2010 California Biomedical Industry Report
PricewaterhouseCoopers LLP and CHI have released the 2010 California Biomedical Industry Survey Report. Here is a link to the Report: http://www.chi.org/basicpage.aspx?id=6704
BIOCOM Acknowledged for Water Advocacy
BIOCOM and other Indirect Potable Reuse (IPR) Coalition partners have received the Special Recognition Award from the California WateReuse Association. The award was given for the group’s advocacy efforts to support water reuse, particularly indirect potable reuse, in San Diego. The IPR Coalition was formed over a year ago, with the goal of getting the IPR Pilot Project through. Its membership includes a diverse group, ranging from business industry representatives to environmental groups (for a complete member list see below).
The California WateReuse Association is a nonprofit organization whose mission is to advance the beneficial and efficient use of water resources through education, sound science, and technology using reclamation, recycling, reuse and desalination for the benefit of our members, the public, and the environment.
BIOCOM has been a longtime supporter of IPR and diversifying Southern California’s water portfolio, so that we can become water independent. Given the current water shortages it is critical that our region explore all avenues to increase our water supply and sources.
Other coalition members include: San Diego Regional Chamber, San Diego County Taxpayers Association, San Diego Coastkeeper, Surfrider Foundation, San Diego Chapter, Coastal Environmental Rights Foundation, Building Office Managers Association, San Diego Chapter, Friends of Infrastructure, Citizens Coordinate for Century Three, Industrial Environmental Association, San Diego and Imperial Counties Labor Council, San Diego Audubon Society, and National Association of Industrial and Office Properties, San Diego Chapter.
Congress Approves Temporary Extension of SBIR Program
The House of Representatives and Senate have both passed legislation that would temporarily extend the Small Business Innovation and Research program through April 30, 2010. Both the House and Senate passed the extension by an overwhelming majority. Congress has attempted to reauthorize the program for several years. However, fundamental policy differences have led to temporarily reauthorizations to continue funding the programs.
In 2003, the Small Business Administration implemented a rule change which restricted eligibility to non-venture capital majority owned firms. Since that time, the number of innovative medical technology companies applying for grants has significantly decreased. MDMA has advocated for a repeal of this rule so that medical device companies with majority venture-ownership to once again compete for SBIR grants.
http://www.prnewswire.com/news-releases/senate-approves-extension-of-sba-programs-82990762.html
FDA Unveils Transparency Initiative
The Food and Drug Administration recently announced the first phase of its transparency initiative. The goal of the initiative is to provide the public a better understanding of the agency’s decision making process and operations. FDA leadership has stated that it intends to make the agency more user-friendly to the public.
In 2009, as part of the initiative, MDMA submitted comments to the Transparency Task Force. MDMA used the opportunity to highlight some of the transparency issues associated with the panel process for device reviews. Specifically, MDMA recommended that the agency restructure the panel process to increase transparency by requiring anonymous and simultaneous voting on approvals, requiring panelists to certify they have read panel materials, focusing only on questions and issues germane to the review of the product, and several other key recommendations.
The FDA will be holding two public hearings regarding the medical device approval processes on February 9 and February 18
Information on the February 9 meeting can be found here:
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm191579.htm
Information on the February 18 meeting can be found here:
http://edocket.access.gpo.gov/2010/2010-1620.htm
Health Care Reform Update
The White House released its health care reform proposal on February 22nd. The proposal keeps intact many features found in the December 24, 2009 approved Senate bill, with the exception of the public option, employer mandate, and there is no mention of a specific data exclusivity period for biosimilars.
As Congressional leaders weigh various options, some public policy experts are suggesting the President wants a bill passed before March 18. Sources say this would be done by moving forward the Senate approved bill by a simple majority in the House, where 218 votes would be needed for approval, then the bill would go back to the Senate for a final vote.
Reconciliation rules in the Senate require 51 votes for approval, and any legislation that moves through the Senate reconciliation process must be a budgetary item that reduces the deficit within 5 years of its passage.
With Democrats divided, many observers are increasingly pessimistic about the prospect of a health reform bill being signed into law this year. Other experts suggest the House may consider moving forward pieces of the Senate approved reform over the course of the next several months by offering a la carte bills that incorporate elements of reform. A mandatory House Democratic Caucus meeting has been scheduled for March 11 at 10 am. The Caucus plans to strategize health care legislation process and review.
Leahy, Sessions, Hatch, Schumer, Kyl, Kaufman Unveil Details of Patent Reform Agreement
Leaders of the Senate Judiciary Committee on March 4, announced details of an agreement on long-pending legislation to make needed reforms to the nation’s patent system.
This is the third consecutive Congress in which Senator Patrick Leahy (D-Vt.), the chairman of the panel, and Senator Orrin Hatch (R-Utah), a former committee chair, have introduced patent reform legislation. A majority of the Committee advanced the legislation last April. In the months since, Senators Leahy, Hatch, Sessions (R-Ala.), the Committee’s ranking Republican, Schumer (D-N.Y.), Kyl (R-Ariz.), and Kaufman (D-Del.) have continued to work toward an agreement to make the legislation ready for Senate consideration.
“With this agreement, we are closer than ever to advancing patent reform legislation through the Senate,” Leahy said in a written statement. “Senator Hatch and I have worked through many Congresses to make meaningful reforms to the nation’s patent system, and I appreciate his commitment to this effort. This compromise may not be everything that everyone wants, but it makes important reforms to the outdated patent system. Strengthening American patents will improve the quality of our inventions and innovations, which will translate into jobs and economic growth in Vermont and across the country. Congress is committed to strengthening our economy, and the Patent Reform Act is an important component of that effort. I hope the leaders will soon schedule floor time for this important legislation.”
“This important bipartisan agreement would institute reforms that significantly streamline and strengthen the U.S. Patent System,” Sessions said in a statement released by Leahy’s office. “In doing so we are strengthening our ability to protect Americans’ ideas and inventions—developments that have done, and will continue doing, so much to improve and to enrich the world. These reforms would guard individuals, small businesses, and universities from frivolous legal challenges and help prevent abuse of the administrative process. They would also provide greater clarity and cut red tape that needlessly wastes time, money, and resources. American innovation goes to the heart of our economy, and our success as a nation must be protected. I urge the Senate to consider and act on this legislation and hope these needed reforms will soon be signed into law."
“Senator Leahy has worked tremendously hard to get this proposal where it is today and he should be commended for it. This bill doesn’t include all the changes I originally sought, but I believe we must come together to reform our patent system,” Hatch said in the press release “It’s the right thing to do. If the United States is to maintain its position at the forefront of the world’s economy and continue to be the global leader in innovation, then we must have an efficient and streamlined patent system. As this legislation moves forward, the full Senate will have an opportunity to weigh in, make changes and see if we can garner even greater support for this proposal.”
The proposed agreement makes changes to first-window post-grant review, inter parties review, willfulness, interlocutory appeals, Patent and Trademark Office funding, and supplemental examinations. The agreement retains several critical improvements in the Committee-reported bill, including the transition to a first-inventor-to-file system, the gatekeeper compromise on damages, the new district court pilot program, and more. The full text of the substitute amendment is available online.
Leahy and Hatch introduced the Patent Reform Act in March 2009. The legislation proposes the first major reforms to the nation’s patent system in more than 55 years. The bill makes needed updates to the system to improve patent quality and increase certainty among parties in litigation.
Since the Judiciary Committee reported the legislation to the full Senate for consideration, industries and stakeholders from all sectors of the patent community have urged action on the legislation.
It’s Coming! Sign Up for Construction Alerts Before Terminal 2 Construction Starts in March
Get ready for an improved airport! Beginning in March, travelers to/from San Diego International Airport will notice construction activity in front of Terminal 2 related to The Green Build, the largest project in the airport’s history.
To accommodate construction activity on the dual-level roadway at Terminal 2, some parking will be temporarily relocated and the pedestrian bridges will be removed. Frequent shuttles will transport travelers from relocated parking areas to the terminals.
The Airport Authority has set up several ways to receive timely information about activity that could potentially impact travel time to the airport. To receive e-mail alerts, please complete the online form. Or, you can follow the airport on Twitter (@SanDiegoAirport) or become a Facebook fan.
The Authority wants to be sure that all travelers are informed about this activity. Please forward this e-mail to your staff, friends and family who may be interested in signing up for these updates.
The Green Build will bring a number of long-awaited upgrades for passengers traveling in and out of San Diego International Airport. All travelers – whether visiting San Diego County on vacation, traveling on business or headed out of town on holiday – will reap the benefits of these improvements. Travelers can expect to take advantage of the finished facilities in 2013.
You can find additional information about The Green Build at www.san.org, or call the construction hotline at (619) 400-2288 and someone will respond within one business day.
The Green Build Highlights:
- 10 new jet gates at Terminal 2
- A dual-level roadway at Terminal 2
- New, expanded dining and shopping options
- More comfortable waiting areas at the gates
- Increased number of security lanes
- Additional aircraft parking
Legislature Poised to Make Budget Cuts
As reported in the last Biocommunique, in January Governor Arnold Schwarzenegger released his proposed budget for the 2010-2011 fiscal year. This budget seeks to address a projected $20 billion shortfall in revenues, and although the Governor’s budget may not resemble whatever is ultimately signed, the state budget will almost undoubtedly impact the life science industry.
The Legislature appears to be preparing this week to cast votes on how to close some of this shortfall, and an issue of critical importance to the life science industry has become a key point of contention. The Sacramento Bee, reports that the Governor is balking on a key component to the Democrats’ plan, a reduction in the percentage of net operating losses (NOL’s) companies can use to offset current year tax liabilities to 68 percent for tax year 2010. NOL’s are particularly important to companies just entering profitability, as life science companies incur large operating losses for many years before they become profitable.
The Democratic proposal seeks to change a key element of the February, 2009, budget compromise in which utilization of NOL’s was suspended for two years in return for conformity to the federal standard of 20 years in which to employ them (up from 10 years). It remains unclear whether the Democrats will head back to the negotiating table with the Governor or pass the measure as currently constructed.
Please keep an eye on the BCQ to keep current on the state budget as it progresses through the process.
Relationship Survey: Gauging the Health of Your Relationship with the FDA
In an ideal world, everyone would have a strong and positive relationship with the FDA. With that as a goal, PricewaterhouseCoopers LLP and BIOCOM have launched their fifth survey –Improving America’s Health V Survey – to gauge the working relationship between the life sciences industry and the FDA. Your feedback is important to make this survey a success. To participate, please send an email to PricewaterhouseCoopers.and.BIOCOM@us.pwc.com with “Life Sciences FDA Survey” in the subject line. A survey will then be forwarded to you. The survey should take only 15 to 20 minutes to complete. All responses to the survey will be kept confidential and private.
Those who participate in the survey will receive a preview copy of the results prior to their public release. The survey will close on Feb. 26. Please help foster improved relations between our industry and the FDA. A copy of the last survey report can be accessed here.
Key Changes to Current Law Made By the Managers’ Amendment to S. 515, The Patent Reform Act
The Patent Reform Act aims to keep America in its longstanding position at the pinnacle of innovation. The U.S. patent system has not been updated significantly in more than 55 years. In the intervening years, our economy has changed dramatically. A well functioning and efficient patent system is critical to American invention and innovation, which are the cornerstones of our economy and job creation.
The bipartisan Managers’ Amendment makes the following changes to current law:
* Transitions the U.S. to a first-inventor-to-file system, which will simplify the application system and harmonize it with our trading partners, reduce costs, and improve the competitiveness of American inventors seeking protection globally;
* Makes important changes to improve patent quality, including by allowing third parties to comment on pending patent applications and explain to the PTO why certain prior art is relevant and by establishing a new, first-window post-grant review proceeding to weed out a patent that should not have issued during the first year after the patent is granted;
* Improves the current system for administratively challenging the validity of a patent at the PTO throughout the life of the patent by transitioning from a reexamination model to an oppositional model which the PTO can complete in 12 months, while also preventing challengers from abusing the inter parties process or pursuing unmeritorious claims, and removing uncertainty from the system that has impeded its use.
* Includes a more robust, procedural, gate keeping role for the court, pursuant to which judges will assess the legal basis for the specific damages theories and jury instructions sought by the parties. The gate keeping provisions will ensure consistency, uniformity, and fairness in the way that courts administer patent damages law. The damages section will also provide more certainty for parties in the standard for increasing damages for willful infringement;
* Creates a supplemental examination process to incentivize patent owners to commercialize their inventions despite potential flaws in the application process; and
* Authorizes fee setting authority for the PTO Director to ensure the PTO is properly funded and can reduce the backlog of patent applications, but mandates a reduction of fees by 50% for small entities and 75% for micro-entities.