Justia Drugs & Biotech Opinion Summaries

Plaintiff filed suit against Novartis, manufacturer of Zometa, alleging products liability, negligent manufacture, negligent failure to warn, breach of express and implied warranty, and loss of consortium. On appeal, plaintiff contended that the district court erred by excluding the causation testimony offered by her expert when it found the testimony to be irrelevant and unreliable. The court concluded that the expert's testimony was relevant because it indicated that plaintiff's bisphosphonate use was a substantial factor in her development of bisphosphonate-related osteonecrosis of the jaw. The court also concluded that the expert's testimony was reliable where he used a differential diagnosis grounded in significant clinical experience and examination of medical records and literature. Accordingly, the court concluded that the expert's testimony created a genuine issue of material fact regarding the specific causal link between plaintiff's bisphosphonates treatment and her development of osteonecrosis of the jaw. The court reversed the district court's summary judgment in favor of Novartis and remanded. View "Messick v. Novartis Pharmaceuticals Corp." on Justia Law

Endo sells Opana® ER extended-release tablets containing a painkiller, oxymorphone. In earlier litigation, Endo sued Roxane and Actavis for patent infringement, 35 U.S.C. 271(e)(2)(A), based on their Abbreviated New Drug Applications to market generic versions of Opana® ER. The lawsuits settled; Endo granted defendants a license and a covenant not to sue. After making the agreements the 122 and 216 patents issued to Endo. They are continuations of the same parent application and directed to extended-release oxymorphone compositions and methods of treating pain using those compositions. Endo also acquired the unrelated 482 patent, concerning purified oxymorphone compositions and methods of making those compositions. The asserted patents are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) entry for Opana® ER. Endo again sued for infringement and sought a preliminary injunction to prevent marketing or sales of generic oxymorphone formulations. The district court held that Endo was estopped from claiming that the activity of defendants, “which has gone on for a substantial period of time, is now suddenly barred because of these new patents.” The Federal Circuit vacated, finding that the defendants did not have an express or implied license to practice the patents at issue.View "Endo Pharm. Inc. v. Actavis, Inc." on Justia Law

Senju’s patent covers an ophthalmic solution for eye drops containing Gatifloxacin, an antimicrobial agent, to kill bacteria. Tear dilution and the outer layer of the eye can prevent Gatifloxacin from passing into and treating the aqueous humor. The patent discloses a solution combining Gatifloxacin with disodium edetate, to expand the intercellular spaces of the cornea, accelerating passage of Gatifloxacin solution into the eye. In 2007, Apotex filed an Abbreviated New Drug Application with the FDA (Hatch-Waxman Act, 98 Stat. 1585), requesting approval to manufacture and sell a generic version of the solution. Senju filed an infringement action. The district court held that, though the ANDA product infringed claims 1–3, 6, 7, and 9, claim 7 was invalid as obvious. The Federal Circuit affirmed. In the gap between the court’s 2010 issuance of findings and its December 2011 entry of final judgment, Senju requested reexamination of claims 1–3, 6, 8, and 9; amended claim 6 to include additional limitations; and added new independent claim. In October 2011, the PTO issued a reexamination certificate cancelling claims 1–3 and 8–11, and certifying amended claim 6, new independent claim 12, and new dependent claims as patentable. Before entry of final judgment in the first action, Senju sought a declaratory judgment that Apotex’s manufacture, use, or sale of Gatifloxacin ophthalmic solution infringed claims set forth in the reexamination certificate. The district court dismissed. The Federal Circuit affirmed, finding the suit barred by claim preclusion. View "Senju Pharm. Co., Ltd. v. Apotex, Inc." on Justia Law

Investors filed a securities fraud action, claiming that BioMimetic misled them about Augment Bone Graft’s prospects for FDA approval. The product is designed to encourage bone growth in patients that undergo foot and ankle surgeries without the need to harvest and transplant tissue. They claim that the FDA privately communicated to BioMimetic that the FDA expected the device’s clinical trials to prove that Augment was effective based on an analysis of all study participants. The clinical trials did not achieve those results. But if BioMimetic removed from the analysis study participants that did not actually receive treatment, the data did indicate that the device was effective. Based on these two analyses, BioMimetic expressed optimism about Augment’s chances for approval to investors. The investors claim that those statements were misleading because BioMimetic did not tell them everything it knew about the FDA’s expectations, particularly the FDA’s desire for the trials to show that the device was effective based on an analysis of the entire study population. The district court dismissed, The Sixth Circuit affirmed. The complaint did not plead a strong enough inference of scienter. BioMimetic could legitimately have believed that the statistically significant results it achieved based on an analysis of the population would be sufficient to obtain approval. View "Kuyat v. BioMimetic Therapeutics, Inc." on Justia Law

Shire markets oral pharmaceuticals under the brand name LIALDA®. Its patent, entitled “Mesalazine Controlled Release Oral Pharmaceutical Composition,” concerns controlled-release compositions for treating inflammatory bowel diseases, such as Crohn’s and ulcerative colitis. The active ingredient is 5-aminosalicylic acid, also called mesalazine or mesalamine, which treats inflamed areas in the bowel by direct contact with the intestinal mucosal tissue. It must pass through the stomach and small intestine without being absorbed into the bloodstream and must be administered throughout the entire length of the colon so that the mesalamine contacts all affected tissues. The oral composition must, therefore, contain a high percentage of mesalamine. The patent teaches an inner lipophilic matrix and an outer hydrophilic matrix to address the limitations of the prior art systems. According to the patent, the combination of a lipophilic and hydrophilic matrix in an inner-outer matrix system, respectively, is advantageous because the inner-outer matrix properties cause the mesalamine to be released in a sustained and uniform manner. Watson submitted an Abbreviated New Drug Application seeking approval to sell generic LIALDA®. Shire sued. After construing claim language, the district court found infringement. The Federal Circuit reversed. The district court’s constructions of “inner lipophilic matrix” and “outer hydrophilic matrix” impermissibly broadened the ordinary meaning of the terms. View "Shire Dev., LLC v. Watson Pharm., Inc." on Justia Law

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

Plaintiff, after being diagnosed with tardive dyskinesia (TD), filed suit against Lilly, manufacturer of the antipsychotic drug, Zyprexa, alleging personal injury and product liability claims. The district court concluded that Lilly adequately warned plaintiff's treating and prescribing physicians of the risk of developing movement disorders like TD. On appeal, plaintiff argued, inter alia, that the district court erred in excluding his expert opinion testimony that 15% of Zyprexa users will develop TD after three years of use. The court concluded that the district court was well within its substantial discretion to conclude that plaintiff had not provided sufficient scientific support for the opinion and to exclude the opinion. The court also concluded that the district court properly applied the learned intermediary doctrine in dismissing the failure-to-warn claim. Finally, assuming Arkansas law recognized an overpromotion exception, the exception would not apply in this case because plaintiff presented no evidence that any representation by a salesperson affected a prescribing doctor's decision to continue plaintiff on Zyprexa and because there was no reliable evidence that Zyprexa had significantly more risk of movement disorders than the drug reps allegedly said it had. Accordingly, the court affirmed the district court's dismissal of plaintiff's complaint. View "Boehm v. Eli Lilly & Co." on Justia Law

Dutasteride is useful in the treatment of androgen responsive diseases. Androgens are a class of hormones; testosterone is the major circulating androgen. Androgens are implicated in diseases including benign prostatic hyperplasia, prostate cancer, acne, male pattern baldness and hirsutism. In some target tissues, including prostate and skin tissue, testosterone produces certain effects by first being converted to dihydrotestosterone. Dutasteride inhibits the enzymes that catalyze the conversion, mitigating some of testosterone’s physiological effects. GSK markets Avodart® and Jalyn™, which contain dutasteride and are FDA-approved to treat benign prostatic hyperplasia. GSK’s patent covers dutasteride and any “pharmaceutically acceptable solvate thereof.” Defendants filed Abbreviated New Drug Applications under 21 U.S.C. 355(j), seeking FDA approval to market generic versions of the drugs. As authorized by 35 U.S.C. 271(e)(2), GSK sued for infringement. Defendants stipulated to infringement, but alleged that the asserted claims were invalid for anticipation, lack of utility, lack of enablement, and inadequacy of the written description. The district court construed “solvate” (of dutasteride), acknowledging considerable extrinsic evidence that, in the pharmaceutical field, “solvate” is limited to crystalline complexes, no matter how created, but concluded that the specification of this particular patent directly contradicted any such narrow usage. The Federal Circuit affirmed without addressing claim construction because no matter which construction is adopted, the term “solvate” involves no performance propertyView "GlaxoSmithKline LLC v. Banner Pharmacaps, Inc." on Justia Law