Join your fellow innovators at the Texas Regional Independent Inventors Conference in Austin as the next stage of the America Invents Acts goes into effect. The United States Patent and Trademark Office (USPTO), National Inventors Hall of Fame and the University of Texas at Austin invite you to get practical advice from successful inventors, entrepreneurs and intellectual property experts. Meet and network with your creative colleagues.

Space is limited, so click here to register early.

The conference will be held September 14-15 at the University of Texas at Austin in the Thompson Conference Center located at 2405 Robert Dedman Drive, Austin, Texas. Presentations and workshops will be conducted by senior USPTO officials, Supervisory Patent Examiners, Trademark staff attorneys and a limited number of one-on-one advisory sessions will also be available, with guaranteed slots for the first 20 registrants.

Presenters will include:

Robert Metcalfe, 2007 National Inventors Hall of Fame Inductee
Karen C. Parker, Director and International Trade Specialist, Austin U.S. Export Assistance Center
John Calvert, Acting Associate Commissioner for Patents Office of Innovation Development
 Elizabeth Dougherty, Director of Inventor Education, Outreach and Recognition, Office of Innovation Development
Darnell Jayne, Supervisory Patent Examiner, Technology Center 3600
Catherine Cain, Trademark Staff Attorney

Afternoon breakout sessions will focus on the America Invents Act (AIA), patent and trademark basics, searching sessions for patents and trademarks, and advanced patent prosecution.

A networking reception will be held on Friday evening, September 14.

Again, space is limited, so click here to register early, guarantee your advice session, and view the conference agenda.

The registration fee is $80 per person ($70 for seniors or students) and includes all sessions and presentations, morning and afternoon refreshments, lunch both days and the networking reception.

Keynote and plenary speakers will be announced soon, so follow updates on the conference at USPTO.gov and on Twitter at@USPTOEvents.

If you have questions about the conference agenda contact the Office of Innovation Development at 866-767-3848.

If you have questions about registration contact the National Inventors Hall of Fame at 330-849-6929.

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podcast_100Legal IQ recently conducted an interview with Dave McAllister, Director of Open Source at Adobe Systems about the latest Open Screen developments.  McAllister offers some exclusive reflections on his work with Steve Jobs:

“He honestly was one of the most futuristic geniuses I’ve ever seen, able to figure the directions for the broad-based consumer and the high-end prosumer.”

Dave talks to Mikk Putk, of IP Insiders, about the risks when tying open innovation to business strategies and how it affects intellectual property protection (IP): “If we’re going to release a technology as open source we also expect, Adobe’s belief is that we are making the directly related patents that we hold on that available for others to use.”

Dave then speaks to Stephen Jenei, of Patent Baristas, about the ongoing Apple v. Adobe/Flash Player v. HTML5 dispute and the future of Flash and open development at Adobe : “Flash and the Flash platform, which includes Adobe AIR, have moved to providing unique capabilities to marketplaces that are interested in advanced features. So we’re seeing Flash continue to innovate, but move the standard capabilities off to other platforms.”

Please click here for the full interview mp3 and transcript

This interview was conducted ahead of Legal iQ’s 6th Annual Global Patent Congress

To attend, please register online, call +44 207 036 1300 or email enquire@iqpc.co.uk

About IQPC

IQPC provides business executives around the world with tailored practical conferences, large scale events, topical seminars and in-house training programs, keeping them up-to-date with industry trends, technological developments and the regulatory landscape. IQPC produces more than 1,500 events annually around the world, and continues to grow. IQPC leverages a global research base of best practices to produce an unrivalled portfolio of conferences.

 

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The BIO 2012 convention in Boston, which ran June 18-21 in Boston pulled down a fair number of tweets in the process.

Here are some we noticed:

Mike SpearMike Spear ‏@mikesgene
@erinatbio #bio2012 payed off for us. BIORadio gave me a chance to speak with researchers and gov’t funders we haven’t tracked down at home.

BIO Intl ConventionBIOIntl Convention‏@BIOConvention
Chris Yochim of @AstraZeneca on the #BIO2012 Academic Zone: academic & research institutions build alliances w industry http://bit.ly/MXIY0M

Sanofi USSanofi US ‏@SanofiUS
We were glad to be there! RT @2ecreative: Who blew #BIO2012 away? @SanofiUS because they showed up! http://ow.ly/c6HbS

BIO Intl ConventionBIO Intl Convention ‏@BIOConvention
@Biogen_Idec_MS promotes science to grades 6-12 in #Boston community see students working in pharmacogenomics #BIO2012 http://bit.ly/LC3gOe

Rob WrightRob Wright ‏@RfwrightLSL
Does Bio International Deliver On Its Claims? http://goo.gl/4aDbL #bio2012 #biotech #pharma

Erin LeeErin Lee ‏@ErinatBIO
Does #bio2012 deliver on its claims? http://bit.ly/PodTDn? Save the date for #bio2013 April 22-25 in Chiacgo

BIO Intl ConventionBIO Intl Convention ‏@BIOConvention
Did you miss one of the 800 speakers, 125 sessions, or 14 topics? Catch them after #BIO2012 – order session recordings: http://bit.ly/LHXLxr

MedImmuneMedImmune ‏@MedImmune
MedI’s Atul Saran gives a deeper look into collaboration between Medi/ @AstraZeneca & @Amgen on @PharmaTV at #BIO2012 http://bit.ly/MZnfpN

Nature BiotechnologyNature Biotechnology ‏@NatureBiotech
Blog: Comparing development costs in China vs. the US #BIO2012 http://bit.ly/NoYaP0

Erin LeeErin Lee ‏@ErinatBIO
Interesting article about women in biotech (from Wisconsin!) http://bio.wisbusiness.com/2012/06/column-wisconsin-execs-see-promising.html #bio2012

Patricia BeggiatoPatricia Beggiato ‏@MommyBeggiato
amazing conference RT“@SDFatBIO: @MommyBeggiato Great to meet you in Boston! Thanks for joining us for #BIO2012. Keep in touch!”

Stephanie FischerStephanie Fischer ‏@SDFatBIO
#BIO2012 benefits Boston even after it ends, thanks to Convention Center initiative to donate leftover swag to charity: http://tinyurl.com/77v9ntk

Helen FilipeHelen Filipe ‏@helenfilipe
Following up with great connections made at @BIOConvention#bio2012 Thank you! Had some sereserendipitous moments

Liz at BIOLiz at BIO ‏@LIZatBIO
‘Speed dating’ spurs bio deals – http://BostonHerald.com  http://bit.ly/Poe7ue #BIO2012

BIO Intl ConventionBIO Intl Convention ‏@BIOConvention
Can you smell the beer? Stop by the Beantown Bar in the North Lobby #bio2012 pic.twitter.com/kVhY1hYm

Mass ConventionMass Convention ‏@MassConvention
@BostonInsider estimates BIO will bring $25 million to $27 million to Boston hotels, restaurants and other facilities: http://ow.ly/bHJTx

Robin DeacleRobin Deacle ‏@RobinDeacle
Favorite BIO tweet «@johnnyhooper My new @keen kicks are proving to be great trade show shoes. @bioconvention @okbio #bio2012»

LillyPadLillyPad ‏@LillyPad
The #BIOTech Industry is close to a TRILLION dollar industry around the world. That’s a big number. #BIO2012

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podcast_100Neil Bowering, Project Manager, IP Easy access, University of Glasgow, joins bloggers Stephen Jenei, of Patent Baristas and Mikk Putk of IP Insiders, to discuss Easy Access IP.

In this exclusive interview, Neil gives some background about the Easy Access IP system, why the University of Glasgow set it up, achievements to date, membership figures, types of IP that have been put into the initiative and what has been achieved through the Easy Access campaign.

Mikk Putk asks Neil to expand upon why the Easy Access IP system was set up as a free of charge service and how authors are rewarded; whilst Stephen Jenei questioned in regards to licencing – how the University defines the Technology.

This interview was conducted in conjunction with the upcoming Global Patent Congress, which will take place from 24th-26th September in Copenhagen, Denmark. For more information please email enquire@iqpc.co.uk or call 0800 652 2363.

Please click here to listen to the podcast.

Please click here to read the transcript.

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After an exhausting time at BIO 2012, we can finally call it a wrap.  Here’s a sampling of the reporting around the blogosphere on the convention:

Julie M. Donnelly at the Boston Business Journal gave the final numbers for BIO 2012: official tally of 16,505 attendees, down from the 22,000 in 2007. Total economic benefit to Boston of $26.8 million. (BIO 2012 by the numbers)

Luke Timmerman of economy gave the Good and Bad of BIO 2012.  The Good: This is probably the one biotech event each year that’s truly international.  The Bad: Too many people selling, not enough people buying.  (Three Good Things About BIO 2012, and Four Not-so-Good)

Kwame Mensah over at Patent Docs wrote a nice overview of a panel discussion on the potential impact of Mayo Collaborative Services v. Prometheus Laboratories, Inc. on the future of personalized medicine and diagnostic method patents in the US.  (Docs at BIO: IP Challenges to Personalized Medicine & Diagnostics)

Fierce Biotech send nine (9!) reporters and editors to BIO 2012 for stories, interviews and other special assignments during the event.  The even hosted a dedicated website for the BIO convention. (Live from the 2012 BIO International Convention)

The Cross-Border Biotech Blog had the opportunity to participate in a new program known as the “BIO Buzz Center” which enables official bloggers to do webcasts over BIO’s website. (Cross Border Biotech – Now on Video)

Biotech-Now gave a reap of the Burrill Industry Report.  “How are we doing? It’s tough,” said G. Steven Burrill, CEO of Burrill & Company.  Noteworthy is that the biotech industry has raised $63bn in capital over the past year – the largest 12-month total haul in the history of the industry. (BIO 2012 Super Session Recap: Burrill State-of-the-Industry Report)

The New Cambridge Observer posted pictures of the Occupy Boston protesters. (Picketers greet 15,000 participants at BIO 2012 Convention in Boston)

About Biotech reported on a group with a different agenda. Rather than promoting an anti-biotech message, they were pushing for fast track release of a new combination cancer drug known as T-DM1, jointly developed by Roche and Immungen. (BIO 2012, Day 2: Industry Address, New Protests, and E&Y Release Global Biotech Industry Report)

Meanwhile, the Boston Herald cornered Rick Perry, Gov. Patrick during this year’s Bio conference, quizzing their scientific know-how.  (Pols flock to Bio 2012)

Rob Wright at Life Science Leader asks himself, “Does Bio deliver? Does Bio help to connect, partner, and innovate?”  He says yes — if you do a little planning. (Does Bio International Deliver On Its Claims?)

Finally, Yali Friedman at the Biotech Blog writes about a panel discussion on panel on how IP is essential for biotechnology and should be used to improve access rather than to drive high prices. (IP is essential, and should be used to improve access)

Next Up: Chicago, IL, April 22-25

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A panel discussion at BIO 2012 pondered the questions as to whether the America Invents Act (AIA) provides a new option replacing patents to secure freedom-to-operate for internally used innovations in biotechnology. Amendments to 35 U.S.C. Section 273 provide for prior user rights, which protect trade secret owners against patent infringement lawsuits.

Therefore, if a company makes an innovation but decides — for economic or strategic reasons — not to seek patent protection for the innovation and instead elects to protect the invention as a trade secret. In such a case, if another company independently invents the same innovation and elects to file and prosecute a patent application — which issues as a patent — then the second to invent party cannot sue the first company for infringement, even though the second company holds a valid patent.

The AIA provides trade secret owners and other alleged infringers with the a prior user defense against patent infringement claims for all inventions if the trade secret owner or other accused infringer can demonstrate internal commercial use (or other commercial uses) of the patented invention at least one year prior to the effective filing date of the patent.  Prior user rights are a personal right. The patent remains valid and enforceable against other companies that are not entitled to a prior user right.

There is an exception to the requirement that a prior user right must be based on commercial use of the subject matter since “activities performed by a nonprofit research laboratory, or nonprofit entity such as a university, research center, or hospital,” if and only if “the public is the intended beneficiary of the use,” are statutorily deemed to be commercial uses for the purpose of obtaining the personal right to continue the use.   The defense is not available to a university or a technology transfer organization whose primary purpose is to facilitate the commercialization of technologies developed by a related university unless “the activities required to reduce to practice the subject matter of the claimed invention could not have been undertaken using funds provided by the Federal Government.”

The prior user right is also limited to a commercial process. The defense is limited to a person who, “acting in good faith, commercially used the subject matter in the United States, either in connection with an internal commercial use or an actual arm’s length sale or other arm’s length of a commercial transfer of a useful end result of such commercial use.”  In addition, “subject matter for which commercial marketing or use is subject to a premarketing regulatory review period during which the safety or efficacy of the subject matter is established…shall be deemed to be commercially used…during such regulatory review period.” Note that such regulatory review is normally either completely secret or substantially secret.

The personal defense “extends only to the specific subject matter for which it has been established that a commercial use that qualified under this section occurred, except that the defense shall also extend to variations the quantity or volume of use of the claimed subject matter, and to improvements in the claimed subject matter that do not infringe additional specifically claimed subject matter of the patent.”  Also, if the owner of the personal defense abandons commercial use of the subject matter at issue, it cannot later “rely on activities performed before the date of such abandonment in establishing a defense under this section with respect to actions taken on or after the date of such abandonment.”

While a user does not need to prove first to invent, there are still plenty of reasons to document inventions. In order to get prior user rights, the user must prove by a high level of proof amounting to clear and convincing evidence that it commercially used a process or a composition, manufacture or machine used in a manufacturing or commercial process at least one year prior to the effective filing date of a patent.  If the patent holder disclosed the invention prior to patent filing but filed the patent application within his one-year grace period for U.S. patent filing, then the prior user must establish the prior commercial use at least one year prior to the patentee’s public disclosure.

A potential prior user will need to take steps to create and maintain careful records.The documentation documentation should be signed and dated and detail the machine, apparatus or process. The records also should show the commercial nature of the use and, if possible, the documentation should be corroborated or witnessed to assist in meeting the clear and convincing standard.

However, it is not clear how closely a prior user’s use must match with the patent claim to get the benefit. A prior user must essentially concede patent infringement to raise prior use as a defense. This does not rule out other infringement defenses but could box in the defendant.  The prior user defense does not create any invalidating prior art against a third party’s patent.  Some wonder if a prior user might be better off raising a defense of patent invalidity.

Another issue is that users won’t want to assert this right lightly; a patent holder bringing an infringement suit can get attorney fees if the user fails to make a proper showing.

Mary Ann Dillahunty, VP of Intellectual Property for Oncolytics Biotech, detailed some of the drawback of prior user rights for biotech companies, including that the prior user may not assign, license or transfer this personal safe harbor to a third party, except as an ancillary and subordinate part of a good faith transfer of an the company or line of business.

This means that a smaller biotech company that makes an innovation cannot convey the defense of prior user rights  to a third parties for manufacturing or distribution purposes.  This makes prior user rights valuable only to full service biotech companies that can do their own manufacturing and marketing. The AIA also includes limitations on the manufacturing sites where prior user rights attach. Given the limitations, a small biotech would be better off filing for patent protection.

In addition, prior user rights add a level of uncertainty to the value of patents since patent holders will not know if there are prior users lurking in the field.  There is also the costs of litigation to determine the user rights and the costs to maintain trade secrets.

Another negative for smaller companies is that could be a question of whether there has been abandonment of the user rights. Smaller companies cannot afford to continue running several different processes in parallel while developing a product and it is not clear if setting aside one process to use another will constitute abandonment.

On the other side of the coin, Brian Barrett, Associate General Patent Counsel for Eli Lilly & Company, felt that prior user rights are mostly positive.  He pointed out that it can allow a company to benefit from prior commercial use while allowing a subsequent inventor to still secure a patent that is enforceable against other (non-prior) users.  It also encourages domestic manufacturing, reduces the need to seek (expensive) worldwide patent protection for minor process.  In addition, this is rarely used and there is little evidence that prior user rights have a negative impact on innovation.

On the negatives, Barrett did concede that it can reward companies that rely on trade secrets instead of filing patent applications, which would provide of public disclosure.  Prior user rights may also devalue patents that otherwise would apply and may be disproportionate in scope relative to risk of a post-eBay court granting an injunction.

So, is it worth the trouble to patent internally-used technology? It really depends on your situation.

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A panel of distinguished lecturers provided thoughts and insights on recent major court cases in the biotech arena — and the decision-making behind them. In a discussion on the effects of Prometheus (and Myriad), the consensus seemed to be that there’s no consensus. On Prometheus, the panel tackled the question of how will the decision effect diagnostic patents?

The decision might be read as rendering much of the innovation in biotechnology, including drug method-of-treatment claims, patent-ineligible. However, Seth Waxman, a lawyer at WilmerHale, felt that the decision will be read narrowly because it was unanimous. Unfortunately, however, the language of the decision creates substantial uncertainty with respect to the patent-eligibility of a large number of issued patent claims in biotech.

Other panel discussions on the topic have showed that the vast majority of companies and venture capitalists are in a tizzy over what this means to investments. With all the uncertainties – clinical trial failure, market failure, etc., and now add this new patent uncertainty — venture capital people may just walk away and “go invest in the 37th iteration of an improved hemorrhoid treatment.”

Others expressed frustration that the Supreme Court never reverses itself, it just makes decisions that can’t be reconciled with earlier decisions. The Court had made an analysis of section 101 as a very broad grant of patentability subject to the further patent rule limitations. That is, 101 sets out very broad array of inventions that are patentable provide and now not true. Here, the Court seems to be skewing patent laws to provide for public policy decisions.

Diagnostic companies should get mobilized over the decision since many diagnostic patents will be challenged to get an interpretation of what is patentable and what is not. The Supreme Court, in declaring all of the claims patent-ineligible in a unanimous decision, emphasizes the role of Section 101 and patent eligibility in guarding against the danger of too broad of patent protection.

In looking at Myriad, the panel noted that isolated DNA has a different structure, different utility compared to the native DNA and lacks lots of things native DNA has. These are markedly different composition with markedly different properties. Such a decision would render taxol unpatentable even though chewing on bark won’t treat cancer while the purified form is incredibly valuable cancer treatment. Myriad is not the model of patent claims — and certainly not the model citizen for biotech companies — but broad rejection of isolated, purified molecules on arguments that not different enough from non-purified state that exists in nature would be detrimental and wrong

Neal Katyal, a lawyer at Hogan Lovells, felt that plenty of cases are unanimous and yet read broadlybroad. He felt the that in reversing the Circuit, the Court wouldn’t have just let Justice Breyer do whatever he wanted. Skepticism about need to patent things to protect economy.

Katyal felt that Myriad is not directly controlled by Prometheus since it deals with a composition and not a process and has both broad and narrow claims. But, it would be wise to consider aspects of Prometheus in terms of uncertainties raised for Myriad.

Earlier, the Court has made plenty of arguments are that section 101 is a broad statute, e.g., Chakrobatry, but it is not that section 101 has no limits. Prometheus suggests that the line has tipped a little towards the not so broad. The Court has noted that its for Congress to decide if limiting of 101 needed – the policy doesn’t need to be decided by the courts.

John Whealan, Associate Dean for Intellectual Property Law, George Washington University Law School, agrees with Waxman. Whealan noted that we can’t just give up on diagnostics. Section 101 cases are impossible to reconcile so it is not an exact test but a matter of degree. In trying to fit what the Court is going to do, look at what the claims trying to do and what is the science.

Kevin Marks, Vice President and General Counsel, Roche Molecular Diagnostics, addressed the question of how businesses may deal with the uncertainty. Companies can use trade secret route but that is very limiting in its protection. The general thought is that we will see diagnostics look to trade secrets more often but they are in a wait and see period. Diagnostic companies are still trying to understand the full impact of the case. How can we craft around the cases? Breyer seems to say that it is not just claims craftsmanship but broader subject matter implications.

Will diagnostic companies decide not do the research in this area because of it? The potential impact is that investors looking for a certain level of return will be turned off. As diagnostics are becoming more like pharmaceutical in the data required for approval, this means that without patents, companies won’t spend that kind of money. This has downstraeam implications since substantial licensing comes out of universities and companies won’t license or pay, without more clear data on how this will be interpreted.

For now, we seem to be in a wait and see period.

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“The relationship between IPRs and biopharmaceutical innovation is together with copyright on the internet perhaps the most contentiously debated topic in the literature.”

~ “Taking Stock: the Gains of Global
Biotechnology Research from IPRs”

Proponents argue that IPRs are essential to pharmaceutical and biotechnological innovation and provide innovators with the necessary incentives to continue to invest in research and to develop new drugs. Critics claim that pharmaceutical IPRs stifle innovation and raise the cost of drug development. In that light, the Biotechnology Industry Organization (BIO) released a report on the contribution of IPRs to the biotechnology ecosystem and economic growth in developed and emerging economies.

The report, titled “Taking Stock: the Gains of Global Biotechnology Research from IPRs,” was unveiled today during the Intellectual Property and Biotechnology – The Way Ahead session.

The report, commissioned by BIO, examines the role played by IPRs in both upstream and downstream phases of the research, development and commercialization of biotechnology products and inventions in developed, emerging and developing economies (particularly as it relates to biopharmaceutical and biotechnological innovation). Upstream being the range of research and development activities which relate to the pre-market and development stages of a product or technology. Downstream being the range of activities that relate to the market and post-market phases (including commercialization) of a product or technology.

In the literature, there is a growing body of evidence suggesting a positive link between economic development and growth, technology transfer, increased rates of innovation and the strengthening of IPRs. This is particularly strong in certain knowledge-intensive sectors such as biopharmaceuticals. Much of the international debate on biopharmaceutical innovation focuses on downstream issues: whether IPRs stand in the way of commercialization and whether they enable or delay access to medicines in developing countries. This discussion is usually placed in the context of the “North-South” divide (i.e. developed vs. developing world) and the extent to which the use of IPRs benefits or damages developing countries.

However, the discussion on the use of IPRs in upstream innovation (or the relationship of IPRs and biotechnology innovation in the context of biotech SMEs and universities) is often theoretical in nature and only at times based on data and collected evidence. Some international debates on IPRs relating to the upstream R&D process also examine the issue of ownership of genetic innovations and biologic materials and so-called research exemptions. There are ongoing concerns about the extent to which the patent system may be used in a manner that slows or hinders access to biotechnological research and innovation.

Based on these findings, the report discusses and explains the impact of IPRs on biotechnological innovation in the upstream process. The report outlines how IPRs have encouraged collaboration between biotechnological entities and, as a result, enabled further research and development of new biotechnologies, specifically in emerging and developing economies. In particular, technology transfer mechanisms such as Bayh-Dole styled frameworks are discussed in the context of emerging and developing economies.

The key findings that have emerged from this report include:

  • IPRs, especially patents, are actively facilitating and contributing to upstream and downstream biotechnology activities in both developed and developing countries.
  • Today, not only mature economies but also major emerging economies are making growing use of the patent system to facilitate biotechnology research and commercialization.
  • Accordingly, biotechnology alliances for research and technology transfer have increased markedly since the early 1990s.
  • Case study analysis suggests that strengthening IPRs and introducing technology transfer frameworks based on IPRs in combination with other reforms can have a positive and sustained impact on innovation, economic development and growth, biopharmaceutical R&D and access to biotech products in emerging economies.

Based on these findings the report makes the following recommendations:

  • Focus the spotlight on upstream phases – Understanding the relationship and interaction between IPRs and the upstream phases of biotech R&D is as important as discussing the role of IPRs in the commercialization of these technologies and products. Therefore, attention should also be devoted to upstream processes, not least in international discussions.
  • A closer look at the nuts and bolts – In this context, we need to deepen our understanding of the mechanics and mechanisms by which IPRs can be used strategically in order to enhance the R&D process.
  • An enhanced architectural mindset – Policymakers should consider the architectural setting and how the use of IPRs during the upstream process can be optimized.
  • The needs of emerging economies – Given the growing positive impact of IPRs in emerging and developing economies, there is a real need to increase our awareness and body of knowledge about frameworks, best practices and specific experiences with the use of IPRs during the upstream phases of R&D.
  • An international observatory of best practices – It is worth creating an international observatory that maps both knowledge as well as instruments that could help galvanize entities around the world to make greater use of IPRs during the upstream phases of biotech R&D.

You can read the whole report here:  ”Taking Stock: the Gains of Global Biotechnology Research from IPRs”

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