News & Analysis as of

How Far Is Too Far? Court Rules for Amarin in Off-Label Marketing Fight against FDA

Drugmaker Amarin Pharma, Inc. (Amarin), recently received a victory in its fight against the Food and Drug Administration (FDA). On August 7, 2015, the U.S. District Court for the Southern District of New York ruled that...more

Purdue Pharma L.P. v. Amneal Pharms., LLC

Case Name: Purdue Pharma L.P. v. Amneal Pharms., LLC, Civ. Nos. 04-Md-1603 (SHS); 13-cv-3372 (SHS), 2015 U.S. Dist. LEXIS 45967 (S.D.N.Y. Apr. 8, 2015) (Stein, J.) - Drug Product and Patent(s)-in-Suit: OxyContin®...more

Amarin Court Holds Truthful Off-Label Speech Entitled to First Amendment Protection

On August 7, 2015, the U.S. District Court for the Southern District of New York issued an opinion in Amarin Pharma, Inc. v. FDA, granting Amarin preliminary relief to engage in truthful and non-misleading off-label speech...more

Pharmaceutical Companies Get Off-Label Marketing Victory

Last week, a federal judge ruled that the Food and Drug Administration (FDA) cannot prohibit a pharmaceutical company from marketing its drugs for off-label uses if its claims are truthful and not misleading. This ruling,...more

District Court Holds That FDCA Does Not Prohibit and Criminalize Truthful Off-Label Promotion of FDA-Approved Prescription Drugs

On August 7, 2015, the U.S. District Court for the Southern District of New York released its Amarin opinion addressing whether truthful, non-misleading off-label promotion of U.S. Food and Drug Administration (FDA)-approved...more

GlaxoSmithKline LLC. v. Glenmark Generics Inc.

Case Name: GlaxoSmithKline LLC. v. Glenmark Generics Inc., USA, Civ. Nos. 14-877-LPS-CJB; 14-878-LPS-CJB, 2015 U.S. Dist. LEXIS 52525 (D. Del. Apr. 22, 2015) (Burke, J.) - Drug Product and Patent(s)-in-Suit: Coreg®...more

Otsuka Pharmaceutical Co., Ltd. v. Burwell

Case Name: Otsuka Pharmaceutical Co., Ltd. v. Burwell, Civ. No. GJH-15-852, 2015 U.S. Dist. LEXIS 68230 (D. Md., May 27, 2015) (Hazel, J.) - Drug Product and Patent(s)-in-Suit: Abilify® (aripiprazole); N/A - Nature...more

Amarin Pharms. Ireland Ltd v. FDA

Case Name: Amarin Pharms. Ireland Ltd v. FDA, Case No. 14-cv-00324 (RDM), 2015 U.S. Dist. LEXIS 68723 (D.D.C. May 28, 2015) (Moss, J.) - Drug Product and Patent(s)-in-Suit: Vascepa® Capsules (icosapent ethyl); N/A...more

Braintree Labs., Inc. v. Novel Labs., Inc.

Case Name: Braintree Labs., Inc. v. Novel Labs., Inc., Case No. 3:11-cv-01341-PGS-LHG, 2015 U.S. Dist. LEXIS 70993 (D.N.J. June 2, 2015) (Sheridan, J.) - Drug Product and Patent(s)-in-Suit: Suprep® Bowel Prep Kit (sodium...more

Spectrum Pharms., Inc. v. Burwell

Case Name: Spectrum Pharms., Inc. v. Burwell, Civ. No. 15-631 (RCL), 2015 U.S. Dist. LEXIS 73218 (D.D.C. May 27, 2015) (Lamberth, J.) - Drug Product and Patent(s)-in-Suit: Fusilev® (levoleucovorin); N/A - Nature of...more

Veloxis Pharmaceuticals, Inc. v. FDA

Case Name: Veloxis Pharmaceuticals, Inc. v. FDA, Civ. No. 14-2126 (RBW), 2015 U.S. Dist. LEXIS 77559 (D.D.C. June 12, 2015) (Walton, J.) - Drug Product and Patent(s)-in-Suit: Astagraf XL® (tacrolimus); N/A...more

Identifying the likely beneficiaries of an emerging biosimilars market

Financial analysts have predicted that over the next five years, biosimilars will be a $10 billion market, so it is understandable why considerable attention and investment is being made in this space. However, while there is...more

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

Patients' Voices Carry: Drug Development Increasingly Driven by Patients' Needs and Concerns

With the recent announcement of Sarepta’s filing for approval of its drug, eteplirsen, for the treatment of Duchenne muscular dystrophy (DMD), coming on the heels of BioMarin’s announcement a few months earlier of a similar...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

FDA Issues Warning Letter to Corporate Sponsor of Clinical Trial

The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company...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

Georgia Senator Introduces The Combination Product Regulatory Fairness Act of 2015

On July 17, 2015, Georgia’s U.S. Senator Johnny Isakson (R-GA), along with co-sponsors, Robert Casey (D-PA), and Pat Roberts (R-KS), introduced a Senate bill entitled, “The Combination Product Regulatory Fairness Act of...more

FDA's Proposed Rules to Address Inaccurate Orange Book Use Codes May Shorten Approval Timelines for Select 505(b)(2) and Generic...

Drug Approval and Patent Listing Process - Before being allowed to market a new drug1 in the U.S., branded drug manufacturers must submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), and...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

Product Recall Trends in 2015

What are the latest trends on product recalls in the United States? Consumer Products. The Consumer Product Safety Commission has been proactive in recent years with consumer product regulations and recalls,...more

Unfortunately Disappointing 3D Printing Law Review Article

We’ve blogged before about the interesting product liability issues created by 3D printing/additive manufacturing, in particular the novel separation that these techniques create (at least potentially) between “manufacturing”...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

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