Justia U.S. Federal Circuit Court of Appeals Opinion Summaries

Apotex submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market a generic version of the anti-allergy eye drop Patanol. Alcon, which markets Patanol, sued Apotex for patent infringement under 35 U.S.C. 271(e)(2)(A). Alcon asserted claims 1-8 of the patent, which is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) entry for Patanol. The district court held that claims would not have been obvious over the prior art and were not invalid. The Federal Circuit affirmed in part. Objective evidence indicated that claims 4 and 8 would not have been obvious. Patanol’s achieving nearly 70% market share within two years of its launch, demonstrates that “the commercial success was caused by the merits of the invention as distinct from the prior art.” The remaining claims were, however, obvious. A person of ordinary skill in the art at the time of invention would have been motivated to use olopatadine to treat human eye allergies as claimed for its established antihistaminic efficacy. View "Alcon Research, Ltd. v. Apotex, Inc." on Justia Law

Allcare owns a patent directed to “managed health care systems” used to interconnect and integrate physicians, medical care facilities, patients, insurance companies, and financial institutions, particularly with respect to utilization review, the process of determining whether a health insurer should approve a particular treatment for a patient. In general, the patent’s claims cover a method of determining whether utilization review is necessary in a particular instance, and whether a recommended treatment is appropriate. If utilization review is required, the method prevents authorization and payment until the appropriateness of the treatment has been determined and the treatment has been approved. The district court held that the patent was not infringed by Highmark, found the case exceptional under 35 U.S.C. 285 and awarded attorneys’ fees and costs to Highmark. The Federal Circuit affirmed the finding that Allcare’s allegations of infringement of claim 102 rendered the case exceptional, but reversed a finding that other claims and actions supported an exceptional case finding. Remand was necessary to determine the amount of fees apportionable to each of the issues. View "Highmark, Inc. v. Allcare Health Mgmt. Sys. Inc." on Justia Law

Whoever “invents or discovers and asexually re-produces any distinct and new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings, other than a tuber propagated plant or a plant found in an uncultivated state, may obtain a patent therefor,” 35 U.S.C. 161. In 1980, Beineke noticed two white oak trees with superior genetic traits, such as excellent timber quality and strong central stem tendency. The trees were in the yard of another and about 105-118 years old. Beineke planted acorns from each. An examiner rejected patent applications because Beineke did not provide evidence that the trees were in a cultivated state. The Board affirmed, finding that the land on which the trees grew had existed as a wooded pasture until a house was constructed around 1930, after the trees began growing; there was no evidence that human activity contributed to the creation of the trees. The Federal Circuit affirmed, without addressing cultivation. Congress recognized that the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions.” The trees were not “newly found seedlings,” and do not fall within the broadened protection of the 1954 amendments. View "In re Beineke" on Justia Law

In 1998, the U.S.PTO issued Registration 334 to WJ for the mark LENS in connection with “computer software featuring programs used for electronic ordering of contact lenses in the field of ophthalmology, optometry and opticianry.” In 2001, Lens.com, an online retailer of contact lenses applied for the mark LENS in connection with “retail store services featuring contact eyewear products rendered via a global computer network.” The PTO cited the 334 Registration as a bar based on likelihood of consumer confusion and refused registration of the mark as merely descriptive of services. In 2002, WJ assigned the registration to Lens.com, which withdrew its cancellation petition under a settlement agreement and obtained the 334 Registration for the mark LENS in connection with “computer software featuring programs used for electronic ordering of contact lenses in the field of ophthalmology, optometry and opticianry.” In 2008, 1-800 Contacts filed Cancellation 925 alleging that Lens.com abandoned or fraudulently obtained the mark LENS because Lens.com never sold or otherwise engaged in the trade of computer software. The Board granted summary judgment of abandonment on the ground that the software is merely incidental to sale of contact lenses, and is not a “good in trade,” solicited or purchased in the market for its intrinsic value.’” The Federal Circuit affirmed. View "Lens.com, Inc. v. 1-800 Contacts, Inc." on Justia Law

Lovenox (enoxaparin) prevents blood clots. Enoxaparin is a version of heparin. Heparin molecules have considerable diversity in characteristics. Additional diversity is introduced when heparin is broken down, raising a problem with the FDA abbreviated new drug application (ANDA) process. ANDAs are used to obtain approval for a generic version of an existing drug and do not require extensive studies needed to initially prove the drug’s safety and efficacy. Aventis, which marketed Lovenox, asked the FDA to deny ANDA approval for a generic enoxaparin unless the applicant took certain steps. The FDA rejected Aventis’s arguments, stating that ANDA does not describe the information necessary to demonstrate that the active ingredient in the generic product is the same as the active ingredient in the reference drug. The FDA identified its own criteria for determining that generic enoxaparin has the same active ingredient as Lovenox. Amphastar was first to file an ANDA for generic enoxaparin and received FDA approval in2011. Momenta was first to bring generic enoxaparin to market, obtaining FDA approval more than a year earlier. Momenta alleged that Amphastar infringed its patent for analyzing heparin and obtained an injunction. The district court found that Amphastar’s quality control batch testing infringed the patent. The Federal Circuit vacated. The court applied an unduly narrow interpretation of the Hatch-Waxman safe harbor, 35 U.S.C. 271(e)(1).View "Momenta Pharma., Inc. v. Amphastar Pharma, Inc." on Justia Law

DGR, seeking an Air Force contract, filed a formal agency-level protest with respect to bid procedures, which the Air Force denied, referencing a DOJ memorandum and a memorandum from the Office of Management and Budget. Pursuant to established appeal procedures, DGR next filed its protest with the GAO, which sustained the appeal despite the contrary Department of Justice and OMB directives. The Air Force was told to rebid the contract consistent with the GAO reading of the Act. The Air Force declined to comply. DGR filed suit, prevailed, and was awarded attorneys’ fees and costs under the Equal Access to Justice Act, 28 U.S.C. § 2412. The Court of Federal Claims determined that the government’s position in the underlying bid protest was not substantially justified. The Federal Circuit reversed. Given the then-existing disagreement among all three branches of the federal government over the law applicable to this bid protest, the Claims Court erred in finding that the government’s position was not substantially justified. View "DGR Assocs., Inc. v. United States" on Justia Law

Gallo served as an FAA air traffic control specialist from 1982 until 1995 when she experienced a job-related injury for which she received OWCP benefits. Gallo recovered enough to return to light duty. In 1996 she lost her medical certification to continue as an operational ATCS. Until 2000 she was assigned to a “non-operational” automation specialist position, which did not provide the same retirement credit or weekend pay. She received OWCP benefits for the differential. Gallo fully recovered in 2000 and received medical clearance; the Agency terminated OWCP benefit. She applied for restoration under 5 U.S.C. 8151(b)(2), which provides the right to priority consideration for restoration to federal employees who have overcome a compensable injury. The Agency assigned Gallo to a supervisory ATCS position. In setting her salary, the Agency did not take into account pay increases granted to operational ATCS employees during while Gallo was working as an automation specialist. The Merit Systems Protection Board denied her claim. The Federal Circuit reversed. The Board erred in interpreting “resumes employment with the Federal Government” under section 8151(a), and any pay increases that Gallo would have received based on her creditable service time with the federal government are “benefits based on length of service.” View "Gallo v. Dep't of Transp." on Justia Law

Defense contractor Raytheon, specializes in infrared imaging. Indigo, also specializing in infrared imaging, was founded by former Raytheon employees including Woolaway, who promised not to recruit Raytheon employees. Indigo began consulting for Raytheon, governed by Confidential Disclosure Agreements. In 1997, Raytheon became concerned that Indigo was recruiting Raytheon personnel to gain access to trade secrets. The companies settled the matter by agreement. The relationship between Raytheon and Indigo terminated in 2000. In 2000, Indigo won a military contract; in 2003, Indigo was selected over competitors, including Raytheon, to receive another subcontract. In 2004, Raytheon acquired and disassembled an Indigo infrared camera and found what it believed was evidence of patent infringement and trade secret misappropriation. In 2007, Raytheon found a correlation with the expertise of former employees who had departed for Indigo. The district court dismissed claims of trade secret misappropriation as time barred. The Federal Circuit reversed. The district court erred by resolving genuine factual disputes in favor of Indigo, the moving party, and concluding that Raytheon should have discovered its claims before March 2, 2004. View "Raytheon Co. v. Indigo Sys. Inc." on Justia Law

01 Communique is the owner of the 479 Patent, which relates to technology that enables one computer to access another computer remotely via the Internet. The patent contains five independent claims describing systems, methods, and products for enabling such remote access, as well as numerous claims dependent therefrom. It discloses use of a “locator server computer” as an intermediary between a “remote computer” (the computer seeking access) and a “personal computer” (the computer to be accessed). The locator server computer “includes” software, referred to in the patent as a “location facility,” that locates the personal computer. The district court entered summary judgment of noninfringement, based on construction of a single claim term, “location facility.” The Federal Circuit vacated, finding the claim construction erroneous. View "01 Communique Lab., Inc. v. Logmein, Inc." on Justia Law

Grober invented a platform that stabilizes a camera for filming motion pictures from moving vehicles. Known in the entertainment industry as the Perfect Horizon, the technology won Grober an Academy Award in technical achievement. He received a patent, entitled “Autonomous Self Leveling, Self Correcting Stabilized Platform.” for the invention, designed to compensate for motion caused by waves, currents, wind, and other motion during land, air, and sea operations of a camera. Grober claimed infringement. The district court entered summary judgment in favor of defendants. The Federal Circuit vacated the claim construction and the grant of summary judgment and remanded. A patent is infringed if even a single claim is infringed and the district court misconstrued term “payload platform.” View "Grober v. Mako Prods., Inc." on Justia Law