Basics of Patent Law in India
From DrugPedia: A Wikipedia for Drug discovery
Contents |
[edit] History
In 1957, Govt. of India appointed Justice N. Rajagopala Ayyangar examine and review the Patent law in India who submitted his report September 1959 recommending the retention of Patent System despite shortcomings. The Patent Bill, 1965 based mainly on his recommendations incorporating a few changes, in particular relating to Patents for food, drug, medicines, was introduced in the lower house of Parliament on 21st September, 1965. The bill was passed by the Parliament and the Patents Act 1970 came into force on 20th April 1972 along with Patent Rules 1972. This law was suited changed political situation and economic needs for providing impetus technological development by promoting inventive activities in the country.
Uruguay round of GATT negotiations paved the way for WTO. Therefore India was put under the contractual obligation to amend its patents act in compliance with the provisions of TRIPS. India had to meet the first set of requirements on 1- 1-1995. This was to give a pipeline protection till the country starts giving product patent. It came to force on 26th March 1999 retrospective from 1-1-1995. It lays down the provisions for filing of application for product patent in the field of drugs or medicines with effect from 01.01.1995 and grant of Exclusive Marketing Rights on those products.
India amended its Patents Act again in 2002 to meet with the second set of obligations (Term of Patent etc.), which had to be effected from 1-1-2000. This amendment, which provides for 20 years term for the patent, Reversal of burden of proof etc. came into force on 20th May, 2003. The Third Amendment of the Patents Act 1970, by way of the Patents (Amendment) Ordinance 2004 came into force on 1st January, 2005 incorporating the provisions for granting product patent in all fields of Technology including chemicals, food, drugs & agrochemicals and this Ordinance is replaced by the Patents (Amendment) Act 2005 which is in force now having effect from 1-1-2005 .
[edit] ESTABLISHMENT OF PATENT ADMINISTRATION IN INDIA
Patent system in India is administered under the superintendence of the Controller General of Patents, Designs, Trademarks and Geographical Indications.
The Office of the Controller General functions under the Department of Industrial Policy and Promotion, Ministry of Commerce and Industry. There are four patent offices in India. The Head Office is located at Kolkata and other Patent Offices are located at Delhi, Mumbai and Chennai. The Controller General delegates his powers to Sr. Joint Controller, Joint Controllers, Deputy Controllers and Assistant Controllers. Examiners of patents in each office discharge their duties according to the direction of the Controllers.
Hierarchy of Officers in Patent office
Controller General of Patents, Designs, Trademarks & GI
Examiners of Patents & Designs
Assistant Controller of Patents & Designs
Deputy Controller of Patents & Designs
Joint Controller of Patents & Designs
Senior Joint Controller of Patents & Designs
[edit] Patentable Inventions:
A patent can be granted for an invention which may be related to any process or product. The word “Invention “ has been defined under the Patents Act 1970 as amended from time to time.
“An invention means a new product or process involving an inventive step and capable of industrial application” (S. 2(1)(j))
“ new invention” is defined as 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 that it does not form part of the state of the art; Where, Capable of industrial application, in relation to an invention, means that the invention is capable of being made or used in an industry
(S.2 (1)(ac)) Therefore, the criteria for an invention to be patentable are,
(1) An invention must be novel
(2) has an inventive step and
(3) is capable of industrial application
To be patentable, an invention should fall within the scope of patentable subject matter as defined by the patent statute. The invention must relate to a machine, article or substance produced by manufacture, or the process of manufacture of an article. A patent may also be obtained for an improvement of an article or of a process of manufacture. With regard to medicine or drug and certain classes of chemicals no patent is granted for the product itself even if new, only the process of manufacturing the substance is patentable. However, product patents would be available for drugs and food materials from 2005 as India’s obligations under the TRIPs Agreement would kick in from that point of time. If any substance falls outside the scope of patentable subject matter, it cannot be patentable.
[edit] NOT PATENTABLE INVENTIONS
There are some products and processes, which are not patentable in India They are classified into two categories in the patent act
a) Those which are not inventions (S.3)
b) Invention relating to atomic Energy (S.4)
Various types of non-patentable inventions under Section 3 are as follows- 3(a) An invention which is frivolous or which claims anything obvious contrary to well established natural laws.
Merely making in one piece, articles, previously made in two or more pieces is frivolous. Mere usefulness is not sufficient (Indian vacuum brake co. ltd vs. Laurd (AUR 1962 CAK 152).
Perpetual motion machine alleged to be giving output without any input is not patentable as it is contrary to natural law.
3(b) An invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment
3(c) The mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substances occurring in nature;
3(d) 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.
[Note: Before amendment of Section 3 (d) by the Patents (Amendments) Ordinance 2004 it reads as “mere discovery of any new property or new use for a known substance or mere use of a known process, machine or apparatus…”The insertion of the word “mere” before ‘new use for a known substance’ in this clause by the Patents (Amendment) Ordinance 2004, is for the purpose of drafting clarity only as without it the sub-section would have remained ambiguous. This does not restrict the nonpatentability and give rise to ambiguity and possible misuse. There is no need of giving wider meaning to it.]
3(e) 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:
3(f) The mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way.
3(h) A method of agriculture or horticulture. (i) A method of producing a new form of a known plant even if it involved a modification of the conditions under which natural phenomena would pursue their inevitable course is not patentable. (N.V. Philips Gloeiammpenfabrieken's Application 71 RFC 192).
3(i) Any process for the medicinal, surgical, curative, prophylactic diagnostic therapeutic or other treatment of human being 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.
Plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals; Example: Clones and new variety of plants are not patentable. But process / method of preparing Genetically Modified Organisms are patentable subject matter.
3(m) A mere scheme or rule or method of performing mental act or method of playing game;
3(n) A presentation of information
3(o) Topography of integrated circuits;
INVENTIONS RELATING TO ATOMIC ENERGY (S.4)
“No Patent shall be granted in respect of an invention relating to atomic energy falling within subsection (1) of section 20 of the Atomic Energy Act, 1962
[edit] Various types of Patent Applications in India
1. Ordinary application
2. Convention application
3. PCT international application
4. PCT National phase application
5. Application for Patent of addition
6. Divisional Application
[edit] Procedural requirements
An application for a patent in the prescribed form along with the prescribed fee has to be filed in the appropriate patent office. Examiners of patents scrutinize the application accompanied by a specification so that it satisfies the requirements. After examination, the Patent Office will raise objections and once the applicant convinces the Controller Of Patents will put the specification in the Official Gazette and on its acceptance without any controversy, a patent shall be granted.
A patent grant gives the patentee the exclusive right to make or use the patented article or use the patented process by preventing all others from making or using the patented article or using the patented process. The patentee can assign, grant licenses or deal for consideration.
The patent application passes through the following stages:
[edit] FILING
An application for a patent can be filed by the true and first inventor. It can also be filed the by the assignee or legal representative of the inventor. If an application is filed by the assignee, proof of assignment has to be submitted along with the application. The applicant can be national of any country.
Form of Application
Every application shall be accompanied by a provisional or complete specification. Provisional applications are generally filed at a stage where some experimentation is required to perfect the invention.
Filing of a provisional specification allows the applicant to get an early application date.
Provisional Specification shall contain:
a. Title,
b. Written Description,
c. Drawings, if necessary and
d. Sample or model if required. The complete specification shall contain:
a. Title,
b. Abstract,
c. Written Description,
d. Drawings (where necessary),
e. Sample or Model (if required by the examiner),
f. Enablement and BestMode,
g. Claims and
h. Deposit (Microorganisms)
Priority Date
Priority date is the date of first filing allotted by the patent office to an application. If a provisional application is followed by a complete application, the priority date shall be date of filing of the provisional application. If an Indian application is filed after a foreign or PCT application, the priority date shall be the date of filing of the foreign or PCT application. If an application is divided into two applications, the priority date shall be date of filing of the parent application.
Priority date is the date of reference used by the patent to determine the newness of the invention. If the claimed invention is part of public knowledge before the priority date, it will not be eligible for a patent. Under US Law, priority date is pushed back to the date of conception for determining novelty and Non-obviousness.
[edit] Place of Filing
Patent Application can be filed at any of the four patent offices in India. Patent Offices are located at Kolkata, New Delhi, Chennai and Mumbai.
Documents to be submitted at the time of filing The following documents have to be submitted at the time of filing a patent application:
Form 1 - Application for the grant of patent.
Form 2 - Provisional or Complete Specification.
Form 3 - Statement and undertaking by the applicant.
Form 5 - Declaration as to inventorship.
Form 26 - Authorization of patent agent or any other person.
Priority document details have to be filed for a Convention application.
[edit] PUBLICATION
A patent application will be published on expiry of eighteen months after the priority date. It can be published earlier, if such a request is made by the applicant. The application will not be published if directions are given for secrecy, until the term of those directions expires. It will also not be published if the application is withdrawn three months before publication date.
On publication, specification including drawings and deposits shall be open for public inspection. The rights of the patentee start from the date of publication but they cannot be enforced until after patent grant.
[edit] EXAMINATION
1. Request for Examination
The process of examination starts with a request for examination. The request has to be made within 36 months from the date of priority or filing. However, if secrecy directions have been given for the application, the request can be made six months after the directions are revoked or thirty six months from the date of priority or filing, if that date is later.
2. Examination
On receiving the request, the controller shall direct the patent application to the Examiner for examination. To start with, the examiner makes a formal examination by verifying the propriety and correctness of all documents filed with the application. Later, he verifies the patentability of the application. The patentability analysis includes all patentability requirements.
After confirming that the application falls within the scope of patentable subject matter, the examiner conducts a prior art search to check if there is prior art, which anticipates the invention claimed. Prior art search for anticipation includes search for anticipation by publication, filing of complete specification, etc. He then verifies the existence of inventive step, Industrial application, and Enablement and Best mode.
The examiner will give the examination report within 1 month from the date of reference by controller and that term shall not exceed three months. If the examination report is adverse, the controller sends a notice to the applicant and gives him an opportunity to correct and if necessary an opportunity of hearing. The Controller might ask the applicant to amend the application in order to proceed further. If the applicant does not make such changes, the application might be rejected.
The Controller has the power to divide the application, post date the application, substitute applicants and reject the application. An order of division will be given if the application contains more than one invention and if it is required to file separate applications for each invention. The application might be post dated to a period of six months if requested by the applicant. Substitution of inventors is generally done if the inventor has been wrongfully mentioned or if a joint inventor has not been mentioned in the application.
The controller has the power to reject the application, if the applicant does not comply with his requirements.
[edit] OPPOSITION
1. Pre-grant Opposition
Any person can file an opposition for grant of patent after the application has been published. Opposition may be filed on any of the following grounds: a. Non compliance of patentability requirements. b. Nondisclosure or Wrongful disclosure of genetic resources or traditional knowledge.
2. Post-grant Opposition
Any person can file an opposition within a period twelve months after the grant of a patent. It can be filed based on the following grounds:
a. Wrongful obtainment of the invention by the inventor.
b. Publication of the claimed invention before the priority date.
c. Sale or Import of the invention before the priority date.
d. Public use or display of the invention.
e. The invention doesn’t satisfy the patentability requirements.
f. Disclosure of false information to patent office.
g. Application for the invention is not filed within twelve months from the date of convention application.
h. Nondisclosure or wrongful disclosure of the biological source.
i. Invention is anticipated by traditional knowledge.
3. Process of Opposition
On receiving a notice of opposition, the controller notifies the patentee. He then constitutes an Opposition board to deal with the opposition. The Opposition board decides the issues after giving reasonable opportunity of hearing to both the parties. The Opposition board might invalidate the patent, require amendments or maintain the status quo. If amendments are required, they have to be made within the prescribed period in order to maintain the patent.
E. GRANT
If the application satisfies all the requirements of the patent act, the application is said to be in order for grant. An application in order for grant shall be granted expeditiously. A granted patent shall be published in the official gazette and shall be open for public inspection. Every granted patent shall be given the filing date. The patent will be valid throughout India. A granted patent gives the patent holder the exclusive right to make, use, sell, offer for sale and import the product or use the process. However, the government can make use of the patent for its own purposes or for distributing an invention relating to medicine to hospitals and dispensaries. Furthermore, any person can make use of the patent for experiment or education.
[edit] Assignments
A patentee may assign the whole or any part of the patent rights to the whole of India or any part thereof. There are three kinds of assignments: legal assignment, equitable assignment and mortgages. An assignment of an existing patent is a legal assignment where the assignee may enter his name as the patent owner. A certain share given to another person is called an equitable assignment and a mortgage is when patent rights are wholly or partly transferred to obtain money.
[edit] Licenses
A patentee may, by a license, permit others to make, use, or exercise, the invention which otherwise would not be allowed. The license should be in writing and the terms of which must be given in the application filed with the Controller. A license maybe given in express terms or implied from the circumstances. An exclusive license excludes all other persons including the patentee from the use of invention In a limited license the limitation may arise as to persons, time, place, manufacture, use or sale.
Compulsory Licenses and Government use of inventions
Under certain circumstances like when reasonable requirements are not satisfied, a very high royalty is quoted, when a patent cannot work without another related patent or on notification by the Central government, the Controller can grant a license to an interested person.
The Central or State government can use for a purpose of its own all patented inventions or processes either with or without royalty.
[edit] Revocation of a patent
A patent may be revoked by various modes namely revocation in the public interest by the Government or relating to atomic energy by Controller. A patent may also be revoked for non-working. The High Court may revoke a patent on noncompliance with the requirements for use of an invention or on petition by a person interested on various specified grounds.
A patentee may at any time offer to surrender his patent by giving notice to the Controller, whom after hearing the parties may revoke the patent.
Patent enforcement and Infringement of patents
Infringement of a patent is the violation of the exclusive rights of the patentee. Determination of infringement depends on the scope of exclusive rights of the patentee, whether the infringer’s acts amount to making, using, selling or distributing a product or using a method and if in fact the acts amount to an infringement. The burden of proof is on the patent owner for proving infringement.
Defenses
The defendant in a suit for infringement may plead one or more defenses. He can claim the patent owner is not entitled to sue for infringement or deny any infringement. Any leave or license express or implied to use the invention does not amount to infringement and where infringement is invalid on certain grounds. Acts done in connection with government use, experiment, research, education and falling within the scope of innocent infringement or done after failure to pay renewal fee or before the date of amendment of the specification do not amount to infringement. A defendant may also counter claim for revocation of patent.
Remedies
Injunctions act as a preventive relief to the patentees. The patent owner at the start of a trial can request for an interim injunction in order to restrain the infringer from continuing the infringement to prevent further losses. Permanent injunction is given based on the merits of the case at the end of the trial. A patent owner is entitled to the relief of damages as compensation to the patentee and not punishment to the infringer. The patent owner may also opt for the account of profits where he has to prove use of invention and the amount of profit derived from such illegal use.