About Author: A. A. Durgavale*, M. V. Mahale, S. R. Kane, Dr. S. K. Mohite, Dr. C. S. Magdum
Department of Quality Assurance,
Rajarambapu College Of Pharmacy,
Kasegaon, Tal - Walwa, Dist. - Sangli - 415404
Reference ID: PHARMATUTOR-ART-1058
Abstract
Intellectual Property (IP) refers to property created with the use of intellect. In other words, this refers to creation of mind. These are rights given to person over creation of their minds. They usually give the creator an exclusive right over use of his or her relation for certain period of time. Intellectual property differs from other form of properties as it does not have any physical shape and can be seen. Protection of Intellectual property is done by offering time limited rights to investor in form of patents.
Intellectual property laws vary from jurisdiction to jurisdiction, such that the acquisition, registration or enforcement of IP rights must be pursued or obtained separately in each territory of interest. However, these laws are becoming increasingly harmonized through the effects of international treaties such as the 1994 World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), while other treaties may facilitate registration in more than one jurisdiction at a time. Certain forms of IP rights do not require registration in order to be enforced. There are various forms of IP like Copyrights and related rights, Trade Marks, Geographical Indications, Industrial Designs, Lay out Designs of Integrated Circuits, Protection of Undisclosed Information (Trade Secrets), Patents, Plant varieties.
Introduction
Intellectual property is all about human creativities(1). Intellectual property rights are considered as reward for creative and skillful work in execution of ideas(2). In other manner, industrial property and intellectual property are closely associated sometimes ago and IP was considered as industrial property(3) .Traditionally a number of intellectual property rights such as, trademarks and industrial designs were collectively known as industrial property(4). Finally we can define that the intellectual property is a “product of mind”. It is similar to any property consisting of moveable or immoveable things wherein the proprietor or owner may use his/her property as he/she wishes and nobody else can lawfully uses his property without his/her permission.
The different kinds of intellectual property rights could be categorized as 1. Copyright, 2. Trademark, 3. Geographical indications, 4. Industrial designs, 5. Semiconductor chips and integrated circuits, 6. Patents and 7. Trade secrets(5) 8. Plant varieties.
PATENTS:
The term patent can be defined as “a monopoly right conferred to the inventor who has invented a new product or process through his/her intellectual efforts capable of industrial application(6). These are granted on the basis of certain requirements they are novelty, inventive step, industrial application and written description. It gives full rights to use or exploit the invention to the owner. The assignee only enjoys the rights. if the owner can assign or license the invention to the assignee. The inventor needs to disclose the invention in written form with description in order to obtain exclusive monopoly over the invention for a specific duration(7). If the patent expires the invention is considered to be as public domain and anyone can use it. All inventions are not patentable; certain inventions have been prohibited from the purview of patents though satisfy all the requirements of patenting. Inventions, which are against public order and morality(8), are generally not patentable(9).
Patent law - a branch of law, which regulates the issue and maintenance of exclusive monopoly over inventions it, intends to strike a balance between the promotion of technological innovation and dissemination of its fruits(10).
The Indian Patent Act(11):
The first Indian patent laws were first promulgated in 1856. These were modified from time to time. New patent laws were made after the independence in the form of the Indian Patent Act 1970. The Act has now been radically amended to become fully compliant with the provisions of TRIPS. The most recent amendment were made in 2005 which were preceded by the amendments in 2000 and 2003. While the process of bringing out amendments was going on, India became a member of the Paris Convention, Patent Cooperation Treaty and Budapest Treaty. The salient and important features of the amended Act are explained here.
Definition of invention
A clear definition has now been provided for an invention, which makes it at par with definitions followed by most countries. Invention means a new product or process involving an inventive step and capable of industrial application. New invention means any invention or technology which has not been anticipated by publication in any document or used in the country or elsewhere in the world before the date of filing of patent application with complete specification i.e., the subject matter has not fallen in public domain or it does not form part of the state of the art.
Novelty
An invention will be considered novel if it does not form a part of the global state of the art. Information appearing in magazines, technical journals, books, newspapers etc. constitute the state of the art. Oral description of the invention in a seminar/conference can also spoil novelty. Novelty is assessed in a global context. An invention will cease to be novel if it has been disclosed in the public through any type of publications anywhere in the world before filing a patent application in respect of the invention. Therefore it is advisable to file a patent application before publishing a paper if there is a slight chance that the invention may be patentable. Prior use of the invention in the country of interest before the filing date can also destroy the novelty. Novelty is determined through extensive literature and patent searches.
Inventiveness (Non-obviousness)
A patent application involves an inventive step if the proposed invention is not obvious to a person skilled in the art i.e., skilled in the subject matter of the patent application. The prior art should not point towards the invention implying that the practitioner of the subject matter could not have thought about the invention prior to filing of the patent application. Inventiveness cannot be decided on the material contained in unpublished patents. The complexity or the simplicity of an inventive step does not have any bearing on the grant of a patent. In other words a very simple invention can qualify for a patent. If there is an inventive step between the proposed patent and the prior art at that point of time, then an invention has taken place. A mere 'scintilla' of invention is sufficient to found a valid patent.
Usefulness
An invention must possess utility for the grant of patent. No valid patent can be granted for an invention devoid of utility. The patent specification should spell out various uses and manner of practicing them, even if considered obvious. If you are claiming a process, you need not describe the use of the compound produced thereby. Nevertheless it would be safer to do so. But if you claim a compound without spelling out its utility, you may be denied a patent.
RECENT CHANGES IN IPR LAWS IMPACTING PHARMACEUTICAL INDUSTRY:
The pre-Trade Related Intellectual Property Rights (TRIPs) era saw the world divided into group of nations i) allowing patent in all fields of technologies (products and processes) and ii) Having restrictive patent laws providing for process patents in all fields except for product patents in selected fields such as pharmaceuticals and drugs, food etc. In addition, the term of patents, conditions for compulsory licensing, whether importation should be considered as working of patents, etc., varied based on existing national laws. TRIPs attempt to harmonize the IPR laws by bringing the disparities into focus. Since the formation of the World Trade Organization (WTO) on January 1, 1995, several nations have made significant changes in their national laws governing IPR. Proper understanding and utilization of the IPR laws in various countries would help in the global positioning of pharmaceutical companies.
Since June 1995, USA changed the term of patents from 17 to 20 years. The practice of “first of invent’’ as opposed to “first to file’’ has been extended to all members of WTO. All patents in force on 8th June, 1995, will have a term of 20 years from the date of issue, whichever is longer. As per this provision, several patents received an extension of their term. This has had a significant effect on the pharmaceutical industry. In November 1999, the US introduced the system that a patent specification will be published 18 months after its filing. The Japanese Patent Law was amended on December 14, 1994, with amendments falling into two groups, one effective from July 1, 1995 and the other from January 1, 1996. With effect from July 1, 1995 the term of patents was made 20 years from the date of filing. There were other features dealing with provisions for the restoration of lapsed patents, priority-based filing in WTO Member-countries, etc. The second category, effective from January 1, 1996, was the replacement of pregrant opposition proceedings to post-grant opposition and procedures for accelerated patent processing. A few landmark judgments related to “parallel imports’’ into Japan and “research exemption’’ in the area of development of generic drugs are of significance. Further amendments were introduced in 1999 that were made effective from January 2000. On March 10,1999, the Indian Parliament passed a Patent Amendment Bill, which regularized the transitory “mail-box provision” (with effect from January 1,1995) to file product patents for nventions relating to drugs, pharmaceuticals, agrochemicals and to grant “exclusive marketing rights’’ in these selected fields only. Other changes in the Patent Act, 1970, have been introduced to meet the immediate obligations of TRIPS such as the withdrawal of Section 39 that required inventions in India to be first field in India before being filed elsewhere, considering importation as the working of an invention in India, etc. A second patent amendment bill (1999) was introduced in the Parliament in December 1999 to meet all the other obligations of TRIPs. This is presently under review. India also joined the Paris Convention and the Patents Cooperation Treaty on December 7, 1998.
In Spain, the patent law was amended in January 1998 to remove the requirement that pharmaceutical companies must make the patented product in Spain before an injunction would be granted against an accused infringer. Now it is getting easier to obtain interim injunctions from Spanish courts.
In Argentina, the 1995 Patent Law brought provisions in line with TRIPs to make the term of patents 20 years from the date of filing, rather than 15 years from the granting date. The problems of where the old patent law ends and where the 1995 legislation starts have not been satisfactorily resolved.
The Australian Patent Act was changed on August 10, 1998, to give pharmaceutical patents an effective term of 20 years to bring them in line with the laws in USA, Japan and Europe. The most significant provision in Australia for pharmaceutical patent owners has been the extension of patents to give an effective term of 15 years, where product registration requirements have held up the introduction of the product to the market.
IPR AND INDIAN PHARMACEUTICAL INDUSTRIES:
After the GATT changed into WTO, most of the developed countries were awakened to protect their products. Initially most of the world leading pharmaceutical industries built a separate cell for IPR and regulated very well. So the profit of the companies were increased and IP played a major role in controlling the counterfeit and copycat drugs. But in India that time only pharma companies were plan to set their IP cell some of the companies in India established the IPR cell in the year 1995. Majority of the companies started IPR cell after 2000 in India. By the end of year 2004, majority of companies started a separate department to look after the issues related to patents. It can be safely presumed that the patents that are granted to Indian pharma companies or applied by these companies are for either new processes or new drug delivery systems(12).
GATT AND THE INDIAN PHARMA INDUSTRIES:
With the advent of the product patent era, as required by his/her obligations under the WTO’s mandate, India can no longer produce and market patented products in any country where valid product patents exist. During the last four decades nearly, since the advent of IPA 1970 (operative since 1972), Indian companies launched patented drugs in India within 3 years of their first launch by innovator companies at prices one fifth to one tenth of their patented versions. In the new era, Indian companies have to rely on manufacturing and marketing generic (off patent) drugs unless they get licenses from the patent owners. If they are to launch new drugs, they need to develop strategies, skills and adequate resources to enter the drug discovery and development area. The top 15 Indian companies have already initiated major efforts in this area fully realizing that it is indeed a very expensive, long gestation and high risk activity with little guarantee of success(13).
NON PATENTABLE INVENTIONS(14, 15):
An invention may satisfy the conditions of novelty, inventiveness and usefulness but it may not qualify for a patent under the following situations:
(i) An invention which is frivolous or which claims anything obviously contrary to well established natural laws e.g. different types of perpetual motion machines.
(ii) An invention whose intended use or exploitation 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 e.g., a process for making brown sugar will not be patented.
(iii) The mere discovery of a scientific principal or formulation of an abstract theory e.g., Raman effect and Theory of Relativity cannot be patented.
(iv) The mere discovery of a new form of a known substance which does not result in enhancement of the known efficacy of that substance or the mere discovery of any new property or new use of a known substance or the mere use of a known process, machine or apparatus unless such a known process results in a new product or employs at least one new reactant. For the purposes of this clause, salts, esters, 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.
(v) A substance obtained by a mere admixture resulting only aggregation of the properties of the components thereof or a process for producing such substance.
(vi) The mere arrangement or rearrangement or duplication of features of known devices each functioning independently of one another in a known way. If you put torch bulbs around an umbrella and operate them by a battery so that people could see you walking in rain when it is dark, then this arrangement is patentable as bulbs and the umbrella perform their functions independently.
(vii) Any process for medical, 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 economic value or that of their products. For example, a new surgical technique for hand surgery for removing contractions is not patentable.
(viii) Discovery of any living thing or non-living substance occurring in nature;
(ix) Mathematical or business methods or a computer program per se or algorithms;
(x) Plants and animals in whole or any part thereof other than microorganisms but Including seeds, varieties and species and essentially biological processes for propagation of plants and animals;
(xi) A mere scheme or rule or method of performing mental act or method of playing games;
(xii) An invention which, in effect, is traditional knowledge or which is aggregation or duplication of known component or components.
Term of the patent
Term of the patent will be 20 years from the date of filing for all types of inventions.
Application
In respect of patent applications filed, following aspects will have to be kept in mind:
• Claim or claims can now relate to single invention or group of inventions linked so as to form a single inventive concept
• Patent application will be published 18 months after the date of filing
• Applicant has to request for examination 12 months within publication or 48 months from date of application, whichever is later
No person resident in India shall, except under the authority of a written permit sought in the manner prescribed and granted by or on behalf of the Controller, make or cause to be made any application outside India for the grant of a patent for an invention unless (a) an application for a patent for the same invention has been made in India, not less than six weeks before the application outside India; and (b) either no direction has been given under the secrecy clause of the Act or all such directions have been revoked.
Complete Specification:
It may be noted that a patent document is a techno-legal document and it has to be finalized in consultation with an attorney. Submission of complete specification is necessary to obtain a patent. Contents of a complete specification would include the following
1. Title of the invention.
2. Field to which the invention belongs .
3. Background of the invention including prior art giving drawbacks of the known inventions & practices.
4. Complete description of the invention along with experimental results.
5. Drawings etc. essential for understanding the invention.
6. Claims, which are statements, related to the invention on which legal proprietorship is being sought. Therefore the claims have to be drafted very carefully.
Timing for filing a patent application:
Filing of an application for a patent should be completed at the earliest possible date and should not be delayed. An application filed with provisional specification, disclosing the essence of the nature of the invention helps to register the priority by the applicant. Delay in filing an application may entail some risks like (i) other inventors might forestall the first inventor by applying for a patent for the said invention, and (ii) there may be either an inadvertent publication of the invention by the inventor himself/herself or by others independently of him/her. Publication of an invention in any form by the inventor before filing of a patent application would disqualify the invention to be patentable. Hence, inventors should not disclose their inventions before filing the patent application. The invention should be considered for publication after a patent application has been filed. Thus, it can be seen that there is no contradiction between publishing an inventive work and filing of patent application in respect of the invention.
CONCLUSION:
IPR in the pharmaceutical company scenario plays a vital role in the patent filling, legally punishing the counterfeit drug manufacturing industries and establishing the industry name in the market for their drug safety and quality. Whereas in India it increased awareness regarding patents which helped companies file patents in lucrative markets and international treaties that were done will be helpful to Indian companies with respect to filing multiple applications.
REFERENCES:
[1] C. Colstan. Principles of Intellectual Property Law, Cavendish Publishing Limited, London, 1999;
[2] Holyoak and Torremans, intellectual property law, butterworths, second edition, London, 1998, p.3
[3] R Stim, Intellectual Property, Delmar cengage learning. New Delhi, 2001, p.14.
[4] David Bainbridge, intellectual property, Pearson education, fifth edition, first Indian edition, Delhi, 2002, 2003, p.5.
[5] Sreenivasulu N.S, Intellectual Property Rights, Regal publications, New Delhi, 2007, p.7.
[6] SKR.Chowdry and H.K. Sahang, Law of Trademarks,Copyrights,Patents and designs, second edition, Kamal Law House, Calcutta ,1999volume 2,p.76.
[7] Article.28 the TRIPS agreement, national law school of India university, Bangalore, 1998, pp26-27.
[8] Article.27 (2) the TRIPS agreement, national law school of India university, Bangalore, 1998, pp26.
[9] Section 3 of the patent act of India, P.S.Narayan, Intellectual Property Rights, first edition Gogia Law agency, Hyderabad, 2001, p.10.
[10] DS Chisum, cases and materials on patent law, foundation press, New York, 1998, p.1
[11] The Patents Act, 1970 as amended by Patents (Amendment) Act 2005, Commercial Law Publisher (India) Private Ltd., 2005
[12] MD Janodia; JV Rao; S Pandey; D Sreedhar, VS Ligade; N Udupa. Impact of patents on Indian Pharma Industry's Growth and Competency: A View point of Pharmaceutical Companies in India. J. I. P. R., 2009, 14, 432-436.
[13] M.D.Nair TRIPs, WTO, and IPR: Impact of Indian Patent Act- 2005 on Indian Pharmaceutical Industry J.I.P.R, vol 15, November 2010 pp.474-476.
[14] Subbaram N.R. “what everyone should know about PATENTS ? Pharma Books syndicate, Hyderbad., 2003., 1-2.
[15] Shailendra Kumar “A la Patents, Patents, Patents….” The Pharma Review., June 2005, 17-19.
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