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28 BioPharm International eBook October 2021 www.biopharminternational.com in "instances where there is a lack of good-faith effort to develop a federally funded invention for public use" and not as a mechanism for the govern- ment to set prices of patented goods (particularly drugs). With regard to the NIST proposal intended to be a clarification that march-in rights are not meant to be a way of imposing price controls, Allen noted in his comments: "March-in rights shall not be exer- cised exclusively based on the business decisions of the contractor regarding the pricing of commercial goods and services arising from practical applica- tion of the invention." Mr. Allen recommended in his com- ments that the two boldface phrases be deleted for further clarity. He charac- terized these changes as "two potential loopholes" that could be exploited by what he called "opponents" of the law. He asserted that it is most important that the word "exclusively" be removed because "it implies that while pricing may not be the only factor in trigger- ing the march in provision, it could be a factor", which he contends "is not sanc- tioned under the law" because "[i]f a product is successfully commercialized, the government has no authority under Bayh-Dole to second guess pricing deci- sions." He proposed the other change, regarding removing the words "of the contractor" because business decisions regarding patented products are made by licensees not the contractor when, as is common, the contractor is a university. Other commentators echoed these concerns, inc luding Eagle Forum Education and Legal Defense Fund (terming the proposed clarification regarding the "exclusivity" term to be "counterproductive") and Conservatives for Property Rights (CPR) (6), which adopted Allen's critique in its entirety. In addition, CPR's comment noted that having the granting agency interfere with product pricing has been tried before and failed. In one specific instance, the National Institutes of Health included a "reasonable pricing" term in licenses under Cooperative Research and Development Agreements (CRADA) in the late 1980s. According to their statistics, which were affirmed in other comments, university technology transfer under these agreements decreased for six years until the requirement was lifted, going from 32 licensing agreements to 153 a few years after the change. Several other commentators' submis- sions were outcome oriented (in favor or against the proposed changes depending on the desired outcome). The Association of University Technology Managers (AUTM) submitted comments (7) heav- ily fact-laden in favor of maintaining the status quo wherein march-in rights were not exercised or available to influence product pricing protected by patents for inventions made with federal fund- ing. According to AUTM, "US univer- sities, hospitals, research institutes and government labs developed over 25,000 inventions, closed almost 10,000 deals with commercialization partners to bring them to market, and resulted in over 700 products in 2019 alone—many funded by the federal government." Citing their own studies (8) AUTM further asserted that "[a]nother 2019 economic report found that over a 22-year period, inventions arising from universities or hospitals or other public sector research institutions have accounted for up to 5.9 million jobs and added up to $865 billion to the US [gross domestic prod- uct] GDP—much of it catalyzed by the Bayh-Dole Act." This group also asserted these specific arguments in its comments to the NIST proposal: • "If potential licensees and their investors determine that the risks involved in further developing and commercializing federally funded inventions is too great, then price of the end-user product becomes a moot point because there will be no product to price." • "If price is a basis for exercising march-in rights, private-sector entities will shun licensing of federa l ly f unded [intel lect ua l propert y] IP from universities and will avoid collaborating with universities. The private sector will no longer view its robust partnerships with universities as mutually beneficial, but rather as a poison pill that could endanger their broader IP portfolios." • "Fewer licenses will result in fewer new products, a less competitive marketplace and, as a result, higher, not lower, prices." The Alliance for US Startups and Inventors for Jobs endorsed AUTM's position in full in its Federal Register comments, stating that the "hard real- ity—allowing a government agency to control the price of a new drug or a new device after a private company has invested millions of dollars and years of human effort would be the death knell of our pharmaceutical and med- ical device industries as we have come to know them." This group makes the further point that the products AUTM mentions as evidence of the success of the Bayh-Dole Act in supporting innovation, "although based on federally funded initial research, did not come about purely as a result of the research funded by the government, as some assert; these products would never have reached the market at all without the investment of vast amounts of human effort and capital by private organiza- tions and their investors." The Biotechnolog y Innovation Organization (BIO) filed comments that Regulatory Sourcebook BioBusiness The comments received by NIST suggest that the proposal raises more issues than it clarifies.