FDA Lawyers Blog

by Charles J. Raubicheck and Brian J. Malkin

On March 26, FDA issued a decision granting Teva 180-day exclusivity for generic versions of Merck's Cozaar® (losartan potassium) and Hyzaar® (losartan potassium and hydrochorothiazide). FDA appeared reluctant to grant exclusivity, because Merck requested that the single patent for Cozaar® and Hyzaar® be delisted, and the patent expired due to Merck's failure to pay maintenance fees--both usual circumstances where a first-to-file abbreviated new drug application (ANDA) applicant forfeits its 180-day exclusivity.

FDA reasoned that the D.C. Circuit's March 2, 2010 decision in Teva Pharms, USA, Inc. v. Sebelius mandated this outcome. The court found the Hatch-Waxman 2003 amendments "structurally" do not permit new drug application (NDA) holders to deprive first ANDA applicants from obtaining 180-day exclusivity by unilaterally delisting a patent. Similarly, FDA determined that just because a patent expires due to the NDA holder's unilateral decision to not pay maintenance fees, the first applicant should not be deprived from 180-day exclusivity.

by Charles J. Raubicheck and Brian J. Malkin

On March 23, President Obama signed the Patient Protection and Affordable Care Act into law. This Act includes the Biologics Price Competition and Innovation Act ("Biosimilars Act") that enables FDA to approve a follow-on biosimilar product that is "highly similar" to an innovator's biological product. Innovator biologicals have 12 years of FDA market exclusivity from the date the innovator product is approved, in addition to any patent protection.

FDA will set approval standards for biosimilars and interchangeable biosimilars. The first approved interchangeable biosimilar will be eligible for its own period of exclusivity: the earlier of (i) 1 year after commercial launch, (ii) 18 months after a final court decision or dismissal on all relevant patents involved in litigation (see below), (iii) 42 months after approval of the first interchangeable product, if litigation is still ongoing, or (iv) 18 months after approval of the first interchangeable product if not sued for infringement.

Patent litigation for biosimilar products appears more uncertain and time consuming than Hatch-Waxman litigation, requiring a series of relatively short, successive timeframes for innovator biologicals and biosimilar applicants to exchange patent lists, infringement and validity contentions, and proposed patents for litigation. Notably, there is no Orange Book to list patents for innovator biologicals, and there is no automatic 30-month stay for asserted patents. In addition, there are penalties for failing to follow the new statutory procedures: an innovator manufacturer may be limited to a reasonable royalty in the event it fails to bring a timely infringement suit, the action is dismissed, or is not prosecuted to judgment in good faith.

Postscript: For more on the Biosimilars Act, see here and here.

Charles J. Raubicheck will speaker at the American Conference Institute's FDA Boot Camp in New York on March 24-25, 2010. He will speak on FDA "Non-Patent Exclusivities" for pharmaceuticals.

by Charles J. Raubicheck and Brian J. Malkin

On March 19, FDA issued a notice of proposed rulemaking for regulation of outdoor advertising of cigarettes and smokeless tobacco products. Rather than proposing a specific ban, FDA asked for comments for appropriate advertising limits. FDA declined to offer a specific proposal in light of the Supreme Court's decision in Lorillard Tobacco v. Reilly. There, the Supreme Court overturned FDA's outdoor ban on advertising within 1,000 feet of any public playground, park, or elementary or secondary school as an overbroad, unconstitutional restriction of free speech. FDA's new notice indicates that the agency is considering applying the limit only to schools, tailoring the perimeter limit to the metropolitan size, or setting perimeter limits based on billboard size.

by Charles J. Raubicheck and Brian J. Malkin

On March 19, FDA published a final rule restricting youth access and exposure to marketing for cigarettes and smokeless tobacco products. The rule, titled the Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, contains a number of sale and distribution prohibitions designed to prevent the sale of cigarettes and smokeless tobacco products to youths younger than 18. One noteworthy prohibition restricts to adult-only establishments the sale of cigarettes and smokeless tobacco in vending machines or other self-service displays, or the distribution of free samples. The rule's marketing provisions prohibit (1) tobacco brand names sponsoring athletic, musical, or other social or cultural events, or team entry in such events, (2) gifts or other items in exchange for purchasing cigarettes and smokeless tobacco products, and (3) promotional items such as hats and t-shirts with tobacco brands.