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This post looks at the USPTO's recently established "Patents 4 Patients" Program, which aims to accelerate research by quickening the patent examination process. However, subject matter eligibility criteria also seems to be playing a part in hindering research.
In his 2016 State of the Union, President Barack Obama called for the Cancer Moonshot to double the rate of progress in the research of cancer prevention, diagnosis, and treatment. As the lead of this initiative, Vice President Joe Biden travelled across the country and the world, including Rice University, to collect information on current barriers in cancer research, such as inefficiencies in the patent process.
''' Accelerating the Process with “Patents 4 Patients” '''
As a part of the effort to accelerate cancer research, the United States Patent and Trademark Office (USPTO) launched the Cancer Immunotherapy Pilot Program (also known as “Patents 4 Patients”) in July, 2016. This program aims to provide a fast lane for the review of patents that claim one or more methods to treat 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 and advance them for faster review. The USPTO aims to complete its examination of these 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, it has taken an average of 16.5 months for first office action pendency, or the amount of time for the USPTO to mail a First Office Action after a patent application is filed. Additionally, it has taken an average of 26.4 months for traditional total pendency, or the amount of time for the Office to decide whether to issue or abandon a patent. This new Pilot Program certainly has the potential to reduce these pendency periods. However, is the lengthy patent examination process truly the major obstacle for patent applications relating to cancer treatments?
''' Patent Subject Matter Eligibility: A Look at Section 101 '''
Section 101 of Title 35 of the United States Code states that “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, important U.S. Supreme Court decisions have impacted what type of subject matter 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.
As a result 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, patents relating to using gene expressions for the prognosis of breast cancer (US20100035240A1) and using the Flap endonuclease-1 protein as an early indicator of cancer (US20150072355A1) have been rejected by the USPTO because they are applications of laws of nature. However, unlike the USPTO, the patent offices in Europe, Japan, and China have accepted the eligibility of these applications and granted their patents. Stifling the progress of research through patent rejections does not bode well for cancer patients in the United States.
'''More Barriers with the FDA Approval Process'''
Even after a treatment is patented, it can take years to go through the three phases of the clinical trial process and receive approval from the U.S. Food and Drug Administration (FDA). Phase I and II determine the safety and promise of a treatment, and Phase III tests the effectiveness of the new treatment compared to the existing standard. After successfully going through trials, companies file a New Drug Application (NDA) for the FDA to review.
According to DiMasi, Grabowski and Hansen (2016), the average time to go through the three phases of clinical trials is about 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 also slows down R&D in cancer treatment.
'''Improving Patent-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 cancer therapy or treatment. However, the higher amount of claims rejections could discourage investment and deprive researchers of the funding they need during the development process.
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 cancer research, long pendency periods are not the sole barrier to accelerating research. Many inventions are patentable, non-obvious applications of laws of nature, yet after recent court rulings, their patent applications are rejected.
On November 14, the USPTO held the first of two roundtables discussing how to improve the USPTO’s guidance for patent examiners on subject-matter eligibility. As judges and policymakers continue to define what is patentable, they must remember the implications that their decisions and policies have on cancer treatment innovation.
[[Category: Innovation Policy]]
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