Tag: pharma
Louisiana Supreme Court Strikes Down Expansive Interpretation of State Medicaid Fraud Statute
In a decision that has important ramifications for the life sciences industry, on January 28, 2013, in Caldwell ex rel State of Louisiana v. Janssen Pharmaceutical, Inc., (No. 2012-C-2447, No. 2012-C-2466), the Supreme Court of Louisiana, by a 4–3 vote, reversed a $330 million trial court award against Janssen Pharmaceutica, Inc., and entered final judgment in Janssen’s favor. Under the theory of liability that had been pursued by Louisiana at trial, virtually any public statement about any product that might be subject to Medicaid reimbursement could be subject to civil penalties totaling hundreds of millions of dollars—on a state-by-state basis—even if the statement was not made as part of a claim for reimbursement and there was no proof that the providers who wrote prescriptions for it did so for any reason other than a medical determination the product was the more … Read More »
FTC Amendments to Premerger Notification Rules: The Who, What & Why
On November 6, 2013, the Federal Trade Commission released final amendments to the Hart-Scott-Rodino Premerger Notification Rules to clarify when a transaction involving the transfer of rights to all or part of a pharmaceutical (including biologics) patent is reportable under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the “HSR Act”).
The final rule, which is the same as the proposed rule circulated a year ago for public comment, codifies an “all commercially significant rights” test to determine whether a transfer of rights has occurred in an exclusive patent license agreement. Under that rule, if a patent licensor transfers all commercially significant rights to the patent, the transaction may be reportable. The final rule states that if “limited manufacturing rights” are retained by the licensor, then the transaction may also be reportable under the Act.
The final rule, which takes effect on December 16, 2013, is available … Read More »
French Sunshine Act Implemented…Awaiting Guidance
As pharmaceutical and device manufacturers and others are scrambling to finalize interpretations and implementation of the U.S. Physician Payment Sunshine Act, the French government added to the activity by releasing similar transparency regulations. On May 22, 2013, the French Ministry of Health published Decree No. 2013-414, implementing the French Sunshine law, which was enacted on December 29, 2011 and is known as the Bertrand law, after the French Minister of Health, Xavier Bertrand. The compliance date was set for June 1, 2013, and reporting is retroactive to January 1, 2012, giving companies a mere 10 days to interpret the regulations and compile and report data. It is expected that a Circular (i.e., guidance document) interpreting the Decree will be released soon.
The French Sunshine law requires reporting by companies that produce, market, or provide services associated with products listed in a particular … Read More »
Ninth Circuit Affirms Conviction and Sentence in InterMune Pharmaceutical Marketing Fraud Case
On March 4, 2013, the Ninth Circuit affirmed the conviction and sentence of InterMune founder Scott Harkonen based upon a fraudulent press release that misrepresented the results of a clinical trial in the off-label use of the drug Actimmune to treat the fatal lung disease idiopathic pulmonary fibrosis (IPF). A jury convicted Mr. Harkonen of wire fraud based upon the press release, and the district court sentenced him to three years’ probation and a $20,000 fine. (He also was excluded from participating in federal health care programs for five years, and has challenged that determination with a lawsuit of his own).
Giving great deference to the jury verdict, the Court of Appeals (in an unpublished opinion) rejected Harkonen’s First Amendment challenge to his conviction, finding that there were sufficient facts to support the jury’s findings that the press release misrepresented the … Read More »
Agree to Disagree: FDA and Customs Origin and Drug Labeling Requirements
When merchandise is imported into the United States, there is a slew of information required to be reported to United States Customs and Border Protection (Customs) and the Food and Drug Administration (FDA). The information is transmitted electronically, usually by the importer’s designated customs broker. Among the key elements transmitted to Customs and the FDA is the country of origin of the imported product. Unfortunately, the answer to this question is not always easy, and in many cases Customs and the FDA do not agree. While it may not always be possible to reconcile the two agencies’ requirements, compliance with both is nonetheless required.
Country of origin determination and labeling for pharmaceutical products is a prime example of where the FDA and Customs do not see eye-to-eye. The FDA generally defines origin based on the last country of manufacture. Moreover, FDA … Read More »
2013 Should Bring Clarity to Analysis of Settlements of Pharmaceutical Patent Litigation
The Federal Trade Commission (FTC) recently filed a brief with the U.S. Supreme Court in a case that promises to bring some clarity to the analysis of settlements of pharmaceutical patent litigation. Under the Hatch-Waxman Act, a generic drug manufacturer can file an application with the Food and Drug Administration (FDA) stating that a pioneer manufacturer’s patent is invalid or that its generic drug does not infringe the patent. By statute, such an application is a technical act of patent infringement, permitting the pioneer manufacturer to file patent litigation. Some of these patent infringement suits are resolved by settlements that include a payment by the pioneer manufacturer to the generic manufacturer, which agrees to refrain from producing its generic drug for a specified period. The FTC refers to these settlement agreements as “reverse payment agreements” or “pay-to-delay” agreements.[1]
The legality of … Read More »