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

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:

• e-Mail
• Print
• Comments
• Trackbacks
• Share

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:

• e-Mail
• Print
• Comments
• Trackbacks
• Share

The PTO continues to execute on its Green Patent Pilot Program, recently releasing statistics in a report dated June 28, 2010. However, this program now more than a half year old appears to continue to suffer from insufficient use and needs further adapting to customer needs, based on these new PTO statistics. With the December deadline quickly approaching, time is running out...

• e-Mail
• Print
• Comments
• Trackbacks
• Share

The U.S. Patent and Trademark Office (“PTO”) recently proposed rule changes with the goal of “effectively provide a 12-month extension to the 12-month provisional application period (creating a net 24-month period).” 75 Fed. Reg. 16,750 (April 2, 2010). The rulemaking may particularly affect nanotechnology companies because the rulemaking is aimed at giving additional time for companies to determine whether nascent technology is worthy of the pursuit for a patent. While the proposed rulemaking has laudable goals, reducing burden on both applicants and the PTO, the proposed changes are likely to provide little benefit to applicants and will form a trap for the unwary.

• e-Mail
• Print
• Comments
• Trackbacks
• Share

The United States Patent and Trademark Office (USPTO) expanded the Green Technology Pilot Program this part Friday. 75 Fed. Reg. 28,554 (May 21, 2010). The Green Technology Pilot Program, which was first announced on December 8, 2009, allows applicants to obtain accelerated examination of applications “pertaining to green technologies including greenhouse gas reduction (applications pertaining to environmental quality, energy conservation, development of renewable energy resources or greenhouse gas emission reduction),” if certain conditions are met, by filing a petition requesting that the application be advanced out of turn. See 74 Fed. Reg. 64,666 (December 8, 2009). One of those conditions was that the applications must be classified at the USPTO in one of the pre-defined areas.

• e-Mail
• Print
• Comments
• Trackbacks
• Share

We continue to find evidence that cleantech patenting is hot (not just warming, no pun intended).

For example, the attached chart shows a recent rapid rise in US patent application publications which refer to “global warming.” Briefly, only about 400 patent applications published each year with reference to global warming several years ago. Now, that number has essentially tripled and has now cleared 1,000 per year (and the 2010 number is projected to be substantially higher than 2009 – over 438 patent publications have already appeared in 2010). Many of the patent filings may not claim technology directly useful to solve global warming, but clearly global warming increasingly helps frame the patent description.

Two years ago, in May 2008, the European Patent Forum held in Slovenia addressed the topic of patenting and climate change. Connecting patents into the global warming law and policy debate, likely, will continue to grow in importance.

• e-Mail
• Print
• Comments
• Trackbacks
• Share

An important theme in nanotechnology is state government pushing for economic development through funding of nanotechnology high-tech start-up companies and university technology transfer. Adding to this push, a recent report suggests that state governments should increasingly fund “home grown” high-tech start-ups rather than provide money to established companies. Home grown, turns out, provides better return for the state. The report, titled "Good Jobs, Strong Industries, a Better Pennsylvania: Towards a 21st Century State Economic Development Policy," was prepared by the Keystone Research Center and focused on developing jobs in Pennsylvania (see, for example, March 21, 2010 edition of the Pittsburgh Post-Gazette, D1, summarizing the report, case studies, and its implications). The reports’ implications, however, are national. In addition, the Keystone report also advocated for more transparency in how the state funding money is used and the results of the funding.

• e-Mail
• Print
• Comments
• Trackbacks
• Share

The "reasonable royalty," that mythical and highly elusive number that some expert witnesses have built careers on, may at long last condense out of the ether. As Law360 has reported, Intellectual Property Exchange International ("IPXI") may soon become the first financial exchange for selling patent licensing rights as units (similar to stocks). As a result, publicly available financial information on the price of the license rights units could, for example, provide a frame of reference for the market value of such licenses.

For universities negotiating with start-ups, or start-ups negotiating with OEMs to commercialize intellectual property, the exchange may provide a valuable alternative to time-consuming and sometimes expensive development of complex license agreements. This may especially be true very early on with license negotiations for nanotechnology innovations.
 

• e-Mail
• Print
• Comments
• Trackbacks
• Share

Nanobio innovations offer some of the more promising opportunities for the development of medical imaging and diagnostic tools.  According to U.S. Patent Application Publication No. 2009/0324706, assigned on its face to Northwestern University, gold-nanoparticles can be used to direct the synthesis of structures on which lippid bilayers may be supported.  Because the lippid structures sequester cholesterol, the structures can be imaged in localized regions within a blood vessel where plaque may be present.

AuraSense LLC, a Northwestern University start-up founded by Chad Mirkin (listed as an inventor in the 2009/0324706 publication), has recently received a $2.5 million investment to commercialize its cholesterol sequestering technology that can be used to image cholesterol hot-spots. Such an investment in a university start-up may be seen as evidence that investment rounds are proceeding after a dismal 2009.  Indeed, more investments like these will help keep American innovation primed with job growth and exciting new nanotech- and nanobio-based products.

• e-Mail
• Print
• Comments
• Trackbacks
• Share

While the snowfall may have closed the U.S. Patent and Trademark Office (PTO) for a fourth day in a row, a fresh crop of patents have issued again as happens each Tuesday. Many of these patents are vital to the future of nanotechnology and cleantech. Below are my top 10 patent observations based on a brief review of the most current PTO data available online.

Starting with the last, but not the least: 

10. The PTO has now classified 5,909 patents as being under Class 977 as nanotechnology patents. This number continues to grow solidly. As highlighted in our posting Update on USPTO Nanotechnology Class 977 in August 2009, the number of 977 patents then was only 5,594. So over 300 nano patents have been granted in six months, which is higher than average (typically, the annual number of granted nano patents is only 250 - 500 patents per year).

• e-Mail
• Print
• Comments
• Trackbacks
• Share

On December 7, 2009, the USPTO announced that it will implement a green technology pilot program (Pilot Program) to expedite the examination of patent applications directed to certain green technology inventions. While eligibility is currently limited to applications filed before December 8, 2009, the USPTO has hinted toward expanding the program if successful. We will continue to monitor this program as it progresses into 2010.

• e-Mail
• Print
• Comments
• Trackbacks
• Share

For those of us who are watchers of the activities at the SCOTUS, the oral arguments of In re Bilski took place at the high court on November 9, 2009.  To provide first-hand insight, Foley featured a same-day webinar that adressed the appeal concerning the parameters of determining patent eligibility in a case that will impact all technology areas — from electronics, financial services, and insurance, to life sciences industries. With the final decision not due until mid-2010, this hearing provided the first critical insight into whether the Supreme Court will significantly narrow or expand the scope of the patent eligibility under 35 U.S.C. § 101.

• e-Mail
• Print
• Comments
• Trackbacks
• Share

- By Matthew Swietlik & John Lazarus

Among 589 patents issued in 2008 across nine categories studied in Foley's Cleantech Patent Landscape Report, hybrid vehicles accounted for 113, or over 19 percent. Corporate entities accounted for over 96 percent of hybrid vehicle patents issued in 2008, while individual inventors accounted for only about 3.5 percent of hybrid vehicle patents. 

• e-Mail
• Print
• Comments
• Trackbacks
• Share

 - By John Lazarus

Collectively, individual inventors accounted for the vast majority of all hydropower (i.e., hydro, wave and tidal power) patents granted in the U.S. during 2008 (28 of 38 total U.S. patents granted - almost 74 percent). All other corporations or entities each accounted for less than three percent. These patents may represent an area of interest for corporations looking to enhance, or enter, the hydropower field by acquiring or licensing the rights to new hydropower technologies.

• e-Mail
• Print
• Comments
• Trackbacks
• Share

 - By John Lazarus

Among the 589 U.S. patents issued in 2008 across nine categories in Foley's Cleantech Patent Landscape Report, the category that produced the most patents was solar energy with 156 patents.

• e-Mail
• Print
• Comments
• Trackbacks
• Share

- By Steve Rutt

The US Patent and Trademark Office continues to classify selected issued U.S. patents as “nanotechnology patents” under class 977. As of today, August 7, 2009, the US PTO has selected 5,594 patents as 977 nanotechnology patents (based on a cursory search of the public PTO web page at www.uspto.gov). Several important points:

• e-Mail
• Print
• Comments
• Trackbacks
• Share

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.

• e-Mail
• Print
• Comments
• Trackbacks
• Share