Replace and Thus Repeal Bayh-Dole Commercialization

Whatever its outcome, this election marks the start of political turmoil for months to come. In the coming “fog of war”, anti-patent activists will seek fresh support for stale schemes to crush Bayh-Dole’ (B-D’s) commercialization cornerstone. Mega-tech muscle will push new versions of HR 9 litigation on Capitol Hill. Electronic Frontier Foundation lobbyists will be roaming State House corridors selling schemes to further weaken research university innovation ecosystems. see  Meanwhile recent sporadic outbreaks of drug pricing abuse have emboldened left-of-center activists hoping to establish “R&D de-linkage“ and the nation’s innovation mechanism. De-linkage was strongly promoted by the B-D bashing UN High Level Panel Report on Access to Medicine. De-linkage proponents say R&D de-linkage would “change the way we finance the development of new drugs, vaccines, and diagnostic tools, and, more specifically, to progressively eliminate the link between high prices and incentives to induce investments in R&D. Its life science innovation applicability is strongly endorsed by Senator Sanders ; “By de-linking research and development incentives from product prices, and by eliminating legal monopolies to sell products, it is possible to induce investments that are medically more important, procure products at low prices from competitive suppliers, radically lower pricing barriers for access to new medicines, reduce wasteful marketing and research and development activities, and dramatically lower the overall costs of acquiring innovation, while expanding access to that innovation. In short, although drug price intervention would adversely affect our existing system’s commercialization it also may provoke fundamental structural change in the system itself. We must take both possibilities very seriously by actively spreading the B-D gospel on the Hill. Pro-patent interests, especially research universities and medical centers engaged in life science research must penetrate the inevitable post-election fog with facts like those referenced below.

The U.S. Commerce Department recently released a comprehensive and far more relevant Report, entitled, “The U.S. Economy and Intellectual Property 2016 Update” see Report, co-authored by the Economics & Statistics Administration and the United States Patent and Trademark Office finding that “IP-intensive industries continue to be a major, integral and growing part of the U.S. economy.” Key patent job contribution findings included 3.9 million jobs in 2014. IP-intensive industries supported a total of 45.5 million jobs (27.9 million jobs directly and 17.6 million more jobs through the supply chain), which is about 30% of all employment in the U.S. These jobs are high-paying — IP-intensive workers earn an average weekly wage of $1,312, which is 46% higher than workers in non-IP-intensive industries. In terms of gross domestic product (GDP), the value added by IP-intensive industries increased substantially between 2010 and 2014. IP-intensive industries contributed $6.6 trillion to the U.S. economy in 2014, up from $5.1 trillion in 2010.”

Dismantling an innovation ecosystem rooted so deeply into our world-leading economy is ill-advised and risky. But as DC moves leftward, those who philosophically have always supported central planning believe the recent drug pricing abuses are not outliers but have become and demonstrate the norm.  To them patent exclusivity is an invitation to block information dissemination and to abuse pricing. They prefer to transfer the cost of funding innovation to government and away from users. They prefer incentivizing innovation through pre-determined prizes, not  B-D-based decentralized project selection and public private partnerships. One of the leading advocates of such change is Knowledge Ecology International (KEI)

Knowledge Ecology International

The UN High Level Panel Report on Access to Medicine may have flopped in the General Assembly, but it rekindled KEI’s crusade to establish systemic de-linkage as the way to assure lower prices and earlier access to life science products. KEI is seeking structural replacement of our U.S. market reliant innovation ecosystem with a far more centralized system. (Readers may recall that KEI’s Jamie Love lobbied Congress to pressure NIH’s unlawful implementation of price-based B-D March-in.) Love had high praise for the UN Panel’s support for “delinkage” saying, “Under the current system, we rely too much on high drug prices to incentivize innovation, and this reduces access. The most important recommendations from the UN experts is to delink the cost of R&D from the prices of drugs. You cannot rely upon high drug prices to finance R&D without harming patients and creating unequal access. Policy coherence means making innovation and access happen at the same time. Delinkage is key to policy coherence he added that  “ according to the report, universities and research institutions that receive public funding must prioritize public health objectives over financial returns in their patenting and licensing practices.”

Recently KEI announced at its its website ,  “KEI is holding a December 2, 2016 meeting on the de-linkage of R&D costs from drug prices.” saying,  “For more information about delinkage, see:”  KEI’s conference roster is already weighted heavily with past proponents of de-linkage, prize rewards and other alternatives to our B-D based commercialization. KEI itself is committed to establishing de-linkage as described in the UN Report. Scheduled in order to gather congressional support for its de-linkage objective, the conference opens KEI’s new de-linkage lobbying campaign. Strange as they may seem, research university advocates must familiarize themselves with KEI’s de-linkage objective.  It’s expanded application to university research may be presented by proponents as an “alternative” to B-D commercialization to curb perceived drug product abuse. But that is just their opening gambit. Their true objective is to replace B-D commercialization with their centralized system.