Presentation on theme: "Operationalizing an ARV/FDC Patent Pool Warren A. Kaplan, PhD, JD, MPH Boston University School of Public Health Assistant Professor of International Health."— Presentation transcript:
Operationalizing an ARV/FDC Patent Pool Warren A. Kaplan, PhD, JD, MPH Boston University School of Public Health Assistant Professor of International Health Boston, MA
Context : A long historical record, but few pharma/biotech pools have been created What should be the function of an ARV/FDC patent pool? Increase market share?, incentivize innovation? increase competition? lower price?, improve generic penetration?
From the industrys side of the table: Some cautionary lessons(I) Recent patent pools in the electronics industry were established in order to promote a standard or a technology and, as these have led to a substantially larger market for patent owners, they have succeeded. Patent pools whose main driver is price control, not promotion and larger market size, are not very likely to be successful as far as industry is concerned. There will be too many IPR owners who will conclude that joining a pool will not satisfy their expectation for licensing income.
Some cautionary lessons (II) If industry patent owners protecting a valuable market advantage are to offer non-exclusive licences to all-comers, they need some economic incentives. If a firm looks at their own profit and determines that the cost of the pool is high ( i.e., lowered royalties on individual products, high transaction costs, placing their IP at risk from challenge by others in the pool) then they may start to contemplate other alternatives.
Pharma/Biotech Pools have had Several Objectives 1.Primary Objective: Clearing Patent Thickets –Golden Rice Pool – 2001: 70 different patents held by 40 different organizations (http://www.goldenrice.org/Content2-How/how9_IP.html) –GFP Pool (Green Florescent Protein: 2001) (http://www.gehealthcare.com) 2.Primary Objective: Collective IP Management and Licensing –stART Licensing, Inc. (2005)- patent portfolio related to animal reproductive technologies (http://www.geron.com/pressview.asp?id=709)
Proposed Pharma/Biotech Pools 1.The SARS IP Working Group – proposed 2005 make SARS vaccines and treatments readily available in case of a pandemic. 2.Essential Medical Inventions Licensing Agency (EMILA) – proposed 2006 manage patent pools or licensing programs that increase generic competition and access to patented medical products and vaccines 3.UNITAID pool for AIDS medications – proposed 2006 pool patents on fixed dose combination AIDS drugs
Proposed Pharma/Biotech Pools 4.Applera Corp: molecular diagnostics Building a standard involving hardware, operating system, microprocessor and content 5.Fred Hutchinson Cancer Research Center: (Goldstein, 2005) ID breast cancer markers 6.Proposed pool for rDNA tools for Diagnostics (IP and Technology Law Journal, Jan Goldstein et al.)
Operational Rules about Pools Where can one find rules about pools? –Survey existing pool administrators- to the extent they can divulge –Review consultations by court/administrative agencies in U.S. and EU rulings by U.S. Department of Justice and letters to patent owners who ask for advice –DOJ Letters all post-1990 –All related to creation of pools for telecommunication industry
1.Pool only includes essentialpatents e.g., those without substitutes 2.Pool members retain right to license separately 3.A fair and reasonableroyalty rate. Are these the right rules for an ARV/FDC pool? Are these the right rules for a pool based on compulsory licenses? Department of Justice has focused primarily on three pro-competitive operational rules
Forcing a Patent Pool Market: Industry unlikely to join ARV pool if they think CL will be used Public health: CL are required to back-stop voluntary license negotiations How to induce industry to voluntarily license? –Offer push/pull incentives? Patent extensions, APCs, create fund for R&D, prize for specific FDC, tax break etc. etc…
First order question: Who owns what, where? Much due diligence required (specific dosages, formulations, methods of mfg., APIs, and so on). All this IP will have to be identified as a first step Patentees may have in-licensed enabling technology with restrictions placed on further licensing Joint ownership of patents could be a headache… Figuring this out takes time… and, if not pro bono, it takes money
Patents must be essential Who decides which IP is essential? Use agreed-upon clinical/pharmacological or treatment guideline standard to set essentiality? What result if potential licensee already has license to a pooled patent?- they should not be forced to pay twice Menu of licensible IP, rather than take them all? –What are operational costs to having menus?
Patentees allowed to license outside pool In virtually all patent pools, patent owners grant a nonexclusive licence to the pool and retain the right to licence its patents outside the pool. –members of the pool can take their technology in directions unrelated to the pool and market the outcome: In principle, encourages new innovations –Probably a big selling point for industry –If patent owner wants to compete with her own pooled product, isnt that their business? –Maintaining freedom to operate outside pool may facilitate price discrimination –Same issues for a CL-driven pool?
Fair and reasonable royalties collected from licensees Changing market conditions may render licence terms reasonable at the outset of the pools, unreasonable years later. Licensors (i.e. particularly biomedical patent holders), let their investors think that their IP is extremely valuable and this cuts against the idea of zero, or low priced royalties.
Fair and reasonable royalties collected from licensees: No royalty discrimination (MFN) Royalty discrimination between countries is actually preferred from a public health viewpoint Why cant ARV/FDC pools dispense with MFN clauses? –Different royalties for FDCs, vs. blister packs vs. loose pills? –The more complexity is built into a pool, the costlier and less desirable it might be. Royalty discrimination within countries may even be attractive for industry (public sector v. private sector?)
Royalty allocations back to patent owners from licensees… How does royalty rent change when new patents are added? With numerical proportion rules, new IP dilutes the share that other parties get. Patent counts do not reflect the value of the underlying IP Value proportional allocation rules are too complex… ALL THESE ISSUES ARE NEGOTIABLE..
Confidentiality and know how DOJ: Procedures and auditing features cannot disseminate competitively sensitive proprietary information among owners of pooled patents Separate know how licenses may need to be negotiated Difficult to operationalize but, in the end, ALL IS NEGOTIABLE… AT A PRICE –Transaction and opportunity costs
About those grant backs… Grantbacks can promote competition within patent pools by enabling licensors to practice improvements that licencees make to the licenced technology. Royalty-free grantbacks discourage holding up the pool Non-exclusive grantbacks allow licensees who made the improvement to exploit IP outside the pool What to do with improvements made by original patent owner?
Patent validity etc.. Licensees need to have a mechanism to bring relevant information regarding the validity and essentiality of patents in the pool to the attention of the independent experts No royalties on patent applications- too much uncertainty Procedures for removing IP from pool
Although outside the scope of this meeting, there are other alternatives… Cross-licensing agreements Standard-setting bodies may achieve many of same goals Mutual covenants not to sue (multiple non-suit agreements) NOTE: Over-regulation of one form could just lead to substitution of other forms Need a functional perspective- dont worry about the form, make sure the function works to a public health advantage…
Recommended Reading Preliminary Legal Review of Proposed Medicines Patent Pool for UNITAID IPDS Intellectual Property Design Solutions E. Richard Gold, Tina Piper, Jean-Frédéric Morin, L. Karen Durell, Julia Carbone and Elisa Henry, July 26, 2007