Prescription Drugs Pharmaceutical Industry

News & Analysis as of

Takeda Pharms. U.S.A., Inc. v. West-Ward Pharm. Corp.

Case Name: Takeda Pharms. U.S.A., Inc. v. West-Ward Pharm. Corp., 785 F.3d 625 (Fed. Cir. May 6, 2015) (Circuit Judges Newman, Dyk, and Hughes presiding; Opinion by Dyk, J.; Dissent by Newman, J.) (Appeal from D. Del.,...more

Shire Development, LLC v. Watson Pharms., Inc.

Case Name: Shire Development, LLC v. Watson Pharms., Inc., 787 F.3d 1359 (Fed. Cir. June 3, 2015) (Circuit Judges Prost, Chen, and Hughes presiding; Opinion by Hughes, J.) (Appeal from S.D. Fla., Middlebrooks, J.) - Drug...more

Federal Circuit Delays Sandoz Biosimilar Launch

In a closely-watched case between Amgen and Sandoz regarding the first biosimilar approved (Zarxio), the Federal Circuit interpreted key Biologics Price Competition and Innovation Act (BPCIA) provisions regarding Sandoz's...more

Teva Pharms. USA, Inc., v. Sandoz, Inc.

Case Name: Teva Pharms. USA, Inc., v. Sandoz, Inc., Fed. Cir. Nos. 2012-1567, -1568, -1569, -1570, 2015 U.S. App. LEXIS 10229 (Fed. Cir. June 18, 2015) (Circuit Judges Moore, Mayer, and Wallach presiding; Opinion by Moore,...more

Little Reprieve for Prisoner Zyprexa Suit

Happy birthday, Louise Fletcher, who won an Academy Award for her portrayal of the sadistic Nurse Ratched in One Flew Over the Cuckoo’s Nest (1975). Happy birthday also to Albert Brooks, writer/director/star of Modern...more

OIG Report Raises Serious Medicare Part D Fraud, Waste and Abuse Concerns

Last month, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released a comprehensive report and data brief detailing its concerns about the ability of Medicare Part D sponsors – as...more

21st Century Cures Act Passes House: Could Usher In Broad Reforms to Drug Approval Process

On Friday, July 10th the U.S. House voted overwhelmingly to streamline the approval process of prescription drugs and medical devices by the FDA. If passed in the Senate and signed by President Obama, the “21st Century Cures...more

The Compounding Regulations Surrounding Drug Compounding

Drug compounding as a practice has, until recently, been met with far looser regulation than the manufacture of drugs. This practice serves to meet the needs of individuals who require certain formulations not available in...more

Proposed 340B Rule Would Impose Penalties for Overcharging, Plus Other Charges

A recently-released proposed rule would impose civil monetary penalties on drug manufacturers that intentionally overcharge healthcare providers for medications purchased under the 340B Discount Drug Program. The proposed...more

The Revolution that Wasn’t: New Jersey’s Direct-To-Consumer Exception to the Learned Intermediary Doctrine

The learned intermediary doctrine – in which a manufacturer’s duty to warn runs to the physician, not to the patient – is one of the most potent weapons in the arsenal for a pharmaceutical or medical device manufacturer faced...more

Whistleblower Lawsuit Rests on Allegedly Withheld Documents

On June 19, the whistleblower in a False Claims Act suit argued that the court should take action to secure documents that demonstrate Abbott Laboratories encouraged off-label marketing and doctor kickbacks. The whistleblower...more

King Drug Co. of Florence, Inc. v. SmithKline Beecham Corp. (3rd Cir. 2015)

Ever since the Supreme Court's decision in FTC v. Actavis in 2013, courts (predominantly district courts) have grappled with the scope of the decision. It was evident that the presence of a large cash payment from the...more

A “Too Old” OTC Product Does Not A Class Action Make

This past weekend, we attended a fundraising 5K race organized by a friend who lives with a form of muscular dystrophy. We volunteered to photograph the event, because the usual photographer was not able to attend. And...more

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it...more

FDA Reports Results of Annual Crack Down on Illegal Internet Pharmacies

Last week, FDA announced that more than 1,050 websites had illegal drugs and devices seized or received warning letters as part of the Eighth Annual International Internet Week of Action (IIWA). IIWA is an international...more

Federal Circuit Tackles Claim Construction Review under New Standard

The More Things Change (Lighting Ballast Control LLC v. Philips Electronics North America), the More They Stay the Same (Teva Pharmaceuticals USA, Inc. v. Sandoz Inc.) - On June 18, 2015, the Federal Circuit handed down...more

No Prescription For Consumer Protection

Allowing plaintiffs to pursue claims under consumer protection statutes in prescription medical product liability litigation is trying to pound a square peg into a ham sandwich. It doesn’t fit, and the combination isn’t very...more

G.D. Searle LLC v. Lupin Pharmaceuticals, Inc. (Fed. Cir. 2015)

Over seven years ago, the Federal Circuit delivered a mixed ruling against Pfizer in litigation against Teva) relating to the pain medication Celebrex® (celocoxib) (where "celocoxib" is...more

Biosimilars Coding & Reimbursement Significance under Medicare Part B

On April 15, 2015, CMS issued a preliminary recommendation for a HCPCS code for Zarxio, the first biosimilar product ever to be approved by the FDA. CMS’s recommendation provides the first indication of how the agency will...more

Louisiana Appellate Court Overturns Improper Application of “Law of the Case” Doctrine

Today is the day when we will learn whether the Governor of Louisiana will enter the 2016 presidential race. That reminds us of Louisiana’s rather colorful collection of politicians, including Huey Long and Edwin Edwards....more

Public Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA’s Hackles if They Do Not Meet Basic...

For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the...more

Court Report - June 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Mayne Pharma International Pty Ltd. v. Merck & Co., Inc., et al. 1:15-cv-00438; filed May 29, 2015 in the District Court...more

June Xarelto Update – Science Day

Judge Fallon, the federal judge in New Orleans who oversees the MDL coordinated proceedings, held his most recent hearing for all of the pending Xarelto lawsuits on June 10, 2015. At that time, the judge was provided with a...more

HRSA Issues 340B Drug Discount Program Civil Money Penalty Proposed Rule

On June 17, 2015, the Health Resources and Services Administration (HRSA) issued a proposed rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health Service Act as part of the...more

Tightening Control over Prices for Crucial Medicines

Governmental regulation of vital and essential medicines (hereinafter Essential Drugs) in the Russian Federation in the form in which it exists today has been functioning since 2010. The list of Essential Drugs (“EDL List”)...more

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