News

March 2014

Welcome

Spring’s optimism is a fitting time to consider New York State’s investment in technology commercialization. As discussed in Facts and Figures on New York State’s Innovation Growth, the numbers reveal that measurable progress is being made toward growing New York’s innovative ecosystem. Technology development events reveal a burgeoning emphasis on the importance of networks to support technology commercialization. This issue looks at two New York State resources that can provide support to entrepreneurs; NEXUS for clean energy and PP2. These and the technology commercialization clinic network mean wherever the technology comes from in the State, it can access resources to help it develop. Good News for tech commercialization in New York State.

New York State Pollution Prevention Institute

The New York State Pollution Prevention Institute (NYSP2I) is a research and technology transfer center funded by the New York State Department of Environmental Conservation. It promotes cost-effective methods to conserve energy, reduce waste and improve performance. NYSP2I is comprised of a partnership between Rochester Institute of Technology (where its headquarters are located), Rensselaer Polytechnic Institute, Clarkson University, University of Buffalo and the ten New York State Regional Technology Development Centers (RTDCs).

NYSP2I’s purpose is to promote the transformation and development of sustainability within businesses and organizations statewide in a collaborative program to make New York a green leader. P2I strives to provide comprehensive and integrated programs of research, technology development and diffusion, outreach and training and education in order to reduce toxic chemical use, emissions, waste generation and to efficiently use raw materials, energy and water. To achieve statewide coverage of pollution prevention programs and services, NYSP2I will partner with RTDCs, technical providers in the public and private sectors, universities and nonprofit organizations.

NYPS2I offers various programs and services to reach their goals. These include direct client assistance programs to develop cost-effective and environmentally friendly solutions to companies; professional training and outreach workshops offered to companies, government agencies and non-profit organizations such as Workshop on Sustainability Strategies and Green Engineering Workshop; research and development services through partner universities; industry specific initiatives to solve common environmental problems in a particular industry sector; community grants program to provide funding and technical support for projects that raise awareness of pollution prevention practices; academic programs focusing on green chemistry; life cycle assessment to reduce the environmental impact of a product; sustainable supply chain and technology program to teach New York State manufacturers to use global sustainable manufacturing and green supply chain; and the Green Technology Accelerator Center (GTAC) to accelerate the introduction of sustainable technologies into the market. The GTAC and Sustainable Supply Chain and Technology Program are part of the new Green Initiative Programs that was launched on April 26, 2012. The new initiative is aimed to create opportunities for sustainable innovation, environmental stewardship and production efficiency.

NEXUS-NY

Are you located in New York State? Interested in the field of clean energy? You can commercialize your own technology and Nexus-NY can help you!

Nexus-NY or the New Energy Xcelerator in Upstate New York is a five-year program sponsored by NYSERDA with a $6 million dollar grant. The program’s goal is to accelerate the commercialization of clean energy technologies throughout New York State. The program is administered by High Tech Rochester and helps entrepreneurs in the field of clean energy by contributing funding, providing an immersive learning program, and connecting technology teams with experienced mentors and investors.

The funding from the program goes towards evaluating the commercial potential of the technology and is used for such things as building prototypes and conducting market research. The immersive learning program stresses customer identification, engagement and business model optimization. Nexus-NY also introduces entrepreneurs to mentors and investors. Participants are then offered the opportunity to pitch ideas to a panel of investors in Upstate New York.

There are two phases to the Nexus-NY program. The first frame is where the initial screening takes place. In that process, entrepreneurs are placed into teams and their technology is developed. In phase two, they develop the business plan and work to develop a prototype. And, in the third and final phase, entrepreneurs prepare for the launch. Nexus-NY offers several great opportunities for entrepreneurs in Upstate New York that are interested in clean energy.

Penn State Office of Technology Management Will Auction Intellectual Property Licenses

Pennsylvania State University announced that it will host what it believes to be the country’s first online auction of intellectual property licenses by a university. So far, only engineering patents will be available for auction. Future auctions will be held for biotechnology patents, chemistry patents, material patents, information technology (IT) patents, and molecular biology patents. Bidding opens on the general engineering patents on March 31st and continues until April 11th. Licenses are valued between $5,000 and $50,000. Bidding is done by creating an account on http://patents.psu.edu. An account can also be created to receive notifications when new patents become available.

The licenses offered are exclusive, meaning that the licensee and Penn State will agree on an exclusive field of use and territory where the licensee is the sole owner of the patent rights. The agreement also includes a provision requiring the winning bidder to pay all the patent maintenance fees. However, unlike most university research licenses, Penn State does not require the payment of any ongoing royalties. In addition, Penn State retains the right to pursue third-party infringers allowing the licensee to participate in enforcement only if Penn State’s enforcement efforts are not successful after six months. The licensing agreement also contains a “marketing efforts” provision that requires the licensee to use reasonable efforts to diligently bring one of the licensed products into the commercial market. Finally, the agreement allows the licensee to sub-license the technology if the sub-licensee agrees to the same terms and pays a fee.

The goal of the auction is to get the intellectual property “off of the shelf and in the hands of companies that can use the technology, at very favorable terms and price points. The buyers get the rights to use the IP, and the University gets a financial return. It’s a win-win situation,” said Penn State Associate Vice President for Research and Technology Transfer Ron Huss. Associate Vice President Huss cites a variety of reasons why the technology has not yet been picked up by a commercial entity. Interim Vice President for Research Neil Sharkey stated that the idea for the auction did not come from a desire to get the most money possible out of the sale of the licenses, but to create knowledge of technologies that have potential for real-world impact. However, if people are not aware of the technology that has been developed, it has no value.

Previous patent auctions by companies have had limited success over the past years, noting specifically auctions by Kodak and NASA in 2012. It will be interesting to see if Penn State is successful in its auction and if so, if consumers eventually see these technologies used in the marketplace. If successful, this might be a process that university technology transfer offices in New York State should consider. In addition to bringing licensing fees that the university would not have had, the auction also draws attention to the university’s research efforts and capabilities.

Experimental Use Exception to Patent Infringement

Anyone who uses a patented invention without authorization is liable for patent infringement under patent statute 35 U.S.C. § 271(a). There is a longstanding common-law exception to this provision. The experimental use exception allows for de minimis use of a patented invention when the purpose is experimental. However, within the last twenty years, the Federal Circuit has addressed numerous experimental use issues and its decisions have made the common-law experimental use exception inoperable in most practical situations.

In Roche Products, Inc. v. Bolar Pharmaceuticals Co. (1984), Roche, a brand-name pharmaceutical company, sued Bolar, a generic drug manufacturer, for using Roche’s patented chemical. Bolar used Roche’s patented active ingredient in experiments to determine if its generic product was a bioequivalent. The Federal Circuit held that the experimental use exception did not apply because Bolar intended to sell its generic product in competition with Roche’s product after patent expiration and thus conducted experimentation solely for business interests. It also concluded that experimentation conducted in pursuit of FDA approval was an inherently commercial purpose in furtherance of a business agenda.

The court further narrowed the exception in 2000 in Embrex v. Service Engineering Corp. Embrex had the exclusive license to a patent directed at vaccinating birds from disease while still in the egg. In an attempt to design a method around the patent, Service Engineering Corp. inadvertently crossed over into Embrex’s patent scope. Although its method had failed, the Federal Circuit still found the inadvertent use to be infringement. The court recognized early precedent for exceptions for amusement, satisfying idle curiosity or strictly philosophical inquiry. However, the court still held that Service Engineering Corp. had conducted the tests in furtherance of its business venture and that experimentation done expressly for commercial purposes cannot be immunized from infringement under the experimental use exemption.

The Federal Circuit again limited the experimental use exception two years later in Madey v. Duke University. Madey, a research professor at Stanford University, owned a patent to two free electron lasers. He then brought the lasers with him to his new position at Duke University. Duke University continued to use the equipment after Madey resigned. The Federal Circuit reversed the lower court’s grant of summary judgment of non-infringement ruling that because Duke was a major academic institution in the business of research and education, the lower court should determine if the educational purpose was in the scope of the exception. On remand, the lower court found that even though the use of the patented invention was for educational purposes, it was still at least in part in furtherance of a legitimate business purpose and therefore did not qualify for the exception.

Based on the Madey decision, it appears that the Federal Circuit precludes experimental use of patented subject matter by all non-profit research organizations including federal laboratories, research foundations, and research hospitals. Further, these cases render any use of the patented invention for testing, designing around a patent, or in pursuit of scientific knowledge too closely related to business interests to be infringement. The only remaining scenario where the experimental use exception may be used is in the case of an individual’s general interest without any intention to profit. Even in this scenario, the use must only be de minimis, small-scale tinkering.

In reaction to Roche, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (“Hatch-Waxman Act”) that passed an amendment codified as §271(e)(1) termed the “Safe Harbor Provision.” This rule exempts from infringement use of a patented invention solely for “uses reasonably related to the development and submission of information under the Federal Law which regulates the manufacture, use, or sale of drugs or veterinary biological products.” The Safe Harbor Provision is seen as a reversal of Roche. This allows generic drug companies to experiment with patented brand name drugs to make bioequivalencies, but actual submission of the data to the FDA would constitute an act of infringement. The exception expands over everything submitted to FDA, including medical devices.

The U.S. Supreme Court determined the scope of §271(e)(1) in Merck KGaA v. Integra Lifesciences I, Ltd. (2005). The Court held that the research must be “reasonably related” to the pursuit of information that would be used in FDA applications to qualify for the §271(e)(1) exception, even if the research at issue was ultimately not submitted to the FDA. It is important to note that neither §271(e)(1) nor the common-law exception were addressed by the Leahy-Smith America Invents Act (AIA) or its legislative history. Consequently, the USPTO has not taken a stance on whether the AIA changes the applicability of these exceptions. Most experts in the field advise inventors against relying on the experimental use exception except to the extent that §271(e)(1) applies.

Facts and Figures on New York State’s Innovation Growth

The Innovation Review has reported on numerous economic development resources and programs in New York State. It can be difficult to gauge how much impact these investments have had in New York’s innovation economy. Anecdotally, the New York State Science and Technology Law Center has seen a rise in projects both requested and undertaken. While correlation does not necessarily imply causation, data from the State Science and Technology Institute (SSTI), a national nonprofit organization that seeks to lead, support and strengthen efforts to improve state and regional economies through science, technology and innovation, has shown a marked growth in New York State in the areas of venture capital and intellectual property.

dollars_by_state

Change in US Venture Capital Investment Dollars over five years (2008-2013)
NY: 88.78%
CA: -1.53%
MA: -9.91%
RI, SC, ND, ME, DC, SD only states greater growth %

deals_by_state

Change in US Venture Capital Investment Deals over five years (2008-2013)
NY: 51.72%
CA: -5.61%
MA: -20.97%
MI, OK, RI, TN, NE, DC only states greater growth %

share_of_venture_capital

Change in share of Total US Venture Capital investment dollars over five years (2008-2013)
NY: 4.70%
CA: 0.48%
MA: -0.86%

utility_patents

Change in number of Utility Patents by State over five years (2008-2013)
CA: 88.69%
MA: 82.28%
NY: 73.78%

number_of_patents

Number of utility patents in 2013:
CA: 36,193 utility patents
NY: 8,489 utility patents
MA: 6,409 utility patents

top_patenting_universities

university_patents

Top 100 Patenting Universities 2012 (NYS has 9):
Columbia: 78 patents in 2012
NYU: 61 patents in 2012
Cornell: 55 patents in 2012
SUNY: 46 patents in 2012
University of Rochester: 27 patents in 2012
Rensselaer Polytechnic Institute: 16 patents in 2012
Rockefeller University: 15 patents in 2012
Yeshiva University: 13 patents in 2012
CUNY: 6 patents in 2012

Data sets used for information:
Utility and Design Patents by State, 2008-2013
U.S. Seed and Early Stage Venture Capital Investment by State, 2008-2013

Welcome

Welcome to the February edition of the Innovation Review. This edition is heavy on issues related to big data, reflecting many state, national and international conversations on the topic. It’s been a busy month in the patent legislation area. The White House held a conference to update the public on what has happened in the arena of patent policy and announce new initiatives. State Attorney Generals have continued their efforts to limit patent abuse, recently by lobbying the Senate for patent reform, specifically seeking provisions to allow state consumer protection authorities more jurisdiction over “patent trolls.”

Staff and students from the New York State Science & Technology Law Center participated this month in another Pre-Seed Workshop, this one in Binghamton. NYS STLC Director Jack Rudnick will be appearing on WCNY’s Financial Fitness March 7th at 8pm. The topic is Developing a High Growth Economy in Upstate New York and will include Nasir Ali of Upstate Venture Connect and Somak Chattopadhyay ofArmory Square Ventures as panelists.

JD students are continuing their work on shorter term projects for companies and individuals with new technologies. Any entity seeking technology commercialization assistance is encouraged to fill out the online intake form on the NYS STLC website.

As always, please feel free to contact us with any questions or comments at nysstlc@law.syr.edu

What is Big Data?

Big Data has been a hot topic gaining popularity in the media. But what is it? Big Data is a term for the collection of data sets that are large, complex, structured and unstructured. In the past, it has often been unmanageable and difficult to process using traditional database management tools and data processing applications but that has changed with increased computing power. Big Data is characterized by the sheer quantity of data generated, how fast the data is being produced and processed, and the variety of new sources of data.
Businesses have been hiring specialists and financing new technology hoping to gain the ability to organize and access these previously unimaginable amounts of data with the goal understanding relationships within and between the data. Finding relationships in the data may provide the business with valuable insights that can allow for better decision-making, which has the benefits of cost reductions, reduced risk, and greater operational efficiencies. Specific applications of Big Data analysis will vary depending on the business and the industry.

Businesses are not the only beneficiaries of Big Data mining. Individuals whose information is being used can get a direct benefit. For example, Netflix and Amazon provide highly customized recommendations to consumers based on analysis of their previous selections. Communities benefit from Big Data analysis when users of a similar product or residents of the same geographical area report adverse events of product usage or services. Finally, society benefits when Big Data is analyzed for national security purposes.

Although Big Data may have multiple applications, there are many potential limitations arising from legal issues of security, privacy, and consent. There has been recent controversy about the National Security Agency (NSA) and data collection. The NSA has collected information from organizations such as Microsoft, Apple, Google, Yahoo, YouTube, Skpe, and Facebook. However, there are many private organizations that are collecting data as well. There are rumors that there has been enough momentum to get some legislation passed on data privacy, especially after the recent Target hacking incident in late 2013. Members of Congress have expressed interest in laws protecting consumers’ data from being stolen and passed quickly. There are already four proposals this year for data security and breach notification legislation. However, potential legislation will be met head-on by retail and banking industries that are worried about increased regulations and the effects on their businesses.