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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

Entrepreneurship Weekly Roundup: 1/27/2017

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 entrepreneurship this week:


The Right to Entrepreneurship

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

This week, McNair’s Jacobe focuses on the link between entrepreneurship and human rights. While the intersection between activism and entrepreneurship has yet to gain significant traction in the U.S., international collaborations between the two sectors have found success. Jacobe points out that “Human rights and entrepreneurship have the ability to reinforce one another,” citing reports from Fordham University and Pontifical Catholic University of Peru on the potential of human development-centered entrepreneurial ventures. According to Jacobe, U.S policy should reflect a balance that advances entrepreneurship and promotes protection of human rights.


Prairie meets CES: Top 10 trends to watch in 2017

Keith Fix, Contributor, Silicon Prairie News

The annual Consumer Electronic Show (CES) took place earlier this month in Las Vegas. Silicon Prairie’s Fix shares his 2017 predictions for major trends to shake consumer technology, and artificial intelligence, smart homes, intelligent systems (Amazon Echo), wearables, self driving cars, virtual reality, and drones are among his top picks. Fix expects the industry to experience further fragmentation and democratization as startups continue to develop new technologies in order to keep pace with consumer expectations.


In a tech-saturated world, customer feedback is everything

Jeremy Bailey, Contributor, TechCrunch

TechCrunch’s Bailey emphasizes the importance of gauging customer feedback throughout the design process in the tech industry. Too often, design teams undervalue the power of customer interactions. As evidence, Bailey cites AirBnB’s notorious success in growing its consumer base by 200% after meeting for one afternoon with its early users. In order to achieve a dynamic and responsive design model, companies should restructure their “internal bureaucracy” and adopt a “customer-centric” mindset. Bailey suggests that design teams take a simple approach: development of a problem statement, collaborative hypothesis-generation, and constant reevaluation.


Most Small Businesses Create Fewer Than One New Job a Year, Study Finds

Ruth Simon, Senior Special Writer, The Wall Street Journal

According to a recent study from JPMorgan Chase & Co. Institute that spanned the payroll records of 45,000 small business in 2015, small business hiring has been sluggish and inconsistent. In fact, the sector’s median level of employment growth sits at less than one new full time position per year. Although small businesses are often considered the crucial driver of the American economy, most do not expand. While small businesses employ 17% of America’s labor share, 89% employ fewer than 20 workers. Professor Scott Stern, who studies entrepreneurship at MIT, explains that the “belief that entrepreneurship in general is a driver of economic growth and prosperity” might be misguided.


How to Find and Start Your Next Entrepreneurial Effort

Nathan Resnick, Contributor, Entrepreneur

Nathan Resnick, founder of Sourcify, a startup based in Tel Aviv that helps connect entrepreneurs with trusted manufacturers, offers helpful advice for millennial entrepreneurs who are considering their next venture. Resnick advises entrepreneurs to consistently gauge audience feedback during early planning stages as audience responses help narrow the focus of a project.  Resnick emphasizes the importance of an entrepreneur’s willingness to acquire new skills and embrace market competition.


Fintech Companies Could Give Billions of People More Banking Options

Jake Kendall, Author, Harvard Business Review

Harvard Business Review’s Kendall is the director of Digital Financial Services Lab, an early stage incubator that supports entrepreneurs who launch fintech startups in developing companies. Financial technology, or fintech, refers to the high-tech industry involved in computer software development of innovative financial services, such as digital banking programs. Despite investment into fintech increasing eight-fold since 2011, its benefits have largely been restricted to mature economies.

Kendall identifies three main challenges that fintech startups operating in developing countries must overcome: “lack of cloud infrastructure, users who are “less digital” than rich-world users, and users who live economically chaotic lives based primarily in the informal sector.” Still, many entrepreneurs are launching fintech startups to support the 2 billion customers living in regions without formal banking services. Plus, an increasing global trend of mobile phone ownership serves as a promising platform for fintech startups.


3 charts that show the effect of venture fundraising on founder ownership

Adley Bowden, VP of Market Analysis, PitchBook

PitchBook released an article illustrating the diluting effects of venture fundraising on founder ownership. The data used in the graphic analysis are taken from the results of a survey conducted by J.Thelander Consulting’s of 380 private venture-backed companies in the US. Although capital raises are a critical and necessary component of any startup’s success, PitchBook’s Bowden emphasizes that founders should understand the diluting effects of venture fundraising on their equity percentages. According to Bowden, “If all goes well and the company’s value increases, this is a win-win situation, but in the case that things don’t go well, the economics can turn against founders fairly quickly.” The article includes three charts that track founders’ shares in their companies – distinguishing between biotech, medical device, and tech industries – through various funding stages. At pre IPO, all three industries reveal founder ownership percentages below 10%.


15 charts that illustrate how the US venture industry looked in 2016

Kyle Stanford, Analyst, PitchBook

PitchBook also recently released an article that depicts the state of venture capital in 2016. The article features 15 charts of the key performance indicators that are frequently used in measuring VC activity. Utilizing standard industry metrics, PitchBook’s full report offers an in-depth analysis of VC-backed firms in the U.S, including graphics on angel and seed funding, fundraising by quarter, VC-backed exits, and corporate VC participation.