Water Allocation Plan to Impact Industry
For the last several months, BIOCOM has worked with a coalition including the Mayor and representatives of the City Water Department to come up with a viable water allocation methodology for City of San Diego businesses. Historically our industry has been a leader in water conservation, the use of recycled water and supportive of finding new water sources. While the Water Allocation Methodology will require our industry, which has been on the forefront of implementing water efficiency measures, to further conserve; it is understood that due to the drought all San Diegans must do their part and conserve further.
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After receiving input from various groups including BIOCOM, the City proposal reflects changes made as a result of our feedback. The City’s modified indoor reduction of 3% for commercial water use will help to mitigate the economic impact of cutbacks to the life science industry. Some other positive changes have occurred with the water allocation variance process, which now takes into account many of the life science industry’s concerns, such as: process water, past conservation credits and the ability to aggregate between different meters. Our hope is that the new four-month billing cycle (previously two-month) to calculate allocations will account for the life science industry’s highly variable water use. We have found the City’s commitment to review and resolve water allocation variance applications within 30 days reasonable.
BIOCOM is continuing to work with the City on defining process water and developing Allocation Variance water efficiency practices (best management practices). The Water Allocation Methodology is slated to go before City Council next month.
For more information please see the links below:
The Mayor held a press conference this week and following is the link to both the Press Fact Sheet and the Report: http://www.sandiego.gov/mayor/news/index.shtml
City’s Water Emergency Website: www.sandiego.gov/wateremergency
You can find the Water Allocation Methodology Report on the City Council Committee Meetings website (under NR&C) http://docs.sandiego.gov/ccagenda_nrc/n090325.pdf
For tips on water conservation, visit the San Diego County Water Authority’s website: http://www.20gallonchallenge.com/
SANDAG makes recommendations for Federal Highway Stimulus funds
SANDAG staff has recommended $127 million in federal highway stimulus funds that come to the San Diego region be shared, with 60 percent going to highway projects and 40 percent divided between the 18 cities and the county. To accomplish that goal, the vast majority of the funds will be concentrated on two large highway projects, thereby freeing up other regional money to be spent on a long list of local projects in need of funding.
The recommendations include the following:
Set aside $105 million in economic stimulus funds for the widening of the 5.5 miles of State Route 76 between
Melrose Drivein the City of Oceanside to
South Mission Roadin Bonsall. Federal stimulus funding will ensure that work on the long-awaited project begins quickly.
Direct $18 million in federal highway stimulus funds to the I-805/Carroll Canyon Road widening project in the city of San Diego.
Direct $4 million to a Transportation Enhancement-eligible regional project –the Grossmont Station Pedestrian Enhancement Project.
Reprogram approximately $49 million in local TransNet half-cent sales tax fundsto a fund for distribution to all 18 cities and the county government for use on high priority local transportation projects. This will allow those projects to move forward expeditiously.
Reprogram approximately $74 million in local TransNet half-cent sales tax andother regional funds to other TransNet Early Action projects.
Additional stimulus funds to be distributed by the state are expected to go toward the I-805 Auxiliary Lanes project between SR 54 and E Street in Chula Vista and to complete the SR 905 freeway project connecting the Otay Mesa border crossing with I-805.
The San Diego Association of Governments (SANDAG) is the San Diego region’s primary public planning, transportation, and research agency, providing the public forum for regional policy decisions about growth, transportation planning and construction, environmental management, housing, open space, energy, public safety, and binational topics. SANDAG is governed by a Board of Directors composed of mayors, council members, and supervisors from each of the region’s 18 cities and the county government.
Medical Device News from MDMA
New FDA Leadership Announced
President Obama announced the nomination of Dr. Margaret Hamburg to be the Commissioner of the Food and Drug Administration. Dr. Hamburg has held a number of positions within the Federal government including serving as Assistant Director of the National Institute of Allergy and Infectious Diseases of the National Institutes of Health as well as serving as the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. Dr. Hamburg will undergo the Senate confirmation process before the Health, Education, Labor and Pensions Committee.
In addition, President Obama also announced the appointment of Dr. Joshua Sharfstein as Principal Deputy Commissioner for the FDA. Dr. Sharstein is currently the Commissioner of Health for the City of Baltimore. In addition, Dr. Sharfstein spent time on Capitol Hill as a staff member of Congress Henry Waxman. He will not have to undergo Senate Confirmation.
It is widely speculated that Dr. Hamburg will primarily oversee food responsibilities of the agency and Dr. Sharfstein will oversee the drug, device and cosmetic offices.
http://www.whitehouse.gov/the_press_office/Weekly-Address-President-Barack-Obama-Announces-Key-FDA-Appointments-and-Tougher-Food-Safety-Measures/
Patent Reform Legislation Introduced
New legislation aimed at reforming the patent system was introduced in both chambers of Congress recently. The bills introduced in each house are comparatively similar, with a few minor differences. The legislation includes provisions that would dramatically alter the manner in which damages are awarded in infringement cases; a position MDMA and many other innovative industries do not support.
http://uk.reuters.com/article/governmentFilingsNews/idUKN0328050120090303
Massachusetts Finalizes Regulations on Physician-Industry Relationships
Officials in Massachusetts gave final approval to a law involving the relationships between doctors and drug and device manufacturers. Applicable to state-licensed physicians, the code of conduct mandates that device manufacturers must report most financial payments made to physicians which exceed $50 for various types of consulting and speaking engagements. The $50 limit will be calculated based on individual transactions and will not be aggregated. In addition, the new code bans complimentary items, such as pens and mugs, while restricting most types of meals. There are also several exemptions for payments which were allowed for in the new code, including payments made in conjunction with genuine research and clinical trials, demonstration or evaluation units, and rebates and discounts.
The regulations take effect July 1 of this year and the first company reports will be due on July 1, 2010.
IP Update: CAFC: Holds Claims Limitations OK, Continuation Application Limitations Not
It’s not over ‘til it’s over. – Yogi Berra
TheUSPTO attempted to implement new rules that limit both the number of continuation applications that may be filed and the number of claims that may be included within each application (actually, family ofpending applications). Inventor Tafas (and GlaxoSmithKline) filed suit seeking to block implementation of these rules. In the district courtcase, Tafas v. Dudas, the court agreed with the plaintiffs and blocked implementation of the rules on summary judgment. On appeal, the Federal Circuit (CAFC), in a 2-1 decision, recently held that some of the limitations on continuations improperly conflict with 35 U.S.C. § 120(entitling the application to the filing date of a prior-filed application), but that the remaining limits are "within the scope ofthe USPTO's rulemaking authority."
The case is now on remand to the lower court, which must address a laundry list of issues not previously decided.
One of the more disturbing results for patent applicants is that the CAFC did not feel that the USPTO requirement for submission of an examination support document (ESD) in certain circumstances was burdensome. The ESD includes numerous parts, e.g., a preexamination prior art search, a list of the most relevant references and limitations disclosed by each reference, an explanation of how each independent claim is patentable over the submitted references, and an analysis of how each limitation of the claims is disclosed and enabled by the specification. This requirement has been often criticized forthe likelihood of dramatically increasing the costs of patent filings and the risks of limiting scope of the invention by prosecution history estoppel, not to mention the increased risk of exposure to assertions of inequitable conduct in litigation. One could foresee the USPTO using this requirement as a mechanism to reduce the backlog of patent applications awaiting examination by discouraging less well-heeled applicants.
Want to know more about this and other recent developments in IP laws that affect your business? Please register for "IP Management in Tough Economic Times", the IP Workshop presented by the BIOCOM IP Committee on April 23, 7:00 a.m. to 11:00 a.m. at BIOCOM. Registration is available now.
Submittedby BIOCOM's Intellectual Property Committee, by Les Overman with Stephen Reiter. The opinions expressed herein are those of the contributors and not their respective employers.
Please send your comments or suggestions to BiocomIP@gmail.com.