Justia Patents Opinion Summaries

Myriad obtained patents after discovering the precise location and sequence of the BRCA1 and BRCA2 genes, mutations of which can dramatically increase the risk of breast and ovarian cancer. The discovery enabled Myriad to develop medical tests for detecting mutations for assessing cancer risk. Myriad’s patents would give it the exclusive rights to isolate an individual’s BRCA1 and BRCA2 genes and to synthetically create BRCA composite DNA. The district court entered summary judgment, finding the patents invalid under 35 U.S.C. 101 because they covered products of nature. On remand following the Supreme Court’s decision, Mayo Collaborative Servs. v. Prometheus Labs, Inc., the Federal Circuit found both isolated DNA and composite DNA patent-eligible. The Supreme Court affirmed in part and reversed in part, noting that the case did not involve “method claims” for new applications of knowledge about the genes or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. A naturally-occurring DNA segment is not patent-eligible merely because it has been isolated, but composite DNA is patent-eligible because it is not naturally-occurring. Myriad did not create or alter the genetic information encoded in the genes or the genetic structure of the DNA. Even brilliant discovery does not alone satisfy the section 101 inquiry. Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs chemical bonds that bind gene molecules together. The claims are not expressed in terms of chemical composition, nor do they rely on the chemical changes resulting from the isolation of a particular DNA section. Composite DNA, however, is not a “product of nature;” a lab technician unquestionably creates something new when introns are removed from a DNA sequence to make composite DNA. View "Assoc. for Molecular Pathology v. Myriad Genetics, Inc." on Justia Law

Monsanto invented and patented Roundup Ready soybean seeds, which contain a genetic alteration that allows them to survive exposure to the herbicide glyphosate. It sells the seeds subject to a licensing agreement that permits farmers to plant the purchased seed in only one growing season. Growers may consume or sell the resulting crops, but may not save any of the harvested soybeans for replanting. Bowman purchased Roundup Ready soybean seed for his first crop of each growing season. To reduce costs for his riskier late-season planting, Bowman purchased soybeans intended for consumption; planted them; treated the plants with glyphosate, killing all plants without the Roundup Ready trait; harvested the resulting soybeans that contained that trait; and saved some of these harvested seeds to use in his late-season planting the next season. After discovering this practice, Monsanto sued for patent infringement. Bowman raised the defense of patent exhaustion, which gives the purchaser of a patented article, or any subsequent owner, the right to use or resell that article. The district court rejected Bowman’s defense; the Federal Circuit affirmed. In a unanimous decision, the Supreme Court affirmed. Patent exhaustion does not permit a farmer to reproduce patented seeds through planting and harvesting without permission. Under the patent exhaustion doctrine, the initial authorized sale terminates all patent rights to the patented item and confers on the purchaser, or any subsequent owner, the right to use or sell the thing, but the doctrine restricts the patentee’s rights only as to the “particular article” sold. It leaves untouched the patentee’s ability to prevent a buyer from making new copies. By planting and harvesting patented seeds, Bowman made additional copies of Monsanto’s patented invention, which falls outside the protections of patent exhaustion. If Bowman were granted an exception, patents on seeds would retain little value. View "Bowman v. Monsanto Co." on Justia Law

In an infringement suit, the district court declared Minton’s patent invalid under the “on sale” bar since he had leased his interactive securities trading system to a brokerage more than one year before the patent application, 35 U. S. C. 102(b). Seeking reconsideration, Minton argued for the first time that the lease was part of testing and fell within the “experimental use” exception to the bar. The Federal Circuit affirmed denial of the motion, concluding that the argument was waived. Minton sued for legal malpractice in Texas state court. His former attorneys argued that Minton’s claims would have failed even if the experimental-use argument had been timely raised. The trial court agreed. Minton then claimed that the court lacked jurisdiction under 28 U. S. C. 1338(a), which provides for exclusive federal jurisdiction over any case “arising under any Act of Congress relating to patents.” The Texas Court of Appeals rejected Minton’s argument and determined that Minton failed to establish experimental use. The state’s highest court reversed. The Supreme Court reversed, holding that Section 338(a) does not deprive state courts of subject matter jurisdiction over Minton’s malpractice claim. Federal law does not create that claim, so it can arise under federal patent law only if it necessarily raises a stated federal issue, actually disputed and substantial, which may be entertained without disturbing an approved balance of federal and state judicial responsibilities. Resolution of a federal patent question is “necessary” to Minton’s case and the issue is “actually disputed,” but it does not carry the necessary significance. No matter the resolution of the hypothetical “case within a case,” the result of the prior patent litigation will not change. Nor will allowing state courts to resolve these cases undermine development of a uniform body of patent law. View "Gunn v. Minton" on Justia Law

In 1995, respondent filed a patent application covering 117 claims under the Patent Act of 1952, 35 U.S.C. 112. The patent examiner denied all of the claims for lack of an adequate written description. Respondent appealed to the Board of Patent Appeals and Interferences, pursuant to section 134 of the Act, which approved some claims but denied others. Pursuant to section 145 of the Act, respondent filed a civil action against the Director, but the district court declined to consider respondent's newly proffered written declaration in support of the adequacy of his description, thus limiting its review to the administrative record. On appeal, the Federal Circuit vacated the judgment. The Court held that there are no limitations on a patent applicant's ability to introduce new evidence in a section 145 proceeding beyond those already present in the Federal Rules of Evidence and the Federal Rules of Civil Procedure. If new evidence was presented on a disputed question of fact, the district court must make de novo factual findings that take account of both the new evidence and the administrative record before the Patent and Trade Office. Therefore, the Court affirmed the judgment of the Federal Circuit. View "Kappos v. Hyatt" on Justia Law

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

Alice Corporation holds patents that disclose a scheme for mitigating “settlement risk,” i.e., the risk that only one party to an agreed-upon financial exchange will satisfy its obligation. The patent claims are designed to facilitate the exchange of financial obligations between parties, using a computer system as a third-party intermediary. The patents claim: a method for exchanging financial obligations; a computer system configured to carry out that method; and a computer-readable medium containing program code for performing that method. CLS, a global network that facilitates currency transactions, challenged the claims as not infringed, invalid, or unenforceable. Alice counterclaimed infringement. After the Supreme Court’s decision in Bilski, the district court held that the claims were ineligible for patent protection under 35 U.S.C. 101. The Federal Circuit and a unanimous Supreme Court affirmed. Section 101, which defines the subject matter eligible for patent protection, contains an implicit exception for laws of nature, natural phenomena, and abstract ideas. In applying the exception, patents that claim the building blocks of human ingenuity, which are ineligible for patent protection, must be distinguished from those that integrate the building blocks into something more, making them patent-eligible. The claims at issue are directed to a patent-ineligible concept: the abstract idea of intermediated settlement, which is “‘a fundamental economic practice long prevalent in our system of commerce.” The method claims, which simply require generic computer implementation, fail to transform that abstract idea into a patent-eligible invention. Stating an abstract idea, adding the words “apply it with a computer,” simply combines two steps, with the same deficient result. Taking the claim elements separately, the functions performed by the computer at each step are purely conventional: creating and maintaining “shadow” accounts, obtaining data, adjusting account balances, and issuing automated instructions. They do not purport to improve the functioning of the computer itself or improve any other technology or technical field. The system claims are no different in substance from the method claims, reciting a handful of generic computer components configured to implement the same idea. View "Alice Corp. v. CLS Bank Int'l" 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