India: Patent Law in India

Last Updated: 13 December 2007
Article by Jaya Bhatnagar and Vidisha Garg

Introduction:

The Patents Act 1970, along with the Patents Rules 1972, came into force on 20th April 1972, replacing the Indian Patents and Designs Act 1911. The Patents Act was largely based on the recommendations of the Ayyangar Committee Report headed by Justice N. Rajagopala Ayyangar. One of the recommendations was the allowance of only process patents with regard to inventions relating to drugs, medicines, food and chemicals.

Later, India became signatory to many international arrangements with an objective of strengthening its patent law and coming in league with the modern world. One of the significant steps towards achieving this objective was becoming the member of the Trade Related Intellectual Property Rights (TRIPS) system.

Significantly, India also became signatory of the Paris Convention and the Patent Cooperation Treaty on 7th December 1998 and thereafter signed the Budapest Treaty on 17th December 2001.

History:

Being a signatory to TRIPS, India was under a contractual obligation to amend its Patents Act to comply with its provisions. India had to meet the first set of requirements on 1st January 1995 to give a pipeline protection till the country starts granting product patent.

On 26th March, 1999, Patents (Amendment) Act, 1999 came into force retrospective effect from 1st January, 1995. The main amendments are as follows:

  1. Section 5(2) was introduced which provides for filing of applications for patent in the field of drugs, medicines and agro-chemicals. These applications were kept pending in the mailbox or black box. This mailbox was to be opened on 1st January 2005.
  2. Provision of Exclusive Marketing Rights (EMR) was brought in by way of Chapter IV A. Thus, pipeline protection was provided for pharmaceutical and agro-chemical manufacturers whose applications for product were lying in black box.
  3. Section 39 was omitted from the Act, thereby enabling the Indian residents to file the applications for in an outside India simultaneously.
  4. Chapter II (A) was inserted in the Indian Patent Rules dealing with International Applications under PCT.

The second phase of amendment was brought in by the Patents (Amendment) Act, 2002 which came into force on 20th May 2003. The main features of the amendments included:

i. Term of patent was extended from 14 to 20 years, wherein the date of patent was the date of filing of complete specification. Also the difference in term of a drug/food patent and other patent was removed.

ii. The definition of "invention" was made in conformity with the provisions of TRIPS Agreement by introducing the concept of inventive step, thereby enlarging the scope of invention.

iii. Deferred examination system was introduced.

iv. Introdutcion of the provision of publication of application after 18 months from the date of filing thereby bringing India at par with the rest of the world.

v. Microorganisms became patentable, whereas inventions relating to traditional knowledge were included in the list of "what are not inventions".

vi. The concept of unity of invention in accordance with EPC and PCT.

vii. Section 39 was reintroduced thereby prohibiting the Indian residents to apply abroad without prior permission or first filing in India.

viii. Provisions of Appellate Board were brought in by inserting section 116. All appeals to the decision of the Controller would be appealable before the Appellate Board. The Head Quarter of the Appeallate Board is to be in Chennai.

ix. Section 117 provided for Bolar provision for the benefit of agrochemical and pharmaceutical industry.

The third and final amendment to the Patents Act, 1970 came by way of Patents (Amendment) Ordinance, 2004, which was later replaced by The Patent (Amendment) Act, 2005, and Patents (Amendment) Rules, 2006 with retrospective effect from 1st January, 2005. With the third amendment India met with the international obligations under the TRIPS. Significant achievements of this amendment were:

  1. Deletion of section 5, opening of mailbox and grant of product patents. Thus this amendment led to the dawn of the "product patent regime" in India.
  2. Abolition of Exclusive Marketing Rights (EMR).

Current Position:

The present Indian position in respect of patent law is governed by the provisions of the Patents Act, 1970 as amended by the Patents (Amendment) Act, 2005 (hereinafter referred to as the Act) and Patents Acts Rules, 2006 (hereinafter referred to as the Rules)

The Head Patent Office is located at Kolkata and its branch offices are located at Delhi, Mumbai and Chennai. Patent system in India is administered by the Controller General of Patents, Designs, Trademarks and Geographical Indications. Each office has its own territorial jurisdiction for receiving patent applications and is empowered to deal with all sections of Patent Act.

The jurisdiction for filing the patent application depends upon:

  1. Indian applicant(s): determined according to place of residence, place of business of the applicant or where the invention actually originated.
  2. Foreign applicant(s): determined by the address for service in India.

What Are Inventions?

The Act provides for the definition of the invention, which is now compliant with the provisions of TRIPS. The criteria for patentability of an invention are novelty, inventive step and industrial applicability.

Section 2(1)(j) of the Patent Act, 2005, defines the "invention" as a new product or as process involving an inventive step and capable of industrial application.

Under the Act "New invention" is defined under section 2(1)(l) of the Patents Act

"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 that it does not form part of the state of the art.

Thus, according to this definition of new invention, Act talks of absolute novelty, i.e. the invention should have neither been used anywhere in the world nor published in any part of the world. However, the later sections of the act for the purpose of anticipation and opposition proceedings deal with the relative novelty i.e. not used in India and not published in any part of the world. Further, entire Act refers to the word invention and not new invention. Therefore, for all purposes relative novelty is the criterion.

Exceptions To The Novelty Rule:

There are a few exceptions where the rule of novelty is not applicable. These cases are as follows:

  1. Subject matter published without the consent of the inventor.
  2. The invention was published in consequence of the display in an exhibition notified by the Government or reading the paper before a Learned Society. Grace period of 12 months is given in such cases to file the patent application.
  3. Previous communication to Government of India.
  4. Public working for reasonable trials.

"Inventive Step" is defined under Section 2 (1) (ja) of the "Act". Prior to the Amendment of 2005, inventive step meant a feature that makes the invention not obvious to a person skilled in the art. The new Act of 2005 defined inventive step more precisely.

"Inventive step means a feature of an invention that involves technical advance as compare to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art."

Thus, in addition to the non-obviousness criterion two other conditions were added i.e. it should also involve technical advancement as compared to the existing knowledge or having economic significance, or both, in addition to being non-obvious.

The terms “technical advance” and “economic significance” have not been defined clearly and are unambiguous. It cannot be left to presumption “economic significance” is synonymous to the phrase “capable of industrial application” in section 2 (1)(ac) or in footnote 5 to Article 27. The meaning of the phrase “technical advance” cannot be presumed either, in absence of a specific definition or reference.

The Patents Act 1970 had a very limited scope of protection wherein the essential elements of invention were new, useful and manner of manufacture. Even though manufacture was not defined in the old Act, the Patent Office established the practice of interpreting manufacture as process resulting in a tangible product. The landmark decision of Calcutta High Court on the process of production of Bursitis virus containing vaccine (Dimminaco AG vs Controller of Patents, 2002) changed the practice and now the definition of invention is interpreted keeping in mind the term ‘industrial application’ as under section 2(1)(j).

The Act defines ‘capable of industrial application’ in relation to an invention as capable of being made or used in an industry.

An invention is capable of industrial application if it satisfies the three conditions cumulatively:

  1. can be made;
  2. can be used in at least one field of activity;
  3. can be reproduced with the same characteristics as many as necessary.

What Are Not Inventions?

Section 3 of the Act, deals with non patentable inventions.

  1. Inventions which are frivolous or contrary to well established natural laws.
  2. For example: inventions relating to perpetual motion alleged to be giving output without any input is not patentable as it is contrary to natural law. 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).

  3. Inventions whose primary or intended use or commercial exploitation could be contrary to public order or morality (such as something against accepted norms of a culture in a society), or which causes serious prejudice to human, animal or plant life or health or to the environment.
  4. For example terminator technology which involves inserting a gene sequence in a seed to stop germination or growing recombinant plants leading to disappearance of butterflies.

  5. 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. However isolation of living thing or non-living substances is patentable as it involves human technical intervention.
  6. 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 mere discovery of any new property, or new use of a known substance, or mere use of known process, machine, or apparatus unless such known process results in a new product or employs at least one new reactant.
  7. Explanation to Section 3 (d): "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.

    It may be seen from section 3(d) that new use of a known substance is not permissible. It means that claims for second medical use are not allowed in India. Further, derivatives of known substances are considered to be the same substance unless they "differ significantly in properties with regard to efficacy".

    The term "efficacy" under section 3 (d) has been held vague, as it does not indicate the kind of efficacy required under the provision. It is also ambiguous because it is unclear whether the phrase "enhancement of known efficacy" is the same as the phrase "technical advance" under section 2 (1), (ja).

    However, the explanation provided to section 3 (d) does not rule out the grant of patent to derivatives, complexes, combinations, isomers and so on, if enhancement of its efficacy as a consequence of its properties can be shown.

  8. Substances obtained by mere admixture such as physical admixture are not patentable under the Act.
  9. However, compositions consisting of combination preparations comprising of two or more known active ingredients are patentable if "synergism" or super additive effect is shown clearly, for example pharmaceutical compositions or any other chemical compositions

  10. The mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way.

    1. Methods of agriculture or horticulture.
    2. For example 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. Processes for medical, surgical, curative, prophylactic, diagnostic, therapeutic, or other treatment of human beings or animals or plants that would render them free of disease or to increase their economic value.
    4. In United Kingdom, a method for treating an old animal with an enzyme two hours prior to butchering was allowed to be patented as the treatment increased the economic value of the animal by making the meat soft (Swift Application RPC 37, 1962). Such a process would not be patentable under the Indian Patent system.

      The words ‘diagnostic & therapeutic’ has to be read as diagnosis of diseases in human beings and animals. Accordingly, method of screening antibodies for a specific activity is permissible.

    5. 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. For example clones and new variety of plants are not patentable. But process/method of preparing genetically modified organisms is patentable subject matter.
    6. Computer program per se, a mathematical method or a business method or algorithms.
    7. Literary, dramatic, musical or artistic work or any other aesthetic creations including cinematographic works and television productions are not patentable as they are covered under the copyrights, design and entertainment laws.
    8. Scheme/rule/method of performing a mental act or method of playing a game.
    9. Presentation of information.
    10. Unfortunately neither the Act nor the Rules defines a mathematical method, or a business method or a computer program per se or algorithm. Under such circumstances, one has to rely on the practices built up under Articles 52(1), 52(2) and 52(3) of the EPC, where similar provisions corresponding to the Indian Act under section 3(k), 3(m), and 3(n) exists.

      A program producing technical effect or program having technical character is permissible in EPO as it is not program per se. Accordingly, software related inventions may be patentable if accompanied by a novel and non-obvious technical effect which adds to the art of technology.

    11. Topography of integrated circuits.
    12. An invention falling within the scope of traditional knowledge such as the use of herbal medicines.

Inventions relating to atomic energy are not patentable under section 4. Such applications are referred to the Department of Atomic Energy. The decision of the Department of Atomic Energy is final and no appeal lies to the decisions of the Department of Atomic Energy.

With the amendments effected patents are now granted for inventions relating to both product and process. The invention must relate to a machine, article or substance capable of industrial application, 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. Further, with regard to medicine or drug patent is now granted for the product and process of manufacturing the substance.

Procedural Aspects

Who Can File A Patent Application?

An application for a patent for an invention can be made by any of the following persons either alone or jointly with another:

  1. true and first inventor
  2. his /her legal assignee
  3. legal representative of deceased inventor or assignee

Foreign Filing License:

No person resident in India shall, except under the authority of the written permit can file any application outside India for the grant of a patent unless:

  1. An application for a patent for the same invention has been made in India not less than 6 weeks before the application is filed outside India, and
  2. Either no secrecy direction has been given under Section 35(1) in relation to the application in India or all such directions have been revoked.

A request for foreign filing license may be filed on prescribed form with detailed description of the invention and the drawings, if any, and the prescribed fee.

Publication:

Every application is ordinarily published after the expiry of 18 months period form the date of filing of the application or the date of priority of the application whichever is earlier.

The applicant can request publication of his application prior to the normal period under a request through a prescribed form and fee.

The early publication rule however does not apply if:

  1. Secrecy directions are imposed under Section 35 of the Act.
  2. Application has been abandoned under Section 9(1) of the Act.
  3. The applicant has withdrawn his application three months prior to the expiry of said prescribed period of 18 months.

Early publication can result in acceleration of substantive examination of application and in early grant. Also, early publication is important for obtaining provisional protection in cases where the applicant anticipates infringement.

Provisional Protection:

On and from the date of the publication of the application for patent and until the date of grant of patent in respect of such patent, the applicant will have like privileges and rights as if the patent for the invention have been granted on date of publication of application. However, the applicant cannot institute the infringement proceedings unless the patent is granted. This provision is advantageous to the applicant for the purpose of claiming damages from the date of advertisement.

Applications for patent under section 5(2) relating to pharmaceuticals and agrochemicals are exceptions to this system and will have protection from the date of grant of patent and not from the date of publication of the invention. Further, the Indian manufacturers who have made significant investment and were producing and marketing the product in respect of the application filed under section 5 (2) prior to January 1, 2005 will continue to manufacture the product, even after the grant of patent on said application (pharmaceuticals and agrochemicals) and no infringement proceedings will be instituted against the manufacturer. The patent holder will be entitled to receive reasonable royalty from the manufacturer.

Request For Examination:

The request for substantive examination by applicant or any other interested person has to be filed on prescribed form, with the prescribed fee, after the publication of patent application, but within 48 months from the priority date of the application or from the date of filing the application whichever is earlier.

The applications shall be examined only on filing the request for substantive examination. Thus the applicant can defer the examination of the application by at least 48 months from the date of priority. If the request is not filed the application shall be deemed to have been withdrawn by the applicant.

Patent Procedure:

On receiving a request for examination, the Controller refers the application and specification and other documents to the Examiner, ordinarily within 1 month from the date of its publication or 1 month from the date of request for examination whichever is later.

The examiner submits the report to the Controller ordinarily within one month but not exceeding 3 months from the date of reference of the application by the Controller.

The Controller would then dispose off the report ordinarily within one month from the date of receipt of such report and issue the first examination report. The first examination report is issued ordinarily within 6 months from the date of the request for the examination or 6 months from the date of publication whichever is later.

Time for putting the application in order for grant under section 21 is twelve months from the date of receipt of first examination report. No extension of time is permissible. Therefore, it is necessary to comply with all the requirements and objections raised by the patent office within twelve months from the date of first examination report.

Once all the requirements are met with and the examiner is satisfied with the arguments and amendments of the applicant, the application proceeds for grant. The grant is notified in the Patent Journal, published weekly by the Indian patent office. The post grant opposition proceedings may follow within one year from the date of said notification.

Opposition Proceedings:

The Indian Patent system provides for two opposition proceedings, one before the grant of the patent and one after the grant of the patent.

The grounds for Pre and Post Grant Opposition are the same namely:

  1. wrongful obtaining,
  2. prior publication,
  3. prior claiming,
  4. prior public knowledge and use,
  5. obviousness,
  6. not an invention,
  7. insufficiency,
  8. failure to file the information regarding foreign filing under Section 8
  9. convention application not made within 12 months,
  10. not disclosing or wrongly mentioning the source and geographical
  11. origin of biological material in the complete specification,

  12. complete specification was anticipated having regard to the knowledge, oral or otherwise available within any local or indigenous community in India or elsewhere (traditional knowledge).

Pre-grant Opposition Procedure:

The pre grant representation may be filed by any person within six months of date of publication of the application or before the grant of the patent whichever is later. It may be noted that the Controller is empowered to grant the patent soon after six months from date of publication.

The pre-grant opposition proceeding may be carried out in parallel with the Examination proceeding.

The opponent is required to submit statement and evidence, if any, in support of the representation and request for a hearing if he so desires. However, the representation is not considered by the Controller unless a request for examination is filed by the applicant.

On receipt of the request for examination from the applicant, the Controller initiates Examination proceeding and also issues a notice to the applicant along with the copy of the statement and evidence filed by the opponent.

The applicant may file his statement and evidence in support of his application within three months from the date of the notice. Thereafter, after the Controller has considered the submission and the representations made, the the patent is either granted or rejected. The acceptance may be with or without amendment to the specification. The decision is issued ordinarily within one month from the date of the completion of the proceedings. It may be noted that no fee is required to be paid for entering into pre-grant opposition. An appeal can be filed in the appellate board against such decision.

Post-grant Opposition Procedure:

The process of post grant opposition initiates with a notice of opposition filed by the opponent (who is an ‘interested person’) within 1 year from the date of publication of grant along with full written statement and evidence to the Controller. The patentee is required to file a reply statement and evidence within

Two months failing which, the application will be abandoned. This time period is extendible by one month provided the request for extension is filed within the two-month period. Reply evidence filed by opponents is to be strictly confined to patentee’s evidence. Further evidence may however be filed with the leave of the Controller.

All the documents are handed over to the Opposition Board constituted by the Controller for recommendation. Controller takes decision after a hearing along with the members of the Opposition Board. An appeal may be made against the decision before the Appellate Board within three month from date of the order.

Term Of Patent:

The term of every patent granted under the Act is twenty years from the date of filing.

The patents in force on 20th May 2003 stood extended for the term of 20 years.

The term of patent in case of International applications filed under the PCT, designating India, is twenty years from the international filing date accorded under the PCT.

Renewal fee is required to be paid annually to keep the patent in force. Restoration of patents is possible if applied within 18 months from the date of lapse.

Appeal Procedure:

Section 117A provides for appeals to the Appellate Board. Sub-section (1) of section 117A makes it clear that no appeal will lie from any orders apart from those mentioned under sub-section (2) of section 117A.

While there is a provision for appeal from the order in a post-grant opposition under section 25 (4), there is no provision for appeal under section 25(1). The Controller can, under the Rule 55, sub-rules (5) and (6) of the Patents Rules, as they stand presently, refuse to grant the patent or require amendment of the complete specification.

In a significant development, the Intellectual Property Appellate Board (IPAB) has come into force with effect from April 2, 2007. All appeals relating to patent cases pending at the High Courts have been transferred to the Appellate Board except the infringement suits and counter suits for revocation. The appellate board comprises a bench of three members including a technical expert.

Patent Rights:

The Act provides for patent protection for inventions relating to both processes and products.

In case of patents relating to product, the grant provides exclusive right to prevent unauthorized persons from making, using, offering for sale, selling or importing the product in India.

In case of patents relating to process, the patentee receives an exclusive right to prevent unauthorized persons from using the process and offering for sale, selling or importing for those purposes the product obtained directly from the process in India. Product produced by the process is also protected.

Registration Of Assignment:

Registration of assignment etc. is compulsory under the Act, though no time limit has been specified for registration of assignment. However, the registration dates back to the date of execution of the instrument. Unless licensee or assignee is entered in the register of patents they cannot file a suit for infringement.

The license Agreement has to be registered under section 69 of the Patents Act at the appropriate Patent Office by filing prescribed form with the prescribed fee. After it is registered, the licensee name is entered in the Register of Patents.

Commercial Working Of Patents:

Section 146(2) provides every patentee and licensee to furnish to the Controller periodical statement of the extent to which the patented invention has been worked on commercial basis in India. Such statements should be furnished in the manner prescribed under Rule 131.

Therefore, filing a statement regarding the working of patented invention on a commercial scale in India is a mandatory requirement. Failure or refusal by the patentee or licensee calls for penalty provisions. Further, submission of false information is punishable by imprisonment up to six months or fine or both. Most important is that failure to work the invention in India is attracted under section 84(c) for the grant of compulsory license.

Importation of the patented article/product does not amount to working of the Patent in India. Any working of the patent for the production of the patented article or the use of the patent process in the production of any articles for sale to the public would appear to amount to working on a commercial scale. The working on a commercial scale is that the demand for the particular article in India is met at a reasonable price.

If the patentee has granted license to company ‘A’ in Japan to manufacture the patented product in Japan and export and sell them to India, it does not amount to working the patented product in India. Company ‘A’ is therefore not required to submit information on prescribed form. Accordingly, the patentee has to submit the information.

If the patentee provides technical assistance for manufacturing the patented product in India to an Indian based affiliate duly licensed to manufacture the patented product in India, the Indian based affiliate can file Form 27.

If the patentee submits the form 27 without mentioning that a license has been issued to the Indian based affiliate, then the patentee is attracted by penalty provisions under section 122(2) of The Patents Act, as the information furnished in Form 27 is knowingly false. The co-owners can submit form either jointly or separately.

Thus either the patentee or the licensee may submit information of commercial working of the patent. If there is no licensee in India, the patentee will be punished if he fails to submit the information or furnishes false information. In case there is a licensee in India and he is authorized by the patentee to furnish the information to the patent office and if he fails to furnish such information or submits false information, he is liable to be punished under section 122(2).

All or part of the information submitted in a statement of working may be published by the Controller. A statement of working would remain confidential till such time and if at all it is published by the Controller.

Compulsory License:

Sections 84 to 94 of the Patents Act relate to compulsory licensing of patented products. A person may apply for a compulsory license three years after the grant of a patent on the following grounds:

• the reasonable requirements of the public have not been satisfied, or

• patented invention is not available at a reasonable affordable price or

• the patented invention is not worked in India.

Compulsory license may also be granted on notification by Central Government on exceptional circumstances related to public interest namely national emergency, extreme urgency example scarcity of petroleum products, earthquake etc, and public non-commercial use

The Controller will notify and grant licenses without any consideration as in other cases in respect of patents on such terms and conditions that the article is available to the public at lowest price.

The Compulsory license provisions is aimed at curbing the practice of meeting the demand for patented articles solely by importation from abroad thereby discouraging

  • transfer of technology,

  • development in existing trade & industry,

  • non-establishment of new trade & industry,

  • refusal to grant licenses to work the patent locally,

  • imposing unreasonable terms on licenses thereby discouraging voluntary licensing and imposing restrictive conditions on the use,

  • sale or lease of the patented articles thereby prolonging the patent monopoly rights even after the patent has expired.

  • Revocation of the patent for non-working has been adopted in almost all countries.

In considering the application for the grant of compulsory license, the Controller shall take into account the nature of the invention; the time which has elapsed since the sealing of the patent; the measures already taken by the patentee or any licensee to make full use of the invention; the ability of the applicant to work the invention to the public advantage; capacity of the applicant to undertake the risk in providing the capital and working the invention; whether the applicant has made efforts to obtain a license from a patentee on reasonable terms and conditions and such efforts have not been successful within a reasonable period (6 months) as the Controller may deem fit.

Where the Controller is satisfied that a prima facie case has been made, the Controller will direct the applicant to serve copies of the application on patentee and any other person appearing in the Register of Patents and upon hearing the parties may give his decision. An appeal lies to the appellate board. The Controller can terminate the compulsory license when circumstances that gave rise to the grant no longer exist.

Further, in determining royalty Controller shall keep in mind the nature of the invention; the expenditure incurred in making and developing the invention; expenditure in obtaining patent and its maintenance; patented invention is worked and the licensee gets reasonable profit; patented article is available to public at reasonably affordable price; license granted is non-exclusive; the right of the licensee is non assignable; that the license is for a balance period of the term of the patent or shorter term;

Bolar Provision:

Section 107 A (a) of the Patents Act provides that any act of making, constructing, using, selling or importing a patented invention solely for uses reasonably related to the development and submission of information for regulatory approval will not amount to infringement.

This provision is helpful for persons who wish to exploit the patent after the expiry of the terms of the Patent as they can obtain the marketing approval before the term of patent expires and can immediately manufacture after the expiry of the term of Patent.

Parallel Importation

:

Section 107 A (b) provides for Parallel Importation of patented products. The provision declares that importation of patented products, by any person from a person who is duly authorized under the law to produce and sell or distribute the product, would not be considered as infringement.

The phrase "duly authorized under the law" was inserted in place of "duly authorized by the patentee" by the Patent (Amendment) Act, 2005. Effectively, this provision refers to and relies on the applicable local laws of the country exporting the goods to India.

The provision allows export from a country where there is no protection of the article patented in India.

Parallel Importation provision has been introduced as a mechanism to help in price control through the act of competition. The

Principle of exhaustion of right is also applicable in this provision.

Cross Border Licensing:

Grant of Compulsory License to manufacture and export patented pharmaceutical products to any country having insufficient or no manufacturing capacity by an Indian manufacturer is possible either through the importing country granting compulsory license to the Indian manufacturer or through allowance of importation of the patented pharmaceutical products from India by notification.

This provision is based on Para 6 of DOHA Declaration on TRIPS Agreement.

Conclusion:

India has always acknowledged the importance of a strong patent system for the development of industry and commerce, which is evident for the amendments done to bring India at par with the modern world. With the promulgation of the product patent regime in India, most of the countries are now looking for business opportunities. There has been a considerable rise in the patent filing. Innovators and inventors from all fields of technology are keen on protecting their intellectual property.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions