(bl(6l From: T0: Subject: Objection to Proposal (80 FR 16389) Date: Monday, April 13, 2015 7:08:03 AM Dr. Chang and to others whom it may concern: After reading 80 FR 16389 "Prospective Grant of Exclusive License: Small Molecule Therapeutics Against Hepatitis Virus Infection,? I wish to file an objection. I do not believe that the proposed plan complies with Title 35 USC 5209 and for several reasons. Foremost among these reasons, is the fact that recipient of this exclusive license, to the best of my knowledge, is a Delaware- based corporation that has only recently been formed and therefore has no demonstrable track record of bringing such inventions to market to "promote the invention's utilization by the public." Moreover, the exclusive, world-wide grant is far greater than "reasonably necessary" (2) the Federal agency ?nds that the public will be served by the granting of the license, as indicated by the applicant's intentions, plans, and ability to bring the invention to practical application or otherwise promote the invention?s utilization by the public, and that the proposed scope of exclusivity is not greater than reasonably necessary to provide the incentive for bringing the invention to practical application, as proposed by the applicant, or otherwise to promote the invention's utilization by the public; Lastly, the pro osed grant of exclusive licensing is in bold contradiction to prohibition on essening competition, as this exclusive license will, by the very nature of being exclusive, lessen competition. As it currently stands, the drug in question, has been known for decades. If this drug is truly as revolutionary as hoped, then the Federal government could, and should, license these patents to anybody who demonstrates the ability "promote the invention's utilization by the public" rather than exclusively license them to one start-up company with no record of having produced anything. If NIH proceeds as planned, it will only cause the public to view this as a brazen attempt to "bury" a discovery by licensing it to a company that quite possibly will never be able to deliver. Please consider this a formal objection. You may forward this to representatives to Virotas, and if provided with information related to my concerns, 1 will gladly, humbly withdraw said objection. KNOWLEDGE EWLOGV INTERNATIONAL Aprii ta, 2015 Kevin w. Chang. Senior Licensing and Patenting Manager Office 0t Technology Transler 6011 Executive Blvd, Suite 325 Rockville, MD 20852 Re: Prospective Grant of Exduswe License: Small Molecuie Therapeutics Against Hepatitis Virus intention: A Notice by the National institutes of Health on 03/27/2015 Document Citation. 50 FR 16389. Page. 16389 716390 (2 pages), Document Number' 201506974, URL Dear Dr. Changt We are writing in regard tn the Federal Register nuttce (the Notice") concerning possible exciusive licenses tut patents on the Pieventicn and treatment oi Hepatitis Virus iniecllont [80 FR 16389716390] The United states and other counln'es are currently laced extreme hardships in paying iortreatrnents tor the hepatitis vims (HCV). and in the past have also been confronted by barriers to Innovation as a cansequencc cl restrictive licensing at HCV patents, Any license on patents should inctude provisions that do the leiinwing- 1. Ensure that the patented "Invention is being utilized and that its benefits are to the extent permitted by law or Government reguiations available to the pubilc on reasonable lerms" [See: 35 use 201m]. induding specifically for prices that are reascnahle. In evaluating the reasonabteness of the price. we suggest that the iniicwinn conditions apply as separate tests: a The price should be no mgherthan the unweighled average pme in other ocunlries that are economicain similar and campetillve with the United States in world markels' such as Canada Ausualta, France. lhe UK. Gelmany and Japan. This would be a tes| to ensure the US does not pay more for own NIH funded inventions, making the US less compciilivc in globai markets KEl/Punlrc citizen cammenls an NIH ilcanss Page i of b. The prices should be low enough that reimbursement bodies, both public and private, provide reimbursement for all HCV patients, regardless of the severity of the liver damage, with low co-payments- 2. Enable research. The NIH should ensure that third parties may conduct research on or with the invention, royalty free and without permission. 3. The license should provide that under 35 USC 202(c)(4), the World Health Organization (WHO) may request from the NIH a license to practice or have practiced on its behalf, the patented invention, subject to the following procedures: a. The WHO can identify an important public health concern that is not being met by the holder of the license to the NIH owned invention, including but not limited to the goal of access to medicine for all; h. The WHO can explain the steps it has taken to address the issues, including attempts to negotiate voluntary licenses from the holder of the license to the NIH owned invention; and c- The WHO can explain how its proposed use and licensing of the invention will address the unmet health need, without unreasonably prejudicing the legitimate interests of the license holder, taking into account the legitimate interests of third parties and the goal of access to medicine for all. 4. Transparency. The NIH should require the license holder to provide the NIH with reports that detail its Rad) outlays on the drug, including the costs of each clinical trial, with overhead as a separate line item- The NIH should require the license holder to provide the NIH with reports on annual sales, as measured by both units and revenues, by country, and within the United States, by major type of reimbursement body and government agency. in our opinion, each of the requested provisions in the contract are not only reasonable, but very modest in terms of ambition, and respond to obvious concerns about the license involving patents on HCV treatments. We could request that an NIH funded invention be less expensive in the United States than elsewhere, or limited to some multiple of actual investments. adjusted for risks. or suggest any number of other public interest safeguards that would be justi?ed by the public's funding of the invention. The points listed above are not only reasonable licensing terms, they should be looked at as minimal terms for the grant of exclusive rights on an NIH owned invention, assuming the NIH is operating with the interests of the public in mind. KEl/Public Citizen comments on license of HCV patents Page 2 of 6 (KEI and Citizen 89/59 that the mutants DH/vs latler ars fully available [a the puber under Swncere'y, James Packard Luve 0mm: Knowbedge Eco'ogy Imernanonal 1621 Connccucm Avenue, Suvle 500 DC 20009 Andrew 5 Gmdman, Esq Counsel' Pohcy 2; Mars Knowledge Eco'ogy lnternahonal 1621 Connccucm Avenue, Suvte 500 KE/ll'ubhc szen commems ow NIH ncense Roberl We'ssman President Pubhc szen I600 20m Skeet NW DC 20009 Peter Maybarduk Globa' Access to Medmmes Program Dweclor Puch cmzen 1600 20m Street NW DC 200mg Page 3 cl 5