Infringers & Innovators: Debunking Myths Srividhya Ragavan University of Oklahoma Law Center

Process patent regime is inadequate Mechanisms used by third world countries to enable access to medication are flawed Prevailing Perceptions

Objective: To protect innovations in process of making the same product –Enables minor innovations M+N+O to make product MNO becomes M’+N’+O’ to make product MNO or MNO’ Process Patent Regime

Product patent regime – advocated through TRIPS Minor innovations encouraged through: –Use of sophisticated claiming mechanisms – Judicial law making Patent Regimes of Developed nations

Assuming product MNO patented using a product–by- process claims –Objective: protects a product produced using the claimed process Sophisticated Claiming Mechanisms

What happens when another person makes the same product using a new process? New Process & Known product

1992: Atlantic Thermoplastics Co. v. Faytex Protection to the product is only when it made using the claimed process. Distinguished use of the claim for validity and infringement –Use of different process will not infringe (may not clear validity test) Patent Regimes of Developed nations

Product MNO made by M+N+O owned by X Corp. MNO made by M’+N’+O’ by Y Corp Results in India & US before TRIPS Y Corp can market MNO Implications??

European Patent Guidelines –Use innovations protected using purpose-limited- product claims –Eg: Patent for pyrrolidine derivaties Hence, Y Corp can also market MNO in Europe provided Y Corp highlights a new use European Regime

Developing nations lack the procedural sophistications that enable patenting of minor innovations. Minor innovations will become unpatentable Y Corp in the post –TRIPS regime cannot market in India while it can market in US and Europe Post- TRIPS Patent regime in Developing Nations

Biotechnology patents as an example –Diamond v. Chakrabarty –Amgen v. Chugai – 1991 –In Re Deuel – 1995 –University of California v. Eli Lilly –In Re Fisher Judicial Law Making

Access remains the biggest impediment Price as an impediment –Compulsory Licensing –Price Control –Move to push for price discrimination –And, that price control with or without compulsory licensing does not work. Flawed Access Mechanisms in Developing Nations

The state price control programs –Maine Program –Florida Program –Vermont Program –Michigan Program US Supreme Court on balancing Care & Cost Of Medicaid & Medicare Programs

The Wrong TRIPs.. Fear of Parallel Importation –Reaction to the fear of parallel importation Agreements in exchange of TOT –Video and computer industry –Onus on government –Better access leads to less price control –Promotion of technology – TRIPS objective