The event CONNECT: Most Innovative Product Awards 2005 will be held on Friday, December 9th, 2005 from 10:00 a.m. to 2:00 p.m. at Hilton La Jolla Torry Pines, 10950 North Torrey Pines Road, La Jolla, CA 92037. The event will honor local innovation across multiple industries, including the biotech industry.

California’s Healthcare Policy Forum, sponsored by the California Healthcare Institute, will be held November 17-18, 2005 in San Francisco, and will bring together executives from biomedical device and pharmaceutical companies, leaders from academic research institutions in California, and state policymakers to discuss public policy challenges facing the bioscience community’s work and needs.

The event The Patenting of Life Forms: 25 Years since the Chakrabarty Patent will be held on Wednesday, October 26th from 6:00-8:00 at Palo Alto Research Center (“PARC”) , 3333 Coyote Hill Rd., Palo Alto, CA. The speakers will include Mark E. Andrews, BioTech Nation, National Public Radio; Mark Bosse, Gilead Sciences; Dr. Ananda Chakrabarty, University of Illinois at Chicago; George Elliot, Technology Center 1600, USPTO; Elizabeth Howard,Orrick, Herrington, and Sutcliffe LLP.

The event BayBioNEST’s Holiday Soiree for the Bioscience Community will be held at NASA Ames, 943 NASA Parkway, Moffett Field, CA from 6:30-9:30 on Thursday, December 8, 2005.

The Bioscience Forum will be held on Tuesday, October 18th through Thursday, October 20th, 2005 at two California Locations, the Clarion Hotel in San Francisco at 401 East Millbrae Avenue, Millbrae, CA and at the University of San Diego, Institute of Peace and Justice. The Symposium will present the latest information from the USPTO Examining Group 1600, which deals with Biotechnology, Pharmaceuticals, and Organic Chemistry, and will provide the most current information from the USPTO regarding a variety of issues, including registration practice, electronic filing of patent applications, sequence listings, and other matters.

The BIOCOM December Breakfast Meeting will be held on Wednesday, December 7, 2005 from 7 a.m. to 9 a.m. at the Marriott La Jolla , 4240 La Jolla Village Drive, La Jolla, CA 92037. The guest speaker will be Rolf Benirschke, a member of the San Diego Chargers Hall of Fame in 1997, San Diego Hall of Champions and the Academic All-America Hall of Fame.

Cooley Godward LLP will be hosting the event Accelerating Clinical Trials with Biomarkers on December 6, 2005 from 9 a.m. to 4 p.m., which will be held at its offices at 3175 Hanover Street, Palo Alto, CA 94304-1130. The workshop will focus on the incorporation of biomarkers into clinical trials, biomarker discovery, biomarker assay development, and biomarker validation. The confirmed speakers for this event include Mark McCamish, M.D., CMO, Perlegen; Pamela Contag, Ph.D., President, Xenogen; Robert McCormack, M.D., Veridex; Nancy Mize, Ph.D., Pacific BioDevelopment; and Cameron Carter, M.D., Director, Imaging Research Center.

The UC San Diego School of Medicine, the J. Craig Venter Institute, the Scripps Institution of Oceanography, CalIT2, and the Gordon and Betty Moore Foundation will be sponsoring the event Celebrating a Decade of Genome Sequencing. The Symposium will be held on Tuesday, December 6, 2005 at the Price Center Ballroom at the USCD campus.

In “The Impact of a Brand Generic Launch on the Recovery of Patent Damages” published in the Summer 2005 IPL Newsletter, James D. Veltrop and Chad A. Landmon explore the positive and negative effects of a brand name drug company making the decision to also launch a brand name generic. In light of the extensive litigation between brand and generics drug companies, the authors’ discussion raises some interesting issues to consider.

With respect to the two sides of the debate, the authors write:

On the one hand, the launch of the brand generic significantly reduces the profitability of the launch by the first generic competitor, who otherwise is often entitled to a six-month window of exclusivity before other generics can enter the market. In addition, the launch of its own generic allows the brand company to increase sales, albeit potentially at the expense of significant profits on its brand product. On the other hand, if the brand company also has patent claims against the generics, its launch of a brand generic might generate additional costs because any damages it might be entitled to recover could be substantially less than it might have recovered had it refrained from launching the brand generic in the first place. Because the brand generic would be a noninfringing alternative to the generic product, lost profits damages could be wholly or partially unavailable and the brand company would have to rely on a lower measure of damages than lost profits. . . . the launch of a brand generic might suggest that the brand company lacks confidence in either the merits of its patent claims or its ability to collect the full measure of damages from generic companies. Alternatively, it could suggest that the brand company is at least partially motivated by other factors, such as reducing the incentives of generic companies to challenge brand company patents.

According to the authors, the practice of launching brand name generics is thought by many generics companys to undermine the Hatch-Waxman Amendments, which made generics more widely available. Passed by Congress in 1984 in order to shorten the generics approval process,
the Hatch-Waxman Amendments enabled generics companies to launch a generic product simply by filing an Abbreviated New Drug Application (“ANDA”), which demonstrated that the generic product is bioequivalent to the brand drug that was already approved. In this manner, generics companies were able to quickly launch generics products, without having to bear the expense of producing safety and efficacy data. The authors go on to say, however, that

[H]aving recently passed the Medicare Modernization Act, it is doubful that Congress will take up again soon the Hatch-Waxman Amendments. Thus, the practice of launching authorized generics during the 180-day exclusivity period likely will remain a key brand company strategy for some time to come.

While the authors present an excellent summary of the issues involved with this debate, as a consumer myself, I wonder why brand name drug companies are pursuing this strategy at all, despite the litigation that is arising out of the generics-brand name disputes. How can companies think it makes good business sense to launch an expensive and then a cheaper version of its own products? While it is true that once a generic is available, some consumers will choose to buy the generic over the brand name product automatically, others will be reluctant to go with a generic simply because it was manufactured by a different company. However, if one company manufactured both versions of the drug, the majority of consumers would without a doubt simply purchase the cheaper version of the medication. In my mind, this practice seems to be a lousy business strategy that is out of sync with common sense. Although from a patent perspective, it may have some valid rationales, but from a business perspective, the brand generics strategy seems to undermine the company’s investment in the brand product.

As for the brand generics strategy itself, I can see why the generics companies dislike it, but I am conflicted as to whether or not it really undermines Hatch-Waxman. Certainly the practice has antitrust implications, but I suspect Congress intended to protect the public with Hatch-Waxman more so than the generics companies. Since the public receives a generic, regardless of whether or not it is a brand product, I don’t see how this undermines Hatch-Waxman. Apparently, however, my view is not a popular one among generic companies. Thus, the debate continues.

Mountain View-based Alza Corporation, a subsidiary of Johnson & Johnson, suffered a blow this week with the ruling by the Northern District of Virginia that Mylan Laboratories’s generic version of the overactive bladder treatment Ditropan XL did not infringe an Alza patent and that the Alza patent itself was invalid as anticipated and obvious.

Mylan was the first generic pharmaceutical company to file an Abbreviated New Drug Application (“ANDA”) for 5 mg and 10 mg of Oxybutynin, the active ingredient in Ditropan XL. Mylan will be eligible for 180 days of market exclusivity after it receives approval from the Food and Drug Administration (“FDA”). Earlier this year, Mylan received tentative approval for the drug from the FDA, which generally means that approval will be granted upon the resolution of any outstanding patent issues.

Alza has already announced that it intends to appeal the decision to the Court of Appeals for the Federal District in Washington, D.C.

The decision comes after Alza initiated another suit earlier this month, along with McNeil-PPC, Inc., against Hayward-based Impax Laboratories, Inc and Andrx Pharmaceuticals LLC in the United States District Court for the District of Delaware, alleging that defendants infringed their patents by seeking to make generic versions of Concerta prior to the expiration of the patents. Concerta is marketed as a treatment for attention deficit disorder (“ADD”) and attention deficit hyperactivity disorder (“ADHD”). The patents were issued in 2005 and cover the administration of the drug methylphenidate hydrochloride in an increasing concentration over a period of time. Plaintiffs argue that defendants’ drugs also cover the administration of the drug in an increasing concentration over a period of time, therefore infringing their patents. Genetic Engineering News has reported that sales of Concerta were $770 million in the 12 months ended in July, 2005.