Budget Unresolved, but Anti-Biotech Bills Blocked
As of midnight September 1st, the California Legislature has adjourned for the year, although the state budget remains to be resolved (see last issue of the Biocommunique). Some policy changes could still be made in the final state budget, but most of the possible changes to law passed this year are now known.
Of particular significance to BIOCOM members is the fact that no legislation considered to be adverse to the interests of the life sciences industry successfully passed both houses of the Legislature this year. Although we do not yet know the disposition of all the bills awaiting Governor Schwarzenegger's signature or veto, we do know what has gone to his desk. It is a major victory that there are no bills which we must request a Gubernatorial veto on.
A quick outline of the disposition of the 24 bills on which BIOCOM took an active position is posted in the "State Legislature" tab of the "Legislative Monitoring" section of the Public Policy portion of the BIOCOM website. Please note that any bill not listed as "To Enrollment" died at some point in the legislative process. After the September 30, 2008, deadline for signing or vetoing bills, a comprehensive list of bills and a summary of BIOCOM's participation in them will be available in the public policy portion of the BIOCOM website
Upcoming Public Policy Events
BIOCOM's public policy staff works to proactively address legislation and policy affecting small, medium and large life science companies. In an effort to help keep you engaged and informed, here is an update on some of BIOCOM’s upcoming public policy events:
Legislative Roundtable with Senator Denise Moreno Ducheny
Wednesday, September 10, 2008
12:00 p.m. - 1:00 p.m.
Senator Denise Moreno Ducheny, BIOCOM’s 2007 Legislator of the Year, will be joining us for an informal roundtable luncheon discussion on September 10th from 12-1.
Click here to register
BIOCOM, IFMA and ISPE Facilities Reception
Thursday, September 11, 2008
5:30 p.m. - 7:30 p.m.
The annual BIOCOM, International Facilities Management Association (IFMA) and the International Society for Pharmaceutical Engineering (ISPE) Facilitities Reception is geared towards facility managers and service providers but is open to all BIOCOM, IFMA and ISPE members. This is a relaxed evening to mingle with other facility managers and enjoy interaction with other organizations.
Click here to register
Suits and Surfers: An Uncommon Alliance for a Common Goal
Wednesday, September 24, 2008
5:30 p.m. - 8:30 p.m.
In San Diego water is too precious a resource to be used just once. Using recycled water is cost-effective, reliable and good for the environment. Join us to discuss this important issue. Click here to register
6th Annual BIOCOM PAC Legislators and Candidates Reception
Wednesday, October 1, 2008
5:30 p.m. - 7:30 p.m.
This reception provides a unique opportunity for members of the life science industry to join together to become better acquainted with elected officials and candidates, and get face-to-face with some of the most influential leaders in San Diego.
Click here to register
IP Update: Generic Companies Can't Sue Innovators for Infringement
It is not uncommon for a company making and selling a product to want to remove the cloud of a potential patent infringement suit by suing the patent holder in a declaratory judgment (DJ) action. Being first to bring suit confers certain strategic advantages. However, there has to be a “case or controversy” to bring such a suit. Recent case law has refined the requirements that define this.
In Prasco LLC v Medicis Pharmaceutical Corp. and Imaginative Research (Fed. Cir. 2008) a generic drug maker sought to remove the risk of a patent infringement suit by the brand drug maker by filing a declaratory judgment suit.
Imaginative Research owns patents relating to a prescription strength benzoyl peroxide wash. Medicis, the exclusive licensee, sells the product under the brand name TRIAZ and the box containing the drug is appropriately marked identifying the licensed patents. Prasco makes a generic version (OSCION).
The district court dismissed the case for lack of jurisdiction. Appealing to the Court of Appeals for the Federal Circuit (CAFC), Prasco argued that jurisdiction exists because the defendants (1) marked the competitive product and (2) Medicis had previously sued Prasco over a different patent and product. The defendants also refused to sign a covenant not to sue. Prasco admitted, however, that the defendants were unaware of the competitive product prior to receiving the complaint.
In MedImmune v. Genentech, the Supreme Court replaced the CAFC’s original test for DJ Jurisdiction requiring a “reasonable apprehension” of imminent litigation with a new “substantial controversy . . . of sufficient immediacy” test. The CAFC affirmed that Prasco’s controversy failed the new test and that DJ jurisdiction does not exist “without some affirmative act by the patentee” (as opposed to a “subjective or speculative harm”). In addition, the court found that the marking of “products with the applicable patents provides little, if any evidence that [the patentee] will ever enforce its patents.”
Therefore, a generic drug maker cannot sue for non-infringement simply because the patent holder sells a branded competitive product.
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.