Pharmaceutical Industry

News & Analysis as of

Patent Owners: Better Address All Obviousness Arguments Raised by Petitioner

Pharmatech Solutions, Inc. v. LifeScan Scotland Ltd. - In a final written decision addressing an obviousness challenge, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB, the Board) found the...more

Court Report - October 2014 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. AstraZeneca Pharmaceuticals LP et al. v. Pharmadax USA, Inc. et al. 8:14-cv-01710; filed October 23, 2014 in the Central...more

Dr. Reddy’s Laboratories Settles on Eve of Trial – Agrees to Cooperate with Plaintiffs

Much has happened since our last post on the Nexium “pay for delay” class action lawsuit. Jury selection began in the District of Massachusetts on Monday, October 20, 2014. The day prior, one of the generic drug makers, Dr....more

Blog: Litigation Round-Up: Some Recent Drug & Device Settlements, Investigations, Inquiries

Settlements - Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies,...more

SEC – USAO Charge Trader In Analyst Insider Trading Case

Earlier this month the SEC brought an insider trading case against Zachary Zwerko, a financial analyst at a pharmaceutical company identified only as Pharma Co. SEC v. Zwerko, Civil Action No. CV 8181 (S.D.N.Y. Filed Oct. 10,...more

Corporate Inversions and Related Transactions

The past several months have seen a flurry of business activity by and between U.S.- based corporations and foreign competitors. Mergers have been announced between foreign and domestic pharmaceutical companies, drug...more

Oral Argument In Teva Pharmaceuticals: Supreme Court To Decide Federal Circuit’s Standard Of Review Of District Court Claim...

On October 15, the Supreme Court heard oral argument in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. (No. 13-854). The issue presented in the case is “Whether a district court’s factual finding in support of its...more

Takeda Pharm. Co., Ltd. v. Mylan Inc.

Nature of the Case and Issue(s) Presented: The issue here concerns whether the owner of a pharmaceutical patent may simultaneously assert a claim for infringement under § 271(e)(2), and a claim pursuant to the Declaratory...more

Do You Offer or Accept Copayment Coupons? OIG says YOU are Responsible for Compliance with Federal Law

In recent years, copayment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Copayment coupons are typically offered to commercially insured patients in order...more

Depomed, Inc. v. Actavis Elizabeth LLC

Nature of the Case and Issue(s) Presented: Depomed sued Actavis for infringing seven patents related to a dosage form capable of being retained in the stomach, allowing for the delayed-release of gabapentin in the small...more

Fresenius Kabi USA, LLC v. Dr. Reddy’s Labs., Ltd.

Nature of the Case and Issue(s) Presented: Plaintiff filed suit alleging infringement of claims 1, 16, 36, and 37 of each of the patents-in-suit. The patents-in-suit all claim pharmaceutical compositions containing propofol...more

Federal Circuit Judges Disagree on Use of Post Filing Date Evidence of Nonobviousness

On October 20, 2014, the Federal Circuit issued an order denying the petition for rehearing or rehearing en banc filed in Bristol-Meyers Squibb Co. v. Teva Pharmaceuticals, USA, Inc. While the order itself may not be...more

United Therapeutics Corp. v. Sandoz, Inc.

Nature of the Case and Issue(s) Presented: UTC claimed that Sandoz induced infringement of the ’007 patent by instructing physicians to dilute its product for use intravenously. The asserted claim required a particular...more

Court Decisions in the U.S. and China Bolster Law Enforcement’s Ability to Prosecute Global Corporate Corruption

On October 6, 2014, the United States Supreme Court declined to accept an appeal involving violations of the Foreign Corrupt Practices Act (“FCPA”)—the U.S. statute that criminalizes the bribing of foreign officials. The...more

The New EU Clinical Trials Regulation Aims at Harmonization and Transparency

On June 16, 2014, Reg. (EU) No. 536/2014 on Clinical Trials on Medicinal Products for Human Use (Regulation) has entered into force. Once it becomes applicable, the Regulation will provide a comprehensive legal framework for...more

Supreme Court: Should Appeal Give Deference to Lower Courts on Claim Construction?

On October 15, the Supreme Court heard oral argument in Teva Pharmaceuticals USA Inc., et al. v. Sandoz Inc., et al., case number 13-854. At issue is the level of deference that the Court of Appeals for the Federal Circuit...more

Hospira, Inc. v. Burwell

Nature of the Case and Issue(s) Presented: Precedex is commonly used as a sedative. Specifically, the FDA has approved Precedex for two uses: (i) sedation of initially intubated and mechanically ventilated patients during...more

In re Cornerstone Therapeutics Inc. S'holder Litig., Consol. C.A. No. 8922-VCG (Del. Ch. Sept. 10, 2014) (Glasscock, V.C.)

In this opinion on a motion to dismiss, the Court of Chancery held that, in a controller transaction governed by entire fairness review, a plaintiff need not specifically plead non-exculpated breaches of duty as to...more

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act Cases: October 2014

Trends & Analysis - Between our last Qui Tam Update and the end of June, 65 health care–related qui tam cases were unsealed (28 in April, 18 in May, and 19 in June). Within those 65 cases...more

New Challenge to 340B Rule Regarding Orphan Drugs

On October 9, 2014, Pharmaceutical Research and Manufacturers of America (PhRMA) filed a complaint (the October 9 Complaint) against the U.S. Department of Health and Human Services (HHS), the Health Resources and Services...more

Guest Post: Nature's Indelible Marker - Naturally abundant, stable isotopes have already protected the identity and origin of $1.5...

The pharmaceutical industry is an important segment of the world economy. In 2013, worldwide sales of prescription drugs were over $830 billion. If one adds in over-the-counter medicines and other health-related products...more

Canadian Competition Bureau chief takes a tough stance on pay-to-delay agreements

The Canadian Competition Bureau intends to take a tough approach to so-called “pay-to-delay” settlements, potentially anti-competitive agreements in which generic drug manufacturers agree to delay the launch of a low-cost...more

Recent False Claims Act Decision Provides Important Guidance To Manufacturers And Resellers About Trade Agreements Act Compliance

The United States Court of Appeals for the District of Columbia Circuit recently upheld a District Court's dismissal of a False Claims Act (FCA) complaint against a federal government contractor in a case that will be of...more

Curtailing Access to Combat Abuse - New DEA Regulations Focus on Prescription Medication Collection

The Drug Enforcement Administration’s (DEA) new regulations aimed to cut down on prescription drug abuse will soon allow patients to return unused pharmaceuticals to authorized locations. The new rules go into effect October...more

Trade & Manufacturing - October 2014

In This Issue: - Export-Import Bank Is Reauthorized Through June 2015 - Roadblocks to Bali Package Implementation Remain As Summer Deadline Passes Without A Clear Path Forward - Customs Litigation: Federal...more

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