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

The patents at issue involve a 0.03% bimatoprost ophthalmic solution that can is effective as eye drops to treat glaucoma, by alleviating intraocular pressure, or to promote hair growth. The 029 patent was assigned to Duke University and issued in 2008. The 404 patent, assigned to Allergan. Apotex submitted Abbreviated New Drug Applications (ANDAs) to the FDA seeking to market a generic version of Allergan’s Latisse® product, which treats hair loss. Allergan and Duke filed suit. In a consolidated Hatch-Waxman action, the district court held that the asserted claims of the 029 and 404 patents are not invalid for anticipation, obviousness, insufficient written description, or lack of enablement, and that Apotex infringed the patents. The Federal Circuit affirmed the district court’s claim construction that a method of “treating hair loss” may include a method of promoting hair growth without also arresting or reversing hair loss; that that in this case a previous disclosure was too sparse and ambiguous for a person of ordinary skill to comprehend as anticipating the 029 patent; and that the 819 patent does not inherently anticipate the claims of the 029 patent, but reversed findings that asserted claims of the 029 and 404 patents are non-obvious and that the 404 patent was conceived prior to the date of publication of the2001 Brandt references.View "Allergan, Inc. v. Apotex Inc." on Justia Law

The related patents claim priority from a 1998 application and concern drugs for treatment of spinal nerve injuries, often associated with herniated discs. Between spinal vertebrae are soft “spinal discs,” that permit the spine to flex and move by absorbing and distributing compressive forces. A spinal disc becomes herniated when tissue surrounding it tears and nucleus pulposus, normally inside the disc, leaks into the epidural space of the spine. Nucleus pulposus secretes TNF-α, a powerful signaler of inflammation and other injuries. The nerve roots that extend from the spinal cord pass through the epidural space; if they come into contact with TNF-a, back pain or numbness may result. Nerve root injuries may be reduced or eliminated by “inhibiting” the TNF-α. Tobinick brought an interference proceeding. The Patent Trial and Appeal Board dismissed, construing “administered locally” as administering the claimed therapeutic compound “directly to the site where it is intended to act, that is, to the location where the nucleus pulposus is causing the symptoms of the nerve disorder.” The Board found that Tobinick’s patent application did not contain written description support so that he lacked standing to bring the interference. The Federal Circuit reversed, finding that Tobinick’s application contained sufficient written description support for local administration; it describes administering the therapeutic compound to the epidural space adjacent to a herniated spinal disc, which is the site where it is intended to act and the location where the nucleus pulposus is causing symptoms of the nerve disorder.View "Tobinick v. Olmarker" on Justia Law

Monsanto developed a genetic modification in soybean seeds (Roundup Ready® (RR)), known as the 40-3-2 event (RR trait), which enables soybean plants to tolerate application of glyphosate herbicide to kill weeds. Monsanto owns the patent for the RR trait and granted Pioneer a license to produce and sell seeds containing the traits. After Pioneer became a subsidiary of DuPont, Monsanto and Pioneer entered into an amended license, under which DuPont produced and sold RR trait seed. In 2006, DuPont announced that it had developed a glyphosate-tolerant trait, OGAT, expected to confer tolerance to both glyphosate and acetolactate synthase inhibitor herbicide. Testing indicated that OGAT alone did not provide sufficient glyphosate-tolerance for commercial use. DuPont then combined OGAT with the RR trait; the OGAT/RR stack provided increased yields in field trials. DuPont did not sell any OGAT/RR product, however, and discontinued development. Monsanto sued DuPont for breach of the license and patent infringement. The district court granted partial judgment to Monsanto, holding that the license was unambiguous and did not grant the right to stack non-RR technologies with the licensed” trait, but allowed DuPont to amend its answer to assert reformation counterclaims and defenses. The court ultimately told DuPont to “either voluntarily dismiss these reformation claims or produce … all documents … previously withheld.” DuPont continued litigating its reformation counterclaims and produced previously withheld internal e-mails that showed its awareness that it did not have the right to commercialize the OGAT/RR stack. The court found that DuPont’s position was not rooted in fact, that DuPont made misrepresentations and had perpetrated a fraud on the court, struck DuPont’s reformation defense and counterclaims, and awarded limited attorney fees to Monsanto. The Federal Circuit affirmed.View "Monsanto Co. v. E.I. du Pont de Nemours & Co." on Justia Law

In 1996, Campbell and Ian successfully produced the first mammal ever cloned from an adult somatic cell: Dolly the Sheep. Known as somatic cell nuclear transfer, the process involves removing the nucleus of a somatic cell and implanting that nucleus into an enucleated (i.e., without a nucleus) oocyte. A somatic cell is any body cell other than gametes (egg or sperm). An oocyte is an egg cell prior to maturation and a nucleus is the organelle that holds a cell’s genetic material (DNA). Often called “adult” cells, somatic cells are differentiated, i.e., they are specialized to perform specific functions. Liver, heart, and muscle cells are differentiated, somatic cells. To create Dolly, Campbell and Wilmut fused the nucleus of an adult, somatic mammary cell with an enucleated oocyte. The obtained the 258 patent for the process. The Patent and Trademark Office rejected their claims to the cloned animals, set forth in the 233 application, “Quiescent Cell Populations for Nuclear Transfer.’ In 2013, the Patent Trial and Appeal Board affirmed the rejection, finding that the claimed subject matter was ineligible for patent protection under 35 U.S.C. 101 because it constituted a natural phenomenon that did not possess “markedly different characteristics than any found in nature” and that the subject matter was anticipated by and obvious in light of prior art (35 U.S.C. 102 and 103) because the clones were indistinguishable from clones produced through prior cloning methods, i.e., embryotic nuclear transfer and in vitro fertilization. The Federal Circuit affirmed, citing Section 101.View "In re: Roslin Inst. (Edinburgh)" on Justia Law

Tranexamic acid, the active ingredient in Ferring’s patented product, is used to treat heavy menstrual bleeding (menorrhagia) in women. Tranexamic acid has been widely used in an immediate release formulation for more than 30 years to treat menorrhagia in other countries. Ferring developed a tranexamic acid formulation with fewer gastrointestinal side effects than the immediate release version used abroad, but with the same benefits, by creating a formulation with a tranexamic acid release rate that matched the rate of absorption in the gastrointestinal tract. Ferring’s commercial product is known as Lysteda. In 2004, the FDA approved a fast-track designation for approval of Lysteda, and the Lysteda New Drug Application was approved in 2009 as the first tranexamic acid drug approved for use in the U.S. Apotex sought to market a generic version of Lysted that would avoid infringement of Ferring’s patent applications, but that would be bioequivalent to Lysteda, by altering the rate of absorption. Ferring then sued Apotex for infringement. The district court dismissed after Apotex amended its Abbreviated new Drug ApplicationView "Ferring B.V. v. Watson Labs, Inc., FL" on Justia Law

The Kennedy patents cover a popular treatment for rheumatoid arthritis: a combination therapy of a disease-modifying antirheumatic drug and an antibody. The 766 patent expired in October 2012; the 422 patent will expire in August 2018. In 2002, AbbVie1 obtained a license to the 766 patent. Thereafter, AbbVie obtained FDA approval to sell Humira, an anti-TNFα antibody, for use either alone or in combination with methotrexate to treat rheumatoid arthritis. AbbVie paid Kennedy more than $100 million in royalties for AbbVie’s U.S. sales of Humira. When the 442 patent issued in 2010, Kennedy demanded that AbbVie secure an additional license for that patent in order to continue sales of Humira. Kennedy conceded that the 766 patent encompasses the same inventive subject matter as the 442 patent, but contended that the 442 patent was nonetheless patentable because the 766 patent claims a “broad genus” of methods for treating rheumatoid arthritis, whereas the 442 patent claims a “narrower species” of those treatment methods with unexpected results. AbbVie obtained a declaratory judgment that claims of the 442 patent were invalid over the 766 patent for obviousness-type double patenting. The Federal Circuit affirmed.View "AbbVie Inc. v. Kennedy Inst. of Rheumatology Trust" on Justia Law

Apotex’s 556 patent, titled “Pharmaceutical Compositions Comprising Moexipril Magnesium,” issued in 2004, from an application that claims priority to a Canadian application filed in 2000. The patent is directed to manufacture of moexipril tablets, an angiotensin-converting enzyme (ACE) inhibitor used to treat hypertension. Like other ACE inhibitors, Moexipril and its acid addition salts are susceptible to degradation and instability. To improve stability, the 556 patent discloses tablets consisting mostly of moexipril magnesium obtained by reacting moexipril or its acid addition salts with an alkaline magnesium compound. Several methods for stabilizing ACE inhibitors were known in the prior art. UCB’s accused products, Univasc and Uniretic, moexipril tablets, sold in the U.S. since 1995 and 1997, respectively, are prior art. In allowing the claims of the 556 patent over findings of obviousness, the examiner stated: prior art teaches that only a portion of drug (if any) may be converted to the alkaline salt and that the stable product results entirely or primarily not from conversion to alkaline salts, but from stabilization of the moexipril hydrochloride by the presence of the alkaline stabilizing compound in the final product. In 2012 Apotex accused UCB of infringement. The district court ruled that the 556 patent was unenforceable due to the inventor’s inequitable conduct before the PTO in concealing his knowledge and misrepresenting the nature of Univasc and the prior art and submitting results of experiments that he never conducted. The Federal Circuit affirmed, upholding the finding of inequitable conduct.View "Apotex Inc. v. UCB, Inc." on Justia Law

Tyco owns patents directed to temazepam, a drug used to treat insomnia and marketed under the brand name Restoril. The patents claim 7.5 mg formulations of temazepam having a specific surface area between 0.65 and 1.1 square meters per gram (m2/g). Specific surface area is a measure of the surface area of a drug per unit of weight. Generally, as chunks of drug material are ground down into smaller particles, the specific surface area increases because more of the drug is exposed to the surrounding environment. Mutual filed an Abbreviated New Drug Application (ANDA) with the FDA, seeking approval to manufacture and sell a generic 7.5 mg version of temazepam. The ANDA represented that its product would have a specific surface area of not less than 2.2 m2/g and included a certification representing that the generic drug was not protected by a U.S. patent (21 U.S.C. 355(j)(2)(A)(vii)). Mutual sent Tyco a “paragraph IV certification letter” claiming that the product would not infringe because its specific surface area would not fall within the 0.65-1.1 m2/g range claimed by the temazepam patents. Tyco filed an infringement action, 35 U.S.C. 271(e)(2)(A). Mutual raised antitrust counterclaims. The district court granted summary judgment of noninfringement. Tyco filed a citizen petition, urging the FDA to change the criteria for evaluating the bioequivalence of proposed generic temazepam products in order to “help ensure therapeutic equivalence.” The FDA approved Mutual’s ANDA; months later it denied the petition. The court granted summary judgment to Tyco on the antitrust counterclaims. The Federal Circuit court vacated the summary judgment that Tyco’s infringement claims were not a sham and the summary judgment that Tyco’s citizen petition was not a sham. View "Tyco Healthcare Grp. v. Mut. Pharm. Co" on Justia Law

Braintree manufactures the SUPREP® Bowel Prep Kit, which helps to prepare patients for colonoscopies. In the late 1990s, two colon cleansing options existed; the safest required patients to drink large volumes of unappetizing isotonic prep formulas, resulting in low patient compliance, and a low-volume, hypertonic prep that could cause severe electrolyte shifts, leading to heart failure, kidney failure, neurological impairment, and even death. Braintree’s patent discloses a combination of magnesium sulfate, potassium sulfate, and sodium sulfate, which can be digested in small volumes to safely and effectively induce colonic purging without causing clinically significant electrolyte shifts. Novel filed an abbreviated new drug application (ANDA) and Braintree responded with a patent infringement case (Hatch- Waxman Act, 35 U.S.C. 271(e)(2)(A). The district court granted summary judgment of infringement based on its construction of four disputed claim terms. The Federal Circuit affirmed a finding Braintree’s patent not invalid, but reversed with respect to construction of the claim term “clinically significant electrolyte shifts” and vacated with respect to infringement.View "Braintree Labs, Inc. v. Novel Labs, Inc." on Justia Law

Gilead owns patents directed to antiviral compounds and methods for their use. The 375 and 483 patents list the same inventors and their written descriptions disclose similar content, but they do not claim priority to a common application and have different expiration dates. Gilead sued Natco for infringement of the 483 patent after Natco filed an FDA request for approval to market a generic version of one of Gilead’s drugs that is allegedly covered by the 483 patent. Natco asserted that the 483 patent was invalid for obviousness-type double patenting over the 375 patent. Gilead argued that the 375 patent cannot serve as a double patenting reference against the 483 patent because, even though the 483 patent’s expiration date is 22 months after the 375 patent’s expiration date, the 375 patent issued after the 483 patent. The district court, pursuant to a stipulation, granted Gilead final judgment on infringement. The Federal Circuit vacated and remanded. Because the obviousness-type double patenting doctrine prohibits an inventor from extending his right to exclude through claims in a later-expiring patent that are not patentably distinct from the claims of the inventor’s earlier-expiring patent, the 375 patent qualifies as an obviousness-type double patenting reference for the 483 patent. View "Gilead Sciences, Inc. v. Natco Pharma. Ltd." on Justia Law