By Donald Zuhn --
USPTO Schedules Hearings and Seeks Comments on Genetic Diagnostic Testing
In a press release and corresponding notice in Wednesday's Federal Register (77 Fed. Reg. 3748), the U.S. Patent and Trademark Office announced that it would begin gathering information on independent second opinion genetic diagnostic testing where patents and exclusive licenses exist that cover primary genetic diagnostic tests. The Office is collecting such information in order to prepare a report to the Committee of the Judiciary for both the Senate and House pursuant to § 27 of the Leahy-Smith America Invents Act. As part of the information gathering process, the Office noted that it would be holding two public hearings on the matter, with the first hearing to be held from 9:00 am to 4:00 pm (EST) on February 16, 2012 in the USPTO's Madison Auditorium located at 600 Dulany Street in Alexandria, Virginia, and the second hearing to be held from 9:00 am to 4:00 pm (PST) on March 9, 2012 at the Joan B. Kroc Institute for Peace & Justice at the University of San Diego. The Office is also seeking written comments on genetic diagnostic testing.
Pursuant to AIA § 27, the Office's report to Congress must include an examination of the following topics:
(1) The impact that the current lack of independent second opinion testing has had on the ability to provide the highest level of medical care to patients and recipients of genetic diagnostic testing, and on inhibiting innovation to existing testing and diagnoses;
(2) The effect that providing independent second opinion genetic diagnostic testing would have on the existing patent and license holders of an exclusive genetic test;
(3) The impact that current exclusive licensing and patents on genetic testing activity has on the practice of medicine, including but not limited to: the interpretation of testing results and performance of testing procedures; and
(4) The role that cost and insurance coverage have on access to and provision of genetic diagnostic tests.
The Office's notice also includes a number of additional issues (see pages 3748-49) on which the public is invited to comment.
Those wishing to present oral testimony at either hearing must do so in writing by February 8, 2012 by e-mailing the following information to Saurabh Vishnubhakat at [email protected]: (1) The name of the person wishing to testify; (2) the person's contact information (telephone number and email address); (3) the organization(s) the person represents, if any; (4) an indication of the amount of time needed for the testimony; and (5) a preliminary written copy of the testimony. The Office noted that the public hearings would be made available via a webcast (with details to be provided at a later date).
Those wishing to submit comments must do so by March 26, 2012 by sending such comments by e-mail to [email protected] or by regular mail addressed to Saurabh Vishnubhakat, Attorney Advisor, Office of Chief Economist, United States Patent and Trademark Office, Mail Stop External Affairs, P.O. Box 1450, Alexandria, VA 22313–1450. Comments sent by e-mail should include "Genetic Testing Study" in the subject line.
USPTO Issues Reminder Regarding Deadline for Commenting on Locations of Satellite Offices
The U.S. Patent and Trademark Office issued a press release today reminding the patent community that the deadline for submitting written comments on potential locations for additional USPTO satellite offices is 11:59 pm (ET) on January 30, 2012. The Office noted that this deadline would not be extended. Last November, the Office issued a notice in the Federal Register outlining the specifics of its request for comments (see "USPTO News Briefs," December 15, 2011). In that notice, the Office noted that:
Comments should provide information that supports the USPTO's purposes of establishing satellite offices, including that the location will:
(1) Increase outreach activities to better connect patent filers and innovators with the USPTO, including the number of patent filings and grants by the city/region as well as other information that provides insight into the region’s innovation activity;
(2) Enhance patent examiner retention, including quality of life indicators such as average household income, cost of living factors, and other factors related to employee retention;
(3) Improve recruitment of patent examiners, including data on employment rates and other economic factors in the area, science and technology professionals, as well as legal professionals in the workforce and other related information;
(4) Decrease the number of patent applications awaiting examination; and
(5) Improve the quality of patent examination.
In today's release, USPTO Director David Kappos stated that the Office was "looking forward to reviewing community feedback on locations for Satellite Offices to recruit and retain top talent, and to better serve our applicant community," adding that the Office was "committed to conducting an open and transparent selection process that will ultimately yield the best locations for the USPTO and its user community."
USPTO Establishes Retention Period for Patent-Related Papers
In a notice published in Wednesday's Federal Register (77 Fed. Reg. 3745), the U.S. Patent and Trademark Office announced that it is establishing a one-year retention period for patent-related papers that: (1) began on September 1, 2011, for papers scanned into IFW or SCORE prior to September 1, 2011; or (2) began or begins on a paper's submission date, for papers scanned into IFW or SCORE on or after September 1, 2011. The Office originally proposed the retention plan in a Federal Register notice in August (see "USPTO News Briefs," September 1, 2011).
Under the new retention plan, the USPTO will dispose of papers after the expiration of the one-year retention period unless, within sufficient time prior to disposal of the paper, an applicant, patent owner, or reexamination party files a bona fide request to correct the electronic record of the paper in IFW or SCORE, and the request remains outstanding at the time disposal of the paper would have otherwise occurred. Previously, the Office retained papers indefinitely. Additional information regarding the retention plan, as well as the Office's response to the lone comment it received in response to its earlier notice, can be found in the latest notice.
According to the notice, the Office will continue to accept comments regarding the new retention plan, which can be sent by e-mail to [email protected] or by regular mail addressed to: Mail Stop Comments -- Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450.
Don,
You can see the "hand writing on the wall" as to where this requirement by the AIA (Abominable Inane Act) to report on the impact of patented genetic testing on independent second opinions is heading: if the ruling in AMP v. USPTO doesn't enable such testing to provide independent second opinions, Congress is threatening to legislate it in. Oh boy, I can just see another "compulsory licensing" provision for such patented genetic testing, just like the compulsory licensing provisions for catalytic devices under the Clean Air Act. As usual, Congress is clueless that such "compulsory licensing" will likely mean diminished activity in developing such genetic testing. Businesses aren't going to invest money in research which they can't recoup because they have to make it "freely available" due to compulsory licensing.
Posted by: EG | January 27, 2012 at 08:59 AM
Hopefully the choice of locale for the first satellite office will boost Detroit's economy -- which needs all the help that it can get. It will be interesting to see whether California, Colorado, or Nevada wins out for the West Coast location. From the criteria listed in this post, one wonders whether Silicon Valley has a chance of making the cut, if the USPTO is making its determination based partly on cost of living. Otherwise, it would seem to be a logical choice.
http://www.aminn.org/patent-legislation
Posted by: patent litigation | February 05, 2012 at 12:24 PM