1. UNNI NALSAR The Fascinating World of Patents Seminar on Industrial Property, 25 th January 2007 At Hotel International, Kochi Organised by EU-India TIDP & CUSAT V.K. Unni Asst. Professor - Law NALSAR University of Law, Hyderabad www.nalsar.ac.in E-mail: unni@nalsarlawuniv.org

2. UNNI NALSAR The Fascinating World of Patents  Patent law deals with new industrially applicable inventions  It envisages a very powerful and special mode of protection for inventions  The patentee is given a monopoly to work the invention for a period of around 20 years  Compared to other streams of IPR the property right granted is very strong  A patent is never granted in an automatic way, there is a structured procedure for obtaining a patent

3. UNNI NALSAR The Fascinating World of Patents  Patents can be given for products as well as processes  Here a monopoly is granted to the patentee for disclosing the details of the invention, which he would have kept as a secret  The disclosure made by the patentee should enable a person skilled in the art to work/make the invention once the patent expires  This would mean that an adequate and enabling disclosure is a condition precedent for obtaining a patent

4. UNNI NALSAR “Patents” How it all started ???  The origins of patent law can be traced from the medieval times  It all started with the granting of “Letters Patent” which were in effect open letters with king’s seal  The Letters Patent granted the rights to foreign weavers/ craftsmen so that they can practise their trade  The first letters patent was granted to a weaver who wanted to practise his trade in England

5. UNNI NALSAR The Fascinating World of Patents Justification for Patents  It encourages research and invention  Induces inventors to reveal their inventions instead of keeping them as a secret  It offers a reward for the effort of developing inventions to the stage where it is commercially viable  Provides inducement to invest money in new lines of production, which may not be profitable, if too many people venture into it

6. UNNI NALSAR The Fascinating World of Patents  The patent system guarantees a limited term of protection in return for the inventor’s willingness to disclose details of his invention and finally to abandon his property right in it  The conventional justification is that in a patent system inventors are rewarded for their time, work and risk of capital by the grant of a patent  The society is also benefited by stimulating investment and employment because details of the invention are added to the store of available knowledge

7. UNNI NALSAR The Fascinating World of Patents Patentability Requirements  The invention has to be novel  It should involve an inventive step, i.e. it should be non-obvious  It should be capable of industrial application  It should not be excluded specifically by the statute

8. UNNI NALSAR The Fascinating World of Patents Novelty  Invention must be new, it must not already have been available to the public  An invention can be new only if it does not form part of the “state of art” / prior art  The prior art comprises of all matters made available to the public before the date of the invention whether by written, oral description, by use or in any manner  Prior publication could have occurred anywhere in the world

9. UNNI NALSAR  But disclosures that are made in confidence will not be considered as prior publication  Thus disclosures made in such circumstances won’t have any bearing on the novelty of the invention  Case-law: Visx Inc v. Nidek Co. Ltd (1999), FSR 405, here a prior oral disclosure was made during a train journey. But the disclosure was made in confidence so the invention did not loose novelty

10. UNNI NALSAR The Fascinating World of Patents How many acts of disclosures are needed ?  Windsurfing Intl. Inc v. Tabur Marine (Great Britain) Ltd. (1985) RPC 59 Here the boat built by a boy which was used in public only for 2 week ends at a beach was held as sufficient disclosure to pre-empt a later patent  Thus even a single act of disclosure can destroy the novelty of an invention

11. UNNI NALSAR The Fascinating World of Patents Lux Traffic Controls v. Pike Signals Ltd. (1993) RPC 107  Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public  The court held that there is no need to prove that anybody actually saw the disclosure, provided the relevant disclosure was in public  When a prototype is kept in public it is irrelevant whether a skilled person examined it or not  In such cases there is prior disclosure, consequently there is loss of novelty

12. UNNI NALSAR The Fascinating World of Patents  Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not  In Pall Corp. v Commercial Hydraulics (Bedford) Ltd. (1990) FSR 329 Samples of a product were sent to some of its potential customers for testing. The technical details/ construction of the product was impossible to be determined on such visual inspection. Here the court held that there is no prior disclosure and thus there was no impact on the novelty

13. UNNI NALSAR The Fascinating World of Patents Inventive Step  Inventive step' means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art.  The use of the expression "economic significance" in the new law is interesting; it is neither a classical patentability criterion nor does it have anything to do with inventions.

14. UNNI NALSAR Patents would not be available on the following grounds:  the mere discovery of a known substance which does not result in the enhancement of the known efficacy of that substance.  the mere discovery of any new property or new use for a known substance.  the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least employs one new reactant.  One can argue that a minor alteration to an existing drug molecule, resulting in "enhancement of its known efficacy" could lead to the grant of a patent on that molecule.

15. UNNI NALSAR The Fascinating World of Patents Nine-point test to analyze obviousness Landmark case in U.K., Haberman v Jackel International Ltd. (1999) FSR 683  what was the problem which the invention addressed;  how long had the problem existed;  how significant was the problem;  how widely known was the problem and how many were likely to be seeking a solution;

16. UNNI NALSAR The Fascinating World of Patents  what prior art would have been known to those in the field,  what other solutions were proposed prior to publication of the patent;  what other factors were there that held back exploitation of the solution;  how well has the product been received;  has the commercial success of the product been due to its technical merits. This decision leads to the position that commercial success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)

17. UNNI NALSAR The Fascinating World of Patents Industrial Application  Industrial application is another requirement for patentability  The invention has to be worked industrially  This requirement distinguishes patents from copyright  An invention is capable of industrial application if it can be made or used in any kind of industry including agriculture

18. UNNI NALSAR The Fascinating World of Patents  Industrial application doesn’t cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies  The above said exclusion doesn’t extend to products consisting of substances used in any such method  The word treatment and diagnosis imply an illness or disease of some kind and doesn’t include pregnancy

19. UNNI NALSAR The Fascinating World of Patents What are not patentable??? Sec. 3  an invention which is frivolous or which claims anything contrary to well established natural laws; Sec 3 (a)  an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment, Sec 3(b)  the mere discovery of a scientific principle or the formulation of an abstract theory; or discovery of any living thing or non living substance occurring in nature, Sec 3[c]

20. UNNI NALSAR The Fascinating World of Patents  " the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Sec 3 (d)* Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;". * Inserted by the 2005 amendment

21. UNNI NALSAR The Fascinating World of Patents  a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance; Sec 3 (e)  the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way, Sec 3(f)  Sec 3(g) has been omitted by the 2002 amendment

22. UNNI NALSAR The Fascinating World of Patents  any method of agriculture or horticulture, Sec 3(h)  any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products. Sec 3(i)  Plants and animals in whole or in any part thereof, other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)  A mathematical or business method or a computer programme per se, or algorithms Sec 3(k)

23. UNNI NALSAR The Fascinating World of Patents  A literary,dramatic, artistic, musical works, cinematographic films, television productions Sec 3(l)  Method of performing a mental act or method of playing a game, Sec. 3(m)  Presentation of information, Sec 3(n)  Integrated circuits, Sec 3(o)  An invention which, in effect, is traditional knowledge, or is an aggregation or duplication of known properties of a traditionally known component, Sec 3(p)

24. UNNI NALSAR The Fascinating World of Patents Ownership of patents  Normally it is the inventor who owns the patent  Incase the inventor has assigned the patent, the owner of the patent will be different  Disputes mainly arise over ownership of inventions between employees and employers  In India there is no provision which deals with employee-employer inventions

25. UNNI NALSAR The Fascinating World of Patents Rights of a patent holder (Sec 48)  When a patent is for a product the patent holder has the exclusive right to make, use, sell, distribute such article or permit his agent to do so, or issue a license.  A patent is always territorial in nature  In case of a process patent the patent holder has the exclusive right to use or exercise the method/process in India  If any person violates any of these rights then there will be infringement

26. UNNI NALSAR The Fascinating World of Patents  The following can be considered as the public interest provisions vis a vis the patent monopoly  Opposition of patents  The Indian law provides for both pre grant and post grant opposition  As per Sec 25 (1) when an application for a patent has been published but has not been granted, any person may,in writing, represent by way of opposition to the Controller against the grant of the patent. (pre-grant opposition)

27. UNNI NALSAR The Fascinating World of Patents  The Indian law also provides for post grant opposition  After the grant of patent but before the expiry of a period of one year from the date of grant, any interested person may give notice of opposition to the Controller, Sec 25 (2),  The grounds can be many like lack of novelty, obviousness, insufficient description of the invention etc  Then the Controller of patents has to constitute an opposition board to consider this opposition

28. UNNI NALSAR The Fascinating World of Patents  The opposition board has to hear both the parties and give its opinion to the controller,  Thus the Controller can either, maintain, amend or revoke the patent after the said proceedings

29. UNNI NALSAR The Fascinating World of Patents Compulsory Licensing  The aim or purpose of this provision is to ensure hat the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention  Grounds for compulsory licensing can be classified the grounds into two categories, (private and public)  Those that can be invoked directly by a private company like Dr. REDDY’S / Torrent, this is known as a licence on ‘private grounds and those that can only be invoked by or with the help of the government, known as a licence on ‘public grounds’

30. UNNI NALSAR The Fascinating World of Patents  Sec 84 deals with compulsory licensing on private grounds  After 3 years from the grant of the patent any person shall apply to the controller to issue him a compulsory license to work the patent  The grounds for making such application are  The reasonable requirement of the public with respect to the invention are not satisfied  Patented invention is not available to the public at a reasonably affordable price  Invention is not worked in the territory of India

31. UNNI NALSAR The Fascinating World of Patents  Thus if the controller is satisfied that these conditions are not being met, he will grant a compulsory license upon the terms he may think fit  Sections 86-89 deals with the procedures to be followed while granting a compulsory license

32. UNNI NALSAR The Fascinating World of Patents  The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market  The license shall be for the balance term of the patent or for a shorter term Compulsory Licensing on Public Grounds  If the central govt. is satisfied that a compulsory license shall be granted for any patent because of circumstances arising out of national emergency/ extreme urgency/ public non commercial use, then it shall grant such license at anytime after the grant of the patent (Sec 92)

33. UNNI NALSAR The Fascinating World of Patents  If the controller feels that because of national emergency, extreme urgency and public non commercial uses which includes cases like AIDS, tuberculosis, Malaria, epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act.  This beneficial provision can be really helpful in the case of emergencies

34. UNNI NALSAR The Fascinating World of Patents  Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems, Sec 92A (By virtue of 2005 amendment)  However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India.  Sec 92A incorporates the 2003 August 30 decision of TRIPS Council, into the Indian law

35. UNNI NALSAR The Fascinating World of Patents Government use of inventions  The government is free to use a patented invention without running the risk of being sued for infringement  By virtue of Sections 99-103, the Central Government or any authorised person can use an invention for the purposes of the Central Government/ State Government/ PSU, provided adequate compensation is paid.  Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use, here there is no mention of any compensation to be paid to the patent holder

36. UNNI NALSAR The Fascinating World of Patents Bolar Exception Sec 107A (a)  This provided for a research exemption as an exception to the general rules of patent infringement.  This research exception enables a manufacturer of generic drugs to use a patented invention to obtain marketing approval without the patent owner's permission before the patent expires  Thus even in cases where there is a product patent for a drug molecule, an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule  The generic drug maker can then market their own version of the patented drug as soon as the patent expires.

37. UNNI NALSAR The Fascinating World of Patents Parallel Importation Sec 107A (b)  As per Sec 107A (b) it is not an infringement to import a patented product, if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product.  Thus India /Indian companies can import drugs from least developed countries by basing their operations in those countries, because least developed countries will not have any patent protection until the year 2016

38. UNNI NALSAR The Fascinating World of Patents Revocation of patents  These proceedings can be instituted at any time after the grant of the patent, while the patent is in force.  Revocation can be made by the  1.The Controller (Sections 65 and 85) or  2.The Appellate Board (Section 64(1), or  3.The High Court (Sections 64(1) when raised in a counter claim for patent infringement and 64(4) or  4.The Central Government [Section 66, revocation in public interest]

39. UNNI NALSAR The Fascinating World of Patents Revocation of Patents (Sec 85)  When a compulsory license has been granted, after 2 years from the date of such grant any interested person/ central govt. can apply before the controller to revoke the patent  The grounds are reasonable requirements of the public with respect to the invention not satisfied/ patented invention is not available to the public at a reasonably affordable price

40. UNNI NALSAR The Fascinating World of Patents Thank You Very Much V.K. Unni Asst. Professor - Law NALSAR University of Law, Hyderabad www.nalsar.ac.in E-mail: unni@nalsarlawuniv.org