Impact and Strategy for University Research and Technology Transfer Live Webinar – October 14,...

Impact and Strategy for University Research Impact and Strategy for University Research and Technology Transferand Technology TransferLive Webinar – October 14, 2011

SESSION 2:SESSION 2:Practical Strategies for Adapting to the New Reality

of The America Invents Act (AIA)

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– Technology Transfer Tactics – To order this program, call: 239-263-0605

or visit: www.technologytransfertactics.com

Expert guidance on key changes in operations,procedures, and decision-making such as:

* Direct Impact of First to File* Documentation and disclosure* Engaging the university community* Patent decision-making and filing* Securing investment funding* Assessing threats of post-grant opposition* Cost impact projections* Q&A with the experts


or visit: www.technologytransfertactics.com 2

Wesley D. Blakeslee, BS, JD, CLP, is executive director of Johns Hopkins Technology Transfer. He was formerly an associate general counsel at The Johns Hopkins University, where he practiced intellectual property and complex business law. Wes holds an engineering degree from Penn State University, and a law degree from the University of Maryland School of Law and is a Certified Licensing Professional. He began his professional career as an engineer and systems analyst with NASA, was later a partner in a small regional firm, and in 1983 formed his own practice in Westminster, Maryland, USA. From 1983 to 1989, while in private practice, Wes also served as director of computer development at the University of Maryland Law School, where he also taught computer law. He is frequently a featured speaker at national, state and local conferences and has been cited as a national authority on intellectual property issues in the Chronicle of Higher Education, and other publications.


or visit: www.technologytransfertactics.com3

Brad Brockbank is a Principal of Segue Consulting, a health care strategy, policy, and management consulting firm. He has also served as a Director, Commercialization Practice, for Foresight Science and Technology since 2009. Mr. Brockbank has more than 25 years’ experience in biomedical and environmental technology commercialization, business and economic development, and public policy.

From 1996 to 2008, he built and directed the Intellectual Property and Technology Commercialization Program at National Jewish Medical and Research Center (now National Jewish Health). Previously, he developed and implemented environmental technology commercialization and stakeholder involvement strategies for the Departments of Energy and Defense, and the Western Governors Association, as an employee of Battelle Memorial Institute and the Pacific Northwest National Laboratory.



Hannah Dvorak-Carbone, PhD, is an Assistant Director in the Office of Technology Transfer at the California Institute of Technology (Caltech) and a registered US Patent Agent. Her responsibilities include reviewing invention disclosures; making patent filing decisions and monitoring ongoing patent prosecution; overseeing the office’s financial operations; and negotiating options, licenses, and other agreements related to Caltech intellectual property. Prior to joining OTT, Hannah spent several years as a management consultant with the Toronto office of McKinsey & Company.



Charles D. Goodwin is Director of Technology Licensing at the University of Connecticut’s Center for Science & Technology Commercialization, the university’s technology transfer office, and has been a registered U.S. patent agent since 2002. Charlie holds a Ph.D. in biochemistry from Johns Hopkins University School of Medicine. Following post-doctoral work at the University of Washington and a faculty position at Johns Hopkins, he joined a Maryland-based biotech start-up company, Purification Engineering, Inc as one of its first scientists, later becoming Manager of Regulatory Affairs and Quality Control. He started his career at the University of Connecticut in 1987 when he was recruited as UConn’s first technology transfer manager. After passing the Patent Bar Exam, Charlie has increasingly focused on coordinating the patent filing and prosecution for UConn’s inventions by outside law firms. He prepares a number of UConn’s provisional patent applications and also manages the protection and licensing of copyrightable materials developed at UConn.



• Timely disclosure to OTT more important than ever, to establish early filing/priority date– “Race to the patent office” is on– Can no longer “swear behind” cited references

• Provisionals still in the law, but the “cover sheet” provisional may be inefffective to protect essence of invention



Brad

Do people believe that institutions may need to consider more centralized management of lab notebooks and expectations of their rigorous use, as adefensive strategy for those occasions where derivation can be proven?Various meanings of disclosure here needs elaboration.Disclosure as in early disclosure provided by AIADisclosure as in invention disclosure to TTODisclosure as in public disclosure via communication and collaboration with colleagues, at conferences, etc.

Already, the question is being asked “Do we still need to keep labnotebooks/records?” Despite the phasing out of Interference proceedingunder the AIA, the answer is YES!• Carefully written, complete and accurate records in a dated or date-

verifiable manner must be kept by all researchers and made available to their institutions. Such records remain essential for:

– Responsible conduct of research– Deciding on authorship and inventorship– Preparation of Invention Disclosure forms for your TTO– Providing clear experimental protocols and data for multi-year, multi-researcher

projects– Complying with federal requirements to keep data for 3 years after a grant ends– Answering questions during patent prosecution– Providing documentation for defense against possible derivation claim under new AIA– Supplying information regarding an allegation of scientific misconduct.



The AIA, together with the Stanford v. Roche decision, gives a good reason to review university IDFs and make updates as needed to:

– Confirm that university inventors are actively “hereby assigning” inventions to their university, not just “agreeing to assign.”

– Assure that researchers are providing complete information on past (at least 2 years?), present and future publications and public disclosures related to any aspect of their invention. This is a good time to remind them that “publications” can occur in many forms and in different media.



“Defensive” disclosures are risky– Starts clock on one-year grace period– Jeopardizes foreign rights– If someone else files first, need to prove derivation– Level of disclosure required still unclear



• With the First-to-File System taking effect in about 18 months, everyone will be trying to work faster. Therefore IDFs should be reviewed/revised with a goal of making them easy to use by researchers, easy to review/evaluate by TTOs, and easy to work with by patent agents and attorneys who will preparing provisional applications under increased time pressure – “working on deadline”

• With the AIA and its new terms like “otherwise available to the public,” we should ask for detailed information on poster sessions and seminars given – going back 2 to 3 years.



• When an Invention Disclosure Form reflects work from multiple labs and institutions – especially where there is an industrial collaborator, we should ask for even more detail about presentations by any of the collaborating entities and ask whether meetings among the collaborators were held and whether notes were kept. (re: inventorship, etc.)

• Under AIA there is increased risk to your IP if a non-university collaborator files the first patent application



“But I really want to talk to people about my research and publish it. Can we still seek a patent?”

[Shore of Sea of Galilee]

13Charles D. Goodwin

• YES!!!

• But the timing of presenting,publishing and patenting must becarefully coordinated.

• Leadership and mission considerations– Timing for full implementation of AIA will take

about 18 months– Senior administration needs to support

importance of tech transfer

• Researcher education and engagement– It’s up to the TTO the “spread the word”– 80:20 rule



Researcher engagement



80%

11%

15%

38%

5%

51%

Faculty Disclosures

At Caltech, • 20% of faculty

account for almost 90% of disclosures

• Just 40 individual faculty members account for 80% of disclosures

• The AIA is a new opportunity to try to “teach” some of the same old messages to researchers:– Federal agencies encourage and require technology

commercialization programs – It is part of your job!– You can publish AND patent.– Talk to your TTO early and often.– With AIA there will be more prior art to fend off and the

defending will be done at a later time – at filing date not at the date of invention, which in the past could be years before filing.



Remind researchers that a “publication” can be:- A printed journal article or a book- A handout at a seminar or class - An on-line meeting abstract- A Poster presentation - the specific contents of a poster may

sometimes be hard to document 1 or 2 years after the poster event; you may never know if it was photographed.

- An e-journal paper, including on-line “previews”- A magazine or newspaper story- A thesis once it is cataloged and accessible- A posting to a web page or blog



• Invite your university start-ups and local entrepreneurs to your seminars, etc on patent reform.

• Also invite smaller institutions in your area who may have limited in-house expertise on IP matters.



• Engagement is an ongoing process -- educating new faculty, new disclosers, while revisiting with the big 20% to help them understand AIA implications



• Provisional Patent Filing• File early, file often! But… • Filing early and often as a risk mitigation

strategy requires a significant budget commitment or a lower "acceptance rate" for conversion to utilities.





Provisional Patent FilingDevelop (if needed) a clear and timely process for evaluating and communicating invention disclosure • Develop a strategy at your university:

• Will you file lots of provisionals and do the careful evaluation later?•Will you sometimes file on concept only inventions, or will you always want some real data?• Will all your provisionals be “fully” written looking like utility applications ready for final filing? • Or do you want many of the provisionals to be lots cheaper and just hit the high points with a few claims?• Could you afford an in-house patent agent/attorney?

TTO needs a clear understanding with outside law firms

- How fast can they work?

- What features of an invention disclosure can help them?- Will they agree to file only a $2,000 provisional or whatever

cap the TTO feels is appropriate? - Some inventions will warrant only a basic patent application

on the few focused features believed to be novel & important.





Post-provisional Period -1st year after prov’l filed

• Be clear with the inventors as to what they need to do if the provisional is to be converted to a utility application.• If it makes sense try to set “milestones” at which the filing of a further provisional might be warranted during the lifetime of the first provisional to create several different possible priority dates on which to establish that you did have an invention that you could describe and enable adequately.



Post-provisional Period (con’t.)• Also consider filing later provisionals during the one year to cover incremental data or seminars that go beyond the first provisional.

•Use the provisional application as a component of your marketing materials – under confidentiality. (This is one reason not to just add a PTO cover sheet to a manuscript and call it a patent application.)

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How Caltech does it

• Researchers educated about importance of pre-publication disclosure to OTT

• Provisional applications filed on all disclosures made on campus

– Licensing staff are registered US patent agents

– “Cover sheet” provisionals filed in-house

• OTT reviews with inventors 8-9 months later

• About 50% of provisional applications converted to U.S. utility filings

• Faculty input and licensing interest used to determine foreign coverage

How UConn does it• UConn has a licensing group of 5 professionals including 1 patent agent.• UConn has affiliated units focused on start-ups and incubators for tech companies.• Faculty encouraged to disclose around the time of submitting publications, abstracts, etc. • Grad Students introduced to IP via “Responsible Conduct of Research” courses and other

seminars.• CSTC (UConn’s TTO) holds biweekly meetings to make patent-related decisions.

– Start-up manager, research administrators, etc. participate.

• Provisionals are filed on about 40 to 50% of all disclosures:– About half are filed by outside counsel; and – About half are filed by in-house patent agent: short spec; > 10 claims; & attachments.

– None are “Cover Sheet” provisionals. • Research progress (sometimes), faculty input, licensing status and start-up interest

impact:– decisions to convert to US Utility applications, and

– decisions to file PCT/foreign applications. • About 70% to 85% of all provisionals filed are converted to US utility applications. • Under AIA, UConn might file more provisionals.

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How Johns Hopkins does it

• Researchers educated about importance of pre-publication disclosure to OTT

• Provisional applications filed on most patentable disclosures made on campus– Licensing staff are registered US patent agents– “Cover sheet” provisionals filed in-house

• OTT reviews with inventors within first 30 days • About 40% of provisional applications converted, primarily

PCT filings • Faculty input, licensing interest and nature of specific

technology used to determine foreign coverage

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Challenges? – Increased risk to investors means greater demand for risk

reduction/de-risking inventions; can additional de-risking of technical and business risks compensate for increased IP risk under AIA?

– Challenges will be especially acute for smaller institutions that don’t have aggressive/established technology maturation/gap funding programs (or regional/state entities that can help).

– The new PTO processes to challenge patents will add more unpredictability to whether or not one will get an enforceable patent.



Opportunities?— If a patent survives the gauntlet of possible challenges, it

should have less risk and a greater relative value.— In start-up licenses one may need to forego some upfront $ and

ask for $$ when a patent gets beyond the opposition time periods.

— Universities well positioned to protect IP under new rules may be more competitive in attracting funding for their startups.



Assessing threats– Companies may start targeting university patents

for post-grant review (perhaps instead of taking a license?)

– Implications for practice? i.e., spend more up front on patentability analysis, freedom to operate analysis, commercial triage evaluation?



• Should we expect licensees or potential licensees to test the value of our patent cases by submitting 3rd party information to the PTO and by starting opposition proceedings? (Can we legally demand that they not do so as a provision of a license???) (Are we being too paranoid by even asking the question?)

• Will universities become more active in challenging the patent applications and issued patents of others?



Costs of “file early, file often”– Filing more provisionals?– Filing “better” provisionals?

Costs of inter partes reviews, post-grant review– Budget for it? Or “roll over” and not fight?– Budget for up front investment in triage and

evaluation to ensure stronger position going in?



Impact of AIA on PTO fees:– The bad news: a 15% surcharge on many fees is

already in effect.– The good news: Under the newly created “Micro

Entity” designation, universities and some independent inventors may receive a 75% discount on fees.

– BUT, it is expected to be about a year before the discount gets through all rule making steps.



Range of Possible Impact of AIA on outside attorney time and costs.

– More rush jobs to get early filing dates – more $– Responding to PTO questions and rejections based on

3rd party submissions during prosecution – very hard to estimate how often this will happen or $ impact.

– Responding to post-grant reviews/oppositions – likely to be costly, but should be cheaper than interferences or litigation – very hard to know how many patents will be challenged (What is the experience and costs with oppositions in Europe? One source says 8% of EP opposed.)



Impact of AIA on internal TTO Costs (including staff time, etc.)

– During next 2 years there will be lots of questions and need for training – a real cost in staff time.

– Need for more educational seminars on campus than usual – a real cost in staff time.

– Databases and other systems will need minor updates to accommodate new terminology and new procedures.

– Encourage one of your TTO staff to become patent agent?– Add person dedicated to quicker marketing and/or market

research for your university’s technologies?– Technology Transfer Tactics –

To order this program, call: 239-263-0605 or visit: www.technologytransfertactics.com 36

• Please utilize the public chat box located at the lower portion of your screen.

• Press “01” on your touch tone phone.



• To purchase this program on: – CD– On demand video – PDF Transcript

Please call 877-729-0959 or visit www.technologytransfertactics.com

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