Author: Vijayalakshmi K.V., Student of Aakson Institute of Management Studies
Patents is an intellectual property right to inventions and is the entitlement of exclusive right, for limited period, handed by the Government to the patentee, in exclusive right, for limited period, handed by the Government to the patentee, in exchange of full exposure of his invention, for banning others, from making, using, dealing , importing the patented product or process producing that product for those purposes.
The purpose of this system is to encourage inventions by promoting their protection and application so as to contribute to the development of diligence, which in turn, contributes to the creation of technological invention and to the transfer and dispersion of technology. Under the system, Patents insure property rights(legal title) for the invention for which patent has been granted, which may be extremely precious to an individual or a Company. One should make the fullest possible use of the Patent System and benefits it provides. Patent right is territorial in nature and a patent attained in one country isn’t enforceable in other country. The formulators their procurators are needed to file separate patent operations in different countries for carrying the patent in those countries.
Legislation – The Patent System in India is governed by the Patents Act, 1970( No 39 of 1970) as amended by the Patents( Correction) Act, 2005 effective for1-1-2005 and the Patents Rules 2003, as amended by the Patents( Correction) Rules, 2006 effective from05-05-2006.
What’s Patentable Invention Under the Patents Act, an invention means “ a new product or process involving an inventive step and also able of being made or used in the assiduity ”. It means the invention to be patentable should be specialized in nature and should meet the following criteria-
i) Novelty The mammy bared in the specification isn’t published in India or away before the date of form of the patent operation in India.
ii) Inventive Step The invention isn’t egregious a person professed in the art in the light of the previous publication/ knowledge/ document.
iii) Industrially applicable; Invention should retain mileage, so that it can be made or used in the assiduity.
What isn’t Patentable The following are non-patentable inventions within the meaning of the Act –
a) an invention which is frivolous or which claims anything obviously contrary to well established natural laws;
b) marketable exploitation of which could be contrary to public order or morality or which causes serious prejudice to mortal, beast or factory life or health or to the terrain.
( c) the bare discovery of any new property of any new property or new use for a known substance or of the bare use of a given process, machine or outfit unless similar given process results in a new product or employs at least one new reactant.
(d)The bare discovery of any new property of new use for known substance or of the the bare use of given process, machine or outfit unless similar given process results in a new product or employs at least one new reactant;
(e) A substance attained by bare amalgamation performing only in the aggregation of the parcels of the factors there of or a process for producing similar substance;
( f) the bare arrangement re-arrangement or duplication of known bias each performing singly if one another in a given way;
(g) a system of husbandry or horticulture;
(h) any process of the medicinal, surgical, restorative, precautionary( individual remedial) or other treatment of mortal beings or any process of a analogous treatment of creatures to render them free of complaint or to increase their profitable value or that of their products. (i) shops and creatures in whole or any part thereof other than micro-organisms but including seeds, kinds and species and basically natural processes for product or propagation of shops and creatures.
( j) a fine or business system or a computer programmed per se or algorithms
( k) a erudite, dramatic, musical, or cultural work or any other aesthetic creation whatsoever Including cinematographic workshop and TV products.
(l) a bare scheme or rule or system of performing internal act or system of playing game;
(m) a donation of information n) geomorphology of integrated circuits;
(o) an invention echoic in effect, is traditional knowledge or which is an aggregation or duplication of known parcels of traditionally known element or factors,
( p) inventions relating to infinitesimal energy and prejudicial to the defence of India;
(q) in the case of inventions relating to substance( repaired or produced by “ chemical processes ’( including blends, optic glass, semiconductors and intermetallic composites) and substances intended for use or able of being used as medicine and food, no patent will be granted in respect of claims for the substances themselves, but claims for the methos or processes of manufacture will be patented, “ Chemical process ’ includes biochemical, biotechnological andmicro-biological process.
The Law relating to Patents contained in the Patents Act, 1970 ( 39 of 1970) which came into force on the 20th April 1972. This Act was amended to March 1999 and June, 2002 to meet India’s scores under the Agreement on Trade Related ASPECTS OF Intellectual Property Rights(passages) which forms part of agreement establishing the World Trade Organization( WTO).
For entitlement of exclusive marketing rights(EMR’s) for period of 5 times or till the process patent is granted or patent operation is rejected, whichever is before.
Patent act of 1970 included country wide interactive sessions with interest groups, including scientists, academicians, economists, representatives of sectors ( similar as Medicinals, biotech and software), chambers of commerce, private and public sector units, intelligencers, on-governmental associations ’, representatives of State Government, attorneys and attorneys and other interest groups an expansivity-Ministerial discussion. Suits concerning violation of Patents Not suit for a protestation under section 105 or for any relief under section 106 or for violation of a patent shall be introduced in any Court inferior to d quarter Court having governance to try the suit, along with the counter claim, shall be transferred to the High Court for decision.
Burden of evidence in case of suits concerning violation – In any suite for breach of a patent where the subject matter of patent is a process for carrying a product, the Court may direct the defendant to prove that the process used by him to gain the product, identical to the product of patented process, is different from patented process if,-
( a) the Subject- matter of the patent is a process for carrying a new product; or
b) there’s substantial liability the identical product is made by the process and the patentee or a person inferring title interest in the patent for him, has been unfit through reasonable sweats to determine the process actually used handed that the patentee or a person inferring title or interest in the patent from him, first proves that the product is identical to the product directly attained by the patented process. In considering whether a party has discharged the burden assessed upon him by sub-section
( c ) the Court shall not bear him to expose any manufacturing or marketable secrets, if it appears to the court that it would be unreasonable to do so.
Power of Court to grant relief in cases of foundationless pitfalls of violation proceedings –
( 1) Where any person( whether entitled to or interested in a patent or an operation for a patent or not) threatens any other person by leaflets or announcements or by dispatches, oral or in writing addressed to that or any other person, with proceedings for breach of a patent, any person displeased thereby may bring a suit against him soliciting for the following reliefs, that’s to say –
( a) a protestation to the effect that the pitfalls are unwarrantable;
b) an instruction against the continuance of the pitfalls and c) similar damages, if any, as he has sustained thereby.
(2) Unless in similar suit the defendant proves that the acts is respect of which the proceedings were hovered constitute or, if done, would constitute, an breach of patent or of rights arising from the publication of a complete specification in respect of a claim of the specification not shown by the complainant to be invalid, the Court may grant to the complainant all or any of the reliefs supplicated for.
Explanation – A mere announcement of the being of a patent doesn’t constitute a trouble of proceedings within the meaning of this section.
Reliefs in suits for breach – The reliefs which a Court may grant in any suit for contraventions include an instruction (subject to similar terms, if any, as the Court thinks fit) and at the option of the complainant, either damages or an account of gains.
( 2) The Court may also order that the goods which are set up to be infringing and accoutrements and tools, the predominant use of which is in the creation of in fringing goods shall be seized, roped or destroyed, as the Court deems fit under the circumstances of the case without payment of any compensation.
Register of Patents under section 67 – Upon the entitlement of a patent, the Controller shall enter in the register of patents at each applicable office, the name address and nation of the heir as the patentee thereof, the title of the innovation (including the orders to which the innovation relates)., the date of the patent and the date of (entitlement) thereof together with address for service of the patentee.
Patent Case Illustration
The article deals with the case law “Novartis AG. V. Union of India” is one of the landmark judgments in the Indian Patent regime. This was the long run battle fought by Novartis for the grant of patent for the invention of a drug that he discovered for the treatment of leukemia.
Section 3(D) of Patents Act 1970
Section 3 of the Patents Act 1970 says about the inventions which are not patentable. Under section 3(d) of the act says that 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. 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.
NOVARTIS AG v. UNION OF INDIA
Facts of the case
Novartis v. U.O.I. is one of the landmark cases in Intellectual Property Law. The case brought into the question, the interpretation of section 3(d) of Indian Patent Act, 1970. The battle started in the year 1980 by the International Pharmaceutical Company, Novartis International AG which invented a drug named “Gleevic” which was an anti-cancer drug. It was used for the treatment of Chronic Myeloid Leukemia (CML) and Gastrointestinal Stromal Tumours (GIST) but the major thing was it was a beta crystalline form of Imatinib mesylate.
Before the advent of TRIPS agreement, the product patents were not patentable, only it was confined to process patents. But after the amendment in 2005, section 5 of the Indian Patent Act, 1970 was repealed and the product patents were also included in patentable subject matter.
The patent application filed by Novartis was rejected by Madras Parent Office on the ground of anticipation by previous publication. Also, it was said that it lacks the requirement of novelty and non-obviousness therefore, it is not capable of patented.
After that, Novartis filed two writ petitions in 2006 in Madras High Court under Article 226 of the Constitution of India. it was being also contended that section 3(d) of Patent Act, 1970 was held unconstitutional on the ground that it is not in consonance with the TRIPS agreement. Then the case was transferred to IPAB (Intellectual Property Appellant Tribunal) in 2007 which was dismissed by IPAB also stating the same ground for the rejection i.e. it lacks novelty. It was further held that the ever greening of the patent is not permitted; introducing the minor modifications in the generic drugs is not novelty and hence cannot be patented. After that Novartis filed Special Leave Petition in the Supreme Court in 2009 against the order of IPAB.
Finally in the year 2013, this battle came to an end. The Supreme Court rejected the appeal filed by Novartis. It was held by the court that the beta crystalline form of Imatinib Mesylate is only a new and modification of the substance Imatinib Mesylate. It was further elaborated by the court that “Efficacy” in section-3(d) only means “Therapeutic Efficacy” and the properties which are directly related with the drug is its therapeutic efficacy. After comparing both the forms of the said drug, the court held that the properties of the drug in question do not contribute to the increased therapeutic efficacy.
Ratio decidendi of the case
It was being very rightly said that the ever greening of the patents is not permitted. Moreover, the court protects the rights if common man and restricts the pharmaceutical companies to sell the medicines at very high price which is unreasonable for the common man. Section 3(d) of the Patent Act prevents the companies to sell identical drugs with just changing the molecular structure of the substance. Also, Imatinib Mesylate lacks “inventive step” in it. Therefore, it prohibits the ever greening of the patents.
Conclusion :
Patent is one of the intangible forms of property under Intellectual Property. The grant of patents must follow the tests of novelty, non-obviousness and utility, only then the patent can be granted to the true and first inventor of the patent. The inventions need to be incredibly new and novel. Moreover, the invention needs to be capable of being industrial application and it must be useful to the general public at reasonable and affordable price. To accomplish the purpose of the said act, the provision of compulsory license is established so as to curb the monopoly of the patent owner. Patents are only granted to the person who has invented the thing for the purposeful use of the general. The newness and novelty also need to be included in the invention to get patented. The various case laws have been decided by the court so as to meet the criteria of the invention to get patented. This statutory act is conclusive and includes each and every aspect of invention needs to get patented.
The Patents Act, 1970 bars the ever greening of the patent inventions. This is one of the major features of this act. Also prohibits certain inventions under section 3 of the said act. The medicines and drugs are granted patents very rarely in India. The invention should contain an inventive step also. If all these requisites are accomplished only then the patent can be granted under Indian Patents Act, 1970. The legislation is very beneficial to the patent owners as it ensures that their rights are safeguarded by the said act. But the scope of granting patents to pharmaceutical sector needs to be enlarged. Large numbers of patent applications are filed but only few of them gets the patent grant. This is not good for the development of country. The patents act needs more amendments and wider perspectives should be adopted so that more and more industries can get the patents. Every legislation or statute has some loopholes but the only need is to cur those loopholes and a proper strengthened framework should be established.
FAQ’s
1. What is Patent?
A Patent is a statutory right to an invention granted for a limited period of time to the patentee by the government, in exchange of full disclosure of his invention for excluding others, from making using selling importing the patented product or process to producing that product for those purposes without his consent.
2. What is term of a patent in the Indian system?
The term very patent granted is 20 years from the date of filing of application.
3. What can be patented?
An invention relating either to a product a process that is new, involving an original step and capable of industrial application can be patented.
4. Does India Patent give protection worldwide?
No. Patent protection is territorial right. Effective only in India and not a global patent.
5. Who benefits from Patent?
Inventors benefit from the patent system because they are granted an exclusionary right over the patented invention for a limited time. The patent is used to protect the inventors potential future revenue stream.