Nano & Cleantech Blog : Nanotechnology Lawyers & Attorneys : Foley & Lardner Law Firm : Clean Technology, Green Energy

Nanotech has come a long way just ten years into our new century. A celebration of the ten year mark is being planned for later this year, December 8-10, in the Washington DC area. What provides the starting point for this ten year period? The (formal) starting of the NNI, apparently, as President Clinton left office, not the new millenium per se. Billions have been spent since on nanotech by the federal government. What is the result? 

Nanotech has resulted, primarily, in significant innovation these past years. From 2000-2009, for example, the federal government has granted over 4,000 nanotech patents (4,138 patents classified under the nanotech 977 number, based on patent searching today). From 1990-1999, that number was only 1,603 - less than half. Nanotech stands ready to allow cleantech and biotech to push further into the unknown and provide new products undreamed of but 60 years ago. Nanotech must not lose its focus: innovation.

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A potential "bombshell" is in the making which could ultimately impact nanotech and cleantech: 

On August 2, 2010, several persons with Fabry disease petitioned the federal government (NIH) to effectively break an exclusive license held by Genzyme for the drug Fabrazyme®. To date, the government has only reviewed three of these march-in petitions and, to date, has not granted any of them.

However, this time, lives are at stake and threatened persons are petitioning their government.

This time, the administration in power may review the petition with greater sympathy to the petitioners. President Bush's administration reviewed the last march-in petitions. What would Obama do? (Ok, what will the Obama administration do?)

If this petition is granted, important legal and policy implications will flow that influence all technical sectors like nanotech and cleantech which depend on federally funded inventions. At least ten percent of nanotech patents stem from federal funding.

Bayh-Dole "junkies" will follow these developments closely. Bayh-Dole is the legal system which controls the licensing of federally funded inventions to the private sector, and provides the legal context for the potential march-in.

Possible outcomes range from, for example, (i) some sort of settlement approved by the government, (ii) a narrow "breaking of the patent" which would not be too damaging to Genzyme and would be tailored to this fact pattern, (iii) a broad-based "breaking" of the patent with far-reaching implications to other situations, including nanotech and cleantech, or (iv) petition denied. 

How should the NIH rule?

A related NPR story.  

To read the petition to the NIH directly, read below:

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We wanted to review a case which we can call the case of the "self-serving" NDA.  Let me explain:

One critical application of nanotechnology is in sensing, whether used for medical diagnostics or cleantech. For example, the NNI has recently produced a fifty page report on nanotech sensing at www.nano.gov (“Report of the National Nanotechnology Initiative Workshop, May 5-7, 2009”). When a sector of nanotechnology, such as sensing, becomes the subject of patent and/or trade secret litigation, this signals that the market for the technology has arrived. 

One recent IP litigation has been focused on commercial products for nanotech sensing for glucose monitoring, and an important decision was just rendered. In reading these developments, lessons can be learned with respect to non-disclosure agreements, patent filings, and joint development. Many companies, of course, need to pursue joint development strategies in the real world, and the risks associated with joint development must be managed wisely. 

To Read More about the Case of the Self-Serving NDA:

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Meetings were held recently in the Washington, DC area to discuss revising the National Nanotechnology Initiative (NNI) strategic plan (July 13-14,  www.nano.gov). President Obama’s Office of Science and Technology Policy is also seeking input on nanotechnology's future (for example, see presentation from Travis Earles at www.nano.gov).  

In these important discussions, nanotech history should not be forgotten. Moreover, the business at hand must be considered. These points were driven home most forcefully by Intel’s George Thompson who, in his 30 min webcast, encouraged the NNI to push the nanotech gas pedal. Now is NOT the time to take your foot off the gas!  More particularly, after ten years of fundamental nanotech research, more attention should be paid to addressing the infamous “valley of death” which engulfs many nanotechnologies.  Important technology topics like reliability and reproduciblity of specific nanotechnologies cannot be ignored in the drive to just publish more science papers.   

Thompson also notes the centrality and importance of intellectual property.  People have to be willing to share their innovations and overcome difficult collaboration issues which IP can generate.

It was good to see government look to history before deciding how to push into the future. Consider: ...

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Did you know the federal government has spent $14 billion on nanotech since 2001 via the NNI?  As noted recently by InformationWeek, the government (OSTP) now wants to hear your ideas on how best to push into the future with nanotech. OSTP expresses particular interest in how nanotech can facilitate cleantech, while at the same time we also manage environmental, health, and safety risks associated with nanotech.

In other words, what's the best way to spend the next $14 billion?!

Submissions are due 11:59 EDT on August 15, 2010.  Send to NNIStrategy@ostp.gov.

Thanks to Foley's Antoinette Konski for this alert.

See below for more information.

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Nanotechnology commercialization updates are important in view of the large federal government investment in nanotechnology research (both past and on-going investment). Hence, it is important that the government will soon be meeting to update the National Nanotechnology Initiative (NNI) strategic plan. The topics for this meeting include commercialization and technology transfer. The meeting will be held July 13, 14 at the Hotel Palomar in Arlington, Virginia, and input from the public is being requested. See: http://www.nano.gov. Numerous new developments are emerging which should be considered at this meeting for building new strategies.  For example, .....

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A technology transfer debate may be brewing which could impact nanotechnology heavily. First, the Kauffman Foundation set forth the idea that U.S. innovation could be improved by allowing faculty to choose their own licensing agents and not be limited by the university technology licensing office. Then, the Harvard Business Review recently elected this idea as a top 10 idea for innovation in 2010. Now, the Association of University Technology Manager (AUTM) plans to rebut the Kauffman Foundation idea:

"Kauffman alleges that technology licensing offices are “underperforming” and are a “major impediment.” AUTM does not believe this is the case and wants its membership to know that it is taking a proactive stance by preparing a response to the article. Stay tuned for details as they emerge."

Nanotechnology relies heavily on federal funding, technology transfer, and university inventions so the outcome of this debate is vital. We see in practice examples of complicated, successful, and/or difficult relationships among the complicated triangle of professors, university technology transfer offices, and private sector companies seeking to license from the university. An initial perspective: it might be interesting to see how the system would work in some "test case situations" where a university voluntarily allows its professors to work with other licensing agents. 

We will continue to follow this issue as it develops.

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As enunciated by the Federal Circuit in The Forest Group, Inc. v. Bon Tool Co., __ F.3d __ (Fed. Cir. 2009)(Moore, J.) on December 28, 2009, the court interpreted the 1952 amendment of the marking statute to hold that each violation of the marking statute under 35 U.S.C. § 292(a) occurs for each article sold: “Whoever marks … any unpatented article [with] the word ‘patent’… for the purpose of deceiving the public . . . shall be fined not more than $500 for every such offense.”

Now, $500/article...that can be a lot of money!

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As government stimulus money makes its rounds to the R&D sector, nanotechnology companies are slowly getting their fair share of much needed research grants (for example: see here, here and here). While the influx of fresh cash-on-hand could very well be used to hire from the pool of surplus researchers left in the wake of layoffs, companies may need to take appropriate steps to further protect their IP interests. Companies must therefore ensure that tools such as non-compete and non-disclosure agreements are enforced in order to limit the chance that a new employee (or former-employee's) unintentionally, but inappropriately divulges trade-secrets. 

In instances where new research or joint development opportunities arise, companies should also consider additional measures when the possibility exists that employees share knowledge with collaborators, or unknowingly divulge trade secrets to the new employee about similar technologies acquired while with their former employer.  

Recently, Foley & Lardner attorney Steven Rutt, PhD, gave a talk at the inaugural conference of  the American Society for Nanomedicine in Potomac, Md. As part of his talk, Dr. Rutt presented strategies for companies considering new joint development ventures. Some of these strategies include:

• Avoid ambiguous "boundaries" in the scope of work
• Inventory trade secrets ahead of time; consider provisional filings
• Limit the technical field with caution, as some limitations may not be amended later
• Limit the personnel involved; consider a single person as a controller but be cautious when one person works on multiple projects
• Limit importation of new technology
• Limit duration of joint development
• Define technology to be developed
• Define exit plans including ownership

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At the end of March, MIT President Susan Hockfield met with President Obama at the White House to discuss funding for clean-energy technologies.

This news came just a few weeks after MIT researchers reported that they had developed technology that could enable lithium-ion batteries to charge in seconds instead of hours. They're hoping the advance could lead to smaller, faster-charging batteries that could be used in cell phones and other devices (see a previous posting here.).  Another MIT research team, led by Dr. Angela Belcher also reported that they' have combined nanotechnology with genetically engineered viruses to build batteries that could power hybrid cars and cell phones.

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By J. Steven Rutt[1] & Bruce Wu[2]
Foley & Lardner, L.L.P., Nanotechnology Industry Team

 “Nanotechnology and clean tech are in many ways a natural fit. Many of the large corporations that are active in clean tech are also active in nanotech. Nanotech could end up enabling many next-generation clean technologies such as advanced batteries, water-desalination and water-filtration membranes, building insulation, and of course, solar power.” The Clean Tech Revolution, pg. 46.

“Before his death from cancer in 2005 at age 62, [Richard E.] Smalley and his team came up with a list of the 10 greatest challenges facing humanity. At the top of the list were energy and water, ….The scientists understood that energy and water stood at the base of many of the other challenges. … The [I]nstitute [for Nanoscale Science and Technology], under Smalley’s guidance, decided to focus a good deal of its efforts on the intersection of energy and nanotechnology…” The Clean Tech Revolution, pg. 167. 
 

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The patent landscape in the United States has changed dramatically since the U.S. Supreme Court's decision in KSR in 2007.  Some have argued that the bar to overcome the obviousness rejections have become higher in the United States and as a consequence, it has become more difficult and taken longer for a patent to be granted.  However, to our knowledge, limited data have shown how the patent granting process has been affected since KSR in the United States, in comparison with other countries, such as Japan.  Statistics suggested that there are disparities between the grant approval rate on similar patents filed at United States and Japanese patent offices.

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A recent United Kingdom article indicates that nanotech can also be applied to the food industries, including improving packaging and/or enhancing crop growth.  According to the article, with respect to food packaging, the use of nanotech may help preserve essential nutrients such as vitamins. 

Indeed, with such a broad spectrum of potential applications, it should not be surprising to one that nanotechnology can be valuable in the food industries.  However, one big hurdle that the nanotech scientists will have to overcome is to convince the consumers and the government regulatory officials alike such that they will also share the scientists' optimistic view.

The article can be found here: http://www.guardian.co.uk/science/2009/feb/08/nanotechnology-food-shelf-life.

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Comments by Steve Rutt

Three cheers to Thomas Friedman for noting the merits of investing in nanotech, cleantech, and other high technologies in his February 21, 2009 column. Friedman argues, in essence, that stimulus money is better spent for high technology start-ups rather than "giant wealth-destruction machines." 

The readers are referred to the article here.

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