Public Policy News

User Fee Legislation Subject of Congressional Hearings

The leadership of the House of Representatives has set a tentative timeline for industry user fee legislation as it makes its way through Congress.  Details of each hearing Please note that as with anything, this schedule is always subject to change on short notice:

February 9:  Health Subcommittee Hearing on GDUFA/Biosimilar/Drug Shortages

February 15: Health Subcommittee Medical Device User Fee Hearing

March  7:  Health Subcommittee Misc Hearing on User Fee Issue

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USPTO To Hold Genetic Diagnostic Testing Hearing in San Diego

The USPTO is soliciting written and public comment on several topics related to genetic diagnostic testing in order to prepare a report called for in the Leahy-Smith America Invents Act (“AIA”).  The agency will be hosting a public hearing on this subject in San Diego on March 9, from 9 am – 4 pm, at USD’s Joan B. Kroc Institute for Peace and Justice (5998 Alcala’ Park, San Diego, CA 92110).  In the Federal Register notice, the Agency poses fourteen separate questions (starting in the third column of page 3748) for which it is soliciting input in its Request for Comments on Genetic Diagnostic Testing (77 Fed. Reg. 3748, January 25, 2012).

BIOCOM encourages its members to participate in the hearing by both giving testimony and by submitting written comments.  The deadline for written comments is March 26, 2012. 

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Scope of America Invents Act Rules To Be Subject of Public Hearing

As the USPTO moves forward implementing various provisions of AIA, the agency plans to explain the scope of their proposed rules and changes at a public meeting scheduled for Friday, February 24 at the Sunnyvale Public Library (665 W. Olive Avenue, Sunnyvale, CA 94086) from 10:00 AM – 4:30 PM.

The proposed rules and changes to be covered at the meeting include:


(i) Implementation of Statute of Limitations Provisions for Office Disciplinary Proceedings;

(ii) Changes To Implement the Inventor’s Oath or Declaration Provisions of the Leahy-Smith America Invents Act;

(iii) Changes To Implement the Preissuance Submissions by Third Parties Provision of the Leahy-Smith America Invents Act;

(iv) Changes To Implement Miscellaneous Post Patent Provisions of the Leahy-Smith America Invents Act;

(v) supplemental examination;

(vi) inter partes review;

(vii) post-grant review;

(viii) transitional program for covered business method patents; and

(ix) derivation (effective on March 16, 2013).

The proposed rules for (i) to (iv) have already been published in the Federal Register, and BIOCOM will alert its members once the the rules for (v) to (ix) are published in the Federal Register.

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New Rules Proposed for Supplemental Examination

The USPTO is moving forward implementing the provisions of the Leahy-Smith America Invents Act (“AIA”).  On January 25, the Agency released its proposed rules for supplemental examination and proposed revisions to reexamination fees. The agency plans to explain the scope of the proposed rules at an upcoming AIA roadshow scheduled on Friday, February 24 at the Sunnyvale Public Library, which is located at 665 W. Olive Avenue, Sunnyvale, CA 94086.


BIOCOM encourages its members to attend the event in Sunnyvale and provide feedback by sending in written comments on or before March 26, 2012.  Further detail on the scope of Supplemental Examination Proposed Rule and reexamination fee revisions can be found in the Federal Register Notice entitled, Supplemental Examination Proposed Rule (77 Fed. Reg. 3666, January 25, 2012).

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Institute of Medicine Seeks Feedback from Stakeholders Regarding CIRM

The California Institute for Regenerative Medicine (“CIRM”) has asked the Institute of Medicine (“IOM”) to provide an independent assessment of CIRM's programs, operations, and performance. The IOM Committee on Review of CIRM has called upon the general public to help them with this task.  The IOM survey regarding CIRM will be available to supply your thoughts and views until April 23, 2012.

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Tsunami Preparedness

March 11th marks the one year anniversary of Japan’s tragic Tohoku earthquake and tsunami. In order to better prepare and educate Californians, Cal Emergency Management Agency (EMA) and California Geological Survey (CGS) are coordinating with counties and cities throughout the state for Tsunami Awareness Week , March 26-30, 2012. Your company can help bring awareness to your employees through participating in tsunami drills and providing educational information.

Millions of people enjoy California’s wonderful coastline. Whether you live, work, or visit, it is important to be aware that the coastal region is vulnerable to tsunamis.  California’s large active offshore faults and unstable submarine slopes can cause tsunami activity along the coast.

Strong ground shaking from an earthquake is the natural warning that a tsunami might be coming. If you are on the beach or in a harbor and feel an earthquake, immediately move inland or go to high ground.  If strong shaking lasts for 20 seconds or more, everyone within the tsunami evacuation area should evacuate as soon as it is safe to do so.  Other natural warnings include seeing the ocean quickly recede to expose the ocean bottom, or hearing an unusually loud roar coming from the ocean.  A tsunami can arrive within minutes and may last for several hours.

For tsunamis coming from across the ocean, local communities use a variety of communication methods to broadcast emergency information. Be informed on what signals, sirens, and public services will be employed for your area. Create a plan and be prepared.

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