Tag: Patents

Categories
Government and Policy McNair Center

Patents and the Cancer Moonshot

Patents and the Cancer Moonshot: How Subject Matter Eligibility Affects Research

When standard cancer treatments fail, some doctors are turning to the developing field of immunotherapy. Immunotherapy involves treatments that use the patient’s own immune system to combat cancer. Both pharmaceutical companies and the federal government see the promise in funding research in this innovative field. However, R&D in cancer treatments is a time-intensive process, and it takes months, if not years, before doctors can bring cutting-edge research to their patients.

In January 2016, President Barack Obama called for the Cancer Moonshot to double the rate of progress in cancer research. Vice President Joe Biden traveled across the country and the world (including to Rice University) to collect information on current barriers in cancer research, like inefficiencies in the patent process. However, is the lengthy patent examination process truly what is slowing cancer research?

Accelerating the Process with “Patents 4 Patients”

To help accelerate cancer research, the United States Patent and Trademark Office launched the Cancer Immunotherapy Pilot Program (also known as “Patents 4 Patients”) in July 2016. This program aims to fast track the review of patents that involve treating cancer using immunotherapy.

Usually, the USPTO examines patents in order of their U.S. filing dates. However, under “Patents 4 Patients,” the Patent Office will grant special status to patent applications relating to cancer immunotherapy. The USPTO aims to finish examining petitions submitted before June 29, 2017 within twelve months of granting special status.

Often, USPTO examination takes a long time. Over the last two years, first office action pendency, or how long it takes to mail a First Office Action after a patent application is filed, takes an average of 16.5 months. Additionally, traditional total pendency, or how long it takes to decide whether to issue or abandon a patent, takes an average of 26.4 months. The new Pilot Program certainly has the potential to reduce these wait times. However, long patent examination periods are not the only barriers that researchers face when developing cancer treatments.

Patent Subject Matter Eligibility: A Look at Section 101

Under Section 101 of Title 35 of the United States Code, “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement” is patent-eligible. Over the past few years, the U.S. Supreme Court has affected what is patentable. Under judicially recognized exceptions, laws of nature, natural phenomena and abstract ideas cannot be patented.

Most controversially, in Mayo v. Prometheus (2012), the Court held that correlations between blood test results and patient health were “laws of nature” and that any claims relating to these correlations were patent ineligible under 35 U.S.C. §101. Similarly, in AMP v. Myriad (2013), the Supreme Court held that claims relating to isolations of naturally occurring DNA cannot be patented.

Because of these decisions, the USPTO has rejected or abandoned many patents relating to cancer immunotherapy treatment on the basis that they claim laws of nature. According to Patently-O, patent rejections based on Section 101 objections increased substantially after the Mayo ruling from 15.9% of office actions to 86.1%.

For example, the USPTO has rejected patents relating to using gene expressions to predict chances of breast cancer (US20100035240A1) and using a specific protein as an early indicator of cancer (US20150072355A1) because they are applications of laws of nature. However, unlike the USPTO, the patent offices in Europe, Japan, and China have accepted these applications and granted their patents. Current U.S. patent law does not conform with internationally recognized forms of patent eligibility. Stifling the progress of research through patent rejections does not bode well for U.S. cancer patients. By refusing to protect emerging discoveries, the USPTO undermines cancer treatment research, especially in innovative fields like immunotherapy.

More Barriers with the FDA Approval Process

Even after a treatment is patented, it can take years to go through the phases of the clinical trial process. Phase I and II determine the safety and promise of a treatment. Phase III tests the effectiveness of the new treatment compared to existing standards. After successfully going through trials, companies file a New Drug Application (NDA) for Food and Drug Administration (FDA) approval.

According to DiMasi, Grabowski and Hansen (2016), clinical trials take an average of 9 years and 8 months. After a company submits an NDA, the FDA takes an average of 16 months to review it. This lengthy approval process further slows down R&D in cancer treatment.

Improving Subject Matter Eligibility Guidelines

Excludability in fast-growing fields like immunotherapy is extremely valuable in the early stages of R&D. Patents provide stability and a relative level of certainty, so a more quickly granted patent can help firms stake their claim in a developing treatment. However, the higher amount of claims rejections decreases the probability that companies will be able to protect their research. Questions about what is patent-eligible material could discourage investment and deprive researchers of necessary funding.

The Cancer Moonshot initiative is eager to make the patent process more efficient to quicken the progress of cancer treatment. While Patents 4 Patients could potentially help expedite research, long pendency periods are not the only barrier to accelerating research. Many discoveries are patentable, nonobvious applications of laws of nature. Yet, after recent court rulings, the USPTO still rejects their patent applications.

In late 2016, the USPTO held two roundtables to improve the its guidance for patent examiners on subject-matter eligibility.  As judges and policymakers continue to define what can be patented, they must recognize the impact of their decisions on cancer treatment innovation.

Categories
Government and Policy McNair Center

True Impact of the Bayh-Dole Act

Addressing the True Impact of the Bayh-Dole Act

Since the passage of the Bayh-Dole Act in 1980, many researchers have debated its contribution to the transfer of technology from universities to industry. Some credit the act as an engine of economic growth responsible for the emergence of the biotechnology industry. Critics say that the law decreased data sharing and basic research and increased health care costs. Others think that the act had little impact and that changes in university patenting were inevitable.

University patenting would have increased regardless of the Bayh-Dole Act. However, the act did help universities license patents, creating positive economic benefits especially in the biotechnology industry.

Background

The Bayh-Dole Act was intended to improve the commercialization of federally funded research.

Former Senator Birch Bayh and Senator Bob Dole, authors of the Bayh-Dole Act, in Washington D.C. on July 22, 1985.
Former Senator Birch Bayh and Senator Bob Dole, authors of the Bayh-Dole Act, in Washington D.C. on July 22, 1985.

Before 1980, only 5% of government-owned patents were ever utilized in industry. Corporations found it difficult, risky or unappealing to receive licenses for government patents. Several government agencies did not want to give up ownership of patents to universities or corporations. Agencies such as the National Science Foundation tended to give nonexclusive licenses to anyone, unappealing for companies. As it was easy for any company to procure licenses, the system did not incentivize companies to purchase licenses; most wanted exclusive rights.

The Bayh-Dole Act enabled institutions to keep control of patents invented using federally funded research. The university or business could then grant licenses on its own terms. The act also required universities or businesses to have clear patent policies and encourage development of inventions.

Did the Bill Work?

Claims that the Bayh-Dole Act alone led to increased patenting and economic activity surrounding university patenting are not true. Economic models show that the acceleration of patenting would still have occurred even without the act. David Mowery finds that universities increased their shares of patenting from 0.3% in 1963 to 4% by 1999. However, he notes that this increase had already begun before 1980, which indicates that the Bayh-Dole Act was not its cause.

Since the passage of the Bayh-Dole Act, more than 5,000 new companies have formed from federally funded university research. In 2008, more than 600 new university products were introduced to the marketplace. According to MIT, about 30 billion dollars of economic activity per year and 250,000 jobs can be attributed to technology born in academic institutions.

The Bayh-Dole Act may not have been the only contributor, but these large numbers show the importance of university innovation to the economy and make it clear that innovation spurring legislature can have enormous positive effects on economic growth.

Creation of the Biotechnology Industry

From the 1968-1970 period to the 1978-1980 period, biomedical university patents increased by 295%. Biomedicine, an important part of biotechnology, was therefore growing rapidly before the introduction of the Bayh-Dole Act. Most likely increased funding in the field, advances in science and emergence industry interest also played major roles in the growth of university patenting in this area.

The Bayh-Dole Act likely contributed to increased licensing of university biotechnology patents. The ability of universities to license patents created strong incentives for many scientist-entrepreneurs to form companies around their inventions. At least 50% of current biotech companies began as a result of a university license. Additionally, 76% of biotechnology companies have at least one license from a university.

These license based biotech companies have made huge impacts on the economy. University licensing of biotechnology patents generated more than $40 billion in economic activity in 1999. According to Boston University, biotechnology companies represented over 1.42 million jobs in 2008, and the bioscience sector as a whole represents an employment impact of 8 million jobs. By 2009, 1,699 biotech firms generated annual sales of $48.2 billion.

Addressing Criticisms

Critics of the Bayh-Dole Act cite the decrease of data sharing, higher health care costs and a shift away from fundamental research as flaws of the law.

Because researchers patent new inventions, they might tie up research data in patent rights. This could prevent other researchers from accessing this data, slowing the research process. An article by Neil Thompson and others suggest that this isn’t true in practice. They find no evidence that licensing of academic patents limits the sharing of research data. However, their work leaves open whether licenses on research tools lead to restrictions on continual research in a subject.

Many also argue that health care costs have increased as a result of the Act. Biomedical university patents often can be utilized in the process of drug creation. As these discoveries are not final products, companies must license each patent that they use to create a drug. The cost of licensing many of these patents allegedly drives up the cost of the final product, hurting the consumer. The NIH and USPTO have created guidelines to prevent the unreasonable licensing of biomedical patents. However, these guidelines are not all concrete.

While this “royalty stacking” may contribute to high prices, it is unfair to blame the costs solely on the Bayh-Dole Act. Drug development includes a multitude of phases with high costs that extend beyond patents at each step. Many drugs could also not have been developed without the help of the patented technologies.

Finally, others point out that applied research generates more money from patenting. They argue that the Bayh-Dole Act therefore incentivizes universities to focus on applied research instead of basic research. This too is not true. According to the National Science Foundation, the percentage of basic science research from 1980 to 2001 increased from 66.6% to 74.1%. Applied researched actually decreased from 33.4% to 25.9%.

Conclusion

The Bayh-Dole Act was not the sole factor in the increase of university patenting. However, it does appear to have played an important role in the licensing of university patents, particularly in the biotechnology industry.

The biotechnology is sector is large and growing. In 1980, it was almost nonexistent. By 2009, the sales of just 1,699 biotech firms were worth more than 2.5% of U.S. GDP. Academic intellectual property provides the crucial foundation for this sector. Further incentivizes for university patenting and its licensing could therefore drive yet more economic growth.

In addition, the government could encourage the use of unlicensed academic patents by offering tax breaks to companies who commercialize them. It could also encourage universities that excel at technology transfer such as Stanford or MIT to share best practices to other universities.

Categories
McNair Center Weekly Roundup

Innovation Weekly Roundup: 12/02/16

Weekly Roundup is a McNair Center series compiling and summarizing the week’s most important Entrepreneurship and Innovation news.

Here is what you need to know about innovation this week:

Closing the Gender Patenting Gap Could Unlock Innovation

Barbara Gault, Executive Director, Institute for Women’s Policy Research

A study by the Institute for Women’s Policy research has quantified the gender difference in patenting. The IWPR claims women’s underrepresentation in STEM fields is a major in the patent disparity and notes that patents granted to coed teams are cited more often than patents granted to single gender teams.

The divide is significant; under 20 percent of US patents cite a woman inventor and under 8 percent list a woman as the primary inventor. The IWPR suggests employers help women pay for filing patent applications and expand women’s professional network to close the gap. The McNair Center’s Tay Jacobe has written about has written about the gender gap in STEM.

Is Engine of Innovation in Danger of Stalling?

Christopher Mims, Technology Columnist, Wall Street Journal

The basic discoveries at the heart of the biggest tech companies are growing old fast. Inventions like the transistor and internet, while not relics, were invented between 1940 and 1980 when federal funding allowed for long-term research without immediate commercial use. At that time, the federal government spent 2 percent of GDP on research and development. That figure is now 0.6 percent.

The landscape of R&D has shifted. Now, corporate R&D spending is at 2 percent of GDP, from under 0.6% in the 1960’s. While this appears beneficial at face value, since the corporations who profit off inventions are funding them, it hides the fact that basic discoveries and incremental advancement is overlooked in favor of easily marketable technologies. Arati Prabhakar, Director of Defense Advanced Research Projects Agency (DARPA) explains, “we need public investment in R&D because companies only worry about the next quarter.”

Venture capitalists now fund by backing startups that are then acquired for their innovations. This still places an onus on inventors to work on marketable technologies rather than truly speculative research that used to be the foray of Bell Labs and still is in the domain of IBM Research.

How China’s Government Helps and Hinders Innovation

Anil Gupta, Professor, University of Maryland Smith School of Business; Cofounder of China India Institute
Haiyan Wang, Managing Partner, China India Institute

Although India spends a tenth of what China spends on R&D, Indian research leads to significantly more international patents than Chinese R&D.  The top-10 US tech companies’ Indian based labs were granted 50% more patents than their Chinese counterparts.

China’s shift from low-cost manufacturing to innovation is a case-study in how government policies, particularly insufficient patent protection, can inhibit innovation. Gupta and Wang claim that China’s heavy R&D investment have led to unimpressive results since foreign companies are wary about intellectual property protection in China.

While China accounts for 20 percent of global R&D expenditure, second to the US at 26 percent, they are granted relatively few international patents. Only 2.2% of USPTO patents were of Chinese origin. More patents originated in nations like Japan (18.8%) and Germany (5.5%).

China Logged a Record-Breaking 1 Million Patent Applications in 2015

Ananya Bhattarchya, Editorial Fellow, Quartz

According to a World Intellectual Property Organization report, global patent applications were up 7.8 percent in 2015 to 2.9 million filings. China emphasizes patent quantity over quality and that much of local research is not original research but rather adapting existing inventions for Chinese markets. In line with this theory, the Chinese patent office received 1,010,406 of the 2.9 million global patent applications. In second was the USPTO with 526,000 applications and the top 5 patent offices handled 82.5 percent of applications.

Government subsidies and foreign companies applying for Chinese patents for greater IP protection in the country drives the patent increase.

While China’s office has seen the greatest growth, the USPTO remains the leader in foreign patent applications with nearly 238,000 foreign patent applications.

Happy Holidays from the McNair Center for Entrepreneurship and Innovation. The Innovation Weekly Roundup will return in 2017.

Categories
McNair Center Weekly Roundup

Innovation Weekly Roundup: 11/18/2016

Weekly Roundup is a McNair Center series compiling and summarizing the week’s most important Entrepreneurship and Innovation news.

Here is what you need to know about innovation this week:

On the Trail of Grassroots Innovation Across America

Eillie Anzilotti, CityLab Fellow

While technological innovation and commercial developments garner the most press, social innovation impacts daily life in tangible ways. The Cooper Hewitt Museum’s exhibit on grassroots innovation demonstrates the necessity of innovation for all socioeconomic levels. Examples include emergency water stations on migration routes from Mexico to the U.S., mobile produce markets, and wireless mesh networks.

Instead of high-cost research, low-cost innovation can solve immediate community issues. At the community level it can be easier to address problems with a bottom-up approach. Cynthia E. Smith, the Manhattan museum’s curator of socially responsible design, travelled over 50,000 miles to find social innovations. One goal in these innovations is to promote economic inclusion by addressing barriers to success.

Remarks by Director Michelle K. Lee at the IAM Patent Law and Policy Conference

Michelle K. Lee, USPTO Director & Undersecretary of Commerce for Intellectual Property

Director Lee has discussed what intellectual property policy will look like in the next administration. Intellectual property and innovation have historically enjoyed bipartisan support. Lee believes IP is essential to President-Elect Trump’s promises for job creation and on the economy, noting that IP-intensive industries support over 45 million U.S. jobs and drive economic growth.

Lee listed the USPTO’s achievements in the past eight years. The backlog of patent applications has been reduced by 30 percent despite an increase in filings. Overall pendency times have decreased by up to 25 percent. She argues that PTAB proceedings have increased patent quality by invalidating (some) bad patents early in their lifecycle. Much of the improvements in patent quality come from the Clarity of the Record Pilot (mentioned in last week’s roundup).

She also ran through many of the programs in the past 8 years. These include the Enhanced Patent Quality Initiative, Interpartes Review, the America Invents Act and President Obama’s dedication to the patent system.

Creating diversity in the innovation economy

Jeffrey J. Bussgang, Harvard Business School, Flybridge Capital
Jody Rose, Executive Director New England Venture Capital Association

The New England Venture Capital Association is launching a program, Hack.Diversity, to incorporate underrepresented talent into the innovation economy. Engineers of color will be provided with training, coaching and mentoring from the fastest growing startups funded by the venture capital group.

The Association claims that the program addresses employers’ desires for diverse talent and provides tangible pathways for community colleges and urban schools to funnel talent into high-growth industries. These groups have faced obstacles in reaping the advantages of the innovation economy. As the authors said “like the rest of the country — we face a looming schism and we are leaving behind whole populations that are not fully reaping the benefits of our entrepreneurial growth engine.” Hack.Diversity attempts to make headway in closing the gap.

Categories
McNair Center Weekly Roundup

Innovation Weekly Roundup: 11/11/16

Weekly Roundup is a McNair Center series compiling and summarizing the week’s most important Entrepreneurship and Innovation news.

Here is what you need to know about innovation this week:

Silicon Valley Reels in Wake of Trump’s Presidential Victory

Joshua Brustein and Eric Newcomer, Bloomberg

Silicon Valley tech giants became unlikely political players in this election cycle. The results of the election leave the Valley in an uncertain position. Clinton received 114 times the amount of campaign contributions than Trump from the tech industry, so it should come as no surprise that a Trump presidency was not the industry’s favored outcome. The immediate threat to tech companies with the election of Donald Trump is the possibility of stringent immigration restrictions. Restrictions on immigration make it difficult for high skilled employees to work in the US. Furthermore, Trump’s lack of a clear plan for technology and the tech sector has left the industry in a state of limbo.

Election Day’s Tech-Related Triumphs — and Failures

Jamie Condliffe, MIT Tech Review

Many ballot initiatives on Tuesday were tech-related. Florida voted against an initiative that would have forced those with solar installations to give up payments for energy they feed back into the grid. The outcome will promote the expansion of home solar. Nevada voted to deregulate its electrical market. In transportation innovation, Seattle approved a $54 billion project to develop 62 miles of light rail and 37 new rail stations. Washington state rejected the first carbon tax in the US, partly over concerns that it failed to raise enough revenue for clean energy projects. Montana voted against a proposal to establish and allocate $20 million to the Montana Biomedical Research Authority.

How the tech industry is reacting to Donald Trump’s improbable victory

Paul Sawers, Contributor, VentureBeat

While Trump has been outspoken on economic reform, he largely did not address the the technology industry. While Paypal Founder Peter Thiel supported Trump throughout his candidacy, the majority of tech entrepreneurs expressed dismay over the possibility of Trump presidency. VentureBeat’s Sawers includes several Tuesday night tweets from tech industry leaders on the outcome of the election.

Results of the Clarity of the Record Pilot

Michelle K. Lee, USPTO Director & Under Secretary of Commerce for Intellectual Property

USPTO completed its Clarity of the Record Pilot, a program within the Enhanced Patent Quality Initiative. The Clarity of the Record Pilot enhances patent quality by identifying best practices for clarifying aspects of the prosecution record.

68 unique data points were measured, and each point represents a best practice. Examples of best practices include separately addressing independent claims or providing specific limitations in claims that are anticipated by prior reference when used to reject multiple claims. During the pilot, examiners used 14 percent more best practices in pilot cases as opposed to a control group.

The USPTO will be holding a Patent Quality Conference on December 13 to share more information on the Enhancing Patent Quality Initiative.

Women in STEM: Closing the Gap

Taylor Jacobe, Research Assistant, McNair Center for Entrepreneurship and Innovation

McNair’s Taylor Jacobe focuses on the slow growth in women’s presence in STEM and innovation. Jacobe provides robust, global evidence of the economic benefits of integrating women into the workforce and encouraging girls to pursue careers in these fields.

The Obama administration has made efforts to introduce such initiatives, including work-life balance programs and speaking tours with successful women. However, much work remains in combating gender inequality in the workplace, especially within the STEM fields.

The solution to this inequity is neither simple nor obvious. Jacobe recommends a combination of policy changes aimed at eliminating cultural barriers for women and increasing education opportunities for girls.

Women represent 19.6% of the staff at the top 25 tech companies

Dean Takahashi, Contributor, VentureBeat

A recent study by hiring firm HiringSolved reveals that women constitute only 19.6 percent of staff at the top 25-tech companies. The study indicates a critical need for  integration of women into technology and innovation.

Many Silicon Valley tech giants have introduced measures to address the gender imbalance in their workforce. HiringSolved’s study relies on machine learning and artificial intelligence to sift through its databases of information on gender, ethnicity, and age. Although the firm’s methods are by no means foolproof, the results are telling.

Thank you to Meghana Gaur for contributing to this week’s innovation roundup.

Categories
McNair Center Weekly Roundup

Innovation Weekly Roundup: 11/04/2016

Weekly Roundup is a McNair Center series compiling and summarizing the week’s most important Entrepreneurship and Innovation news.

Here is what you need to know about innovation this week:

Microsoft Puts Slack in Cross Hairs with New Office Chat App

Nick Wingfield, NY Times
Tech companies are moving in on Slack’s popular team-messaging market as Microsoft joins Facebook in taking on smaller players in this space. Microsoft’s size and distribution power is not enough to enter a new market. Their product must be innovative, not just another app in the Microsoft Office suite. Slack, in response, took out a full-page ad in the New York Times. They sarcastically congratulated Microsoft while also highlighting the innovations Slack has brought to numerous workplaces.

Microsoft’s current Office suite is just not keeping pace with the changing dynamics of the workplace, which require collaborative software. Slack, and other team messengers, enables multi-channel communication to organize discussion without relying on email. It is additionally fully searchable and allows a variety of app integrations. Team-messaging applications increase transparency and decentralize discussion. They are used at a variety of workplaces emphasizing collaboration (including here at the McNair Center).

AIA Patents – Approaching 50% of newly issued patents.

Dennis Crouch, Professor – University of Missouri School of Law

Crouch has created a chart showing the percentage of patents granted under the first-to-file provisions in the 2011 America Invents Act (AIA). The AIA changed the patent application rules from first-to-invent to first-to-file. By the end of 2016, half of all new patents issued would have been filed under first-to-file rules.

Patents filed under the AIA are subject to post grant review (PGR). A third party successfully petitioning that at least one claim is unpatentable can initiate the PGR process. The purpose of PGR is to dispose of bad patents early in their life through the USPTO rather than the legal system. Petitions must be entered within 9 months of a patent being issued and a final decision of validity is made in less than a year.

Innovation Labs: 10 Defining Features

 Dr. Lidia Gryszkiewicz, World Economic Forum
 Dr. Tuukka Toivonen, University College London
 Dr. Ioanna Lykourentzou, Luxembourg Institute of Science and Technology

Innovation Labs are essential workspaces for collaborative innovation. However, innovation labs’ missions and features are often ill-defined. A simple “I know it when I see it” style definition is not sufficient. Three experts in social innovation have reviewed innovation labs around the world to determine what features are essential. A few key findings include innovation labs needing heterogeneous participants, focus on experimentation and an expectation of breakthrough solutions. Such distinctions can help guide new labs and promote innovation across a variety of industries and social areas.

Additionally, creating a definition for these labs helps distinguish them from other similar models like living lab and coworking spaces. In summary, the writers of this piece define an innovation lab as “a semi-autonomous organization that engages diverse participants—on a long-term basis—in open collaboration for the purpose of creating, elaborating and prototyping radical solutions to pre-identified systemic challenges.”