Patents in Argentina General overview

1. Patents in ArgentinaGeneral overview Ignacio Sánchez Echagüe Eugenio Hoss Buenos Aires, June 11, 2008 Marval, O'Farrell & Mairal

2. Legislation • Statutory requirements • Patentable subject matter • Patent prosecution • Patent enforcement • Data protection

3. Legislation Higher hierarchy than internal laws • Paris Convention (1958) • TRIPS Agreement (1994) • Patent Law (1995) and its Regulatory Decree • Not member of PCT

4. Patent Law • First-to-file system • Duration of patents: 20 years from filing date • Publication: 18 months from filing date • Substantive examination request: 3 years from filing date • Annuities: after grant • No revalidation or confirmation patents

5. Patentability requirements • Novelty • Inventive activity (non-obviousness) • Industrial application (usefulness) • Support & enablement

6. Patentability requirements - Novelty • Worldwide • Absolute identity • Section 5: “The disclosure of an invention shall not affect its novelty, when within ONE (1) year prior to the date of filing the patent application, or, if applicable, of the recognized priority, the inventor or his lawful successors, have disclosed the invention by any means of communication or have exhibited the same in a national or international fair. Upon filing the pertinent application, the supporting documentation shall be submitted under the conditions to be established by the rules hereof.” • Argentine Patent Office considers that publications of equivalent patent applications destroy novelty

7. Patentability requirements - Inventive activity • Inventive activity ≠ non-obviousness • EU/AR approach - Problem solution approach • Three prong test: • Identification of the closest prior art, • Determination of the problem to be solved, and • Determine whether the invention is obvious under the light of the closest prior art and the problem to be solved • US approach • Three prong test: • The scope and content of the prior art are to be determined, • Differences between the prior art and the claims at issue are to be ascertained, and • The level of the ordinary skill in the art resolved • Secondary considerations (Graham v. John Deere 383 U.S. 1, 148 U.S.P.Q. 459. United States v. Adams 383 U.S. 39, 148 U.S.P.Q. 479)

8. Patentability requirements - Industrial application • Industrial application ≠ utility • Section 4(e): “The subject of the invention will be of application in industry when it leads to the obtention of an industrial result or product, the term "industry" being understood as embracing agriculture, forestry, cattle breeding, fishing, mining, transformation industries in the strict sense, and services”.

9. Patentability requirements – Support & Enablement • The claims have to be duly supported by the specification • The specification has to teach a person having ordinary skill in the art how to make and use the invention

10. Patentable subject matter “… patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.” (Article 27 of TRIPS)

11. Non Patentable subject matter • Discoveries, scientific theories, and mathematical methods; • Literary or artistic works, or any other aesthetic creation, as well as scientific works; • Plans, rules, and methods applied in carrying out intellectual activities, for games, or for economic and commercial activities, as well as computer programs;

12. Non Patentable subject matter (cont’d) • The ways of presenting information; • Methods of diagnosis or surgical or therapeutic treatment, applicable in the human body, and those related to animals; • The aggregation of known inventions, or mixtures of known products, changes in their shape, size, or material, except when their combination or merger makes their separate operation impossible, or when their characteristic qualities or functions are modified in order to obtain a non-obvious industrial result for a technician in the art; and • Any kind of living matter or substance already existing in nature.

13. Patent Prosecution

14. Patent Prosecution Course of action when patent is rejected

15. Patent enforcement • Litigation – General remarks • Civil law country • No binding precedents (no stare decisis) • Written procedures • No jury • No discovery

16. Patent enforcement • Litigation – General remarks • Costs awarded to the winning party • Permanent injunctions • No treble damages • Mandatory pre trial mediation • International exhaustion of patent rights

17. Patent enforcement • Action on the merits • Object of the action on the merits: • Cease of the infringing activities • Damages • Damages: • No punitive damages • In Re.: Destaillats (restitution of fructus) • Actual damages (lost profits) • 3. Expected timeline: 4-6 years

18. Patent enforcement • Action on the merits • Process patents: Reversal of the burden of proof • Section 88 of the Argentine Patent Law provides: “For the purposes of a civil action, when the subject matter of the patent is a process for obtaining a product, the courts shall order defendant to prove that the process for obtaining the product differs from the patented process. • Notwithstanding this, the courts shall be empowered to order plaintiff to prove that the process for obtaining the product infringes the process patent if the product obtained as a result of the patented process is not new. Unless evidence to the contrary is given, it shall be assumed that the product obtained through the patented process is not new if defendant or an expert appointed by the court at the request of defendant is able to prove the existence in the market at the time of the purported violation of a non-infringing product identical to the product obtained as a result of the process and which has its origins other than the owner of the patent or defendant”.

19. Patent enforcement • Preliminary injunctions • Statutory provisions: • Likelihood of validity, if the patent were challenged by the defendant • Irreparable harm to the title holder • Balance of hardships • Likelihood of infringement • Appointment of an Official Expert to analyze the likelihood of validity and the likelihood of infringement • Posting of a Bond • No ex-parte prosecution?

20. Patent enforcement • Preliminary injunctions • KEY ISSUES: • Ex-parte prosecution • Appointment of an official expert • Expected timeline: • From filing the PI to issuance= 1 ½ month • Appeal of the PI= between 6 months to 1 year

21. Data Protection Data Protection under the TRIPS Agreement Section 39.3 of the TRIPS Agreement provides: “Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. …”.

22. Data Protection Data Protection under the Argentine Law Argentine Confidentiality Law No. 24,766 and Decree No. 150/92 allow third parties to indirectly rely on confidential information produced by the originator of the product. The third party obtains a free ride.

23. Data Protection • Data Protection under the TRIPS Agreement • “…Unfair Commercial use…” includes the use of the data made by third parties for approval of their own products without consideration to the originator of the data. The unfair use occurs even if that use consists of “relaying on” that data, directly or indirectly, to obtain that approval.

24. Thank you Av. Leandro N. Alem 928 (C1001AAR) Buenos Aires - Argentina Tel: (54-11) 4310-0100 / Fax: (54-11) 4310-0200 e-mail: marval@marval.com.ar