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Indian Generic Drug Industry in the Post- WTO World

Indian Generic Drug Industry in the Post- WTO World . Srividhya Ragavan University of Oklahoma Law Center. Post – WTO era. Post – WTO world Normative rule based structure Benefit: We can maneuver within the rules Difficulty: We have to learn to play by the rules How do we play by the rules

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Indian Generic Drug Industry in the Post- WTO World

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  1. Indian Generic Drug Industry in the Post- WTO World Srividhya Ragavan University of Oklahoma Law Center

  2. Post – WTO era • Post – WTO world • Normative rule based structure • Benefit: We can maneuver within the rules • Difficulty: We have to learn to play by the rules • How do we play by the rules • By being conscious of intellectual property – both what we can protect and invalidate • An element that has been lacking in the Indian mindset • Industry has to drive the changes in law

  3. Intellectual Property Consciousness • Creation & Protection is a two step process • We have been conscious of our engineering talent • By nature we do not emphasize form • Contracts • Using innovation

  4. A World Conscious of IP • US06161223Pants separable for crotch for style mixing

  5. A bird diaper to enjoy your pet without getting wet… • Facilitates absorption of bird excrement to prevent leaks and provides easy cleaning using soap and water.

  6. Disposable Boxer ShortsUS Patent No. 6,539,554 Issued April 1, 2003 • Here is a patent that issued at the USPTO. I was tempted not to pick it for fear that it was an April Fool's joke being played by the Patent Office • The Background of the Invention starts by saying: "The need for clean underwear is almost universal." I suppose a truer statement could not be made. • Apparently the problem that is being solved by this invention is the difficulty in preparing clean underwear when traveling and/or camping.

  7. Animal ToyUS Patent No. 6,360,693 Issued March 26, 2002

  8. US Patent No. 6,360,375Issued March 26, 2002Buttocks support device

  9. Now I have seen everything. The patent says it is like a bra, just for your buttocks. I suppose this should not come as a shock given that we, as a society, are spending more and more on plastic surgery, health club memberships and other various and sundry exercise and image related products.

  10. A decorative bag . . . comprising: • a flexible waterproof plastic trash bag • premanufactured orange color • facial indicia • opening across width of bag • filled with leaves or other material and closed at top Problem: Unsightly trash bags In Re Dembiczak, 175 F. 3d 994 (1999)

  11. Beerbrella • US Patent No. 6,637,447Issued October 28, 2003

  12. Here is a great invention. • It is rather simple, something you don't see every day but completely ingenious. • The US Constitution says that Congress can provide for the issuance of patents to further the progress of science and the useful arts. • That is the goal, but there is no requirement that every invention be a scientific breakthrough. • Anything useful can be patented in the US. • Frequently simple inventions, or inventions that make people smile or laugh, can be quite lucrative. If the price is right who wouldn't buy this as a gag gift for their favorite beer drinker?

  13. American Patent Regime • Utility • Novelty • Nonobviousness • Patentability is increasingly determined under § 112 • Federal Circuit was established to further the patent system • Industry has driven the definition for each of these requirements

  14. Industry’s Role in the Patent Regime • Biotechnology patent • Diamond v. Chakrabarty & how it created the Maryland belt • In Re Deuel • Amgen v. Chugai • The Problem of the anti-commons • Eli Lilly • In Re Fisher

  15. In Re Fisher (Sep 7, 2005) • Invention: five purified nucleic acid sequences that encode proteins and protein fragments in maize plants - ESTs. • Utility was only as a downstream research tool: • for the identification of polymorphisms) • use as probes or as a source for primers.

  16. If appellant loses the appeal, downstream research enterprises will "win" as they are freed from thousands of "research tool" patents  (minimal utility disclosures). • Monsanto pushed for the appeal (as employees of Fisher). • USPTO is applying a heightened standard of utility to biotechnology inventions — specifically under 35 U.S.C. Section 101 to ESTs

  17. Industry’s role in heightening and reducing the patent standard • How these cases help developing nations. • Developing nations can now argue that they do not allow patenting of ESTs on utility grounds. • Similar story with business method patents

  18. U.S. Patent 6,329,919 System and method for providing reservations for restroom use Assignee: IBM (filed Aug. 2000) Abstract The present invention is an apparatus, system, and method for providing reservations for restroom use. In one embodiment, a passenger on an airplane may submit a reservation request to the system for restroom use. The reservation system determines when the request can be accommodated and notifies the passenger when a restroom becomes available. The system improves airline safety by minimizing the time passengers spent standing while an airplane is in flight. What is claimed is: 1. A method of providing reservations for restroom use, comprising: receiving a reservation request from a user; and notifying the user when the restroom is available for his or her use.

  19. $53.7m $521m $30m Preliminary Injunction Software Patent Lawsuits Open bidding on keywords and tight relevancy standards produce relevant results.

  20. US Patents & Industry • Now US is considering scrapping business methods patents • Court accommodating the industry • US stance on compulsory licensing • eBay & the compulsory licensing story • How injunctions are being used to allow compulsory licensing

  21. How the Indian Generic industry can benefit Ability to achieve industry targets by using appropriate instruments (& this is NOT the Patent Act) Claim Example of product by process claim (Atlantic Thermoplastics & Indian generic industry). The Federal Circuit ruled that the use of a different process did not amount to an infringement of the product-by-process claim. Example of Indian Patent Amendment Act, 2005 – section 3 (d) exclusion for salts, esters, ethers, polymorphs, metabolites, …unless they differ significantly in properties with regard to efficacy. Purpose Limited Product Claims of Europe Ability to distinguish through claims by educating judges on the role of claims Patents distinguished through one or more claims

  22. Claim 1 A method of placing an order for an item comprising: under control of a client system, displaying information identifying the item; and in response to only a single action being performed, sending a request to order the item along with an identifier of a purchaser of the item to a server system; under control of a single-action ordering component of the server system; receiving the request; retrieving additional information previously stored for the purchaser . . .; and generating an order to purchase the requested item . . . fulfilling the generated order . . . whereby the item is ordered without using a shopping cart ordering model. Express Lane Buy it now with just 1 click!

  23. Claims with other elements • KSR Intern. Co. v. Teleflex Inc., • A combination claim survives a validity challenge if there is no teaching, suggestion or motivation to create the combination • This standard helped to create more competitors

  24. Blackberry: • Combination claim • Identical invention – but expressed as a step claim was held as noninfringing under principle of extraterritoriality

  25. TRIPS & Price Control • PhRMA v. Walsh • The Rx Plus Program helped uninsured citizens to cope with prescription drug prices • Manufacturers who did not “voluntarily” enter into rebate agreements with the Commissioner of Maine Care were released to health care providers and the public. • The procedural burdens imposed by the prior authorization requirement shifted patient and physician loyalty to competing drugs of manufacturers not subject to the authorization.

  26. Indian Generic: Future • Ability to watch the US patent regime for exceptions • The Brazilian way: • Cases where the US is in complete disregard of TRIPS • 102 (d) • Foreign application must be filed 12 months before the US application • And, the foreign application should issue as a patent • eBay

  27. Conclusion • We already have engineers • Updating them on patent law & its nuances is the easy part

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