Politics, As Usual, Heat Up
The past two weeks have been action packed on the federal front. Governor Kathleen Sebelius of Kansas became the nominee for Secretary of the Health and Human Services Agency. In a widely watched Supreme Court case, Wyeth v. Levine, the court ruled that state law can govern the viability of a lawsuit, rejecting Wyeth’s claim that the authority vested to the FDA by federal law pre-empts the ability of states to have different standards of legal duties to warn regarding side effects. This opens up therapeutics manufacturers to damage claims in state court based on that state’s standards.
In a related matter, shortly thereafter Congressmen Waxman and Pallone and Senators Leahy and Kennedy reintroduced legislation from last year, the “Medical Device Safety Act of 2009.”This bill would remove the federal statutory protection device manufacturers have from state liability lawsuits and open them up to a torrent of state damage claims. A release on the legislation can also be found here: http://leahy.senate.gov/press/200903/030609b.html.
In addition, Senator Patrick Leahy reintroduced patent reform legislation which stalled last year, the Patent Reform Act of 2009. Links to the bill and statements related to the bill by its author can be found here http://leahy.senate.gov/press/200903/030309b.html. Apportionment of damages and ability to issue challenges to the validity of a patent are two of the main continuing concerns about this bill.
Finally, this week (week of March 9), Congressman Henry Waxman is widely expected to reintroduce legislation to create a pathway for follow-on biologics. Also this week, Congresswoman AnnaEshoo/Congressman Joe Barton are expected to introduce an alternative plan. We will report on these when they are formally introduced.
New NIH Grants Available
The American Recovery and Reinvestment Act of 2009 (Recovery Act) (H.R. 1, S. 1 - PDF-1MB) is a Federal public law passed by the 111th United States Congress and signed into law by President Barack Obama on February 17,2009. The Recovery Act makes supplemental appropriations for job preservation and creation, infrastructure investment, energy efficiency and science, assistance to the unemployed, and State and local fiscal stabilization, for the fiscal year ending September 30, 2009, and forother purposes.
As part of the Recovery Act, NIH has designated at least $200 million in FYs 2009 - 2010 for a new initiative called the NIH Challenge Grants in Health and Science Research, to fund 200 or more grants, contingent upon the submission of asufficient number of scientifically meritorious applications. In addition, Recovery Act funds allocated to NIH specifically for comparative effectiveness research (CER) may be available to support additional grants. Projects receiving these funds will need to meet this definition of CER: “a rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients. Such a study may compare similar treatments, such as competing drugs, or it may analyze very different approaches, such as surgery and drug therapy.” Such research may include the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data as they apply to CER.
This new program will support research on Challenge Topics which address specific scientific and health research challenges in biomedical and behavioral research that will benefit from significant2-year jumpstart funds. Challenge Areas, defined by the NIH, focus on specific knowledge gaps, scientific opportunities, new technologies, data generation, or research methods that would benefit from an influx of funds to quickly advance the area in significant ways. The research in these areas should have a high impact in biomedical or behavioral science and/or public health.
Challenge Areas and Challenge Topics
The NIH has identified a range of Challenge Areas that focus on specific knowledge gaps, scientific opportunities, new technologies, datageneration, or research methods that would benefit from an influx of funds to quickly advance the area in significant ways. Within each broad Challenge Area the NIH Institutes, Centers, and Offices have specified particular Challenge Topics that address their missions. These broad Challenge Areas are provided below. Click on the Challenge Area for the detailed description of the specific Challenge Topics within that area that have been accorded the highest priority by the NIH Institute, Center or Office indicated.
Broad Challenge Areas - PDF (532 KB) or MS Word (493 KB):
Links to High Priority Topics Within Broad Challenge Areas (PDF - 556 KB):
(01) Behavior, Behavioral Change, and Prevention
(02) Bioethics
(03) Biomarker Discovery and Validation
(04) Clinical Research
(05) Comparative Effectiveness Research (CER)
(06) Enabling Technologies
(07) Enhancing Clinical Trials
(08) Genomics
(09) Health Disparities
(10) Information Technology for Processing Health Care Data
(11) Regenerative Medicine
(12) Science, Technology, Engineering and Mathematics Education (STEM)
(13) Smart Biomaterials – Theranostics
(14) Stem Cells
(15) Translational Science
Medical Device News from MDMA
President Signs Economic Stimulus into Law, Includes Comparative Effectiveness
President Obama signed the economic stimulus package into law recently at a signing ceremony in Denver. Among other provisions, the law includes legislation to provide additional appropriations for comparative effectiveness research. The legislation includes $1.1 billion in appropriations to fund comparative effectiveness research through the Agency for Health Care Research and Quality (AHRQ) and the National Institutes of Health (NIH). Early drafts of the legislation included references to cost consideration. However, MDMA and others were successful towards advocating that the comparative effectiveness language focus on clinical comparisons and not cost effectiveness. The $1.1 billion in appropriations includes $400 million for the Secretary to use at their discretion, $400 for NIH and $300 for AHRQ.
FDA Holds UDI Public Workshop
The Food and Drug Administration held a public workshop this week to discuss and hear public comment regarding issues surrounding the implementation of a unique device identification (UDI) system. The workshop addressed issues such as implementation, standards, and developing a database to house a UDI system. MDMA President Mark Leahey addressed the workshop to advocate that a UDI system truly focus onpatient safety. MDMA encouraged use a risk-based approached towards UDI implementation and considers the interests of small device manufacturers.
Information from the workshop can be found here:
http://www.fda.gov/cdrh/meetings/021209workshop/
IP Update: Patent Reform – Here We Go Again
Patent reform legislation has again been introduced in both the House and the Senate. Again we expect a fight between the interests ofthe hi-tech/electronics industry and the biotech/pharma industry. The hi-tech side has its interests reflected strongly in the Bill.
Proposed changes in the Senate Bill (many similar to previous versions) include:
Damages: Requires courts to look to the invention's "specific contribution over the prior art" to determine damages. This was the major sticking point that prevented President Bush from supporting the last bill.
First to File: Efforts to achieve harmonization of US patent laws with patent systems around the world require the US to move to a first-to-file system from first to invent.
Expanded Reexamination Proceedings: Expands the basis on which patent reexaminations may be requested to include evidence of prior public use or sale in the US, in addition to published prior art.
Additional Post Grant Review: Within 12 months of issuance, a third party can file an administrative cancellation petition at the PTO based on any ground of invalidity (rather than simply prior art).
Pre-Issuance Submissions: Third parties can submit prior art to the PTO during examination of the patent application, as well as a statement regarding the relevance of the art.
Patent Litigation Venue: Attempts to reduce forum shopping by limiting where litigants can bring suit.
Interlocutory Appeals: Allows interlocutory appeals of claim construction decisions when approved by the lower court.
Administrative Patent Judges: APJs would no longer preside over interferences (which would no longer be required upon adoption of a “first to file” system). APJs would then preside over derivation proceedings as well as reexamination and post-grant trials.
PTO Powers: The PTO is explicitly granted the power to set its fees, including reducing fees.
Oath: Allows assignees to more easily file patent applications on behalf of the inventor.
Federal Circuit Judges: Allows Federal Circuit judges to reside more than 50 miles from DC.
We will discuss these provisions, as well as what is currently left out, in future articles.
Submitted by BIOCOM's Intellectual Property Committee, by Les Overman with Stephen Reiter and Bernie Greenspan. The opinions expressed herein are those of the contributors and not their respective employers.
Please send your comments or suggestions to BiocomIP@gmail.com.
Go Green On St.Patrick’s Day Recycle Ewaste With San Diego Futures Foundation
Not all recycling is green or environmentally-friendly. “Over 70% of discarded computers and monitors end up in landfills which can leak, mercury, arsenic and other toxins into the ground.” according to the January 2008 edition of National Geographic magazine. Many for-profit salvage companies ship ewaste to developing countries for dismantling, creating toxic waste lands and destroying the environment and the health of exploited workers, many children. It is important to be aware of what happens to your ewaste after it is dropped off.
Please drop off your old computers, monitors, TVs or other electronic equipment with the San Diego Futures Foundation, a 501(c)3 nonprofit organization located in the City Heights area of San Diego. SDFF recycles computers, laptops, CD Drives, copy/fax machines and more at NO COST. For a complete list of donated items, please log onto www.sdfutures.org. Donations are tax deductible.
San Diego Futures Foundation
RECYCLING AND SALVAGE CENTER DROP OFF LOCATION
4283 EL Cajon Blvd, Suite 140San Diego, CA 92105
619.269.1684 option “1”
Hours: Tuesday and Thursdays, 11:30am – 4pm, or by scheduled appointment.