Pharmaceuticals and PBMs

Recent trends in the U.S. Food and Drug Administration’s (“FDA’s”) utilization of Complete Response Letters (“CRLs”) would indicate there may be a disconnect between the intended use of CRLs and the reality of how they are actually being used by the FDA. Pharmaceutical companies seeking to acquire FDA regulatory approval for their New Drug Applications (“NDAs”) or Abbreviated New Drug Applications (“ANDAs”) will often receive a CRL from the FDA instead of an approval.
Continue Reading FDA Complete Response Letters: The design v. reality of FDA’s responses to drug applications

The U.S. Food and Drug Administration (“FDA”) panel’s unanimous recommendation to approve Sandoz’ application for a filgrastim biosimilar of Amgen’s Neupogen® on Jan. 7, 2015, brings into sharp focus the provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) for resolving patent issues. The imminent approval by the FDA of Sandoz’ application now leaves resolution of patent issues for Sandoz to contend with as it prepares to launch its biosimilar filgrastim product. The lawsuit to resolve these issues, however, has just begun.
Continue Reading Patent issues will remain after FDA approval of Sandoz’ application for filgrastim

Dietary supplements represent a huge sector of the consumer market and changes in both intellectual property law and the regulations governing the market entry and advertising of these products is changing.

The new America Invents Act allows anyone to challenge the validity of patents under the inter partes review (IPR) process. In a Sept. 9 webinar, Husch Blackwell Partner Joseph Cwik, who recently won the first pharmaceutical IPR case, will provide an overview of this new process and explain how it is more cost-effective, efficient and successful than the traditional litigation.
Continue Reading Cutting dietary supplement red tape

The Patent Trial and Appeal Board (PTAB) issued its first final written decisions June 20, 2014, in four inter partes reviews (IPR) of pharmaceutical-related patents. The four decisions effectively invalidated all 58 of the challenged patent claims spread across four patents owned by Merck & Cie and South Alabama Medical Science Foundation (SAMSF) who previously accused Husch Blackwell client Gnosis SpA of infringement.
Continue Reading Husch Blackwell leads the charge in first inter partes review wins against pharmaceutical-related patents

Several parts of the America Invents Act (the “AIA”) became law on Sept. 16, 2012, sparking some of the most meaningful changes to patent law seen in decades. One hot provision in the new law is the ability for one to challenge a patent’s validity in a new inter partes review (“IPR”) process. This legal tool could prove to be very valuable in solving some of the biggest business challenges facing generic pharma. This post addresses the business case for generic pharma using the IPR process.
Continue Reading The business case for inter partes review of patents by generic pharma

When inter partes review actions first became available in 2012, no generic pharma companies availed themselves to this litigation tool. Not until 2013 did a generic pharma company first seek inter partes review (“IPR”) of a brand drug patent in Apotex Inc. v. Alcon Pharmaceuticals, Ltd., IPR2013-00012 and -00015. In response to Apotex’s petition for inter partes review, the Patent Trial and Appeal Board (“PTAB”) ruled there was a reasonable likelihood that the two challenged patents were invalid for obviousness. Interestingly, a U.S. District Court previously determined that one of the patents was not invalid based upon the same prior art references.  Id. at Paper 43; March 19, 2013.
Continue Reading After a slow start, generic pharmaceutical companies now accelerate their use of inter partes review patent challenges

Law360 recently quoted Husch Blackwell attorney Don Mizerk in an article about the FDA’s new request for comments.  In the announcement, the FDA established a public docket to receive suggestions for ways to improve the quality of abbreviated new drug applications (ANDAs) and for the FDA to learn about difficulties sponsors are having with

Scrutiny of physician prescribing (particularly pain management) seems likely to increase in 2015 under new CMS regulations that were published on January 10, 2014. The proposed regulation makes policy and technical changes regarding the Medicare prescription drug program (Part D). Among the changes are the granting of explicit authority to deny (under 42 CFR §

When was the last time you thought about your compliance program? As we know, an effective compliance program is important for healthcare companies. It’s also important to review your compliance program periodically and update it according to the latest guidance. OIG guidance and recent Corporate Integrity Agreements (CIAs) are informative about what the OIG is

Pfizer, Inc. recently petitioned the Supreme Court, seeking review of three companion decisions from the First Circuit Court of Appeals.  These decisions found against Pfizer and in favor of multiple third-party payors (TPPs)—the Kaiser Foundation Health Plan, Inc. (an HMO), Aetna, Inc. (a health insurer), and a putative class of employer health plans—on civil Racketeer Influenced and Corrupt Organizations Act (RICO) claims for damages suffered due to Pfizer’s fraudulent marketing of off-label uses for the prescription drug Neurontin, an anti-convulsive approved for the treatment of epilepsy.  At the heart of the dispute is causation—the causal chain that runs from a drug manufacturer, such as Pfizer, to third-party payors of prescription drug benefits, such as HMOs, insurers and other health plans.

The First Circuit’s lead opinion—laying the common predicate necessary to understand each of the companion cases—came in the action brought against Pfizer by Kaiser, in which the court affirmed a $142 million jury award to the HMO.

The Development and Marketing of Neurontin

Neurontin was developed during the 1980s and early 1990s as an anti-epileptic drug.  In 1993, the Food and Drug Administration approved Neurontin for treatment of partial seizures in adults with epilepsy.  A campaign to market Neurontin for off-label conditions—conditions not included on the official label approved by the FDA—began in 1995.  These off-label conditions included neuropathic pain (pain from nerve damage), migraine headaches, and bipolar disorder.  Neurontin was marketed for treatment of these off-label conditions by way of, among other things:  (1) direct marketing to doctors, which misrepresented Neurontin’s effectiveness for off-label indications; (2) misleading information supplements and continuing medical education programs; and (3) articles published in medical journals that touted Neurontin’s off-label effectiveness but suppressed negative information about the drug. 
Continue Reading Pfizer Appeal Targets Fraudulent Drug Marketing Claims Brought Under Civil RICO Statute