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

Figueroa received the flu vaccine in 2008. Within 20 days, he developed numbness in his face, impaired speech, and weakness. He was diagnosed with Guillain-Barré Syndrome, a sometimes fatal nervous system disorder. Because GBS is not listed on the Vaccine Injury Table, 42 U.S.C. 300aa-14(a), it requires proof of causation, although flu vaccine GBS cases have been compensated under the National Childhood Vaccine Injury Act. Figueroa had 36 months from the onset of symptoms to file a petition under the Act (until November, 2011), but, in 2010, he died of pancreatic cancer. His widow timely sought compensation for the vaccine-related neurological injuries suffered prior to his death. A special master dismissed, reasoning that because Figueroa had died of pancreatic cancer, a non-vaccine-related cause, Ms. Figueroa lacked standing to seek injury compensation. The Court of Federal Claims affirmed. The Federal Circuit reversed, interpreting a section that provides: “any person who has sustained a vaccine-related injury, the legal representative of such person if such person is a minor or is disabled, or the legal representative of any person who died as the result of the administration of a vaccine ... may ... file a petition for compensation,” 42 U.S.C. 300aa-11(b)(1)(A) View "Figueroa v. Sec'y of Health & Human Servs." on Justia Law

The 753 patent is directed to a heart rate monitor that purports to improve upon the prior art by effectively eliminating noise signals during the process of detecting a user’s heart rate. According to the patent, prior art monitors did not eliminate signals given off by skeletal muscles (EMG signals), which are brought about when users move their arms or squeeze the monitor with their fingers. Biosig, the assignee of the 753 patent, brought a patent infringement action against Nautilus. After claim construction of the disputed term ”space relationship,” the district court declared the patent invalid. The Federal Circuit reversed and remanded, finding the claims at issue not invalid for indefiniteness. View "Biosig Instruments, Inc. v. Nautilus, Inc." on Justia Law

In the mid-1990s, Biogen scientists discovered that patients with Chronic Lymphocytic Leukemia could be treated using anti-CD20 antibodies like Biogen’s Rituxan. Biogen obtained the 612 patent covering a method for treating patients with CLL involving administering a therapeutically effective amount of the anti-CD20 antibody, entitled “Treatment of Hematologic Malignancies Associated with Circulating Tumor Cells Using Chimeric Anti-CD20 Antibody.” The patent was not limited to any particular type of antiCD20 antibody. In 2002, GSK and Genmab developed a breakthrough anti-CD20 antibody, Arzerra, which is distinctly different from Rituxan in several respects. Unlike Rituxan, which is a chimeric antibody, Arzerra is a fully human antibody, with less risk that the body will reject it and it can bind longer, giving the antibody more time to kill the target B cell. In 2010, Biogen sued GSK for infringement. The district court applied a construction of “anti-CD20 antibody” that narrowed the term based on prosecution history disclaimer. Under that construction, Biogen stipulated that it could not prove infringement and appealed the claim construction. The Federal Circuit affirmed; the district court did not err in finding a clear and unmistakable disclaimer. View "Biogen Idec, Inc. v. GlaxoSmithKline, LLC" on Justia Law

First introduced in 1960, combined oral contraceptive (COC) “birth control pills,” deliver synthetic hormones that regulate the natural ovarian cycle and prevent pregnancy. Bayer filed an application directed to a low-dose, extended-regimen COC in 1993, which eventually led to the 564 patent. Bayer received final approval to market YAZ in the U.S. in 2006. Defendants filed Abbreviated New Drug Applications with the U.S. Food and Drug Administration seeking approval to market generic versions of YAZ, with certifications asserting that the 564 patent is invalid (21 U.S.C. 355(j)(2)(A)(vii)(IV). Bayer responded with patent infringement actions. The district court entered summary judgment that the patent’s claims are not invalid for obviousness in view of numerous cited prior art references. The Federal Circuit reversed, finding that Bayer did not present evidence that overcomes the plain disclosures and express motivation to combine those disclosures in the prior art. View "Bayer Healthcare Pharma, Inc. v. Watson Pharma, Inc." on Justia Law

Saffran is the owner and sole named inventor of the 760 patent, entitled “Method and Apparatus for Managing Macromolecular Distribution,” which concerns “treatment of injured tissues within human or animal bodies, specifically ... the way injured tissues are joined and the way macromolecules are directed to promote healing.” The patent discloses methods and devices for treating injured tissues by sequestering particles and macromolecules in a defined space using a selectively permeable barrier. The specification primarily describes the invention in terms of a strategy for treating serious bone fractures, known as complex or comminuted fractures, where the bone has been shattered into numerous fragments. The district court held Cordis liable for infringing multiple claims of the patent. The Federal Circuit reversed, holding that the district court erroneously construed the “device” and “release means” limitations of the asserted claims. View "Saffran v. Johnson & Johnson" on Justia Law

1999, Drs. Dawson and Bowman submitted the patent application that led to the issuance of the two patents at issue, which concern a method for topically treating and preventing infections of the eye. They claim to overcome difficulties in existing methods through a process for topically applying an azalide antibiotic to the eye. Both patents are entitled “Topical Treatment or Prevention of Ocular Infections.” In 2007, in order to provoke an interference, UCSF filed a patent application that named Dr. Dawson as the sole inventor and generally copied the specification and claims from the patents. Dr. Dawson declined to join UCSF’s submission. The Patent and Trademark Office’s Board of Patent Appeals and Interferences found that Dr. Dawson did not conceive of the claimed inventions by himself prior to his collaboration with Dr. Bowman. The Federal Circuit affirmed, noting that, apart from reduction to practice, conception requires that the inventor know how his “definite and permanent idea of the complete and operative invention ... is hereafter to be applied in practice.” View "Dawson v. Dawson & Bowman" on Justia Law

The patent examiner rejected all of the inventors’ pending claims in an application entitled “Enzyme-Mediated Modification of Fibrin for Tissue Engineering,” filed in 2003, relating generally to the field of tissue repair and regeneration, and more specifically to matrices containing bidomain peptides or proteins. The examiner found obviousness-type double patenting over several patents. The Board of Patent Appeals and Interferences affirmed. The Federal Circuit affirmed; tO'Mahe Board did not err in concluding that the pending claims were barred under the doctrine of obviousness-type double patenting. View "In re Hubbell" on Justia Law

The patents relate to a method of drug delivery via the mucous membrane lining or mucosa in the oral cavity. The oral mucosal route provides direct access to the bloodstream without having to travel through the gastrointestinal tract, which allows the drug to avoid the “first pass effect,” the percentage of drug lost to metabolization in the liver. Drug delivery across the oral mucosa potentially provides patients with rapid onset of action at a lower dosage. The patents disclose use of effervescent agents used as penetration enhancers, which influence drug absorption across the buccal, sublingual and gingival mucosae and use of an additional pH adjusting substance in combination with an effervescent agent for promoting the absorption. Watson filed an Abbreviated New Drug Application for a generic version of FENTORA®. In response, Cephalon instituted a patent infringement suit. The district court found that Watson’s ANDA products did not infringe and held the asserted patents invalid for lack of enablement. The Federal Circuit reversed on the issue of enablement, holding that Watson failed as a matter of law to show with clear and convincing evidence that Cephalon’s patents require undue experimentation to practice the invention. The court upheld the noninfringement finding. View "Cephalon, Inc. v. Watson Pharm., Inc. " on Justia Law

The 314 patent, a reissue of the 440 patent, covers the “statin” drug with the brand name Crestor®, which is approved for use in control of cholesterol and for treatment of atherosclerosis. The active ingredient of Crestor® is the calcium salt of a chemical compound whose common name is rosuvastatin, one of several statin products that lower cholesterol production in the liver by inhibiting the enzyme HMG-CoA reductase. Several generic producers initiated a challenge to the 314 patent by filing an Abbreviated New Drug Application (ANDA) accompanied by a Paragraph IV certification, 21 U.S.C. 355(j)(2)(A)(vii)(IV). An ANDA permits a generic producer to market a drug product based on the federal approval obtained by the original registrant. Submission of an ANDA constitutes a statutory act of infringement pursuant to 35 U.S.C. 271(e)(2)(A). If the challenge to the patent fails, the ANDA cannot be approved until expiration of the patent. The generic producers argued that the 314 patent was invalid on the ground of obviousness and improper reissue, and that the patent is unenforceable for inequitable conduct in the Patent and Trademark Office. The district court ruled that the patent is valid, enforceable, and infringed. The Federal Circuit affirmed. View "Astrazeneca UK, Ltd. v. Aurobindo Pharma, Ltd." on Justia Law

The patent, issued in 1995, entitled “Valve Prosthesis for Implantation in the Body and a Catheter for Implanting Such Valve Prosthesis,” describes a prosthetic heart valve, mounted on a stent and implanted by catheter to avoid open heart surgery. The district court found the patent valid and infringed by and that the infringement was willful. The jury awarded damages of $72,645,555 in lost profits and $1,284,861 as a reasonable royalty. The district court entered judgment on the verdict, but declined to enhance damages for the willful infringement. The court also declined to issue an injunction against future infringement, apparently on defendant’s representation that, if enjoined, it would move its manufacturing operations to Mexico. The court also denied a request to modify the litigation-agreed protective order and to permit patent counsel and technical expert to participate in ongoing reexamination proceedings of the patent in suit and related patents. The Federal Circuit affirmed, but remanded reconsideration of the denial of an injunction in view of the representation of changed circumstances, and for reconsideration of the ruling on the protective order as applied to patents not in suit, to the extent that this issue has not become moot. View "Edwards Lifesciences AG v. Corevalve, Inc." on Justia Law