Justia Patents Opinion Summaries

Generic manufacturers submitted Abbreviated New Drug Applications seeking FDA approval to market generic versions of Copaxone®, to treat multiple sclerosis. Teva, which markets Copaxone®, sued for infringement under 35 U.S.C. 271(e)(2)(A). Its patents are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations entry for Copaxone® and include claims reciting a product called copolymer-1 and two methods of making copolymer-1. The district court found that various claims were infringed, based on holdings regarding indefiniteness, nonenablement, and obviousness. The Federal Circuit affirmed in part and reversed in part, holding that Group I claims are invalid for indefiniteness, but that Group II claims were not proven indefinite. The Supreme Court remanded, holding that the ultimate construction of a claim term is a question of law, subject to de novo review, and that underlying subsidiary fact findings are subject to clear error review. The Supreme Court also issued its opinion in Nautilus v. Biosig, addressing the standard for indefiniteness. Applying the standards set forth in those decisions, the Federal Circuit held that the Group I claims are invalid for indefiniteness. One statement contained a scientifically erroneous claim; given the specification and the prosecution history, the patentee failed to inform with reasonable certainty those skilled in the art about the scope of the invention. View "Teva Pharma. USA v. Sandoz, Inc." on Justia Law

Williamson's patent describes methods and systems for “distributed learning” that utilize standard computer hardware and software linked by a network to provide a virtual classroom. The system includes a presenter computer that controls information that appears on the audience member’s computer screen, audience computers that display the presentation and can communicate with the presenter and other audience members, and a distributed learning server that implements a “virtual classroom” over a network, such as the Internet. Williamson asserted infringement based on defendants’ alleged manufacture, sale, use, and importation of systems and methods of online collaboration. The district court construed “graphical display representative of a classroom” and “first graphical display comprising . . . a classroom region” as requiring “a pictorial map illustrating an at least partially virtual space in which participants can interact, and that identifies the presenter(s) and the audience member(s) by their locations on the map.” The court concluded that the limitation, “distributed learning control module,” was a means-plus-function term under 35 U.S.C. 112(6) and that the specification failed to disclose necessary algorithms for performing all claimed functions, so that claims were invalid as indefinite. The Federal Circuit vacated. On rehearing, en banc, the court again vacated the judgment of non-infringement of certain claims, but found that the court correctly construed the limitation “distributed learning control module,” and affirmed the judgment of invalidity of other claim and remanded. View "Williamson v. Citrix Online, LLC" on Justia Law

The 717 patent relates to a system for increasing the speed of data access in a packet-switched network, making use of “digital digests” that act as short digital fingerprints for the content of their corresponding documents. By communicating the smaller digital digests in place of the documents themselves, the invention reduces the redundant transmission of data throughout the network. On inter partes review, the Patent Trial and Appeal Board concluded that all of the challenged claims except claim 24 were unpatentable as anticipated under 35 U.S.C. 102 alone or additionally as obvious under 35 U.S.C. 103. The Federal Circuit reversed the Board’s constructions of the term “gateway . . . between at least two other computers” in claims 6, 7, and 9 and the terms “sender/computer” and “receiver/computer” in claims 1, 3, 10, 22, and 23, and remanded its unpatentability determinations of those claims. The court affirmed the construction of the “searching” limitation in claim 22, the determination that claim 24 is patentable, the conclusion that claims 11, 12, and 14 were anticipated, and the Board’s denial of the patent owner’s motion to amend claims 1 and 3. View "Microsoft Corp. v.Proxyconn, Inc." on Justia Law

INTTRA owns patents relating to online methods for coordinating containerized shipping. GT sought a declaratory judgment that INTTRA’s shipping methods patents were invalid. While the case was pending, GT petitioned the PTO to review the patents as covered-business-method patents. The Patent Trial and Appeal Board instituted review, but granted INTTRA leave to file a motion to dismiss on the ground that section 325(a)(1) barred the reviews because of the civil action. GT argued that INTTRA had waived that objection by not presenting it within the 14 days allowed by the rule giving a right to seek reconsideration. The Board granted INTTRA’s motion and “terminated” proceedings, without addressing patentability, reasoning that section 325(a)(1) is a statutory limit on Board “jurisdiction.” The Federal Circuit dismissed and denied mandamus relief. The Leahy-Smith America Invents Act, 35 U.S.C. 325 declares that “review may not be instituted . . . if, before the date on which the petition for such a review is filed, the petitioner … filed a civil action challenging the validity of a claim of the patent.” GT identified nothing that precludes the Board from reconsidering an initial institution decision or invoking the 325(a)(1) bar on its own, or inviting the patentee to file a motion after more than 14 days. View "GTNX, Inc.. v. INTTRA, Inc." on Justia Law

In 1996, Drs. Lo and Wainscoat discovered cell-free fetal DNA (cffDNA) in maternal plasma and serum, the portion of maternal blood samples that other researchers had previously discarded as medical waste. cffDNA is non-cellular fetal DNA that circulates freely in the blood stream of a pregnant woman. Applying a combination of known laboratory techniques to their discovery,they implemented a method for detecting the small fraction of paternally inherited cffDNA in maternal plasma or serum to determine fetal characteristics, such as gender. The invention, commercialized by Sequenom as its MaterniT21 test, created an alternative for prenatal diagnosis of fetal DNA that avoids the risks of widely-used techniques that took samples from the fetus or placenta. In 2001, they obtained the 540 patent, which does not claim cffDNA or paternally inherited cffDNA, but claims methods of using cffDNA to diagnose certain fetal characteristics based on the detection of paternally inherited cffDNA. The district court found that the asserted claims of the 540 patent are not directed to patent eligible subject matter and were invalid under 35 U.S.C. 101. The Federal Circuit affirmed. While the discovery regarding cffDNA was a significant contribution to the medical field, that alone does not make it patentable. View "Ariosa Diagnostics, Inc.v. Sequenom, Inc." on Justia Law

OIP Technologies sued Amazon.com alleging infringement of its 713 patent, which claims computer-implemented methods for “pricing a product for sale.” The patent explains that traditionally merchandisers manually determine prices based on their qualitative knowledge of the items, pricing experience, and other business policies. In setting the price of a particular good, the merchandiser estimates the shape of a demand curve for a particular product based on, for example, the good itself, the brand strength, market conditions, seasons, and past sales. The713 patent states that a problem with this approach is that the merchandiser is slow to react to changing market conditions, resulting in an imperfect pricing model where the merchandiser often is not charging an optimal price that maximizes profit and teaches a price-optimization method that “help[s] vendors automatically reach better pricing decisions through automatic estimation and measurement of actual demand to select prices.” The district court granted judgment on the pleadings, concluding that the patent does not claim patentable subject matter under 35 U.S.C. 101. The Federal Circuit affirmed, agreeing that the patent claims no more than an abstract idea coupled with routine data-gathering steps and conventional computer activity. View "OIP Techs., Inc. v. Amazon.com, Inc." on Justia Law

Kaneka owns the 340 Patent, which describes processes for producing oxidized and reduced coenzyme Q10. The claims at issue describe processes for producing oxidized coenzyme Q10. Coenzyme Q10 exists in animal cells. Cells use coenzyme Q10 to produce adenosine triphosphate, which aids cellular respiration. Coenzyme Q10 assists adenosine triphosphate production through redox reactions, in which the coenzyme gives up and gains electrons. Both oxidized and reduced coenzyme Q10 are sold as dietary supplements. In Kaneka’s infringement suit, the district court entered summary judgment of noninfringement, based on its construction of the term “inert gas atmosphere” to mean “a gas atmosphere that is free or substantially free of oxygen and reactive gases,” and of “sealed tank” to mean “a tank that is closed to prevent the entry or exit of materials,” and of “oxidizing.” The Federal Circuit affirmed with respect to certain claims; held that the oxidation step requires some action that results in oxidation but does not require oxidation of “all or substantially all” of the coenzyme Q10; vacated summary judgment of noninfringement of other claims; and remanded. View "Kaneka Corp. v. Xiamen Kingdomway Grp. Co." on Justia Law

The 109 patent, entitled “Gelatinous Elastomer Compositions and Articles,” is directed to composite articles of a thermoplastic gel and a substrate, such as foam or fabric, used as a protective liner between an amputated limb and a prosthetic limb. According to the patent, prosthetic liners that incorporate the claimed composite articles are comfortable and skin-friendly, and more durable than previous liners. Alps licensed several AEI patents, including the 109 patent. Shortly thereafter, Alps, without naming AEI as a co-plaintiff, filed a patent infringement suit against OWW. Alps declined to join as co-plaintiff. OWW moved to dismiss for lack of standing. Alps and AEI executed an amended license agreement 16 months after Alps commenced the action, listing the effective date of the original agreement. The court denied the motion, finding that the terms of the original agreement was sufficed to provide Alps with standing and that, under the nunc pro tunc amended agreement, Alps “clearly possesses the substantial rights to proceed without [AEI].” A jury found the patent valid and infringed. The Federal Circuit reversed the denial of OWW’s motion to dismiss and vacated the judgment. Alps possessed neither legal title nor all substantial rights at the outset of the litigation, and was required to join AEI, as a co-plaintiff. View "Alps South, LLC v. Ohio Willow Wood Co." on Justia Law

Shire markets oral pharmaceuticals under the brand name LIALDA®. Its patent, entitled “Mesalazine Controlled Release Oral Pharmaceutical Composition,” concerns controlled-release compositions for treating inflammatory bowel diseases, such as Crohn’s and ulcerative colitis by direct contact with the intestinal mucosal tissue. It must pass through the stomach and small intestine without being absorbed into the bloodstream and must be administered throughout the entire length of the colon so that mesalamine contacts all affected tissues. The oral composition must, therefore, contain a high percentage of mesalamine. The patent teaches an inner lipophilic matrix and an outer hydrophilic matrix to address the limitations of prior art; the combination is advantageous because the inner-outer matrix properties cause the mesalamine to be released in a sustained and uniform manner. Watson submitted an Abbreviated New Drug Application seeking approval to sell generic LIALDA®. Shire sued. The district court found infringement. The Federal Circuit reversed. The district court’s constructions of “inner lipophilic matrix” and “outer hydrophilic matrix” impermissibly broadened the ordinary meaning of the terms. On remand, following the Supreme Court decision, Teva Pharmaceuticals v. Sandoz (2015), the Federal Circuit again reversed the district court’s constructions of the disputed claim terms and subsequent findings of infringement, and remanded. View "Shire Dev., LLC v. Watson Pharma., Inc." on Justia Law

Commil, holder of a patent for a method of implementing short-range wireless networks, sued, claiming that Cisco Systems, a maker and seller of wireless networking equipment, had directly infringed Commil’s patent in its networking equipment and had induced others to infringe the patent by selling the infringing equipment for use. After two trials, Cisco was found liable for both direct and induced infringement. Cisco had raised the defense that it had a good-faith belief that Commil’s patent was invalid, but the court found Cisco’s supporting evidence inadmissible. The Federal Circuit held that the trial court erred in excluding evidence of a good-faith belief that Commil’s patent was invalid. The Supreme Court vacated and remanded. A defendant’s belief regarding patent validity is not a defense to an induced infringement claim. The Court noted the long held presumption that a patent is valid; 35 U.S.C. 282(a) establishes a high bar, the clear and convincing standard, to rebut the presumption. If a patent is actually shown to be invalid, there is no patent to be infringed. Orderly administration of the patent system requires courts to interpret and implement the statutory framework to determine the procedures and sequences that the parties must follow to prove the act of wrongful inducement and any related issues of patent validity. Accused inducers who believe a patent is invalid have other, proper ways to obtain a ruling to that effect, including seeking ex parte reexamination. View "Commil USA, LLC v. Cisco Systems, Inc." on Justia Law