Justia Drugs & Biotech Opinion Summaries

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

The 096 application states that “[p]athologies of the gastrointestinal (GI) tract may exist for a variety of reasons such as bleeding, lesions, angiodisplasia, Crohn’s disease, polyps, celiac disorders, and others.” It can be difficult to detect the pathologies, although the majority of pathologies result in changes of color and/or texture of the inner surface of the GI tract and may be due to bleeding. The 096 application is directed to a system for detection of blood within a body lumen, such as the esophagus, and includes a swallowable capsule having an in-vivo imager for obtaining images from within the body lumen. An examiner rejected the claims (35 U.S.C. 103) as obvious over several prior art references. The Board of Patent Appeals and Interferences and Federal Circuit affirmed. View "In re: Adler" on Justia Law

The government filed suit against appellants, alleging that they violated federal laws regulating the manufacture and labeling of drugs and biological products by producing, as part of their medical practice, a substance consisting of a mixture of a patient's stem cells and the antibiotic doxycycline (the "Mixture"). The Federal Food, Drug & Cosmetic Act (FDCA) 21 U.S.C. 301 et seq., and the Public Health Service Act (PHSA), 42 U.S.C. 201 et seq., are statutes that promote the safety of drugs and biological products, respectively, by setting forth detailed requirements for how such substances are to be manufactured and labeled. The court held that, by virtue of its use of doxycycline, the Mixture was within the scope of drugs - and, by extension, biological products, - regulated by section 331(k) of the FDCA; appellants failed to establish that the Mixture was exempt from the FDCA's manufacturing and labeling requirements; the Mixture was per se adulterated where it was undisputed that appellants' facilities, methods, and controls for processing the Mixture violated federal manufacturing standards in numerous respects; because its label failed to provide the minimum information necessary to qualify for either exemption from section 352(f), the Mixture was misbranded; and the district court properly enjoined appellants from committing future violations of the FDCA's manufacturing and labeling provisions. Accordingly, the court affirmed the judgment of the district court and dismissed appellants' counterclaims. View "United States v. Regenerative Sciences, LLC, et al." on Justia Law

Synthes owns a patent, issued in 2006, directed to a system for repairing fractures in long bones, such as the femur, using a bone plate along the outside of the fractured bone, attached by anchors inserted through predrilled holes in the plate and then into the bone. The Patent and Trademark Office granted Smith & Nephew’s 2009 reexamination request and rejected all 55 claims of the patent as obvious based on prior art. The Board of Patent Appeals upheld the rejections of 31 of the claims, but reversed the rejections of 24. The Federal Circuit reversed, holding that Smith & Nephew met its burden of showing that the claims at issue would have been obvious. The patentability of the invention turns on the structure of the holes, not the special nature of the non-locking screws. The conical, partially threaded holes were well known in the art, as was the advantage of adding more of them to the head of a bone plate in place of unthreaded holes. The screws and the holes perform a conventional, expected function in securing the plate. View "Smith & Nephew, Inc. v. Rea" on Justia Law

Shirley Gross filed suit against PLIVA after her long-term use of the generic drug metoclopramide, produced by PLIVA, caused her permanent injuries. On appeal, plaintiff, as the personal representative of the estate of Gross, challenged the district court's denial of Gross's request to amend her complaint and her state common law tort claims against PLIVA for injuries sustained as a result of her use of a drug it manufactured. Federal Food, Drug, and Cosmetics Act, 21 U.S.C. 301 et seq. The court affirmed the district court's denial of leave to amend and held that none of plaintiff's claims regarding PLIVA's alleged failure to update its warnings were before the court on appeal; the court found that the complaint did not allege any violation of the federal misbranding laws or parallel state duties, and to the extent these claims were made on appeal, they were waived; and all of Gross's causes of action were preempted by the FDCA. Accordingly, the court affirmed the judgment of the district court. View "Drager v. PLIVA USA, Inc." on Justia Law

A number of suits have challenged the accuracy of the warning label on Pradaxa, a prescription blood-thinning drug manufactured by Boehringer. The litigation is in the discovery stage. The district judge presiding over the litigation imposed sanctions on Boehringer for discovery abuse. Boehringer sought a writ of mandamus quashing the sanctions, which included fines, totaling almost $1 million and also ordered that plaintiffs’ depositions of 13 Boehringer employees, all of whom work in Germany be conducted at “a place convenient to the [plaintiffs] and [to] the defendants’ [Boehringer’s] United States counsel,” presumably in the United States. The parties had previously agreed to Amsterdam as the location. The Seventh Circuit rescinded the order with respect to the depositions but otherwise denied mandamus. View "Boehringer Ingelheim Pharm. v. Herndon" on Justia Law

Defendant appealed his conviction of five felony counts relating to the sale of counterfeit prescription drugs. Defendant sought to introduce evidence establishing a gray market for prescription pills to argue that some of the pills that police seized from him could be genuine. The court concluded that the district court did not err in barring cross-examination regarding gray market evidence where there was no connection to the knowledge element and consequently no relevance; defendant cannot use the privilege against self-incrimination as a means to free himself from the basic rules of relevancy; if the evidence were relevant, the district court did not commit reversible error by directing the evidence to defendant's case-in-chief; and, in the alternative, the gray market evidence should be excluded under Federal Rule of Evidence 403. The court also held that, viewed in the light most favorable to the Government, the evidence sufficiently established defendant's knowledge and, therefore, defendant's sufficiency argument failed. Accordingly, the court affirmed the judgment of the district court. View "United States v. Shauaib Zayyad" on Justia Law