Justia Drugs & Biotech Opinion Summaries

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

Relator filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. 3729-3733, against Omnicare, alleging that defendants violated a series of FDA safety regulations requiring that penicillin and non-penicillin drugs be packaged in complete isolation from one another. The court concluded that the public disclosure bar did not divest the district court of jurisdiction over relator's FCA claims. The court concluded that once a new drug has been approved by the FDA and thus qualified for reimbursement under the Medicare and Medicaid statutes, the submission of a reimbursement request for that drug could not constitute a "false" claim under the FCA on the sole basis that the drug had been adulterated as a result of having been processed in violation of FDA safety regulations. The court affirmed the district court's grant of Omnicare's motion to dismiss, holding that relator's complaint failed to allege that defendants made a false statement or that they acted with the necessary scienter. The court also concluded that the district court did not abuse its discretion in denying relator's request to file a third amended complaint. View "United States ex rel. Rostholder v. Omnicare, Inc." on Justia Law

Takeda owns patents that claim the formulation for the brand-name drug Prevacid® SoluTab,™ which contains the active ingredient lansoprazole, a proton pump inhibitor used to treat acid reflux. It is the only proton pump inhibitor available as an orally disintegrable tablet. A patient allows the tablet to disintegrate in his mouth, leaving behind thousands of granules which the patient swallows. The stated objective of the 994 patent is a formulation with granules small enough to avoid a feeling of roughness in the patient’s mouth upon disintegration. In 2010, Zydus filed an abbreviated new drug application (ANDA) with the FDA, seeking to manufacture a generic version of Prevacid® SoluTab.™ Takeda filed suit, alleging that the ANDA product infringed claims of several patents. Only claim 1 of the 994 patent remains at issue. Zydus counterclaimed, alleging that claim 1 was invalid for failure to comply with 35 U.S.C. 112. The district court construed the claim term “fine granules having an average particle diameter of 400 μm or less,” accepting Takeda’s argument that the term should be construed to include a deviation of ±10%, based on a “universally accepted” 10% standard of error for particle size measurements. The Federal Circuit reversed the finding of infringement and found no invalidity. View "Takeda Pharm. Co., Ltd. v. Zydus Pharm. USA, Inc." on Justia Law

Pauline and her doctors were aware of Pauline’s allergy to heparin, an anti-coagulant; she wore a medical bracelet listing her heparin allergy and her medical records noted the allergy. Her estate alleges that on several occasions, the hospital’s medical staff injected Pauline with heparin “in direct contradiction to her specific directive,” which proximately caused her death. The district court dismissed, for failure to comply with the notice and heightened pleading requirements of the Tennessee Medical Malpractice Act. The court concluded that under Tennessee law the injections were not “procedures” or “treatments” for the purposes of medical battery, but were only component parts of her treatment process, which did not require consent and could form the basis for medical malpractice but not medical battery. The Sixth Circuit reversed, holding that the complaint plausibly alleged medical battery, which is not subject to the Act. View "Shuler v. Garrett" on Justia Law

Novozymes’s 723 patent, entitled “Alpha-Amylase Mutants with Altered Properties,” relates to recombinant enzyme technology. Enzymes are proteins that catalyze biochemical reactions; they facilitate molecular processes that would not occur or would occur more slowly in their absence. The 723 patent claims particular modified enzymes with improved function and stability under certain conditions. Novozymes sued DuPont, alleging infringement. DuPont counterclaimed, seeking a declaratory judgment of invalidity for failing to satisfy enablement and written description requirements of 35 U.S.C. 112. The district court granted Novozymes summary judgment on the issue of infringement and denied DuPont summary judgment of invalidity. A jury concluded that the claims were not invalid and awarded infringement damages of more than $18 million, but the district court granted DuPont’s post-trial motion for judgment as a matter of law that the claims are invalid for failure to satisfy the written description requirement. The Federal Circuit affirmed. To actually possess the variant enzymes claimed in the patent would require Novozymes to confirm its predictions by actually making and testing individual variants or at least identifying subclasses of variants that could be expected to possess the claimed properties, which it did not do before filing its 2000 application. View "Novozymes A/S v. DuPont Nutrition Biosciences, APS" on Justia Law