Pharmaceutical Industry

News & Analysis as of

N.D. Cal Interprets the Biological Price Competition Act

Amgen Inc., et al. v. Sandoz Inc., et al., No. 14-cv-04741RS - On March 19, the Northern District of California became the first court to interpret two key provisions of the Biological Price Competition Act: whether...more

Update on the DOJ's Criminal Investigation into Generic Pharmaceuticals

The Department of Justice Antitrust Division's (DOJ's) investigation into the generic pharmaceutical industry may be expanding. On March 15, 2015, a third generic manufacturer disclosed that it received a subpoena from the...more

FDA Issues Draft Guidance on Use of Electronic Informed Consent in Clinical Trials

On March 9, 2015, the U.S. Food and Drug Administration (FDA) released a draft guidance, Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers, that provides recommendations for clinical...more

Supreme Court Holds That Issuers Can Be Liable for Omitting Material Facts From Statements of Opinion in Omnicare Case

In its opinion in Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, released yesterday, the U.S. Supreme Court held that a securities issuer’s statement of opinion in a registration statement,...more

Product Liability 2014 Year in Review

In This Issue: - Letter From The Chair - Key Practice Trends + Highlights - Consumer Products - Pharmaceutical Products and Medical Devices - Aviation - Toxics Regulation and Toxic...more

Going All In

Functional limitations and Senju Pharm. v. Lupin Pharm. Last year in Senju Pharma. v. Apotex Inc., 746 F.3d 1344 (Fed. Cir. 2014), Senju and Allergan were blocked from suing Apotex on a re-examined set of claims under...more

Court Strikes Expert Opinions, No Punishment Intended

Order Granting Takeda’s Motion to Strike, Takeda Pharmaceutical Co. LTD., et al., v. TWi Pharmaceuticals, Inc., Case No. 13-cv-02420-LHK (Judge Lucy H. Koh) - The Northern District Patent Local Rules are specifically...more

$12.6 Million Sandoz ASP Reporting Settlement Raises More Questions Than It Answers

Recently, HHS-OIG announced a first-of-its-kind settlement over pharmaceutical manufacturer reporting of Average Sales Price (ASP). Sandoz, Inc. agreed to pay a civil monetary penalty of $12.64 million for alleged failure to...more

The Tyranny of the Judiciary

There has always been a tension between the need for a final arbiter of the law and the inherent power associated with such a role placed in the judicial branch. Jefferson himself was wary of this tendency, writing in a...more

Judge Finds Biosimilar Patent Procedures Optional

Judge Seeborg of the U.S. District Court for the Northern District of California issued an order in Amgen, Inc. v. Sandoz, Inc., ruling that the patent dispute resolution procedures of the Biologics Price Competition and...more

Health Alert (Australia) - March 23, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Reports: New South Wales (NSW). Ministry of Health - Media Releases - 18 March 2015 - NSW says protect against mosquitoes after huge...more

Court Report - March 2015 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Bristol-Myers Squibb Co. v. Mylan Pharmaceuticals, Inc. 1:15-cv-00049; filed March 19, 2015 in the Northern District of...more

Dancing Not Required: District Court Denies Amgen’s Bid for Preliminary Injunction, Finds BPCIA “Patent Dance” Optional

The biologics industry has been closely monitoring Amgen Inc.’s (“Amgen’s”) lawsuit against Sandoz Inc. (“Sandoz”) for refusing to engage in the BPCIA’s “patent dance” with respect to Sandoz’s application for Zarxio®, a...more

District Court Rules Against Amgen’s Motion for Preliminary Injunction to Prevent Marketing of Sandoz’s Biosimilar Zarxio

In an order released on March 19, 2015, U.S. District Court Judge Richard Seeborg of the Northern District of California denied Amgen’s motion for judgment on the pleadings as well as its request for a preliminary injunction...more

Corporate Investigations & White Collar Defense - March 2015

The SEC’s Settlement with Goodyear: A Cautionary Tale - Why it matters: In a settlement announced on February 24, 2015, the SEC found Goodyear to be in violation of the FCPA in connection with bribes paid by two...more

The SEC and the Pharmaceutical Industry - Recent Commentary by the SEC's Enforcement Director Identifies Areas of SEC Focus...

Recently, the United States Securities and Exchange Commission’s (“SEC”) Enforcement Director, Andrew Ceresney (“Ceresney”), spoke to pharmaceutical compliance personnel at the CBI’s Annual Pharmaceutical Compliance Congress...more

Notes From The Off-Label Underground

Keeping track of litigation over off-label use/promotion frequently sends us off on tangents. We’ve wandered into abortion cases, securities law cases, criminal cases – even cases brought by criminals....more

A Change of Pace for Product Liability Class Actions: Certification Denied in Two Recent Cases

Oft-referred to as “quintessential class actions”, the majority of product liability actions that have sought certification as class proceedings in the last 10 years have been granted certification. However, two recent...more

FDA Establishes Docket for Public Comments on Drug Compounding

The Food and Drug Administration (FDA) recently announced a new docket for public comments on the compounding of human drug products under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FFDCA). The FDA...more

New FDA Guidance Opens the Door for Electronic Consent Forms That Come with Significant Advantages and Raise Privacy and Secure...

On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials. eICs have the potential to...more

Court Report - March 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Otsuka Pharmaceutical Co., Ltd. v. Sandoz Inc. et al. 1:15-cv-01716; filed March 9, 2015 in the District Court of New...more

FinCrimes Update - February 2015 Summary, Volume 2, Issue 2

On February 25, New York DFS Superintendent Benjamin Lawsky delivered remarks at Columbia Law School focusing on how state bank regulators can better supervise financial institutions in a post-financial crisis era. In his...more

Supreme Court: Patent Claim Construction – Two Standards Of Review

The Supreme Court recently decided a patent case involving a significant procedural issue. In Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831 (1/20/15), the question before the Court was whether the Federal...more

Prescriptions for the Headache of High Cost Drugs

A March 11 policy conference in Washington produced some creative thinking about the problem of high-cost specialty drugs. And on the same day, the RAND Corp. think tank released a study on the subject, “Borrowing for the...more

The First Biosimilar Application Has Been Approved -- But What About the Patent Issues?

As we reported earlier this week, the U.S. Food and Drug Administration ("FDA") approved the first biosimilar application -- an application by Sandoz to market a biosimilar version of Amgen's NEUPOGEN® (filgrastrim) biologic...more

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