The below are comments were filed by KEI and HealthGap on May 22, 2018, regarding a proposed NIH exclusive license on patents for the treatment and diagnosis of Crohn’s Disease, Ulcerative Colitis, Asthma, Psoriasis and Biliary Cirrhosis to Precision IBD
Prior to filing the comments, KEI asked the NIH licensing officer the following questions:
- What is the proposed consideration for the license, including but not limited to the royalty rates?
- What is the term of the license
- Has the NIH determined that a life of patent license is necessary, pursuant to 35 USC 209?
- If yes to 3., what methodology was used?
- Has the NIH determined that a worldwide license is necessary, pursuant to 35 USC 209?
- What provisions does the NIH propose to ensure the inventions are “available to the public on reasonable terms”?
- What measures has the NIH taken to ensure the inventions will be accessible to persons living in developing countries?
- Has the NIH obtained the advice of the Attorney General, pursuant to 40 USC 559?
We received no answers to the questions, despite asking twice.
Note that Precision IBD does not appear to have a web page. Pitchbook claims “The company is currently operating in Stealth mode.”
The following are the comments we filed with HealthGap on May 22, 2018.
Cristina Thalhammer-Reyero, Ph.D., MBA
Senior Licensing and Patenting Manager
Office of Technology Transfer and Development
National Heart, Lung, and Blood Institute
Email: thalhamc@mail.nih.gov.
Date: May 22, 2018
Re: Prospective Grant of Exclusive Patent License: Antibodies Against TL1A, a TNF-Family Cytokine, for the Treatment and Diagnosis of Crohn’s Disease, Ulcerative Colitis, Asthma, Psoriasis and Biliary Cirrhosis, notice published in 83 FR 20081
Dear Dr. Cristina Thalhammer-Reyero,
Knowledge Ecology International (KEI) and HealthGap, two groups concerned about drug pricing and access to patented medicines, oppose the grant of an exclusive license of National Institutes of Health (NIH) patents noticed in 83 FR 20081, to Precision IBD, Inc., located in San Diego, California, unless the following conditions are met:
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A. The NIH has determined that an exclusive license is “a reasonable and necessary incentive” to induce investments for the development and practical application of the invention, as is required by 35 USC § 209, and shares its analysis with the public; and
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B. The NIH limits the scope of rights for the exclusivity to only those rights reasonably necessary to induce investments for the development and practical application of the invention, and in particular, that the field of use is sufficiently narrow, that the term of the exclusivity is sufficiently limited, and that the license contains sufficient safeguards to ensure that the invention is “available to the public on reasonable terms,” as is required by 35 USC § 209 and 35 USC § 201(f).
We propose the following safeguards regarding the pricing of and access to products that use the inventions:
- Products are priced no higher in the United States than the median price charged in the seven largest economies as measured by nominal GNI that have a nominal GNI per capita of at least 50 percent of the United States.
- Prices for products in the United States do not exceed the estimated value of the treatment, as determined by independent health technology assessments selected by HHS.
- Patient co-payments under third party Medicare programs are affordable.
- The geographic area for the exclusivity excludes countries with a per capita income less than 30 percent that of the United States, and, if there is no such exclusion, the company be required to report annually on the reasonable and feasible measures that will be taken to ensure access to patients living in such countries.
- The initial period of exclusivity in the United States is set at seven years, subject to extensions if the company can demonstrate it has not recovered sufficient profits given the risk adjusted value of the clinical trials used to register similar drugs for the lead indication.
- Absent satisfaction of the requirements of proposed safeguard number 5, the exclusivity of the product be reduced when cumulative global revenues for the product exceed $1 billion, by one year for every $0.5 billion in cumulative sales that exceed $1 billion in cumulative sales.
To address research by third parties on the patented invention, we propose the NIH explicitly permit researchers worldwide to use the inventions for research purposes, regardless of whether or not research has a grant or contract from a U.S. government agency, and for both profit or non-profit organizations.
To address transparency, we proposes the following requirements:
The company will be required to disclose to the public:
- The amount of money spent every year on the R&D to obtain FDA and foreign government approvals of the inventions, including in particular, the amount of money spent every year on each trial, and the relevant tax credits, grants and other subsidies received from any government or charity relating to those R&D outlays,
- The prices and revenue for the products, by country, by year,
- The number of units sold, in each country,
- The product-relevant patents obtained in each country, and
- The regulatory approval obtained in each country.
James Love
Knowledge Ecology International
Email: james.love@keionline.org
Brook Baker
HealthGap
b.baker@northeastern.edu