AMP opposes exclusive licensing of NIH proteomics patent

The Association for Molecular Pathology (AMP) opposed the National Institutes of Health (NIH) proposal to exclusively license the subject matter of a cancer-related proteonomics patent application filed by the Agency. AMP's written remarks were submitted to NIH in response to a request for comments in the Federal Register Notice entitled, "Prospective Grant of Exclusive License: The Development of a Companion Diagnostic Kit for Predicting Therapeutic Efficacy of Anti-Cancer Agents." The proposed license grants exclusive worldwide rights to use the relationships between levels of three proteins, PTEN, Akt, and mTOR and cancers of the breast, lung, and kidney. Under the terms of the prospective agreement, the licensor could provide laboratory test services and/or sell test kits.

"The submitted patent application encompasses essentially all methods and techniques that allow practical use of the claimed biological relationships. The breadth of this patent application renders exclusive licensing of even a subset of the protein–cancer associations claimed contrary to the public interest," stated Roger D. Klein, MD, JD, Chair of the AMP Professional Relations Committee. "No one company should be permitted to monopolize medical information in this way."

In its comments, AMP set forth the reasons the organization believes NIH's proposed exclusive fails to meet the regulatory constraints on exclusive licensing of federally owned inventions as set forth in 35 U.S.C. 209(a) and 37 C.F.R. 404.737 C.F.R. 404.7. According to U.S. law, such a license must serve the best interests of the public; must be a "reasonable and necessary" incentive for the attraction of investments required to bring the invention to practical application; and must not lessen competition. Further, practical application of the invention must be unlikely under a nonexclusive license, and the scope of exclusivity cannot be broader than is necessary to bring the invention to practical application. AMP believes the proposed license does not meet any of these criteria.

"This patent application claims a virtually unlimited swathe of protein diagnostics, dramatically inhibiting the growth of potential diagnostic assays and methods, while substantially increasing the costs of and decreasing patient access to those tests that do manage to enter medical practice. By granting an exclusive license for any of the protein-cancer relationships claimed in this , NIH would stifle the practice of medicine, limit patients' access to second opinion tests and discourage innovation in this area," added Dr. Klein.

As a general principle, AMP opposes exclusive licensing of patents on governmental inventions that do not clearly advance the public interest. AMP believes that such licenses, in the rare circumstances in which they are granted, should be narrowly targeted and not reach beyond the extent necessary to ensure commercialization. Importantly, for inventions in which clinical laboratory testing is potentially impacted, sublicenses for confirmatory testing that include reasonable royalty rates and the right to use alternative test methodologies should generally be mandated.

Provided by Association for Molecular Pathology

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Rambus grants Toshiba new patent license

Jul 06, 2006

High-speed chip interface licensing company Rambus Inc. announced Wednesday it has signed a new patent license agreement with Toshiba Corporation.

AMP releases statement on diagnostics in drug labels

May 16, 2011

Today, the Association for Molecular Pathology (AMP) released its new position statement on the appropriate manner to reference diagnostic tests in drug labels. The association also met with officials from the United States ...

Recommended for you

Humiliation tops list of mistreatment toward med students

11 hours ago

Each year thousands of students enroll in medical schools across the country. But just how many feel they've been disrespected, publicly humiliated, ridiculed or even harassed by their superiors at some point during their ...

Surrogate offers clues into man with 16 babies

20 hours ago

When the young Thai woman saw an online ad seeking surrogate mothers, it seemed like a life-altering deal: $10,000 to help a foreign couple that wanted a child but couldn't conceive.

Nurses go on strike in Ebola-hit Liberia

20 hours ago

Nurses at Liberia's largest hospital went on strike on Monday, demanding better pay and equipment to protect them against a deadly Ebola epidemic which has killed hundreds in the west African nation.

ALS Ice Bucket Challenge arrives in North Korea

Aug 31, 2014

It's pretty hard to find a novel way to do the ALS Ice Bucket Challenge by now, but two-time Grammy-winning rapper Pras Michel, a founding member of the Fugees, has done it—getting his dousing in the center ...

Cold cash just keeps washing in from ALS challenge

Aug 28, 2014

In the couple of hours it took an official from the ALS Association to return a reporter's call for comment, the group's ubiquitous "ice bucket challenge" had brought in a few million more dollars.

User comments

Adjust slider to filter visible comments by rank

Display comments: newest first

rwinners
not rated yet Nov 22, 2011
Interesting that such a move could be considered in the first place. Interesting, too, is that the proposed licensee was not named. I wonder who that could be.