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F.I.R.E. Series – November 3, 2011

The Offices of Technology Transfer, in cooperation with the Center for Entrepreneurship proudly present F.I.R.E. in November:

“The Basics of the Patenting Process”

Filing a patent application is one of the surest methods of securing intellectual property protection. An understanding of the basics of this process is important for any researcher, inventor, or entrepreneur. With the recent passage of the Leahy-Smith America Invents Act, a reexamination of this topic is appropriate and timely.

Where: the Class of ’62 Auditorium (G-9425 & 1-9425)
When: Thursday, 3 November 2011, 9:00 – 10:00 AM

Our presenter this month is J. Gibson Lanier, Ph.D., J.D., a patent attorney with Ballard Spahr in Atlanta, GA. Dr. Lanier has been working with the University’s patent portfolio and presenting at the F.I.R.E. Series since 2003.

Please note that due to a scheduling conflict, this presentation will
be held on the first Thursday of November.

Although the F.I.R.E. Series continues to be free and open to the public, a small fee for parking may apply (between $4 and $6). Registration would be appreciated by noon Tuesday, 1 November 2011.

Refreshments will be served. Please contact David Englert, or call 585.784.8856 for more information or to register for this event.

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What does Technology Transfer mean to me, and why do I work with the Office of Technology Transfer?

By: Steve Dewhurst, Chair of Micro and Immuno, URMC

An important part of why I became an academic researcher, at a major medical center, was for the opportunity to contribute to influential discoveries that have the ability to affect the lives of others in a positive way.  Publishing papers, attending scientific meetings, and lecturing at seminars are all expectations that researchers must meet – but none of these are reasons why I became a scientist.  More important is the creation of new knowledge and applying that knowledge to answer important scientific questions. I’m especially excited about using the scientific expertise gained from experiments run in my lab to develop new treatments and cures for diseases.

Technology Transfer plays a vital role in that process.  At its core, technology transfer is aimed at developing discoveries made in the lab and translating them into tangible products that can be marketed and sold to improve lives.  An incredibly successful example of the technology transfer process was the development of the Human Papilloma Virus (HPV) vaccine.  At first the vaccine was only a theory in a lab, but after a successful partnership with the biotech industry the theory became a reality. Eventually the technology matured into a mass-produced, licensed vaccine against cervical cancer.  The underlying science, which included pioneering work done by Dick Reichman, William Bonnez, and Bob Rose at the Medical Center, transformed healthcare for women worldwide. This ground breaking technology was made possible because inventions were created, patents were filed (and awarded), and a complex commercialization process was successfully navigated.

These are all things that the Office of Technology Transfer (OTT) does superbly.

In my own research, I collaborate with a broad range of faculty members (including Handy Gelbard, Sanjay Maggirwar, Burns Blaxall, Brad Nilsson and several others), postdoctoral fellows, and students.   Collectively, we’ve come up with a number of new ideas on which we’ve submitted invention disclosures to OTT.  From these discoveries have come a number of issued patents and significant new funding.  The latter includes NIH SBIR and STTR awards that were funded in collaboration with a UR startup company.  In addition, CTSI incubator funding was recently awarded to Burns and translational NIH P01 funding was awarded to Handy.

OTT has given me the opportunity to develop new therapies for neuroAIDS (with Handy and Sanjay) and heart failure (with Burns and Handy), and has allowed me to collaborate with outstanding medicinal chemists with expertise in drug development at Califia Bio in San Diego (led by Val Goodfellow). Currently, we’re working to develop new partnerships with different biotech companies, with the goal of exploring new ideas related to HIV vaccine development. Again, OTT has been incredibly helpful in this process.  They’ve provided advice along the way, executed material transfer agreements when necessary, and drafted other legal documents essential for working effectively with industry.

The bottom line is, over the past several years, I’ve found the Office of Technology Transfer’s hard work, knowledge, and understanding of the patenting process to be invaluable.  I expect my relationship with OTT to grow and I’m eager to work – even more closely – with them in the future.  NIH’s increasing emphasis on translational research (e.g. the proposed National Center for Advancing Translational Sciences (NCATS)) will raise the importance of NIH-funded scientists developing new medicines, diagnostics, treatments, and vaccines.  This new focus is going to require – more than ever before – close collaboration with those who truly understand the technology transfer process.

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F.I.R.E. Series – October 13, 2011

The Offices of Technology Transfer, in cooperation with the Center for Entrepreneurship proudly presents F.I.R.E. in October:

“What Is an ‘Invention?'”

The Technology Transfer process hinges upon one thing: having technologies to transfer. Technologies come to us from inventors by way of the Invention Disclosure Form. But at what point does a researcher become an inventor and research yield an invention? And just what is an invention? That is a fair question — and one we will attempt to answer at this lively and informative session.

Our presenter is Kathryn Doyle, Ph.D., J.D., Partner and Chair of Riverside Law in West Conshohocken, PA. Dr. Doyle began her career as a research scientist. She switched to patent law and has become a recognized expert in patent law surrounding medicine, pharmaceuticals, devices, tools, genomics, and agriculture.

Where: the Class of ’62 Auditorium (G-9425 & 1-9425)

When: Thursday, October 13, 2011, 9am – 10am

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New Patent Reform Legislation

The Leahy-Smith America Invents Act was passed by the Senate on September 8, 2011, without amendment, and on September 16, 2011, the new legislation was signed into law by President Obama. The new patent reform legislation (H.R. 1249) will help clarify and simplify the patent application process and help harmonize the U.S. patent system with all other foreign trading partners. These changes are intended to enable U.S. inventors at universities and elsewhere to compete more effectively in the global marketplace. The bill is composed of a number of carefully drafted provisions to improve patent quality, reduce patent litigation costs, end backlog of patent applications, streamline office operations, and enhance the overall foundation of the modernized patent system.

 The new legislation makes a number of significant changes. The U.S. will move from a “first-to-invent” system to a “first-to-file” system. Almost all other countries have already adopted this system, awarding patent rights to the first inventor to file a valid patent application. Up until now the U.S. has operated as a “first-to-invent” system, awarding patent rights to inventors who first conceive and reduce a technology or invention to practice. A key advantage to this new provision is that it brings the U.S. system into alignment with the patent laws of most foreign countries. 

It will be interesting to see how this new provision affects small universities and businesses given that it creates a race to the patent office between inventors filing on technologies with similar claims. UR OTT has always encouraged inventors to move quickly with filing invention disclosures so as to get a provisional patent application on file as soon as possible. This new provision will only reinforce that message.

 Another major provision, of the new law, is the Expedited, Non-Judicial Post Grant Review Process. This new condition establishes “post-grant review” before the Patent Trial and Appeal Board to review validity of issued patents within 9 months of grant on any patentability issue except best mode. The new review procedure is intended to create a more efficient and cost-effective avenue to challenge patents.

 Supporters of this new process believe it’s a better way to weed out weak patents containing insubstantial claims and strengthen robust patents that are challenged and survive. Those opposed to this new option argue it will significantly raise the number of patent challenges filed against inventors and contend that the administrative process for reviewing the disputes will be inadequate and undependable compared to those argued in court. The impact of this new procedure will depend on how often it is used and how well the challenge is handled inside the Patent and Trademark Office (PTO). If we assume qualified personnel will be reviewing the cases, then this new provision should prove a more efficient and affordable way to resolve validity questions.

 A third key provision is “Funding for the Patent and Trademark Office.” Funding for the PTO is one of the major political battles this new law is focused on fixing. For years the PTO has generated significant revenue from the fees it charges. Congress regularly sweeps those fees away from the PTO and uses them for other appropriations as it sees fit. The PTO has argued for years that it is not left with enough revenue to resource its operations appropriately. As the backlog of patent applications grows, this issue intensifies. On the other hand, the Federal budget crisis has made those revenues more valuable than ever before to Congress.

 The new Act represents something of a compromise. First, it allows the PTO to set its own fees (until now, fees were set by Congress), and imposes a 15% surcharge on most fees, which was put into effect September 26, 2011. Second, the Act creates a Reserve Fund that sets aside fees in excess of the amount appropriated for the PTO. The money in the Reserve fund must be appropriated by Congress in order for the PTO to use it.

 Also, beginning on September 26, 2011, a fast track or prioritized examination will be available to patent applicants for a fee of $4,800, which will enable applicants to receive a final determination of patentability within one year of their application filing date. This new condition is designed to help expedite the patent process for products, processes, or technologies important to the economy or national competitiveness of U.S. markets. 

 Other Provisions with Minor Impact on the University:

  • Prior art exception for your own publications within one-year of patent filing fine tuned to eliminate certain prior art.
  • Prior user defense established for patent infringement
  • New ability of third parties to submit relevant prior art during prosecution
  • Supplemental examination instituted to cure inequitable conduct
  • Restrictions on ability to sue for false patent marking on products

The America Invents Act marks the conclusion of a long and tough debate on how best to modernize our nation’s patent system. This new legislation seeks to encourage innovation, create new jobs in the U.S., and provide the necessary resources for the USPTO to operate efficiently. The potential the new provisions hold remain promising, while the effects the new law will have on small universities and businesses, across the country, remains to be seen.