by
The Bristol-Myers Squibb (BMS) patent, entitled “Stable Protein Formulations,” describes and claims specific fluid formulations an immunosuppressive agent used in the treatment of immune system disorders such as rheumatoid arthritis. The product has the common name “abatacept” and the brand name Orencia®. Momenta sought Inter Partes Review of the Patent under the America Invents Act, 35 U.S.C. 311. Momenta was attempting to develop a biosimilar counterpart of Orencia®. The Patent Trial and Appeal Board sustained patentability of the patent claims. Momenta filed an appeal under 35 U.S.C. 319. BMS moved to dismiss for lack of standing because Momenta’s proposed product had failed its Phase 1 clinical trials and had been withdrawn. Momenta responded that it had not abandoned its intent to produce a counterpart of the Orencia® product and filed various exhibits concerning its intentions, ultimately submitting a form that was filed with the Securities and Exchange Commission in December 2018, indicating termination of Momenta’s collaboration agreement with respect to the development of a proposed biosimilar to ORENCIA®. Momenta did not withdraw its appeal. The Federal Circuit dismissed the appeal for lack of standing as moot. The cessation of potential infringement means that Momenta no longer has the potential for injury, thereby mooting the inquiry. View "Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co." on Justia Law

by
Athena Diagnostics is the exclusive licensee of the 820 patent, covering methods for diagnosing neurological disorders by detecting antibodies to a protein called muscle-specific tyrosine kinase (MuSK), which is associated with Myasthenia gravis (MG), a neurological disorder where patients experience muscle weakness and symptoms including drooping eyelids, double vision, and slurred speech. Athena markets a test (FMUSK) that functions by evaluating those antibodies. After Mayo developed two competing tests, Athena accused Mayo of infringing its patent. The Federal Circuit affirmed that the asserted claims of the 820 patent are invalid under 35 U.S.C. 101, for claiming ineligible subject matter. The claims at issue are directed to a natural law and lack an inventive concept. View "Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC" on Justia Law

by
RCT owns the 551 patent, which discloses and claims enantiomeric compounds and pharmaceutical compositions useful in the treatment of epilepsy and other central nervous system disorders. The Patent and Trademark Office Patent Trial and Appeal Board, in an inter partes review, concluded that claims 1–13 of the patent are not unpatentable. The Federal Circuit affirmed, rejecting an argument that an ordinary artisan would have recognized the methoxyamino group in compound 3l (disclosed in a prior reference) to be uncommon and to have potential synthetic and stability problems and that a person of skill in the art would then have been motivated to modify compound 3l by replacing the amine of its methoxyamino group with a methylene link to yield a more stable, synthetically accessible, pharmaceutically common and acceptable moiety. The Board’s findings are supported by substantial evidence. Even if a person of skill in the art would have been motivated to modify compound 3l, the evidence suggests that compounds without a methoxyamino or nitrogen-containing group at the αcarbon had reduced activity. View "Mylan Pharmaceuticals Inc. v. Research Corporation Technologies, Inc." on Justia Law

by
IPS’s founder and CEO (King) and Chief Technical Officer (Schwarz) are electrical engineers. IPS manufactured multi-space parking meters. King claims he conceived the idea for a credit-card enabled, solar-powered, single-space parking meter in 2003, consulted with Schwarz, and decided that IPS would offer a retrofit device that replaces the internal components of an existing parking meter. IPS engaged a design firm, D+I, in 2004, providing it with King's list of desired components and functionalities. Schwarz compiled a list of electrical components and product specifications and drew a block diagram conceptualizing the electrical connections. The 054 patent issued in 2013 from a 2006 application, naming King and Schwarz as inventors. It claims a credit card-enabled, solar-powered, single-space parking meter that can retrofit the internal components of existing parking meters. The 310 patent issued in 2010 from a 2008 application, naming as inventors King and three D+I engineers. It claims a credit card-enabled, solar-powered, single-space parking meter. In 2015, IPS sued DPT for infringement. The court granted summary judgment that DPT’s Liberty® Single-Space Meter does not infringe either patent. DPT successfully petitioned the Patent and Trademark Office for inter partes review under 35 U.S.C. 102(e). The Board rejected an anticipation argument, holding that King was the sole inventor of the anticipating disclosure of the 054 patent. The Federal Circuit reversed the decision that the 310 patent claims are not unpatentable as anticipated; affirmed summary judgment of noninfringement of the 310 patent; and vacated summary judgment of noninfringement of the 054 patent; the district court erred in construing the claims too narrowly. View "Duncan Parking Technologies, Inc. v. IPS Group, Inc." on Justia Law

by
Until recently, Sexing Tech held a monopoly on the market for sexed cattle semen in the United States. Sperm‐sorting technology separates bull semen into X‐chromosome bearing and Y‐chromosome bearing sperm cells; the resulting “sexed semen” is used to inseminate cows artificially so that dairy farmers can breed only milk‐producing cows. ABS, a bull‐stud operation, sued, alleging that Sexing Tech had unlawfully monopolized the domestic sexed‐semen market in violation of section 2 of the Sherman Act by using its market power to impose coercive contract terms. ABS sought a declaratory judgment proclaiming those contracts invalid, to permit its own entry into that market. Sexing Tech counterclaimed that ABS infringed its patents and breached the contract by misappropriating trade secrets in developing ABS’s competing technology. Three claims went to trial: ABS’s antitrust claim and Sexing Tech’s patent infringement and breach of contract counterclaims. The Seventh Circuit affirmed the district court, holding that ABS violated a confidentiality agreement it had with Sexing Tech and that Sexing Tech’s patent was not invalid on obviousness grounds. The jury’s assessments of two of the three patent claims still at issue cannot be reconciled under the rules governing dependent claims and enablement, and so a new trial is necessary on them. View "ABS Global, Inc. v. Inguran, LLC" on Justia Law

by
Dr. Barry’s patents, entitled “System and Method for Aligning Vertebrae in the Amelioration of Aberrant Spinal Column Deviation Conditions,” claim methods and systems for correcting spinal column anomalies, such as those due to scoliosis, by applying force to multiple vertebrae at once. Dr. Barry sued Medtronic, alleging that Medtronic induced surgeons to infringe the patents. The jury found infringement of method claims 4 and 5 of the 358 patent and system claims 2, 3, and 4 of the 121 patent, rejected Medtronic’s several invalidity defenses, and awarded damages. In post-trial rulings on the jury issues, the district court upheld the verdict, rejecting challenges as to induced infringement and associated damages for domestic conduct, invalidity of the asserted 358 patent claims under the public-use and on-sale bars, and invalidity of all asserted claims due to another’s prior invention. The district court then rejected Medtronic’s inequitable-conduct challenge and enhanced damages by 20 percent while denying attorney’s fees to Dr. Barry, The Federal Circuit affirmed, rejecting several arguments by Medtronics, principally concerning the public-use and on-sale statutory bars, but also concerning prior invention, inequitable conduct, and induced infringement and associated damages. View "Barry v. Medtronic, Inc." on Justia Law

by
In April 2006, Supernus filed the “100 application” In August 2010, the USPTO issued a final rejection. In February 2011, Supernus filed a request for continued examination (RCE), 35 U.S.C. 132(b). Also in April 2006, Supernus filed an international application, claiming priority from the 100 application, which was subject to opposition. Supernus notified USPTO of the opposition. In October 2011, the European Patent Office issued European Patent EP2010189. The 100 application issued in June 2014, as the 897 patent, titled “Osmotic Drug Delivery System,” reflecting a patent term adjustment (PTA), adding 1,260 days to the patent’s 20-year term. The USPTO attributed 2,321 days to USPTO delay: 1,656 days for USPTO’s failure to meet the mandated statutory response deadlines and 665 days for failure to issue the patent within three years of the application’s filing date. The USPTO reduced the PTA by 175 days to account for overlapping delays, and by 886 days for applicant delay. Of the 886 "applicant delay" days attributed, 646 days were assessed for the period Supernus did not attempt to invoke the protections of the 30-day safe harbor established by 37 C.F.R. 1.704(d)(1). Supernus argued that “37 C.F.R. 1.704(c)(8) does not govern post-RCE submissions.” The USPTO rejected a request for reconsideration. The district court granted USPTO summary judgment. The Federal Circuit reversed. The PTA went beyond the period during which the applicant failed to undertake reasonable efforts, exceeding the limitations set by the PTA statute. View "Supernus Pharmaceuticals, Inc. v. Iancu" on Justia Law

by
Helsinn makes a treatment for chemotherapy-induced nausea using the chemical palonosetron. While developing that product, Helsinn granted another company the right to market a 0.25 mg dose of palonosetron in the United States; that company was required to keep proprietary information confidential. Nearly two years later, in 2003, Helsinn filed a provisional patent application covering a 0.25 mg dose of palonosetron. Helsinn filed four patent applications that claimed priority to the 2003 date. Helsinn’s fourth application, filed in 2013 (the 219 patent), is covered by the Leahy-Smith America Invents Act (AIA). In 2011, Teva sought approval to market a generic 0.25 mg palonosetron product. Helsinn sued for infringement. Teva countered that the 219 patent was invalid under the “on sale” provision of the AIA, which precludes a person from obtaining a patent on an invention that was “in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention,” 35 U.S.C. 102(a)(1), arguing the 0.25 mg dose was “on sale” more than one year before Helsinn filed the 2003 application. The Federal Circuit held, and the Supreme Court unanimously agreed, that the sale was publicly disclosed, regardless of whether the details of the invention were publicly disclosed in the agreements. A commercial sale to a third party who is required to keep the invention confidential may place the invention “on sale” under section 102(a). The patent statute in force immediately before the AIA included an on-sale bar. Supreme Court and Federal Circuit precedent interpreting that provision indicated that a sale or offer of sale need not make an invention available to the public to constitute invalidating prior art. The Court applied the presumption that when Congress reenacted the “on sale” language in the AIA, it adopted earlier judicial constructions. View "Helsinn Healthcare S. A. v. Teva Pharmaceuticals USA, Inc." on Justia Law

by
UCB’s 650 patent, which covers certain chemical derivatives of 3,3- diphenylpropylamines, including a compound called fesoterodine. Fesoterodine is an antimuscarinic drug marketed as Toviaz® to treat urinary incontinence. In inter partes review, the Patent and Trademark Office Patent Trial and Appeal Board held that certain claims were not unpatentable as obvious, 35 U.S.C. 103. The Federal Circuit affirmed, first rejecting UCB’s argument that Amerigen lacked standing because the FDA will not approve Amerigen’s abbreviated new drug application until the expiration of the 650 patent in 2022, so that there was no possibility of infringement. The evidence supported the Board’s finding that the Amergen neither established a general motivation to make a 5-HMT prodrug nor proved that the specific claimed modifications would have been obvious. View "Amerigen Pharmaceuticals, Ltc. v. UCB Pharma GMBH" on Justia Law

by
WesternGeco’s patents relate to technologies used to search for oil and gas beneath the ocean floor. The patents relate to controlling streamers and sensors in relation to each other by using winged positioning devices and generating four-dimensional maps with which it is possible to see changes in the seabed over time. WesternGeco manufactures the Q-Marine, and performs surveys for oil companies. ION manufactures the DigiFIN, and sells to its customers, who perform surveys for oil companies. A jury found infringement and no invalidity and awarded WesternGeco $93,400,000 in lost profits and $12,500,000 in reasonable royalties. The Federal Circuit affirmed, rejecting arguments that WesternGeco was not the patents' owner and lacked standing and that the court applied an incorrect standard under 35 U.S.C. 271(f)(1). The court upheld denial of enhanced damages for willful infringement and reversed the award of lost profits resulting from conduct occurring abroad. The Supreme Court subsequently held “that WesternGeco’s damages award for lost profits was a permissible domestic application of [35 U.S.C.] 284,” but did not decide other challenges to the lost profits award. In light of the Supreme Court’s decision and the intervening invalidation of four asserted patent claims that could support the lost profits award, the Federal Circuit remanded to the district court. View "WesternGeco L.L.C. v. Ion Geophysical Corp." on Justia Law