Justia Drugs & Biotech Opinion Summaries

The related patents claim priority from a 1998 application and concern drugs for treatment of spinal nerve injuries, often associated with herniated discs. Between spinal vertebrae are soft “spinal discs,” that permit the spine to flex and move by absorbing and distributing compressive forces. A spinal disc becomes herniated when tissue surrounding it tears and nucleus pulposus, normally inside the disc, leaks into the epidural space of the spine. Nucleus pulposus secretes TNF-α, a powerful signaler of inflammation and other injuries. The nerve roots that extend from the spinal cord pass through the epidural space; if they come into contact with TNF-a, back pain or numbness may result. Nerve root injuries may be reduced or eliminated by “inhibiting” the TNF-α. Tobinick brought an interference proceeding. The Patent Trial and Appeal Board dismissed, construing “administered locally” as administering the claimed therapeutic compound “directly to the site where it is intended to act, that is, to the location where the nucleus pulposus is causing the symptoms of the nerve disorder.” The Board found that Tobinick’s patent application did not contain written description support so that he lacked standing to bring the interference. The Federal Circuit reversed, finding that Tobinick’s application contained sufficient written description support for local administration; it describes administering the therapeutic compound to the epidural space adjacent to a herniated spinal disc, which is the site where it is intended to act and the location where the nucleus pulposus is causing symptoms of the nerve disorder. View "Tobinick v. Olmarker" on Justia Law

Plaintiff filed various products liability and general tort claims against the Brand Defendants - who initially developed and received FDA approval for metoclopramide - and Generic Defendants - who manufactured and sold the product that plaintiff used. Plaintiff alleged that as a result of his prolonged use of the drug metoclopramide, he developed tardive dyskinesia. On appeal, plaintiff challenged the district court's dismissal of his claims against the Brand Defendants and grant of summary judgment to the Generic Defendants. The court held that plaintiff's products liability claims against the Generic Defendants were preempted under the holdings and reasoning of PLIVA, Inc. v. Mensing and Mutual Pharmaceutical Co., Inc. v. Bartlett, and that plaintiff failed to adequately plead any parallel claims. The court also held that plaintiff's claims against the Brand Defendants failed because plaintiff did not use the Brand Defendants' products and because Texas did not recognize a duty to a consumer who uses a competitor's products. Accordingly, the court affirmed the district court's dismissal of plaintiff's claims against the Generic Defendants and grant of summary judgment to the Brand Defendants. View "Eckhardt, et al. v. Qualitest Pharmaceuticals, Inc., et al." on Justia Law

Monsanto developed a genetic modification in soybean seeds (Roundup Ready® (RR)), known as the 40-3-2 event (RR trait), which enables soybean plants to tolerate application of glyphosate herbicide to kill weeds. Monsanto owns the patent for the RR trait and granted Pioneer a license to produce and sell seeds containing the traits. After Pioneer became a subsidiary of DuPont, Monsanto and Pioneer entered into an amended license, under which DuPont produced and sold RR trait seed. In 2006, DuPont announced that it had developed a glyphosate-tolerant trait, OGAT, expected to confer tolerance to both glyphosate and acetolactate synthase inhibitor herbicide. Testing indicated that OGAT alone did not provide sufficient glyphosate-tolerance for commercial use. DuPont then combined OGAT with the RR trait; the OGAT/RR stack provided increased yields in field trials. DuPont did not sell any OGAT/RR product, however, and discontinued development. Monsanto sued DuPont for breach of the license and patent infringement. The district court granted partial judgment to Monsanto, holding that the license was unambiguous and did not grant the right to stack non-RR technologies with the licensed” trait, but allowed DuPont to amend its answer to assert reformation counterclaims and defenses. The court ultimately told DuPont to “either voluntarily dismiss these reformation claims or produce … all documents … previously withheld.” DuPont continued litigating its reformation counterclaims and produced previously withheld internal e-mails that showed its awareness that it did not have the right to commercialize the OGAT/RR stack. The court found that DuPont’s position was not rooted in fact, that DuPont made misrepresentations and had perpetrated a fraud on the court, struck DuPont’s reformation defense and counterclaims, and awarded limited attorney fees to Monsanto. The Federal Circuit affirmed. View "Monsanto Co. v. E.I. du Pont de Nemours & Co." on Justia Law

In 1996, Campbell and Ian successfully produced the first mammal ever cloned from an adult somatic cell: Dolly the Sheep. Known as somatic cell nuclear transfer, the process involves removing the nucleus of a somatic cell and implanting that nucleus into an enucleated (i.e., without a nucleus) oocyte. A somatic cell is any body cell other than gametes (egg or sperm). An oocyte is an egg cell prior to maturation and a nucleus is the organelle that holds a cell’s genetic material (DNA). Often called “adult” cells, somatic cells are differentiated, i.e., they are specialized to perform specific functions. Liver, heart, and muscle cells are differentiated, somatic cells. To create Dolly, Campbell and Wilmut fused the nucleus of an adult, somatic mammary cell with an enucleated oocyte. The obtained the 258 patent for the process. The Patent and Trademark Office rejected their claims to the cloned animals, set forth in the 233 application, “Quiescent Cell Populations for Nuclear Transfer.’ In 2013, the Patent Trial and Appeal Board affirmed the rejection, finding that the claimed subject matter was ineligible for patent protection under 35 U.S.C. 101 because it constituted a natural phenomenon that did not possess “markedly different characteristics than any found in nature” and that the subject matter was anticipated by and obvious in light of prior art (35 U.S.C. 102 and 103) because the clones were indistinguishable from clones produced through prior cloning methods, i.e., embryotic nuclear transfer and in vitro fertilization. The Federal Circuit affirmed, citing Section 101. View "In re: Roslin Inst. (Edinburgh)" on Justia Law

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