Pharmaceutical Manufacturers

News & Analysis as of

Court Report - June 2015 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Teijin Ltd. et al. v. Macleods Pharmaceuticals Ltd. et al. 1:15-cv-00454; filed June 4, 2015 in the District Court of...more

The Deeper Dive: C-Suite to Prison Pipeline

In recent years, the U.S. Department of Justice (DOJ) has been criticized for failing to prosecute executives for fraud, particularly in the financial sector. In response, the DOJ has begun to more heavily emphasize...more

Federal Circuit Strikes Final Blow to Celebrex Patent

In 2008, the Federal Circuit determined that claims 1-4 and 11-17 of U.S. Patent No. 5,760,068 were invalid for obviousness-type double patenting (OTDP) over a related parent patent, in part because the ‘068 patent was filed...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

HRSA Publishes Proposed Rule on 340B Ceiling Prices and Manufacturer CMPs

On June 17, 2015, the Health Resources and Services Administration (HRSA) published a Proposed Rule that would codify standards for the calculation of ceiling prices by manufacturers for covered outpatient drugs under the...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

FIN4 May Have Embarked on a Risky Hacking/Insider Trading Strategy

I haven’t yet turned to a life of crime, so far be it from me to criticize actual criminals’ profit-maximizing strategies. It’s easy for me to nitpick, but I’m not the one strapping on my mask and trying to earn a...more

All About That Base: Claim Against Fat Loss Supplement Maker Fails For Lack of Ascertainability

Adam Karhu bought a dietary supplement called VPX Meltdown Fat Incinerator (“Meltdown”) in reliance on advertising by Vital Pharmaceuticals, Inc. (“VPX”) that Meltdown would result in fat loss. Concerned that Meltdown did not...more

Cardinal Health to Acquire The Harvard Drug Group for $1.1 Billion

Ohio-based Cardinal Health (CAH) has agreed to buy Michigan-headquartered The Harvard Drug Group (THDG) for $1.12 billion. According to press releases, THDG, which is currently owned by Court Square Capital Partners, is a...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

Federal Circuit Invalidates Diagnostic Method Claims for Prenatal Test Under 35 U.S.C. 101

On June 12, 2015, the Federal Circuit affirmed the finding of U.S. District Court for the Northern District of California (“District Court”) that the method claims in U.S. Patent 6,258,540 (‘540 patent) for detecting...more

Federal Circuit Holds Medical Diagnostic Method Patent Invalid as Claiming Ineligible Subject Matter

Background - In two recent cases, Mayo v. Prometheus and Alice v. CLS Bank, the Supreme Court established a two-part test for determining eligibility for patenting. In step one, the court asks whether the claim is...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

Shareholder Disputes: When is Just and Equitable Liquidation Appropriate?

Unfair prejudice claims are commonplace in the British Virgin Islands (BVI) following the introduction of bespoke provisions in the BVI Business Companies Act 2004 and have all but replaced old fashioned just and equitable...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

340B Update: HRSA Proposes Penalties for Drug Manufacturers that Overcharge Covered Entities

On June 16, 2015, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) released proposed rules on civil monetary penalties and drug ceiling prices under 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

HRSA Takes its First Steps on 340B Rules

The 340B Drug Discount Program has operated for more than 20 years with just a few governing regulations codified in 42 CFR Part 10. Through the Affordable Care Act (“ACA”), Congress adopted several amendments to the 340B...more

Seeking a patent term extension may cut it short

A hidden catch to Australia’s generous regime for extension of term of pharmaceutical patents is that requesting an extension of term can act as a trigger for re-examination. The Australian Patent Office has...more

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