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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.

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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.

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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.

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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.

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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.”

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McNair Center Weekly Roundup

Innovation Weekly Roundup: 10/28/2016

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:

FTC Takes an In-Depth Look at Patent Assertion Entities

Weil Gotshal & Manges LLP – Adam C. Hemlock, John E. Scribner and Lisa Marie Madalone, Lexology

FTC report on Patent Assertion Entities (PAE) delineates the two major business models employed: portfolio and litigation. As the name implies, litigation entities acquire licenses by filing suit. Portfolio entities tend to negotiate licenses over expansive patent portfolios often valued in the millions. Portfolio entities account for 80% of all PAE revenue despite holding only 9% of all licenses.

The FTC has proposed a variety of measures to deter what they deem “nuisance legislation.” The report found that discovery costs were the major factor in causing the accused to settle. In response, measures to reduce the burden of discovery were suggested. Changes reducing the incentive to settle will drastically change the patent litigation landscape since 83% of litigation PAE cases are settled within 18 months.


Three angles to look at Google’s Pixel phone: design patents, antitrust, copyright

Florian Mueller, FOSSPatent

Mueller examines the Google Pixel from the perspective of different areas of law: design patents, antitrust and copyright. Innovators must consider a variety of legal frameworks designed to protect them. However, these protections have also lowered the risk of innovation and prevent copycat designs from flooding the market. Mueller discusses the strategy Apple could take against Google for infringing design patents, but he also discusses why such an exertion might fail in light of Apple v. Samsung. This FOSSPatent post provides a broad overview of the regulatory environment tech innovators face.


What’s New with the Changes to the Trademark Trial and Appeal Board Rules of Practice

Eric Ball and Emily Gische, Attorneys at Fenwick & West writing for IPWatchdog

Soon after we ring in the new year, the Trademark Trials and Appeals Board will enact new inter and ex partes proceeding rules. These new rules become part of Title 37 of the Code of Federal Regulations. Key changes include limiting the number requests for document production to 75 and minimizing surprises right before trial begins. Surprise requests for substantial discovery are being clamped down on as a litigation strategy. Testimony can now be submitted through affidavit solely, as opposed to live recordings, and all filings must be electronic. In sum, these changes will accelerate TTAB proceedings.


Lex Machina releases data on design patent litigation showing strong correlation with trademark infringement actions

Steve Brachmann, IPWatchdog

The theme of this week is design patents and trademarks, and in accordance, Lex Machina has released a design patent litigation report. While overall patent litigation is decreasing, the number of design patent cases filed has remained consistent. This is still a small portion of all patent litigation, about 6 percent. 14.6 percent of design patent cases resulted in a claimant win as compared to 2.5 percent of claimant wins in other patent litigation.  Another key finding is that 36.4 percent of all design patent infringement cases also include a claim of trademark infringement, a rare claim in other filings.


Self-driving car startup cancels first product because dealing with regulators and lawyers “isn’t worth it”

Dave Gershgorn, Quartz Artificial Intelligence Reporter

Most innovation policy tends to focus on intellectual property regulation, but there is a host of additional regulations innovators must abide by depending on industry. With all the momentum surrounding self-driving cars and their go-to-market strategy, it was inevitable that the National Highway Traffic and Safety Administration would attempt to ensure their safety. While such regulation may seem fair and necessary, the founder of one self-driving car startup has decided abiding by these requests is not worthwhile. We must question the ability of current regulation and enforcement to keep pace with innovation.