USPTO Biotechnology/Chemical/Pharmaceutical Customer Partnership Meeting

Biotechnology/Chemical/Pharmaceutical Customer Partnership  

Wednesday, June 8, 2011 Meeting 
Madison Auditorium  

Starting Time of 10:00 AM

 United States Patent and Trademark Office
Alexandria, Virginia 
600 Dulany Street, Alexandria, VA, 

Accessing the event:
Double click on the link below (or copy it into your internet browser)

https://uspto.connectsolutions.com/r80345544/
Click here   for detailed login instructions in MS Word.

  Driving & Metro Directions /Hotels (Word)   Campus Map (html)   Campus Map (Power Point)

 

Morning Session    
10:00 – 10:30 AM. Greetings, TC Update and Overview Jackie Stone, George Elliott and Remy Yucel, Directors, Technology Center 1600
10:30 – 11:15 AM Microsoft v. i4i Ltd.: How potential changes in
the evidentiary standard for an invalidity defense could affect patent prosecution and litigation
Garth M. Dahlen, Ph.D., Esq. Birch, Stewart, Kolasch & Birch, LLP 
11:15 – 11:30 AM Break  
11:30 – 12:15 PM COPA (Clearing the Oldest Patent Applications) – An Overview and Implementation Briefing   John Barlow   SPE, TC2800
12:15 – 1:00 PM Expedited Examinations (Track 1, PPH, Green Tech, AE, and to Make Special) Bennett Celsa   QAS, TC1600 
1:00 – 2:00 PM  Lunch   The Roundhouse Cafe Cafeteria is inside the Madison Building  lower level.
Menu for the Week in PDF will be here. 
Afternoon Session    
2:00 – 2:45 PM Current Sequence Listing Process for Nucleic Acids and Polypeptides  Joe Woitach   SPE, Art Unit 1633 
2:45 – 3:00 PM Break  
3:00 – 3:45 PM Common Issues Examiners Face Regarding PLTs and Plant Utility Patents Anne Marie Grunberg, SPE, Art Unit 1638/1661
3:45 – 4:00 PM Closing Remarks/Discussion Jackie Stone, George Elliott and Remy Yucel, Directors, Technology Center 1600

 

Photos of the speakers  will be here.

Google Search the BCP Web Site

[Caveat – Google’s spiders have not searched through all the links to all of the Power Point slides. These results are only  partial. For example, type in Morning Session  and as of 2/20/11 you only see the Agendas for 17 meetings. Note for some of the earlier links to meetings in 2001 and 2002 they are at the PTO site as listed below and thus no agendas or slides are here for Google to find.]

Supplemental Materials:
    Carlyle Site Drawings
   
Perspective 3D drawing of the building on campus click here 
    Floor plan for a building (pdf 178K) click here
    Close-up plan view of campus map click here 
    Go to http://www.ptoinalexandria.com/index.php for more views and info

 See the BCP’s PTO web page http://www.uspto.gov/web/patents/biochempharm/  for the official announcement for the next meeting close to the final date.

For questions about obtaining these materials
contact Cecilia Tsang at Cecilia.Tsang@USPTO.GOV

To be placed on the BCP’s e-mail announcement list 
contact Cecilia Tsang at Cecilia.Tsang@USPTO.GOV

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BIO and USPTO Trace the Journey of Biotech Inventions

BIO will be co-hosting an event with the United States Patent and Trademark Office (USPTO) to celebrate the 30th anniversary of the issuance of U.S.patent 4,259,444 to Ananda Chakrabarty following the Supreme Court case, Diamond v. Chakrabarty, which held that Chakrabarty’s bioengineered bacterium was eligible for patenting.  The event will be held during the BIO International Convention on the morning of Thursday, June 30, at the Walter E.Washington Convention Center inWashington, D.C. 

See the BIOtech NOW article for more details.

House Judiciary Committee’s Patent Reform Bill is in Need of Reform, Says BIO

PRESS RELEASE

WASHINGTON, D.C. (Friday, April 15, 2011) – Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement regarding the America Invents Act, H.R. 1249, which passed the House Committee on the Judiciary yesterday:
 
“BIO has consistently praised House Judiciary Committee Chairman Lamar Smith (R-TX) for his introduction of a comprehensive patent reform bill similar to the bill adopted by the U.S. Senate earlier this month by a nearly unanimous vote.  Unfortunately, given the addition of the Goodlatte supplemental examination amendment, added to the bill during Committee consideration, we have no choice but to oppose floor consideration of the bill until this issue is repaired.

“The supplemental examination provision as passed by the Senate and originally included in the House bill would allow patent holders to seek a review of their issued patents at their own risk.  The Goodlatte amendment undercuts this provision by creating disincentives for patent owners to use the new procedure by having the U.S. Patent and Trademark Office (PTO) act as quasi-investigative body.

“We commend Chairman Smith for all the work he has done to craft a bill, the America Invents Act, which is a clear improvement over prior House versions of patent reform legislation.  BIO was very supportive of Chairman Smith’s Manager’s Amendment.  We are pleased that the legislation will end, once and for all, the diversion of fees collected by the PTO, allowing the agency to use all of its fees to hire more examiners, reduce the backlog of pending applications, and make other improvements to its operations.  We also commend the inclusion in the bill of many other reforms that will improve the patent system and enhance patent quality, including transition to a “first-to-file” system, the creation of an inter partes review system, and the elimination of other subjective elements of patent law.
 
“Nonetheless, given the importance of adopting a supplemental examination provision much like that which passed the Senate on a bipartisan, 95-5 vote, BIO notes our objection to this bill being considered on the House floor.  We commit to work with Chairman Smith and others to rectify this issue, so that a patent reform bill with broad support can be brought to the floor of the House.”

USPTO Remains Open for Six Business Days if Government Shuts Down

Press Release, 11-26

USPTO Prepares for Possible Government Shutdown

In the event of a government shutdown on April 9, 2011, the United States Patent and Trademark Office will remain open and continue to operate as usual for a period of six business days – through Monday, April 18, 2011 — because the USPTO has enough available reserves, not linked to the current fiscal year, to remain in operation until then. Should a shutdown occur and continue longer than the six-day period, we anticipate that limited staff will be able to continue to work to accept new electronic applications and maintain IT infrastructure, among other functions.  More information will be posted on this website as it becomes available. Thank you.

BIO Hosts U.S./China Biotechnology Examiner Workshop with U.S. Patent and Trademark Office and China’s State Intellectual Property Office

Press Release:

 
WASHINGTON, D.C. (Tuesday, April 05, 2011) – The Biotechnology Industry Organization (BIO) hosted a U.S./China Biotechnology Examiner Workshop with U.S. Patent and Trademark Office (PTO) and China’s State Intellectual Property Office (SIPO) on March 28, 2011 in Beijing, China. The workshop which was organized by BIO for SIPO examiners, focused on biotechnology patenting and encouraged bilateral cooperation between SIPO and the USPTO.“BIO recognizes the commitment on behalf of the Chinese Government and SIPO to spur innovation in the biotech industry and, together with the PTO, we pledge to partner with Chinese leaders to move the industry forward to benefit patients and other consumers worldwide,” said Jim Greenwood, CEO and President of BIO.The workshop was the first of a series of meetings intended to open communication and establish a relationship between the two groups. BIO will work with the SIPO to strengthen China’s regulatory system to encourage innovation and protect intellectual property within the country. The commitment of SIPO will be critical for sending a message to companies that want to do business in China.

“Robust development of the biotech industry in China depends on an advanced intellectual property and patent system,” said Scott Sindelar, Minister Counselor of Agricultural Affairs. “Today’s workshop is timely in sharing experience and regulations of patenting and IP both in the U.S. and China, and establishing greater understanding of each other.”

“Since most Chinese attendees are examiners of intellectual property, [the workshop] provides an opportunity to share experiences and ideas with our American counterparts,” said Yang Xiaowei, deputy Director General of International Cooperation Department of SIPO.

In each of three panels, USPTO and SIPO speakers discussed how each issue is handled by the pertinent provisions in their current patent law and rules. They also addressed office practice and shared practical experiences with the different technical arts in biotech.  Industry and academic speakers provided user perspectives in their interaction with the patent law and practice in each country.

The workshop featured the following panels:

·         The first panel focused on taking a balanced approach to written description and enablement requirements, which are necessary for preventing impediments to patenting activity. Panelists also discussed the type of information that is required for an invention to satisfy the written description and enablement requirements.

·         The second panel focused on issues arising from claims with sequence homology. Panelists discussed the scope of claims using homology or percent of sequence identity language and issues that often arise during examination.

·         The third panel addressed meeting discussed China’s new requirements for patent disclosure for genetic resources, stakeholders’ experiences with China’s new genetic disclosure requirement, and alternative ways to ensure appropriate access and benefit sharing.

The three groups (BIO, PTO and SIPO) are looking forward to future opportunities to work together on issues of common interest.  

Upcoming BIO Events 

BIO Intellectual Property Counsels Committee Spring Conference and Committee Meeting
April 13-15, 2011
Seattle, WA

World Congress on Industrial Biotechnology & Bioprocessing
May 8-11, 2011
Toronto, Ontario, Canada

Partnering for Global Health Forum 2011
June 27, 2011
Washington, DC

BIO International Convention
June 27-30, 2011
Washington, DC

2011 BIO Human Resources Conference
June 26-28, 2011
Washington, DC

The Business Forum at the BIO International Convention
June 28-30, 2011
Washington, DC

BIO India International Partnering Conference
September 21-22, 2011
Hyderabad, India

BIO China International Conference
October 12-13, 2011
Shanghai, China

About BIO

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIO produces BIOtech Now, an online portal and monthly newsletter chronicling “innovations transforming our world.” Subscribe to BIOtech Now.

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BIO’s Amicus Brief: Microsoft v. i4i

The Biotechnology Industry Organization, along with AUTM and CropLife International, filed an amicus brief in the Microsoft v. i4i Supreme Court case.

This case is widely viewed as one of the most fundamental and important patent cases to reach the Supreme Court in probably a decade. Most basically, this case is about the level of certainty a jury or judge must have before finding a patent invalid in litigation. Historically, the law has required a high level of proof, “clear and convincing evidence,” before a patent that has been examined and issued by the US Patent and Trademark Office can be declared invalid by a court. In the Microsoft v. i4i case, the Supreme Court is now being asked to adopt a lower burden of proof, under which patents can more easily be found invalid by a lower “preponderance of the evidence.”

In our joint brief, BIO, AUTM and CLI explain that the current high burden of proof has deep historic roots in Supreme Court law, and has been consistently applied by the lower courts for many decades. Under the current standard, issued patents benefit from a clear and meaningful presumption of validity that cannot be easily overcome. In this way, patents play their intended role as enduring legal instruments that confer real rights, and that developers and investors can rely on for investment and product development decisions. The importance of being able to rely on patent rights is illustrated very clearly in the biotech industry, which would not be able to make large investments over very long development times without assurances that the fruits of their investments are protected by robust patent rights. Lowering the standard for patent validity would frustrate decades of investment-backed reliance interests and would negatively impact biotechnology innovation going forward. Our brief explains that the existing high burden of proof to invalidate a patent is entirely consistent with other instances where the law imposes high burdens of proof to protect the public’s reliance on existing property rights.

In our brief, we also point out that Congress permits patents to be invalidated on a lower burden of proof only by the expert Patent Office, and then only on certain kinds of reliable evidence. Litigants who prefer to argue to a lay jury or generalist judge, or who want to use less reliable evidence, can do so only under a higher burden of proof. Any change to this carefully-crafted balance would have to be made by Congress, not the courts.

The United States’ brief in this case forcefully argues against changing the current standard of patent validity.

Patent Reform Bill good for Biotech

Patent Reform Passes the Senate and Moves to the House

 

Posted by Roy Zwahlen, manager of intellectual property and technology transfer policy at BIO.

On March 8th, the Senate approved the America Invents Act (S. 23) by an overwhelming vote of 95-5.  BIO supports this bipartisan, consensus-oriented bill, formerly known as the Patent Reform Act of 2011.  Once enacted into law, it will strengthen and improve our nation’s patent system, spurring innovation and job creation.

Patents are often the main assets of small biotech companies, and they rely on this intellectual property to attract investors to fund the lengthy and expensive research and development process necessary to bring breakthrough new therapies and other biotech products to patients and consumers.  The improvements made by the America Invents Act would benefit the biotechnology industry, and indeed all sectors of the U.S. economy, by enhancing patent quality and the efficiency, objectivity, predictability, and transparency of the patent system.

Increased Resources for the PTO

The America Invents Act contains two provisions that would provide greater resources and operational flexibility for the Patent and Trademark Office (PTO).  First, it would end the diversion of fees collected by the PTO in excess of its budget, and would permit the PTO to retain such fees for use in either the current or future budget years.  It would also give the PTO the authority to set and adjust fees for patent applications, while requiring discounts in fees for small businesses.  These measures will help the PTO improve its long-range budgeting and planning for capital and human resources, hire more examiners to process the more than 350,000 patent applications it receives annually, and reduce the current backlog of more than 700,000 pending applications.

Improvements to PTO Re-Examinations

The America Invents Act would create new and improved proceedings for interested members of the public and the patent owner to seek review of issued patents by the PTO.  The new procedures would result in a more transparent and efficient system of patent quality review. Importantly, patent owners would have a new procedure under which they could go back to the PTO whenever they find new information that might affect the validity or scope of their patent claims without fear of later being accused of concealment or misrepresentation in court by an alleged infringer under the much-maligned inequitable conduct doctrine.  These new procedures would create more business certainty, less risk in investment in biotechnology products, greater assurances in licensing rights, and greater enforceability of patents.

False Patent Marking Litigation

False patent marking litigation occurs when a manufacturer labels a product with an incorrect or expired patent number.  Current law allows any member of the public to sue and sets the fine at $500 per falsely marked article, which has spawned a cottage industry of law firms using this law to shake down industry for settlements in return for promises to drop the lawsuits.  Historically, this was not of great concern until 2009 when the number of these lawsuits greatly increased.  The America Invests Act would require that, in order to sue, someone must have suffered a competitive injury.  This utilizes a common legal principle to ensure that those actually injured are receiving compensation, while excluding those trying to take advantage of a statutory loophole for personal gain.

First Inventor to File

One of the most hotly debated provisions of the America Invents Act would change America’s first to invent system to a first inventor to file system.  This system is embedded in international patent practice, with the United States as the only exception.  While some argue that America’s first to invent system is superior, it is inherently fraught with uncertainties, and problems arise when biotechnology companies try to protect their inventions here and abroad. This bill would remove these uncertainties, while providing adequate protections against misappropriation of an invention by someone other than the true inventor.

Additional Benefits

The America Invents Act would provide several additional benefits for the biotechnology industry, including making it easier for the actual owners of the invention to file patent applications and eliminating the “best mode” requirement as a defense in infringement litigation.  Generally, the removal of subjective elements of patent law helps to create a more equal playing field for all interested parties of an invention.

Senate Judiciary Chairman Patrick Leahy (D-VT), Ranking Member Charles Grassley (R-IA), and the other members of the Senate Judiciary Committee are to be commended for their tireless efforts to build bipartisan consensus on this legislation, which resulted in wide support of its passage in the Senate.

 

We look forward to working with the House Committee on the Judiciary as it continues its consideration of patent reform, and hope to see meaningful patent reform signed into law later this year.