECG signals in a way that filters out the interference. Claim 1 refers to a “heart rate monitor for use by a user in association with exercise apparatus and/or exercise procedures.” The claim comprises a cylindrical bar fitted with a display device; electronic circuitry including a difference amplifier; and, on each half of the bar, a “live” electrode and a “common” electrode “mounted ... in spaced relationship with each other.” The exclusive licensee alleged that Nautilus, without obtaining a license, sold exercise machines containing its patented technology. The district court granted Nautilus summary judgment on the ground that the claim term “in spaced relationship with each other” failed the definiteness requirement. The Federal Circuit reversed, concluding that a patent claim passes the threshold so long as the claim is “amenable to construction,” and, as construed, is not “insolubly ambiguous.” The Supreme Court vacated. A patent is invalid for indefiniteness if its claims, read in light of the patent’s specification and prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention. Section 112’s definiteness requirement must take into account the inherent limitations of language. The standard mandates clarity, while recognizing that absolute precision is unattainable. The Federal Circuit inquired whether the claims were “amenable to construction” or “insolubly ambiguous,” but such formulations lack the precision section 112 demands. To tolerate imprecision just short of that rendering a claim “insolubly ambiguous” would diminish the definiteness requirement’s public-notice function and foster the innovation-discouraging “zone of uncertainty.” The Court remanded so that the Federal Circuit can reconsider, under the proper standard, whether the relevant claims in the 753 patent are sufficiently definite. View "Nautilus, Inc. v. Biosig Instruments, Inc" on Justia Law

Akamai is the exclusive licensee of a patent that claims a method of delivering electronic data using a content delivery network (CDN). Limelight also operates a CDN and carries out several of the steps claimed in the patent, but its customers, rather than Limelight itself, perform a step of the patent known as “tagging.” Under Federal Circuit case law, liability for direct infringement under 35 U.S.C. 271(a) requires performance of all steps of a method patent to be attributable to a single party. The district court concluded that Limelight could not have directly infringed the patent at issue because performance of the tagging step could not be attributed to it. The en banc Federal Circuit reversed, holding that a defendant who performed some steps of a method patent and encouraged others to perform the rest could be liable for inducement of infringement even if no one was liable for direct infringement. The Supreme Court reversed. A defendant is not liable for inducing infringement under section 271(b) when no one has directly infringed. The Federal Circuit’s contrary view would deprive section 271(b) of ascertainable standards and require the courts to develop parallel bodies of infringement law. Citing section 271(f), the Court stated that Congress knows how to impose inducement liability predicated on noninfringing conduct when it wishes to do so. Though a would-be infringer could evade liability by dividing performance of a method patent’s steps with another whose conduct cannot be attributed to the defendant, a desire to avoid this consequence does not justify fundamentally altering the rules of inducement liability clearly required by the Patent Act’s text and structure. View "Limelight Networks, Inc. v. Akamai Techs, Inc." on Justia Law

Lexmark sells the only type of toner cartridges that work with its laser printers; remanufacturers acquire and refurbish used Lexmark cartridges to sell in competition with Lexmark’s new and refurbished cartridges. Lexmark’s “Prebate” program gives customers a discount on new cartridges if they agree to return empty cartridges to the company. Every Prebate cartridge has a microchip that disables the empty cartridge unless Lexmark replaces the chip. Static Control makes and sells components for cartridge remanufacture and developed a microchip that mimicked Lexmark’s. Lexmark sued for copyright infringement. Static Control counterclaimed that Lexmark engaged in false or misleading advertising under the Lanham Act, 15 U.S.C. 1125(a), and caused Static Control lost sales and damage to its business reputation. The district court held that Static Control lacked “prudential standing,” applying a multifactor balancing test. The Sixth Circuit reversed, applying a “reasonable interest” test. A unanimous Supreme Court affirmed. The Court stated that the issue was not “prudential standing.” Whether a plaintiff comes within a statute’s zone of interests requires traditional statutory interpretation. The Lanham Act includes in its statement of purposes, “protect[ing] persons engaged in [commerce within the control of Congress] against unfair competition.” “Unfair competition” is concerned with injuries to business reputation and sales. A section 1125(a) plaintiff must show that its injury flows directly from the deception caused by the defendant’s advertising; that occurs when deception causes consumers to withhold trade from the plaintiff. The zone-of-interests test and the proximate-cause requirement identify who may sue under section 1125(a) and provide better guidance than the multi-factor balancing test, the direct-competitor test, or the reasonable-interest test. Static Control comes within the class of plaintiffs authorized to sue under section 1125(a). Its alleged injuries fall within the zone of interests protected by the Act, and it sufficiently alleged that its injuries were proximately caused by Lexmark’s misrepresentations. View "Lexmark Int'l, Inc. v. Static Control Components, Inc." on Justia Law

Medtronic designs, makes, and sells medical devices. Mirowski owns patents relating to implantable heart stimulators. Under a licensing agreement, Medtronic practices certain Mirowski patents in exchange for royalty payments. Mirowski notified Medtronic of its belief that several Medtronic products infringed the licensed patents. Medtronic challenged that assertion in a declaratory judgment action, while accumulating disputed royalties in escrow for distribution to the prevailing party. The district court concluded that Mirowski had not met its burden of proving infringement. The Federal Circuit reversed, reasoning that where the patentee is a declaratory judgment defendant and, like Mirowski, is foreclosed from asserting an infringement counterclaim by the continued existence of a licensing agreement, the party seeking the declaratory judgment (Medtronic) bears the burden of persuasion. The Supreme Court reversed, first holding that the Federal Circuit did not lack subject-matter jurisdiction. Citing 28 U. S. C. 1338(a) and 1295(a)(1), the Court stated that if Medtronic had acted consistent with the understanding of its rights that it sought to establish in the declaratory judgment suit (by ceasing to pay royalties), Mirowski could have terminated the license and sued for infringement. The declaratory judgment action, which avoided that hypothetical threatened action, also “arises under” federal patent law. Operation of the Declaratory Judgment Act is only procedural, leaving substantive rights unchanged, and the burden of proof is a substantive aspect of a claim. When a licensee seeks a declaratory judgment against a patentee that its products do not infringe the licensed patent, the patentee bears the burden of persuasion. Mirowski set this dispute in motion by accusing Medtronic of infringement. There is no convincing reason why burden of proof law should favor the patentee. View "Medtronic, Inc. v. Mirowski Family Ventures, LLC" on Justia Law

Plaintiff, a general partnership comprised of two musicians, filed suit alleging copyright infringement against defendant, Lakewood Church, over the use of a song entitled, "Signaling Through the Flames." Plaintiff later voluntarily dismissed the complaint without prejudice. Subsequently, plaintiff filed a motion to vacate its voluntary dismissal under Rule 60(b), which the district court granted. Defendant appealed. The court affirmed the judgment, concluding that a voluntary dismissal without prejudice was a final proceeding under Rule 60(b) and the district court did not abuse its discretion in dismissing the case. View "Yesh Music, et al. v. Lakewood Church, et al." on Justia Law