Justia Patents Opinion Summaries

In 1997 MIDCO alleged that Elekta’s GammaKnife, GammaPlan, and SurgiPlan products infringed its patent, “Method and Apparatus For Video Presentation From Scanner Imaging Sources,” directed to both a method and apparatus for generating a video image from separate scanner imaging sources. Previously, images were not in a common format, and there was no method for comparing and using images from various scanners. In discovery, MIDCO focused on claim 1 and neglected the method claims. The court only construed terms from apparatus claims and dismissed the method claims without prejudice. Its construction included analog-to-digital and software based digital-to-digital conversion. A jury awarded $16 million. The Federal Circuit found that the disclosure did not encompass digital-to-digital conversion. On remand, MIDCO unsuccessfully attempted to revive the method claims. The court entered judgment for Elekta. The Federal Circuit affirmed. MIDCO licensed the patent; Brain Life sued defendants, including Elekta, claiming that Elekta’s GammaKnife, GammaPlan, SurgiPlan, and ERGO++ systems infringed the method claims. The court granted Elekta summary judgment, finding no material difference between current products and those previously adjudicated noninfringing. Brain Life argued that similarity did not bar allegations of infringement of method claims. The court found that, once judgment entered in its favor, Elekta developed and sold products with an understanding that they did not infringe; MIDCO chose not to pursue method claims in the first litigation. Concerning other defendants, the court concluded that the method claims were broader than the apparatus claims and included digital-to-digital conversion. With respect to Brain Life, the Federal Circuit held that its claims were not barred by claim or issue preclusion, but that the Kessler Doctrine bars most of them.View "Brain Life, LLC v. Elekta Inc." on Justia Law

Alcon’s patents disclose methods for enhancing the stability of prostaglandin compositions, including Alcon’s glaucoma and ocular hypertension drug Travatan Z®, which contains travoprost, the synthetic prostaglandin fluprostenol isopropyl ester. Barr submitted an FDA Abbreviated New Drug Application, seeking approval to manufacture and sell an ophthalmic travoprost solution as a generic version of Travatan Z®. Although the Alscon patents are not listed as referenced to Travatan Z® in the FDA Orange Book, Alcon sued, asserting infringement of different Book-listed patents. Alcon did not assert those patents at trial and neither party adduced any evidence specifically relating to those patents. Barr stipulated that its generic product infringed the remaining Alcon patents and that those patents were not invalid. After a Markman hearing, the district court construed the claimed phrase “enhancing the chemical stability” to mean “to increase or increasing the ability of the prostaglandin to resist chemical change (as opposed to merely increasing the physical stability of the prostaglandin or composition). The court distinguished physical stability as referring to physical phenomena such as absorption, adsorption, and precipitation and construed the claim term “prostaglandin” to correspond to the patents’ written description regarding prostaglandins that may be used with the invention. The court held that Barr did not infringe and held the claims invalid for lack of enablement and lack of an adequate written description under 35 U.S.C. 112. The Federal Circuit affirmed with respect to non-infringement, but reversed the invalidity determinations.View "Alcon Research, Ltd. v. Barr Labs. Inc." on Justia Law

In 2004, Becton sought a declaratory judgment of noninfringement of patents concerning Becton’s blood glucose test strip. The defendant, Abbott, sued Becton, Nova (Becton’s supplier), and Bayer, for infringement. In consolidated cases, the court granted summary judgment of noninfringement with respect to two patents and found most asserted claims of another patent invalid due to anticipation. The court later found remaining claims invalid due to obviousness and found the patent unenforceable for inequitable conduct. The court found the case concerning that patent to be exceptional and awarded Becton and Nova costs and fees ($5,949,050) under 35 U.S.C. 285, specifically due after exhaustion of all appeals if the inequitable conduct judgment was upheld. Abbott appealed the judgments of invalidity, unenforceability, and noninfringement, but did not appeal the exceptional case finding or fee award. The Federal Circuit, en banc, affirmed regarding obviousness, noninfringement, and anticipation, but vacated the inequitable conduct judgment. Applying a new standard on remand, the district court concluded again that the patent was procured through inequitable conduct. Becton and Nova sought appellate and remand fees and expenses; fees spent seeking additional fees; pre-judgment interest on fees; and post-judgment interest calculated from the date the district court found the case to be exceptional. The district court reinstated its 2009 fee award and added post-judgment interest calculated from 2012, but denied all additional fees and interest. The Federal Circuit affirmed.View "Therasense, Inc. v. Becton, Dickinson & Co." 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

An antibody is a protein that binds to a foreign substance, called an antigen, to facilitate its removal from the body, and is useful in treating diseases. AbbVie owns patents directed to genetically engineered fully human antibodies that bind to and neutralize the activity of human interleukin 12 (IL-12), a signaling protein secreted by the human body, the overproduction of which can cause psoriasis and rheumatoid arthritis. Because the human body does not typically make antibodies to neutralize its own proteins, it does not produce IL-12 antibodies naturally. Antibodies from a non-human species can cause adverse immune reactions in humans. The AbbVie patents share the same written description and claim priority from a provisional application filed in 1999; they describe the amino acid sequence of about 300 antibodies having a range of IL-12 binding affinities. AbbVie sued for infringement and the defendants sought interference review under 35 U.S.C. 146. The district court entered judgments of invalidity in both the infringement and the interference actions. The Federal Circuit affirmed; all of the asserted claims are invalid for failing to satisfy the written description requirement. View "AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc." on Justia Law

BMS owns the 244 patent and markets a drug for the treatment of hepatitis B. Claim 8 of the patent is directed to a nucleoside analog composed of two regions: a carbocyclic ring and a guanine base. Nucleoside analogs are manmade compounds designed to mimic the activity of natural nucleosides, the building blocks of DNA and RNA. These compounds are modified slightly from their natural counterparts to interfere with the replication of viral DNA—which means that they can serve as possible antiviral compounds. Claim 8 covers one such compound, entecavir. BMS markets entecavir as a treatment for hepatitis B, under the trade name Baraclude®. In an infringement case, the district court found claim 8 invalid as obvious. The Federal Circuit affirmed, noting that three other drugs for treating hepatitis B were invented before the filing date of entecavir; that the three drugs also gained FDA approval before entecavir; and that entecavir’s inventors did not know about its hepatitis B properties until four years after the filing date, and by then the first FDA-approved hepatitis B treatment was launched. View "Bristol-Myers Squibb Co. v. Teva Pharm. USA, Inc." on Justia Law

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