Justia Drugs & Biotech Opinion Summaries

The patent examiner rejected claims in an application directed to a bone screw with a shank that is easy to produce and eliminates the need for an additional element to avoid splaying. The Patent Trial and Appeals Board affirmed. The Federal Circuit vacated on the basis that the examiner and the Board stated different grounds for rejection. View "In re Biedermann" on Justia Law

Plaintiff alleged that Bayer defrauded the United States government through its marketing and sale of the cholesterol-lowering drug Baycol. On appeal, plaintiff challenged the dismissal of the qui tam action she brought against Bayer Healthcare under the False Claims Act (FCA), 31 U.S.C. 3729-3733. Based upon the court's review of plaintiff's allegations regarding the Department of Defense (DoD) contracts, the court concluded that her complaint satisfied Rule 9(b)'s requirements and survived a motion to dismiss under Rule 12(b)(6). Accordingly, the court reversed the district court's judgment with regard to her allegations regarding the DoD contracts and remanded for further proceedings. However, the court affirmed the district court's judgment with respect to the allegations involving federal health insurance reimbursement claims under United States v. ex rel. Roop v. Hypoguard USA, Inc. View "Simpson v. Bayer Healthcare, et al." on Justia Law

Sunovion owns the rights to the patent, which is directed to pharmaceutical compositions of the single-enantiomer drug eszopiclone, the active ingredient in the chiral drug marketed as a sleep medication with the brand name Lunesta®. The district court held, on summary judgment, that Dr. Reddy’s Laboratories did not infringe certain claims in that patent. The Federal Circuit reversed. Although the district court did not err in construing the claim term “essentially free” as containing less than 0.25 percent levorotatory isomer, Sunovion was entitled to a judgment of infringement as a matter of law under 35 U.S.C. 271(e)(2)(A). A generic manufacturer’s “certification” pledging not to infringe cannot override the conclusion that when a drug manufacturer seeks FDA approval to market a generic compound within the scope of a valid patent, it is an infringement as a matter of law. View "Sunovion Pharm., Inc. v. Teva Pharm. USA, Inc." on Justia Law

The patents at issue relate to methods and devices for sealing a vascular puncture, which occurs when a medical procedure requires a puncture through the skin and into a vein or artery to insert a medical device, such as a catheter, into a patient’s vasculature. After such a procedure, the medical professional typically removes the medical device from the vasculature. Prior to development of the technology at issue, the medical professional was then required to apply external pressure to the puncture site until clotting occurred, sometimes for an extended period of time. This caused discomfort and increased the recovery time. The Janzen and Fowler patents disclose methods and devices for sealing a vascular puncture to improve patient recovery. The district court held that the safe-harbor provision of 35 U.S.C. 121 protects the Janzen patent from invalidity due to double-patenting; construed key terms in the Janzen patent; and found that the Fowler patents were not invalid for obviousness. The Federal Circuit reversed the safe harbor ruling, which rendered the rulings regarding the claim constructions moot, and affirmed that the Fowler patents are nonobvious and not shown to be invalid. View "St. Jude Med., Inc. v. Access Closure, Inc." on Justia Law

Bayer’s patent concerns genetically modifying plants to confer resistance to a common herbicide (2,4-D) by inserting a particular DNA segment into plant cells, which reproduce to create new cells that contain that gene. Those cells produce an enzyme that catalyzes a biochemical reaction with 2,4-D in which the herbicide is broken down into something harmless to the plant. A plant with the gene survives 2,4-D application while surrounding weeds do not. At the time of the patent application, the inventors had sequenced one gene coding for one enzyme, using a test supposedly capable of finding other, similar genes. In writing the application, they claimed a broad category based on the function of the particular enzyme, defining the category by using a term with established scientific meaning. Years before the patent issued, experiments showed that the term did not apply to the particular enzyme whose gene was sequenced, but Bayer did not change its claim language. When Bayer sued Dow for infringement, Bayer recognized that the term’s established scientific meaning, did not cover the accused product, which was, itself, different from the enzyme whose gene Bayer’s inventors had sequenced. Bayer argued for broad functional claim construction. The district court entered summary judgment of noninfringement, citing particularly the great breadth of the asserted functional construction. The Federal Circuit affirmed. View "Bayer CropScience AG v. Dow AgroSciences, LLC" on Justia Law

Zizic is the former CEO of BioniCare, which sold the BIO-1000, a medical device designed to treat osteoarthritis of the knee. BioniCare attempted to bill Medicare for the BIO-1000, but many claims were denied as not medically necessary. Q2A contracted with the government to review such claim denials across the nation. Q2A’s denials were reached without physician review, which is required by the Medicare Act, 42 U.S.C. 1395, HHS regulations, and its contract. A former Q2A employee testified that it implemented an internal policy to deny all BIO-1000 claims, which were reviewed by a single nurse rather than a panel of physicians; later allowed non-physician subcontractors to prepare BIO-1000 appeals for review by a single physician; and finally developed a mail merge letter that automatically denied BIO-1000 claims without any review. BioniCare’s trustee in bankruptcy became aware of and disclosed these practices. Zizic filed a qui tam suit under the False Claims Act, 31 U.S.C. 3729-33. The district court dismissed, concluding that it lacked jurisdiction because the allegations against Q2A and RTS were based on prior public disclosures and because Zizic was not an original source of that information. The Third Circuit affirmed. View "Zizic v. Q2Adm'rs LLC" on Justia Law

SkinMedica owns the 494 and 746 patents, which relate to methods for producing pharmaceutical compositions containing “novel conditioned cell culture medium compositions ... [and] uses for the[m].” Skinmedica filed a patent infringement suit against Histogen for producing dermatological products according to methods covered by the claims of those patents. The district court entered summary judgment of noninfringement after construing the phrase “culturing ... cells in three-dimensions” as “growing ... cells in three dimensions (excluding growing in monolayers or on microcarrier beads).” The Federal Circuit affirmed. View "SkinMedica Inc v. Histogen Inc" on Justia Law

Carrera sued Bayer, claiming that Bayer falsely advertised its product One-A-Day WeightSmart as a multivitamin and dietary supplement that had metabolism-enhancing effects due to its ingredient, epigallocatechin gallate, a green tea extract. The daily dose was one tablet and the price was about $8.99 for 50 tablets. Bayer sold WeightSmart through retail stores until 2007 and did not sell directly to consumers. Carrera initially sought to certify a nationwide class under Fed. R. Civ. P. 23(b)(3), bringing a claim under the New Jersey Consumer Fraud Act. The court denied certification because New Jersey law did not apply to out-of-state customers. Carrera then moved to certify a Rule 23(b)(3) class of Florida consumers under the Florida Deceptive and Unfair Trade Practices Act. Bayer challenged certification, reasoning that class members are unlikely to have documentary proof of purchase and Bayer has no list of purchasers. The Third Circuit vacated class certification. If class members are impossible to identify without extensive and individualized fact-finding or mini-trials, a class action is inappropriate. If class members cannot be ascertained from a defendant’s records, there must be “a reliable, administratively feasible alternative,” not a method that would amount to no more than ascertaining by potential class members‟ say so.”View "Carrera v. Bayer Corp." on Justia Law

Baxter’s Colleague Infusion Pump, an electronic device used to deliver intravenous fluids to patients, was known to have a range of defects. The FDA sent Baxter warning letters. Baxter’s response was not satisfactory. In 2005 the FDA sought forfeiture of all Baxter‐owned Pumps. In 2006, Baxter entered into a Consent Decree to stop manufacturing and distributing all models of the Pump within the U.S., and committed to bringing the approximately 200,000 Pumps in the hands of health care professionals into compliance with the FDA Act. Baxter devoted significant resources to fixing the Pumps, but the FDA was not satisfied and ordered a product recall. In a derivative suit, plaintiffs alleged that that Baxter’s directors and officers breached fiduciary duties by consciously disregarding their responsibility to bring about compliance with the Consent Decree, causing Baxter to lose more than $550 million. Plaintiffs did not first ask Baxter’s board of directors to pursue those claims, but alleged futility. The district court dismissed, finding that Westmoreland failed adequately to plead demand futility, as required by FRCP 23.1(b)(3) and Delaware substantive law. The Seventh Circuit reversed, stating that particularized facts furnished by plaintiffs cast a reasonable doubt that the defendants’ conduct was the product of a valid exercise of business judgment. View "Westmoreland Cnty. Emps. Retirement Sys. v. Parkinson" on Justia Law

Prior art concerning treatment of the skin disease, psoriasis, discloses a combination treatment of a vitamin D analog and a corticosteroid. Leo’s patent calls for simultaneous treatment with vitamin D and corticosteroids to heal psoriasis faster and more effectively; a storage-stable combination of vitamin D and corticosteroids in a single formulation did not exist in prior art because vitamin D and corticosteroids have different pH requirements for optimum stability. Because of the storage-stability problem, doctors had to prescribe a regimen that required patients to apply one drug in the morning and another at night, which caused patient compliance issues. Leo discovered that a new set of solvents, including polyoxypropylene 15 stearyl ether, solved the storage stability problem by allowing the vitamin D analog and corticosteroid to coexist in a single pharmaceutical product. The Board of Patent Appeals rejected several claims. The Federal Circuit reversed. The Board incorrectly construed the term “storage stable,” incorrectly found the claimed invention would have been obvious in view of prior art, and incorrectly weighed the objective indicia of nonobviousness. View "Leo Pharm. Prods., Ltd. v. Kappos" on Justia Law