Justia Patents 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

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

Elcommerce.com owns a patent directed to a system and method of monitoring a supply chain of components to coordinate and stabilize the supply of components from various producers. Elcommerce charged SAP with patent infringement. SAP counterclaimed that the patent was invalid, unenforceable, and not infringed. The district court construed claims and entered summary judgment that certain asserted system claims were invalid for indefiniteness under 35 U.S.C. 112. The parties stipulated that the claim construction precluded finding that SAP infringes any of the asserted method claims. The Federal Circuit affirmed construction of the claim terms “independent supply chain sites,” “scanning for,” “detecting,” and “monitoring for changed supply-related data information,” and the resulting stipulation of non-infringement of the method claims. The court vacated the ruling of invalidity of the system claims as based on an incorrect evidentiary premise. SAP incorrectly informed the court that Federal Circuit precedent makes consideration of evidence of the knowledge and understanding of the relevant technology by persons of skill in the field of the invention unnecessary and declined to provide evidence of how such persons would view the description of “structure, materials, or acts” in the specification for performance of the several functions claimed. Invalidity must be proven by clear and convincing evidence . View "Elcommerce.com, Inc. v. SAP AG & SAP Am., Inc." on Justia Law

The Federal Circuit previously held that patent claim construction receives de novo determination on appeal. Such review is conducted on the administrative record and any additional information in the record of the district court, and is without deference to the ruling of the district court. The court had applied that standard to this case and, reversing the district court, held that the claim term “voltage source means” is a means-plus-function term requiring corresponding structure in the specification. The court held the claims invalid for indefiniteness. After granting rehearing, en banc, the Federal Circuit applied the principles of stare decisis, and confirmed the Cybor standard of de novo review. The court stated that after 15 years of experience with Cybor, it concluded that it should retain plenary review of claim construction, to provide national uniformity, consistency, and finality to the meaning and scope of patent claims. View "Lighting Ballast Control, LLC v. Philips Elec. N. Am. Corp." on Justia Law

Solvay’s 817 patent claims an improvement to a method of making a hydrofluorocarbon (HFC-245fa), which does not deplete the ozone layer as legislatively mandated to replace ozone-depleting alternatives. HFC-245fa is especially useful in preparing polymeric materials used for insulation in refrigeration and heat systems. The patent has a 1995 priority date. In 1994, Honeywell and RSCAC entered into a contract, under which RSCAC engineers, in Russia, studied commercial production of HFC-245fa. RSCAC sent Honeywell a report documenting a continuous process capable of producing high yields of HFC-245fa. Honeywell used the report to run the same process in the U.S., before the 817 patent’s priority date. Solvay sued Honeywell, alleging infringement. Honeywell argued that the Russian inventors made the invention in this country by sending instructions to Honeywell personnel who reduced the invention to practice in the U.S. The district court held that the RSCAC engineers should be treated as inventors who made the invention in the U.S. under 35 U.S.C. 102(g)(2), that RSCAC disclosed claim1 in a 1994 Russian patent application such that they did not abandon, suppress, or conceal it. The Federal Circuit affirmed judgment for Honeywell. It is not required that the inventor be the one to reduce the invention to practice if reduction to practice was done on his behalf in the U.S., so Honeywell’s invention qualified as prior art.View "Solvay, S.A. v. Honeywell Int'l, Inc." on Justia Law

EnOcean owns a patent application that claims a self-powered switch, which can be used to turn on and off lights, appliances, and other devices without a battery or connection to an electrical outlet. The named inventors originally filed a patent application disclosing the switch in Germany in 2000; in 2001 they filed a Patent Cooperation Treaty (PCT) international application with a similar disclosure. The Board of Patent Appeals and Interferences declared an interference in 2010 between EnOcean and Face, the real party of interest in a U.S. Patent that also claims a self-powered switch. The Board found the Face claims were unpatentable under 35 U.S.C. 103 based on prior art. Face did not appeal. The Board then applied a presumption that EnOcean’s claims were unpatentable for the same reasons. EnOcean’s argument for rebutting the presumption required determination that EnOcean’s claims could benefit from the filing dates of its German and PCT applications, eliminating a reference from prior art. The Board accorded no benefit of priority to the claims and found all of EnOcean’s claims unpatentable under section 103. The Federal Circuit vacated in part, finding that the Board erred in treating certain EnOcean claims as means-plus-function claims and in finding that certain EnOcean claim limitations lack support in its priority German and PCT applications.View "EnOcean GmbH v. Face Int'l Corp." on Justia Law