June 24th, 2011 | View Archive
HOUSE APPROVES PATENT REFORM LEGISLATION
By a vote of 304 to 117, the House passed on Thursday H.R. 1249, the America Invents Act. If the bill becomes law, it would be the first major overhaul of the patent system in more than 50 years.
The House approved six minor amendments, as well as a manager's amendment, before shooting down seven other amendments, including proposals that would have stripped a controversial provision that critics say exempts banks from some patent rules.
In order to win over House appropriators, who feared that the bill's original language would have given the PTO too much control over its fees, Smith offered a manager's amendment that establishes a fund for excess PTO fees to be controlled by Congress. This differs from the version that passed the Senate, which blocked diversion of money budgeted for the patent office and allowed the PTO to generate its own fees and hold on to any excess.
Among other changes, the bill transitions the United States to a "first-to-file" system, under which the inventor who files an application first is awarded a patent. The bill also adopts improved post-grant procedures for challenging questionable patents while increasing protection for patent owners.
The Senate adopted its version of a patent reform bill earlier in the year. Both chambers will need to reconcile their versions of the measure before they can send a bill to President Obama, who has supported the Senate bill (S.23) and qualified support for the House bill (HR 1249).
MAJOR REGULATORY REFORMS IN BIOMEDICAL RESEARCH COMING SOON
As previously mentioned, the Federal Experts Security Advisory Panel (FESAP) recently issued a series of recommendations (PDf) on the select agents program, which will be incorporated into a revision of the select agent regulations expected in the fall of 2011. These proposals could have significant effects, both positive and negative, for campuses working with select agents.
The Department of Health and Human Services has issued a "pre-rule" titled, "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators," which is a heads-up on future regulatory activity. This is likely the first step in an overall review of federal policy for the protection of human subjects, called the Common Rule, which the Administration has been discussing for some time.
The NIH has also issued a notice regarding its consideration of comments on the adoption and implementation of the revised Guide for the Care and Use of Laboratory Animals, Eighth Edition. Although NIH officials have not indicated a timeline for analyzing the comments they have previously received, the notice does say that future "position statements" related to the Guide will have a 60-day public comment period and that until that time, institutions will continue to base their care assurance activities on the seventh edition of the Guide. However, accreditation of laboratory animal care facilities by the international accrediting association (AAALACI) will be based on the newly revised Guide beginning in September, 2011.
Finally, the Office of Management and Budget announced on June 9 that its review of pending regulations on conflicts of interest related to NIH-funded research has been delayed indefinitely. Last August, higher education associations submitted comments to NIH on the agency's notice of proposed rulemaking on conflict of interest. The associations' letter said that the notice in many cases appropriately established the balance between disclosure that benefits the public's interest and the cumulative regulatory burden, but asked that NIH consider ways to mitigate those burdens on institutions and investigators. The four organizations also identified specific areas where the proposed notice could be "improved, clarified, or made more effective."
DOE TO HOLD QUADRENNIAL TECHNOLOGY REVIEW
On July 13, 2011, The Department of Energy will hold a Quadrennial Technology Review Capstone workshop in Washington, DC. The workshop will provide an opportunity to hear and offer feedback on DOE's principles for entry of a technology, activities supported by DOE, and approaches to prioritization of R&D programs for energy system transformation. DOE currently has six strategies for energy transformation which are: vehicle efficiency, electrification, and alternative fuels for the transportation sector; and building/industrial efficiency, grid modernization, and clean electricity supply for the stationary sector.
You can register for the workshop at https://www.orau.gov/dcqtr2011/registration/.
More information is available at http://www.energy.gov/qtr
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