New City Council Member Sworn In
An inauguration ceremony was held at the City of San Diego's Golden Hall Monday, December 8, 2008. Mayor Jerry Sanders was sworn for a second term, along with newly elected city officials: Attorney Jan Goldsmith and City Councilmembers Sherri Lightner, Todd Gloria, Carl DeMaio, and Marti Emerald.
Here is some information on our new City Attorney and City Councilmembers:
San Diego City Attorney: Jan Goldsmith
San Diego City Attorney Jan Goldsmith identifies the role of the City Attorney as that of being akin to the corporate counsel to City of San Diego. During his Campaign for City Attorney, Judge Goldsmith pledged to improve the relationship with the Mayor and Council to best represent the corporation that is the City of San Diego. BIOCOM endorsed Goldsmith for City Attorney and is confident Goldsmith will be successful at forging a more effective working environment with the Mayor and Council while still effectively representing the citizens who elected him to office.
San Diego City Council District One: Sherri Lightner
Over the years, Lightner was an active District One community leader serving on multiple community planning organizations and community associations. She served as President of the La Jolla Town Council (LJTC) and La Jolla Shores Association (LJSA), and as the Secretary of the La Jolla Community Planning Association (LJCPA). Sherri graduated from the University of California at San Diego (UCSD), and is a licensed Professional Mechanical Engineer. When Sherry visited us here at BIOCOM, she felt right at home. Her connection to BIOCOM? Sherri Lightner's husband's office space was once located in BIOCOM’s current facility.
San Diego City Council District Three: Todd Gloria
As the former employee of Health and Human Services and District Director for Congresswoman Susan A. Davis, Councilmember Todd Gloria has a long working relationship with BIOCOM’s Public Polity Department. Councilmember Gloria’s professional work in government has been recognized by numerous organizations, including the San Diego Mediation Center, the Greater San Diego Business Association, the HIV Consumer Council, and he was named a 1999 Harry S. Truman Scholar. He graduated summa cum laude from the University of San Diego.
San Diego City Council District Five: Carl DeMaio
On June 3, 2008 Carl DeMaio was elected to the San Diego City Council to represent District 5. Prior to winning his seat on the City Council, DeMaio was best known in San Diego as a City Hall watchdog. His pledge to the City of San Diego includes balancing the budget, reforming the pension system, fixing infrastructure, and restoring accountability to every level of City government.
San Diego City Council District Seven: Mari Emerald
Councilmember Marti Emerald spent the last 26 years in San Diego as a broadcast journalist, beginning her work as an investigative reporter with 10News in 1985. Marti graduated Magna Cum Laude with a Bachelor of Science degree from National University, taking night classes after work. She was honored as Alumnus of the Year in 2005 because of her many contributions and leadership in the San Diego region. Marti Emerald’s connection to BIOCOM includes her participation in BIOCOM’s Water Forum: Suites and Surfers.
BIOCOM is confident that all of our newly elected City Officials have the analytical skills it will take to help move our City forward in a challenging time. BIOCOM leads the advocacy efforts of the life science community in Southern California with more than 550 members including biotechnology and medical device companies, universities, and research institutions. BIOCOM is actively engaged in ensuring that the life science industry remains a strong and growing sector of San Diego’s economy.
Region Facing Major Water Shortages
Many of you may have seen on the news recently that the City of San Diego has passed a new Drought Ordinance. Not since the early 1990’s has the greater San Diego region faced such an imminent water shortage, one which could lead to mandatory water conservation measures within a fairly short time frame. Many of you may be wondering how we got here and didn’t we already fix this problem once? Due to environmental stresses, extremely dry conditions and court ordered pumping restrictions on the State Water Project our imported water supply from Northern California has been drastically reduced. The City of San Diego purchases 85-90 percent of its water from the San Diego County Water Authority (CWA), which in turn purchases it from the Metropolitan Water District (MWD) of Southern California. MWD, from which the CWA purchases the majority of its imported water, has lost about 250,000 acre feet due to the pumping restrictions. It is not clear how long these restrictions will be in place, but it is expected that Southern California water supplies will be affected for at least the next several years.
The region’s water supplies remain impacted by extremely dry conditions around California. Over the last year, these conditions have significantly reduced water levels in key reservoirs, as well as exacerbated an eight-year drought in the Colorado River basin. The 2007-2008 Northern California winter snow pack was two-thirds of normal, while runoff was forecasted to be 55 percent of normal. These conditions made making this past spring the driest on record for Northern California. Meanwhile, the Colorado River basin watershed sits at half-capacity.
In view of this, the City of San Diego, in cooperation with the CWA, has continued to evaluate current-year water demand and supply requirements and has been encouraging increased conservation by all its water customers. In response to the supply situation, the Mayor recommended and the City Council approved the San Diego Drought Ordinance which will go into effect January 1, 2009. The Drought Ordinance is a four-level response to water shortages. We are currently at Level 1, “Drought Watch Conditions” which is a voluntary reduction of 10 percent.
We all have heard the commercials encouraging San Diegans to take the “20 Gallon Challenge” and reduce their water consumption each day by 20 gallons. It was calculated by the San Diego County Water Authority that if each individual would reduce their water intake by 20 gallons per day, San Diego could reach its 10 percent voluntary water reduction. Unfortunately, we have only reached 60 percent of the goal. This means that unless we have an unseasonably wet winter we will move into Level 2, “Drought Alert Condition” with a mandatory cutback of 20 percent and possible enforced water allocations. The allocation methodology has yet to be worked out by City staff. BIOCOM will be participating in the allocation development process to ensure the fairest possible outcome for the local life science industry. For more information on the Ordinance and the underlying situation, please visit: http://www.sandiego.gov/water/conservation/index.shtml
http://www.voiceofsandiego.org/articles/2008/11/11/news/water111108.txt
Point Loma Plant Granted Clean Water Waiver
Last week the U.S. Environmental Protection Agency (EPA) granted the City of San Diego a five-year waiver of Clean Water Act standards, which would have required the implementation of secondary treatment at the Point Loma Wastewater Treatment Plant (PLWTP).
This means that the EPA will continue to allow PLWTP to treat roughly 175 million gallons of wastewater per day generated by more than 2.2 million residents. The waiver will also save San Diego ratepayers $1.5 billion dollars, at least temporarily, the estimated cost to upgrade the treatment plant. Through a combination of factors, including industrial source control, Advanced Primary Treatment of wastewater, a deep ocean outfall and comprehensive environmental monitoring, both the Environmental Protection Agency and the Regional Water Quality Control Board agreed that the Point Loma Wastewater Treatment Plant does not adversely affect the oceanic ecosystem and does not need to be upgraded at this time.
The City requested the waiver based on findings of a Scientific Technical Review Committee, who reviewed environmental data collected from an ocean monitoring program associated with the Point Loma Wastewater Treatment Plant. The data indicated that the treatment plant does not have a detrimental impact on the ocean environmental surrounding the outfall pipe, which lies 41/2 miles in the ocean. The EPA reviewed the findings and agreed with the City’s assessment and thus granted the waiver.
The Point Loma Wastewater Treatment Facility has been a contentious issue in San Diego for many years. As water becomes scarcer. many people are questioning how little of San Diego’s wastewater is reused. Mayor Jerry Sanders has met with local environmental groups to discuss the limitations on upgrading the Point Loma Facility and future of the City’s wastewater treatment infrastructure. The City is committed to finding a viable, financially sound solution.
The EPA’s decision and the draft permit for renewal is available for public comment through January 28th. A public hearing, conducted by the EPA and the San Diego Regional Water Quality Board, will be held on January 21, 2009 at 9:00am located at 9771 Clairemont Mesa Blvd, Ste A, San Diego CA. For more information on the Point Loma Wastewater Treatment Plant: http://www.sandiego.gov/mwwd/facilities/ptloma.shtml
Medical Device Updates from MDMA
Key Leadership Changes in Washington
President-Elect Barack Obama has selected Former Senate Majority Leader Tom Daschle to run the Department of Health and Human Services. Daschle, a veteran of health policy, will face a confirmation hearing likely in the early months of 2009. Leaders on the Senate Committee on Finance have indicated that Mr. Daschle will likely receive a favorable confirmation process.
President-Elect Obama has also tapped current Congressional Budget Office (CBO) Director Peter Orszag to lead the Office of Management and Budget. Prior to the CBO, Orszag served as a health policy expert at the Brookings Institute and served in the Administration of President Bill Clinton as a special assistant to the President at the National Economic Council.
In Congress, a contentious leadership battle at a key Committee in the House of Representatives has concluded with Congressman Henry Waxman (D-CA) assuming the Chairmanship of the Energy and Commerce Committee. The Committee has substantial jurisdiction over many important issues of interest to device manufacturers including legislative authority over the Food and Drug Administration, Medicaid and other areas. Waxman replaces Congressman John Dingell (D-MI).
R&D Tax Credit Extension Passes
As part of a financial recovery package, Congress passed the extension of the R&D tax credit; a vital tax provision for innovative companies investing in research and development. President Bush signed the legislation into law a few hours later. The new law includes a 2 year seamless extension of the R&D tax credit for 2008 and 2009, and increases the Alternative Simplified Credit rate to 14% in 2009.
Congress Approves Additional FDA Funding
Congress passed a continuing resolution in September intended to temporarily fund government operations until official appropriations are agreed upon. Included in this appropriation was additional funding for operations at the FDA. Specifically, the Agency will receive an additional $150 million in Fiscal Year 2009. The FDA will, in total, receive approximately $300 million more over 2008 appropriation levels.
As a member of the Alliance for a Stronger FDA, MDMA has worked with other stakeholders to lobby the Hill for additional funds. To learn more visit, http://www.marketwatch.com/news/story/fda-funding-increase-tough-budget/story.aspx?guid=%7b25157769-1112-4FD1-93B1-E74A4A5A117A%7d&dist=hppr
Finance Committee Chairman Releases Health Reform Agenda
Senator Max Baucus, Chairman of the US Senate Committee on Finance, released his plan for health care reform in the 111th Congress. The agenda entails broad-based initiatives for health reform in Federal health care programs including expanding access to health care coverage to the uninsured, controlling costs, and improving quality. The plan includes several areas of interest to device manufacturers including proposals on comparative effectiveness, physician-manufacturer relationships, and gainsharing.
The Baucus plan can be found here:
http://finance.senate.gov/healthreform2009/finalwhitepaper.pdf
CMS Releases OPPS, Physician Fee Schedule Rules
In October, CMS released both the Hospital Outpatient Prospective Payment System (OPPS) and Physician Fee Schedule (PFS) Final rules. CMS did not finalize its proposals regarding the gainsharing exception and potentially misvalued services under the Fee Schedule. MDMA argued that the gainsharing proposed exception was problematic for several reasons including that it would implicate the civil monetary statute by potentially patient harm and access to treatments. In addition, MDMA argued that any exception to the program should not be considered until CMS completes the six hospital gainsharing demonstration as mandated by the Deficit Reduction Act of 2005. Regarding the Fee Schedule Final Rule, CMS did not to finalize its proposal to use Internet-based pricing to determine Relative Value Units (RVU). MDMA argued that pricing information from this medium has the strong potential to be inaccurate, causing RVUs to be significantly undervalued, potentially discouraging future medical technology innovation in this particular space.
IP Update: Managing Your IP in These Challenging Financial Times
“Intellectual property is the crown jewel of my company.” Every biotech executive says so. But how do we protect these critical assets when financial constraints confront our companies? We want to conserve resources where it makes sense, but we don’t want to compromise future product opportunities.
Here are three basic steps to take:
Start with an IP Audit. This will allow you to identify your IP inventory and the expenditures associated with each item. You may be surprised to find some unnecessary items on the list; you may also identify some critical gaps that need filling. Perhaps you are maintaining prosecution on an abandoned drug candidate? Perhaps you haven’t adequately protected important aspects of your product, such as the route of synthesis, specific formulations, etc.
Schedule IP reviews in project teams. This will allow you to identify and prioritize inventions that need attention now. While it may seem counterintuitive to actually initiate spending on new filings now, it takes years to get an examined and issued patent. By then the economic picture may be much improved. Also, your competitors may be hot on your heels. Such reviews may reveal the availability of useful new information, e.g., that your development team has new data to support claims for method of treatment; that your CMC team has optimized the synthesis and you need to file for protection; etc.
Realign your IP strategic plan with your business plan. Business plans change and this chaotic environment may be forcing more changes than anticipated. Perhaps the competitive environment has changed and you need to adjust your IP strategy to match. Perhaps you need to adjust the global reach of your IP in light of those changes. Now more than ever, it is crucial to maintain alignment of your business, project, and IP goals.
You are expecting to survive this downturn. Be certain that your IP will not only survive, but will be well positioned to protect the products you are developing.
The BIOCOM IP Committee urges you to contact your IP professional to discuss proper management of your IP.
Submitted by BIOCOM's Intellectual Property Committee, by Bernie Greenspan with Les Overman and Stephen Reiter. This article is the opinion of the authors and not of their respective employers.
Please send your comments or suggestions to BiocomIP@gmail.com.
Life Science Industry Pursues Net Operating Loss Tax Benefit Changes
"Biotechnology industry executives plan to visit Congress on Wednesday to ask for a temporary change in the tax law that would let money-losing companies get cash from the government now, in exchange for tax credits they would pledge not to take if they eventually become profitable. The change, if Washington approved of it, could enable the industry to receive potentially hundreds of millions or even billions of dollars, on the condition that the money would be used for research and development." Please click here to read the entire New York Times article, "For Biotech, a Tax Break Spells Hope" from which the preceding excerpt was taken.