Posts Tagged: "teva"

On May 15, the U.S. Supreme Court issued an order list denying petitions for writ of certiorari filed to appeal several patent rulings, including a pair of 35 U.S.C. § 101 subject matter eligibility cases that the U.S. Solicitor General previously urged the nation’s highest court to hear. The Supreme Court also denied Teva Pharmaceuticals’ petition to review its appeal of the Federal Circuit’s “skinny label” induced infringement ruling over its generic version of carvedilol. While the full Court denied certiorari to these cases, the order list notes that Associate Justice Brett Kavanaugh would have granted cert to these three petitions.

The U.S. Solicitor General on Wednesday filed an amicus brief with the United States Supreme Court advising it to grant Teva Pharmaceuticals’ petition for writ of certiorari relating to generic manufacturers’ liability for infringement through the use of “skinny labels” on generic drugs. The SG’s brief said that the U.S. Court of Appeals for the Federal Circuit (CAFC) got it wrong, and that the decision could upend the careful balance contemplated by the Hatch-Waxman Amendments between incentivizing new brand name drugs and allowing cheaper generics into the market.

On August 19, British brand name pharmaceutical firm GlaxoSmithKline (GSK) filed a brief with the U.S. Supreme Court opposing a petition for writ of certiorari filed by generic drugmaker Teva Pharmaceuticals. Teva’s petition appeals a decision by the U.S. Court of Appeals for the Federal Circuit (CAFC) reinstating a jury verdict that found Teva liable for inducing infringement of GSK’s patents covering the heart failure treatment, Coreg. GSK’s brief argues that the Federal Circuit properly applied the law on induced infringement and that the “skinny label” arguments raised by Teva’s petition only affect 30% of the damages awarded by the jury in the case.

The U.S. Court of Appeals for the Federal Circuit in a precedential decision yesterday affirmed a Patent Trial and Appeal Board (PTAB) decision that Teva Pharmaceuticals had failed to prove Corcept Therapuetics’ U.S. Patent No. 10,195,214 would have been obvious. The patent covers methods of treating Cushing’s syndrome, a disease caused by excessive levels of the naturally occurring steroid hormone, cortisol. Chief Judge Moore authored the opinion.

In GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., the United States Court of Appeals for the Federal Circuit (CAFC) on Friday reversed a district court’s motion for judgment as a matter of law (JMOL) for Teva, finding that Teva was liable for induced infringement of GlaxoSmithKline’s (GSK’s) patent directed to a method of treating Congestive Heart Failure (CHF) using carvedilol….. Chief Judge Prost authored a dissenting opinion, wherein she expressed the majority’s opinion undermined a critical balance between patent protection and public access once a patent expires “by allowing a drug marketed for unpatented uses to give rise to liability for inducement and by permitting an award of patent damages where causation has not been shown.”

On October 9, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a decision in HZNP Medicines LLC v. Actavis Laboratories UT, Inc. affirming the U.S. District Court for the District of New Jersey’s findings of invalidity and noninfringement of certain claims of some of the asserted HZNP (Horizon) patents, as well as the district court’s finding of nonobviousness of one claim of another Horizon patent. The finding of nonobviousness means that Actavis, owned by generic drug maker Teva Pharmaceuticals, is enjoined from engaging in the commercial use, offer for sale, or sale of its product covered in its Abbreviated New Drug Application (ANDA) until the expiration of U.S. Patent No. 9,066,913 (the ‘913 patent) in 2027.

The Federal Circuit recently affirmed a district court ruling finding patent infringement after holding that Actavis LLC, Actavis South Atlantic LLC, and Teva Pharmaceuticals USA, Inc. (collectively, “Actavis”) failed to prove by clear and convincing evidence that the claims asserted by Endo Pharmaceuticals and Mallinckrodt LLC (collectively, “Endo”) were invalid. See Endo Pharms., Inc. v. Actavis LLC, No. 2018-1054, 2019 U.S. App. LEXIS 13348 (Fed. Cir. May 3, 2019) (Before Wallach, Clevenger, and Stoll J.) (Opinion for the Court, Wallach, J.) (Dissenting opinion, Stoll, J.). However, the decision was not a unanimous one, with Judge Stoll authoring a dissent that would have reversed the district court. The patent at issue, U.S. Patent No 8,871,779 (the “‘779 patent”), is directed generally to compounds known as “morphinan alkaloids,” which are used for pain relief. More specifically, the ‘779 patent concerned processes for making “highly pure” morphinan products in the form of hydrochloride salts. Actavis claimed that the ‘779 patent was invalid, citing three key references as prior art. The first reference was a scientific article from 1957 by Ulrich Weiss (the “Weiss reference”) discussing a method for producing oxymorphone, a compound within the scope of the asserted claims. The second reference was U.S. Patent Application No. 2005/0222188 (the “Chapman reference”), which disclosed a purification process related to the asserted claims. Finally, the third reference was another article from 1967 by Henry Rapoport et al. (the “Rapoport reference”), which disclosed another purification process for oxycodone. The district court found that none of these references rendered the asserted claims obvious, and Actavis appealed.

This week in Other Barks & Bites, IPWatchdog’s IP news roundup: the House of Representatives passes drug patent legislation, while antitrust legislation targeting patent-related activities is introduced into the Senate and the Trump administration mandates pricing information for pharmaceutical ads; the Patent Trial and Appeal Board (PTAB) issues a pair of precedential decisions on cases with multiple petitions; the USPTO issues marijuana-related trademark guidelines and a notice on modifying patent term adjustment practices; Gilead strikes a settlement with Teva to bring generic Truvada to the U.S. market in 2020; a new music licensing entity is created in Canada; Fourth Circuit rules that bankruptcy can eliminate damages for trade secret violations; and several amicus file briefs asking the U.S. Supreme Court to eliminate the Federal Circuit’s “blocking patent” doctrine.

Competitors like Mylan and Teva, rather than inventing better treatments or cures for dry eyes chose the shortcut. They attacked Allergan’s patent in the PTAB. Allergan responded by assigning their patent to the Saint Regis Mohawk Tribe who in turn invoked sovereign immunity at the PTAB, and demanded their rights in a real court with a real judge and jury. Mylan, Teva, the PTAB, Congress, and class action lawyers have formed a mob to gang up on Allergan for defending their intellectual property rights. They filed hundreds of suits accusing Allergan and the Tribe of fraud, conspiracy, and sham transactions stemming from an “invalid” patent. The attackers are mistakenly focusing on the patent as the problem. The problem is not the patent, but rather all of the incentives that reward copying instead of innovating.

Migraines are the result of a hereditary neurological disorder which causes certain areas of the brain to become over-excited, creating the throbbing pain and increased sensitivity to lights, smells or sounds which characterize a migraine attack. Not much is known about the brain chemistry that directly causes a migraine, although it’s generally understood that hormonal fluctuations or environmental stimuli can act as triggers. News of successful mid-stage trials for a migraine treatment developed by Alder Biopharmaceuticals Inc. has been greeted with a warm welcome from news media. The results of the trial show that an injectable treatment known as ALD403 administered four times over the course of a year reduced patient suffering from chronic migraines.

Just a few months after establishing this health and wellness cloud platform, IBM has secured its first Foundational Life Sciences partner for Watson Health in Teva Pharmaceutical Industries (NYSE:TEVA) of Petah Tikva, Israel. Statements from senior Teva officials indicate that the world’s largest manufacturer of generic pharmaceuticals will use the personal health cloud to connect more directly with physicians and patients and enable individualized treatment optimization options. It’s hoped that the Big Data tools available through IBM’s Watson analytics will be powerful enough to help Teva and others come up with more effective treatments for the millions of people worldwide suffering from chronic health conditions such as migraine, asthma or neurodegenerative diseases.

This year the pharmaceutical world has already seen some incredible mergers and acquisitions. This rapid pace of activity represents the highest level of pharmaceutical and biotech takeovers since 2009, according to Bloomberg Business. The week of March 30th started with the announcement of four major pharma or biotech mergers which totaled greater than $17 billion in costs, including the $3.5 billion Teva acquisition of Auspex. One particular deal, the purchase of benefits management company Catamaran Corp. by health insurer UnitedHealth Group Inc., will exceed $12 billion on its own.