Justia Drugs & Biotech Opinion Summaries

In 1995 the FDA approved Fosamax® to treat or prevent osteoporosis and Paget’s Disease. Teva developed alendronate sodium, a generic form of the branded drug, and obtained FDA approval on its abbreviated new drug application in 2008. Other generic manufacturers subsequently obtained approval for formulations. The drugs act by inhibiting bone resorption or absorption and suppressing bone turnover; they also inhibit primary mineralization, which is involved in the formation of new bone. Meanwhile, secondary mineralization of existing bone continues, which increases the bone’s mineral content and results in higher bone mineral density. According to the plaintiffs, higher bone mineral density does not necessarily correspond with reduction of fracture risk but can make bone highly mineralized, homogenous, brittle, and more susceptible to fracture. According to some studies, the effects of alendronate sodium linger, with one study reporting that bone turnover may be inhibited by 50% five years after discontinuing treatment. The district court granted judgment on the pleadings in favor of the generic manufacturer defendants finding that state-law strict liability claims were pre-empted by federal law. The Seventh Circuit affirmed. Manufacturers have no control over the design or labeling of generic drugs; the plaintiffs failed to identify anything the generic defendants could do to reconcile their conflicting duties under state and federal law. View "In re: Fosmax (Alendronate Sodium)" on Justia Law

In the late 1990s, people who had taken the prescription diet-drug combination Fen-Phen began suing Wyeth, claiming that the drugs caused valvular heart disease. A 2000 settlement included creation of the Fen-Phen Settlement Trust to compensate class members who had sustained heart damage. Claims required medical evidence. Attorneys who represented certain claimants retained Tai, a board-certified Level 2-qualified cardiologist, to read tests and prepare reports. Tai read 12,000 tests and asserted that he was owed $2 million dollars for his services. Tai later acknowledged that in about 10% of the cases, he dictated reports consistent with the technicians’ reports despite knowing that the measurements were wrong, and that he had his technician and office manager review about 1,000 of the tests because he did not have enough time to do the work. A review of the forms Tai submitted found that, in a substantial number of cases, the measurements were clearly incorrect and were actually inconsistent with a human adult heart. Tai was convicted of mail and wire fraud, 18 U.S.C. 1341 and 1343, was sentenced to 72 months’ imprisonment, and was ordered to pay restitution of $4,579,663 and a fine of $15,000. The Third Circuit rejected arguments that the court erred by implicitly shifting the burden of proof in its “willful blindness” jury instruction and applying upward adjustments under the advisory Sentencing Guidelines for abuse of a position of trust and use of a special skill, but remanded for factual findings concerning whether Tai supervised a criminally culpable subordinate, as required for an aggravated role enhancement. View "United States v. Tai" on Justia Law

Braintree manufactures the SUPREP® Bowel Prep Kit, which helps to prepare patients for colonoscopies. In the late 1990s, two colon cleansing options existed; the safest required patients to drink large volumes of unappetizing isotonic prep formulas, resulting in low patient compliance, and a low-volume, hypertonic prep that could cause severe electrolyte shifts, leading to heart failure, kidney failure, neurological impairment, and even death. Braintree’s patent discloses a combination of magnesium sulfate, potassium sulfate, and sodium sulfate, which can be digested in small volumes to safely and effectively induce colonic purging without causing clinically significant electrolyte shifts. Novel filed an abbreviated new drug application (ANDA) and Braintree responded with a patent infringement case (Hatch- Waxman Act, 35 U.S.C. 271(e)(2)(A). The district court granted summary judgment of infringement based on its construction of four disputed claim terms. The Federal Circuit affirmed a finding Braintree’s patent not invalid, but reversed with respect to construction of the claim term “clinically significant electrolyte shifts” and vacated with respect to infringement.View "Braintree Labs, Inc. v. Novel Labs, Inc." on Justia Law

Gilead owns patents directed to antiviral compounds and methods for their use. The 375 and 483 patents list the same inventors and their written descriptions disclose similar content, but they do not claim priority to a common application and have different expiration dates. Gilead sued Natco for infringement of the 483 patent after Natco filed an FDA request for approval to market a generic version of one of Gilead’s drugs that is allegedly covered by the 483 patent. Natco asserted that the 483 patent was invalid for obviousness-type double patenting over the 375 patent. Gilead argued that the 375 patent cannot serve as a double patenting reference against the 483 patent because, even though the 483 patent’s expiration date is 22 months after the 375 patent’s expiration date, the 375 patent issued after the 483 patent. The district court, pursuant to a stipulation, granted Gilead final judgment on infringement. The Federal Circuit vacated and remanded. Because the obviousness-type double patenting doctrine prohibits an inventor from extending his right to exclude through claims in a later-expiring patent that are not patentably distinct from the claims of the inventor’s earlier-expiring patent, the 375 patent qualifies as an obviousness-type double patenting reference for the 483 patent. View "Gilead Sciences, Inc. v. Natco Pharma. Ltd." on Justia Law

Plaintiffs’ patent concerns the anti-hypertension drug with the brand name Tarka,® a combination of the angiotensin converting enzyme (ACE) inhibitor trandolapril, and the calcium channel blocker (also called “calcium antagonist”) verapamil hydrochloride. The FDA approved a New Drug Application (NDA) for a Tarka® product in 1996. In 2007 Glenmark filed an abbreviated new drug application (ANDA) for a generic counterpart Tarka. Since the patent had not expired, Glenmark filed a Hatch-Waxman “Paragraph IV Certification.” Plaintiffs filed an infringement suit. Launch of Glenmark’s generic product was stayed for 30 months under 21 U.S.C. 355(j)(5(B)(iii). After the stay expired in 2010, Plaintiffs sought a preliminary injunction, which the district court denied. In June 2010 Glenmark launched its generic product “at-risk,” while litigation proceeded. Glenmark admitted infringement and the jury held that the patent had not been proved invalid. The jury awarded $15,200,000 in lost profits and $803,514 in price erosion damages. The Federal Circuit affirmed, rejecting claims that the patent was invalid, that Glenmark was entitled to a new trial based on a prejudicial jury instruction on evidence spoliation, and that no damages should be awarded due to lack of standing of certain Plaintiffs. View "Sanofi-Aventis Deutschland GMBH v. Glenmark Pharm., Inc." on Justia Law

Generic drug manufacturers submitted Abbreviated New Drug Applications for FDA approval to manufacture and sell of generic versions of Boniva® before expiration of Roche’s patents, which are directed to methods of treating osteoporosis by monthly administration of ibandronate, one of a class of compounds known as bisphosphonates. Bisphosphonates generally have a low bioavailability when administered and oral administration of bisphosphonates can result in adverse esophageal and gastrointestinal side effects. Patients taking bisphosphonates previously had to take the bisphosphonate tablet in a fasting state at least 30 minutes before eating or drinking, which created compliance problems. Roche sued, alleging infringement under 35 U.S.C. 271(e)(2) based on the ANDA filings. The Federal Circuit affirmed the district court’s denial of the preliminary injunction. The district court entered summary judgment of invalidity of certain claims due to obviousness under 35 U.S.C. 103(a), finding that once monthly oral dosing of ibandronate was established in prior art and that the combination of prior art references suggested a dosage f about 150 mg per month, or at least indicated that a monthly dose of 150 mg was obvious to try. The Federal Circuit affirmed. View "Hoffmann-La Roche Inc. v. Apotex Inc." on Justia Law

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