FDA Lawyers Blog

by Brian Malkin

On April 29, the Second Circuit determined that Bayer's agreement to provide generic defendant Barr with money to settle and delay market entry of its generic version of Cipro® (ciprofloxacin) does not violate antitrust laws. Viewed as another set back to the Federal Trade Commission's ("FTC's") pleas for Congress to make such pay-for-delay settlements illegal, the Circuit invited plaintiff-appellants to petition for a rehearing en banc.

On April 28, Markus H. Meier, Assistant Director of the Health Care Division at FTC's Bureau of Competition, suggested in a presentation delivered at the American Conference Institute's Paragraph IV Disputes Conference in New York City that he hoped the Second Circuit was rethinking its precedent for Tamoxifen. In Joblove v. Barr Labs, Inc, (In re Tamoxifen Citrate Antitrust Litig., 466 F.3d 187, 208-12 (2d. Cir. 2005)), the Court found another pay-for-delay settlement did not violate antitrust laws. The Conference was co-chaired by FLH Partner Barry S. White and included a presentation by FLH Partner Brian J. Makin on Patent and IP Overview for Drugs and Biologics: Hatch-Waxman, Trade Dress, and More that focused on IP issues and biologics.

Under the settlement, Bayer agreed to: 1) pay Bar $49.1 million immediately, 2) make quarterly payments of between $12.5 and 17.125 million for the duration of the patent except for the last six months prior to the patent's expiration, and 3) provide Barr a guaranteed license to sell brand-name Cipro® at a reduced rate, i.e., authorized generic, for six months prior the patent's expiration. In return, Barr agreed to stipulate to the patent's validity and not to market a generic version of Cipro® until the patent expired.

by Charles J. Raubicheck

On April 29, FDA published a Federal Register Notice requesting public comments on the use of symbols on the front of retail food packages that convey specific information to consumers about the health value of particular foods. These symbols would be in addition to the nutrition labeling on the information panel of the package. Examples are the Smart Choices checkmark and the Heart Healthy symbol.

FDA is concerned about the prevalence of obesity, particularly in children, and believes that use of symbols visible on the front of food packages may help educate consumers to choose more nutritious foods. The agency states that it has already begun consumer tests on its own to gain knowledge about consumers' understanding of particular symbols currently in use in the U.S. FDA particularly seeks the views of the food industry, which may have done or is aware of unpublished research in this regard. The agency especially identifies package design and consumer understanding as the main areas of interest.

by Brian J. Malkin and Jennifer A. Hardy

On April 29, Dendreon Corporation's therapeutic vaccine, Provenge®, received FDA approval. FDA's decision for Provenge® was a highly anticipated and has a controversial past. The breakthrough drug will be the first therapeutic vaccine for cancer to reach the market.

Provenge® is specifically indicated for the treatment of advanced prostate cancer, and--as opposed to many other cancer therapies--the side effects for Provenge® are quite mild. The treatment involves removing of some of the patient's blood and cells to be cultured with Dendreon bioengineered proteins, similar to those found on cancer cells. The cells are then infused back into the patient to trigger an immune system attack on prostate tumors. Patients treated with Provenge® reportedly lived an average of 4.1 months longer than those with placebo.

In 2007, FDA denied approval of Provenge® after receiving a favorable recommendation from an advisory panel earlier the same year. The reasons behind the initial rejection are cited as deficiencies in Dendreon's Biologics License Application (BLA) that precluded approval. Many, however, have speculated that there was a conflict of interests or a matter of bureaucratic territory disputes that held up the approval.

Later in 2007, CareToLive, a nonprofit patient advocacy group based in Ohio, sued FDA for withholding approval of Provenge® in 2007. The suit alleged that the head of FDA's Office of Oncology Drug Products, Dr. Richard Prazur, sabotaged the application to assert his position as head of cancer therapy approvals, when Provenge® was under review by a rival agency unit. Prazur was also responsible for placing two advisors with obvious conflicts on interest on the panel to review Provenge®.

While the approval of Provenge® has been already hailed by researchers, patient advocates and investors alike have identified several problems facing the new drug. Dendreon's limited manufacturing capability mean that only an estimated 2,000 patients can be treated in the next year. Also Provenge® is expensive ($31,000 per vaccine in a series of three, $93,000 total) and the insurance industry's attitude towards Provenge®'s premium price-tag is unknown.

FLH Partners Brian J. Malkin, Robert S. MacWright, Ph.D. , and Grace L. Pan will join the world's leading biotechnology companies at the annual BIO convention this year, to be held in Chicago from May 3 to May 6. The FLH team will be located at Booth 2734, where they will feature a number of articles on biotechnology authored by FLH and will answer questions of fellow participants and exhibitors.