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

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

Hibbard, then 41 years old and working as a teacher, received a flu vaccination in 2003. She claims that the flu vaccine caused her to develop a neurological disorder known as dysautonomia, a dysfunction of the autonomic nervous system and sought compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C.300aa-1 to 300aa-34. Following a two-day hearing, a special master found that Hibbard had failed to show that her dysautonomia resulted from autonomic neuropathy caused by the vaccine she received in 2003. The Court of Federal Claims upheld the decision. The Federal Circuit affirmed, finding substantial evidence to support the denial. View "Hibbard v. Sec'y Health & Human Servs." on Justia Law

A jury found that Demant and Widex infringed the 749 and 850 patents. The court entered judgment finding noninfringement of the 749 patent, finding that prosecution history estoppel barred the finding of infringement under the doctrine of equivalents. The patents relate to technology for reducing acoustic feedback in a programmable digital hearing aid. All hearing aids have: a microphone that picks up sound and converts it to an electrical signal, a speaker (receiver) that converts the signal back into sound waves, and sound processing circuitry that adjusts received sound to compensate for any hearing impairment. Some of the amplified sound from the speaker may also travel back to the microphone via an “acoustic feedback path” and is amplified along with all other sound arriving at the input microphone. The resulting cycle of amplification causes the whistling sound known as “feedback.” The common specification. with a 1986 priority date, describes a method of reducing feedback by creating an electrical feedback path and inserting a programmable filter in that path to mimic the effects of acoustic feedback on the phase and amplitude of a sound signal in the transmission channel. This electrical feedback signal then cancels the acoustic feedback signal. The Federal Circuit affirmed. View "Energy Transp. Group, Inc. v. Wm. Demant Holding A/S WDH, Inc." on Justia Law

Abbott owns the 752 patent and the 509 patent, which share a common specification that describes methods and devices “for the in vivo monitoring of an analyte using an electrochemical sensor to provide information to a patient about the level of the analyte” in the bloodstream. The specification describes methods and devices for monitoring glucose levels for diabetics. And notes that a variety of devices exist for monitoring glucose levels in the blood stream, but some of these devices include sensor guides that are “typically bulky and do not allow for freedom of movement.” In response to a third-party request for reexamination, the Board of Patent Appeals and Interferences rejected several claims in the patents as indefinite, anticipated, or obvious over several combinations of prior art references. The Federal Circuit vacated in part, noting that the U.S. PTO conceded that the examiner’s official notice rejections should be withdrawn. The rejections were based on unreasonable claim constructions; under the broadest reasonable construction, “electrochemical sensor” is properly interpreted to mean a discrete electrochemical sensor devoid of external connection cables or wires to connect to a sensor control unit. View "In re Abbott Diabetes Care, Inc." on Justia Law

Pozen developed a method for treating migraines by combining two drugs, sumatriptan and naproxen, in a single tablet, which it markets with GlaxoSmithKline as Treximet. Sumatriptan, a 5-HT receptor agonist, was developed in the late 1980s and is widely accepted as an effective medicine for migraines, but it does not prevent the reoccurrence of migraine symptoms. Naproxen is anonsteriodal anti-inflammatory drug. Pozen filed a New Drug Application (NDA) for Treximet and obtained approval from the FDA in 2008; the relevant patents are included in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), 21 U.S.C. 355(b)(1). Generic pharmaceutical manufacturers filed ANDAs (abbreviated new drug applications) to market generic forms of Treximet before the expiration of Pozen’s patents, certifying that the patents listed in the Orange Book are “invalid or will not be infringed” by the generic products. Thereafter, Pozen filed complaints for infringement, 35 U.S.C. 271(e)(2)(A). The district court held that Pozen’s patents are not invalid as obvious under 35 U.S.C. 103 and were infringed by the ANDA filings and enjoined the generic manufacturers from making, using, importing, selling or offering to sell their generic products in the United States. The Federal Circuit affirmed. View "Pozen, Inc. v. Par Pharma., Inc." on Justia Law

The 772 application is directed to methods and compositions for recombining DNA in a eukaryotic cell (a cell with a nucleus), such as a human cell. The Board of Patent Appeals and Interferences affirmed rejection of independent claim 29 of the 772 application, as obvious over the combination of a patent and an article. Claim 29 covers a method of recombining DNA in a eukaryotic cell using modified versions of wild-type Int. The Federal Circuit affirmed. The disclosures provide substantial evidence that a person of ordinary skill in the art would have had a reasonable expectation of success for using the modified integrases disclosed in the article in place of wild-type Int in the method taught in the patent. View "In re Droge" on Justia Law

Medtronic sought a declaratory judgment of non-infringement and invalidity of reissue patents covering a cardiac resynchronization therapy device (previously called a biventricular pacer). The district court entered judgment of noniinfringement in favor of Medtronic and judgment of validity and enforceability in favor of the patent holder. The Federal Circuit vacated and remanded, holding that the district court relied on a legally incorrect allocation of the burden of proof to find non-infringement in the limited circumstances of the case and incorrectly construed the claim terms in question. View "Medtronic, Inc. v. Boston Scientific Corp." on Justia Law

Santarus is the exclusive licensee of patents on formulations of benzimidazole proton pump inhibitors, a class of chemical compounds that inhibit gastric acid secretion and help prevent and treat stomach acid-related diseases and disorders. Santarus provides the PPI product omeprazole in formulations covered by the Phillips patents, brand name Zegerid. Par filed an Abbreviated New Drug Application (ANDA) for FDA approval to sell a generic counterpart of the Santarus Zegerid products, invoking the Hatch-Waxman Act (the Drug Price Competition and Patent Term Restoration Act of 1984), which established Paragraph IV certification, 21 U.S.C. 355(j)(2)(A)(vii)(IV), whereby an entity that seeks to market a generic counterpart of a patented drug product or method of use, before the patent has expired, may challenge the patent before actually marketing the drug. The district court found that Par’s ANDA products infringe the patents, but found all asserted claims invalid on the ground of obviousness, 35 U.S.C 103 and found certain claims invalid on the ground of inadequate written description, 35 U.S.C. 112. The district court held that there was not inequitable conduct by the inventor, his assignee, or their counsel in procuring the patents. The Federal Circuit reversed with respect to obviousness, but otherwise affirmed. View "Santarus, Inc. v. Par Pharma., Inc." on Justia Law

Generic pharmaceutical manufacturers filed abbreviated new drug applications, seeking FDA approval to market generic formulations of the chemotherapy agent pemetrexed, currently marketed as Alimta. Permetrexed won FDA approval in 2004 for use in treating mesothelioma and then in 2008 for treatment of non-small cell lung cancer. A 1989 patent application claimed pemetrexed and a broader group of related antifolates containing pemetrexed’s characteristic core structure. The application, eventually abandoned, founded a family of related applications that yielded the three patents at issue; two have expired, but the 932 patent remains in effect until 2016, due to a patent term extension of over four years to compensate for delays, 35 U.S.C. 156. The ANDAs asserted that the 932 patent was invalid, unenforceable, or would not be infringed by the proposed generic products, 21 U.S.C. 355(j)(2)(A)(vii)(IV). Lily, which markets Alimta, sued alleging infringement, 35 U.S.C. 271(e)(2)(A). The district court rejected arguments that the 932 patent claims were invalid for obviousness-type double patenting over two earlier-issued claims. The Federal Circuit affirmed. View "Eli Lilly & Co. v. Teva Parenteral Med., Inc." on Justia Law