Congresswoman Davis Visits BIOCOM
Last week BIOCOM hosted Congresswoman Susan Davis to our monthly Legislative Roundtable series. Congresswoman Davis represents California's 53rd Congressional District, which encompasses much of the City of San Diego, Coronado, Imperial Beach, part of La Presa and Lemon Grove. The congresswoman serves on the House Armed Services Committee as chairwoman of the subcommittee on mlitary personnel. She also sits on the House Education and Labor Committee and the House Administration Committee. This month's discussion focused on National Institutes of Health (NIH) funding, intellectual property (IP) and foreign drug importation.
At the beginning of July, Congresswoman Davis demonstrated her dedication to further science innovation by co-signing a bipartisan letter urging a "robust investment" in the National Institutes of Health (NIH) funding the upcoming appropriations cycle. Congresswoman Davis shared with BIOCOM members that she has had young scientists visit her office letting her know that they cannot get government grants to pursue their research. This concerns her greatly because she knows how competitive the global market is and that American scientists are recruited by other nations where they are promised greater funding. She believes that is very critical to continue innovation in the United States and understands that providing grants via NIH funding is the tool to keep creativity flourishing.
Attendees also talked with Congresswoman Davis about the importance of having strong patent laws and thanked her for supporting BIOCOM's position by voting against H.R. 1908, the Patent Reform Act of 2007, which would radically alter the current patent process. To develop a single new drug and bringing it to market takes on average 12-15 years and costs $1-1.5 billion. If the IP around the compound is not protected, life science companies would never be able to get funding for their research. BIOCOM members urged the congresswoman to continue to strengthen the patent system.
With both presidential candidates stating that they would support foreign drug importation, BIOCOM members expressed their concerns with the safety of these drugs. At current levels of funding, the FDA does not have the resources to regulate imported drugs. Congresswoman Davis told attendees that public perception needs to be changed, especially with the senior demographic. The general public does not understand why other nations get American developed drugs at such a discounted rate. BIOCOM members explained that other nations receive our drugs at a lower cost because they are essentially subsidized by our citizens in that prices in the United States must make up for the below cost reimbursement given by some other countries. The pharmaceutical and life science industry has created many discount drug programs for seniors to obtain the medications they need. For a comprehensive list visit: http://www.cahealthadvocates.org/drugs/resources.html.
BIOCOM would like to Congresswoman Davis for taking time to visit with our members. We would like to encourage all BIOCOM members to join us for our Legislator Roundtables and come share your concerns with your elected officials.
Green Tip: Watch what and how you eat
Many of us do not hesitate to grab a paper plate (or gasp a Styrofoam plate, which will never decompose) or plastic silverware to eat our lunch at the office. According to the US Environmental Protection Agency, "US residents, businesses, and institutions produced more than 251 million tons of solid waste per year, which is approximately 4.6 pounds of waste per person per day." Reduce your waste by making it a habit to bring your own mug and dishware for those meals you eat at the office. Encourage your company to provide reusable dishes, silverware, and glasses.
State Budget Impasse Continues
As you probably know by now, the California Constitution requires a budget to be passed and signed by the Governor by June 30. There are, however, no penalties to the Legislature or Governor for failing to meet this deadline. California requires a 2/3 "supermajority" vote to pass the state budget; with the current composition of the Legislature, that means if all Democrats vote for the budget, at least 6 Republicans in the Assembly and 2 Republicans in the State Senate must also vote for the budget. It would not be an exaggeration to say that negotiations between the parties, such as they are, have been unusually acrimonious and unproductive this year, at least to this point. The Republicans and Democrats have both proposed budget solutions they know are unacceptable to the other party - in the case of the Democrats, some in their own caucuses have expressed reservations about the proposals put forward.
The Democrats in the State Assembly did put a budget proposal up for a vote on Sunday, August 17. This proposal failed on a 45-30 vote, with one Democratic member absent and one abstaining. The plan would have raised the personal income tax rate for households earning more than $321,000 to 10 percent and those earning more than $642,000 to 11 percent, an increase from the current 9.3 percent. It also would have suspended use of NOL (net operating loss) carry-forward for two years, although they would continue to accrue. The plan would have used program cuts and accounting shifts to account for the rest of the state's $15 billion budget shortfall.
Governor Schwarzenegger has proposed a plan with a temporary 1 percent sales tax increase for three years, associated with a future spending cap and "rainy day fund" designed to avoid such crises in the future. Outlines of the legislative plans can be found at this link:
http://www.cbp.org/documents/080613_BudgetComparisonSide-by-Side.pdf, while a summary of the Governor's plan can be found at http://www.gov.ca.gov/index.php?/fact-sheet/10443/.
As of this writing, negotiations continue but resolution does not appear to be on the immediate horizon.
IP Update: A Little More Fine Tuning Of The FDA Exemption To Patent Infringement
In Merck v. Integra, the Supreme Court of the United States (SCOTUS) held that activities that would normally be considered to infringe a patent would be excepted if the activities are "solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products." SCOTUS interpreted this safe harbor exception rather liberally – asserting that it was not limited to use of a patented method or product in clinical trials only, but also applied to preclinical research. However, the Court, in a footnote, specifically declined to determine the applicability of this safe harbor to patents for research tools.
In Proveris Scientific Corp. v. Innovasystems, Inc., decided August 5, 2008, the Federal Circuit (CAFC) tackled this issue. Proveris Scientific's patent is directed to a system and apparatus for characterizing aerosol sprays (as commonly used in drug delivery devices, e.g., nasal spray pumps and inhalers). Innova used an apparently infringing device in order to characterize a drug product for FDA regulatory approval. The CAFC discussed the safe harbor as a correction by the Hatch-Waxman Act for a "second distortion" in the drug approval process - by reducing the de facto extension of market exclusivity innovator companies otherwise had as a result of delayed approval of generic drugs. This correction allowed generic companies to develop otherwise infringing products in order to compete with the innovator company immediately after patent expiration. The CAFC held that because the Proveris Scientific device "is not subject to FDA premarket approval, and therefore faces no regulatory barriers to market entry upon patent expiration, Innova is not a party who, prior to enactment of the Hatch-Waxman Act, could be said to have been adversely affected by the second distortion. For this reason, we do not think Congress could have intended that the safe harbor of section 271(e)(1) apply to it. Put another way, insofar as its OSA device is concerned, Innova is not within the category of entities for whom the safe harbor provision was designed to provide relief."
The next question to be considered regarding the applicability of this safe harbor may be about research tools that can also be the regulated product, such as a monoclonal antibody.
Submitted by BIOCOM's Intellectual Property Committee, by Les Overman with Stephen Reiter and Bernie Greenspan. This article is the opinion of the authors and not of their respective employers.
Please send your comments or suggestions to BiocomIP@gmail.com.
Sorrento Valley Shuttle Faces Rate Increase
Funding for the Sorrento Valley Coaster Connection has been lost forcing the Metropolitan Transit System (MTS) to implement a $1 fare in September. The long-term viability of this service is in jeopardy. A number of local companies are working with MTS on a public/private partnership to sustain the service. If your employees use the Coaster Connection, or you provide a private shuttle service, please contact Reed Vickerman at Amylin Pharmaceuticals (858) 642-7024 / rvickerman@amylin.com to find out more about the proposed plan. The Coaster and Connection are critical to the economic health of the Sorrento Valley/UTC area, help us insure their survival.