Paris Convention

The Paris Convention for the Protection of Industrial Property, signed in Paris, France, on 20 March 1883, was one of the first intellectual property treaties. It established a Union for the protection of industrial property. The Convention is currently still in force. The substantive provisions of the Convention fall into three main categories: national treatment, priority right and common rules.

National treatment

According to Articles 2 and 3 of this treaty, juristic and natural persons who are either national of or domiciled in a state party to the Convention shall, as regards the protection of industrial property, enjoy in all the other countries of the Union, the advantages that their respective laws grant to nationals.

In other words, when an applicant files an application for a patent or a trademark in a foreign country member of the Union, the application receives the same treatment as if it came from a national of this foreign country. Furthermore, if the intellectual property right is granted (e.g. if the applicant becomes owners of a patent or of a registered trademark), the owner benefits from the same protection and the same legal remedy against any infringement as if the owner was a national owner of this right.

Priority right

The "Convention priority right", also called "Paris Convention priority right" or "Union priority right", was also established by Article 4 of this treaty. It provides that an applicant from one contracting State shall be able to use its first filing date (in one of the contracting State) as the effective filing date in another contracting State, provided that the applicant, or his successor in title, files a subsequent application within 6 months (for industrial designs and trademarks) or 12 months (for patents and utility models) from the first filing.

Paris convention members 

Reference

https://en.wikipedia.org/wiki/Paris_Convention_for_the_Protection_of_Industrial_Property

Patent Cooperation Treaty (PCT)

source http://www.wipo.int

1) What is the Patent Cooperation Treaty (PCT)?

The PCT is an international treaty with more than 145 Contracting States.1 The PCT makes it possible to seek patent protection for an invention simultaneously in a large number of countries by filing a single “international” patent application instead of filing several separate national or regional patent applications. The granting of patents remains under the control of the national or regional patent Offices in what is called the “national phase”.

The PCT procedure includes:

Filing: you file an international application with a national or regional patent Office or WIPO, complying with the PCT formality requirements, in one language, and you pay one set of fees.

International Search: an “International Searching Authority” (ISA) (one of the world’s major patent Offices) identifies the published patent documents and technical literature (“prior art”) which may have an influence on whether your invention is patentable, and establishes a written opinion on your invention’s potential patentability.

International Publication: as soon as possible after the expiration of 18 months from the earliest filing date, the content of your international application is disclosed to the world.

Supplementary International Search (optional): a second ISA identifies, at your request, published documents which may not have been found by the first ISA which carried out the main search because of the diversity of prior art in different languages and different technical fields.

International Preliminary Examination (optional): one of the ISAs at your request, carries out an additional patentability analysis, usually on an amended version of your application.

National Phase: after the end of the PCT procedure, usually at 30 months from the earliest filing date of your initial application, from which you claim priority, you start to pursue the grant of your patents directly before the national (or regional) patent Offices of the countries in which you want to obtain them.

Comparison of Paris and PCT Route

The report enables you to evaluate your chances of obtaining patents in PCT Contracting States. An international search report which is favorable, that is, in which the documents (prior art) cited would appear not to prevent the grant of a patent, assists you in the further processing of your application in those countries in which you wish to obtain protection. If a search report is unfavorable (for example, if it lists documents which challenge the novelty and/or inventive step of your invention), you have the opportunity to amend the claims in your international patent application (to better distinguish your invention from those documents), and have them published, or to withdraw the application before it is published.

What happens to my application in the national phase?

Once you have entered the national phase, the national or regional patent Offices concerned begin the process of determining whether they will grant you a patent. Any examination which these Offices may undertake should be made easier by the PCT international search report and the written opinion and even more by an international preliminary examination report.

Reference

http://www.wipo.int/pct/en/faqs/faqs.html

World Trade Organization (WTO)

The World Trade Organization (WTO) is an intergovernmental organization which regulates international trade. The WTO officially commenced on 1 January 1995 under the Marrakech Agreement, signed by 123 nations on 15 April 1994, replacing the General Agreement on Tariffs and Trade (GATT), which commenced in 1948.The WTO deals with regulation of trade between participating countries by providing a framework for negotiating trade agreements and a dispute resolution process aimed at enforcing participants' adherence to WTO agreements, which are signed by representatives of member governments ^:fol.9–10 and ratified by their parliaments. Most of the issues that the WTO focuses on derive from previous trade negotiations, especially from the Uruguay Round (1986–1994).

The WTO is attempting to complete negotiations on the Doha Development Round, which was launched in 2001 with an explicit focus on developing countries. As of June 2012, the future of the Doha Round remained uncertain: the work programme lists 21 subjects in which the original deadline of 1 January 2005 was missed, and the round is still incomplete.The conflict between free trade on industrial goods and services but retention of protectionism on farm subsidies to domestic agricultural sector (requested by developed countries) and thesubstantiation of fair trade on agricultural products (requested bydeveloping countries) remain the major obstacles. This impasse has made it impossible to launch new WTO negotiations beyond the Doha Development Round. As a result, there have been an increasing number of bilateral free trade agreements between governments. As of July 2012, there were various negotiation groups in the WTO system for the current agricultural trade negotiation which is in the condition of stalemate.

GATT rounds of negotiations

The GATT was the only multilateral instrument governing international trade from 1946 until the WTO was established on 1 January 1995.Despite attempts in the mid-1950s and 1960s to create some form of institutional mechanism for international trade, the GATT continued to operate for almost half a century as a semi-institutionalized multilateral treaty regime on a provisional basis.

Compulsory Licence

What is compulsory licensing?

Compulsory licensing is when a government allows someone else to produce the patented product or process without the consent of the patent owner. It is one of the flexibilities on patent protection included in the WTO’s agreement on intellectual property — the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement.
  

Are these flexibilities new?

No. They always existed in the TRIPS Agreement, ever since it took effect in January 1995.
  

But what about the November 2001 Doha Ministerial Declaration on TRIPS and Public Health? Didn’t that change the rules?

Not in general. Two provisions to do with least-developed countries andcountries that do not have production capacity directly involved changes to the rules of the TRIPS Agreement. For the main part the declaration was important for clarifying the TRIPS Agreement’s flexibilities and assuring governments that they can use the flexibilities, because some governments were unsure about how the flexibilities would be interpreted. Let’s focus on the general case first.
  

OK. What is the general case?

For compulsory licensing, it’s when the generic copy is produced mainly for the domestic market, not for export.
  

Is this the same as tearing up the patent?

No. The patent owner still has rights over the patent, including a right to be paid for the authorized copies of the products.
  

Does there have to be an emergency?

Not necessarily. This is a common misunderstanding. The TRIPS Agreement does not specifically list the reasons that might be used to justify compulsory licensing. However, the Doha Declaration on TRIPS and Public Health confirms that countries are free to determine the grounds for granting compulsory licences.

The TRIPS Agreement does list a number of conditions for issuing compulsory licences, in Article 31. In particular:

• normally the person or company applying for a licence has to have tried to negotiate a voluntary licence with the patent holder on reasonable commercial terms. Only if that fails can a compulsory licence be issued, and
• even when a compulsory licence has been issued, the patent owner has to receive payment; the TRIPS Agreement says “the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization”, but it does not define “adequate remuneration” or “economic value”.

There’s more. Compulsory licensing must meet certain additional requirements: it cannot be given exclusively to licensees (e.g. the patent-holder can continue to produce), and it should be subject to legal review in the country.

You said “normally” …

Yes, this is where the confusion about emergencies arises. For “national emergencies”, “other circumstances of extreme urgency” or “public non-commercial use” (or “government use”) or anti-competitive practices, there is no need to try first for a voluntary licence. It’s the only instance when the TRIPS Agreement specifically links emergencies to compulsory licensing: the purpose is to say that the first step of negotiating a voluntary licence can be bypassed in order to save time. But the patent owner still has to be paid.

THE PATENTS ACT, 1970
Section 84
Compulsory licences
	(1) At any time after the expiration of three years from the date of the grant of a patent, any person interested may make an application to the Controller for grant of compulsory licence on patent on any of the following grounds, namely:—                (a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or                (b) that the patented invention is not available to the public at a reasonably affordable price, or                (c) that the patented invention is not worked in the territory of India. (2) An application under this section may be made by any person notwithstanding that he is already the holder of a licence under the patent and no person shall be estopped from alleging that the reasonable requirements of the public with respect to the patented invention are not satisfied or that the patented invention is not worked in the territory of India or that the patented invention is not available to the public at a reasonably affordable price by reason of any admission made by him, whether in such a licence or otherwise or by reason of his having accepted such a licence. (3) Every application under sub-section (1) shall contain a statement setting out the nature of the applicant's interest together with such particulars as may be prescribed and the facts upon which the application is based. (4) The Controller, if satisfied that the reasonable requirements of the public with respect to the patented invention have not been satisfied or that the patented invention is not worked in the territory of India or that the patented invention is not available to the public at a reasonably affordable price, may grant a licence upon such terms as he may deem fit. (5) Where the Controller directs the patentee to grant a licence he may, as incidental thereto, exercise the powers set out in section 88. (6) In considering the application field under this section, the Controller shall take into account,—                (i) the nature of the invention, the time which has elapsed since the sealing of the patent and the measures already taken by the patentee or any licensee to make full use of the invention;                (ii)   the ability of the applicant to work the invention to the public  advantage;                (iii)   the capacity of the applicant to undertake the risk in providing capital and working the invention, if the application were granted;                (iv)   as to whether the applicant has made efforts to obtain a licence from the patentee on reasonable terms and conditions and such efforts have not been successful within a reasonable period as the Controller may deem fit:                      Provided that this clause shall not be applicable in case of national emergency or other circumstances of extreme urgency or in case of public non-commercial    use or on establishment of a ground of anti­competitive practices adopted by the patentee, but shall not be required to take into account matters subsequent to the making of the application. Explanation.—For the purposes of clause (iv), "reasonable period" shall be construed as a period not ordinarily exceeding a period of six months. (7) For the purposes of this Chapter, the reasonable requirements of the public shall be deemed not to have been satisfied—                 (a) if, by reason of the refusal of the patentee to grant a licence or licences on reasonable terms,—                               (i) an existing trade or industry or the development thereof or the establishment of any new trade or industry in India or the trade or industry of any person or class of persons trading or manufacturing in India is prejudiced; or                               (ii) the demand for the patented article has not been met to an adequate extent or on reasonable terms; or                               (iii)   a market for export of the patented article manufactured in India is not being supplied or developed; or                               (iv)   the establishment or development of commercial activities in India is prejudiced; or                (b) if, by reason of conditions imposed by the patentee upon the grant of licences under the patent or upon the purchase, hire or use of the patented article or process, the manufacture, use or sale of materials not protected by the patent, or the establishment or development of any trade or industry in India, is prejudiced; or                (c) if the patentee imposes a condition upon the grant of licences under the patent to provide exclusive grant back, prevention to challenges to the validity of patent or coercive package licensing; or                (d) if the patented invention is not being worked in the territory of India on a commercial scale to an adequate extent or is not being so worked to the fullest extent that is reasonably practicable; or                (e) if the working of the patented invention in the territory of India on a commercial scale is being prevented or hindered by the importation from abroad of the patented article by—                               (i)   the patentee or persons claiming under him; or                               (ii)   persons directly or indirectly purchasing from him; or                               (iii)   other persons against whom the patentee is not taking or has not taken proceedings for infringement. Reference https://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm http://ipindia.nic.in/ipr/patent/eVersion_ActRules/sections/ps101.html

  

Novartis v. Union of India & Others

Novartis v. Union of India & Others is a landmark decision by a two-judge bench of the Indian Supreme Court on the issue of whether Novartis could patentGleevec in India, and was the culmination of a seven-year-long litigation fought by Novartis. The Supreme Court upheld the Indian patent office's rejection of the patent application.

The patent application at the center of the case was filed by Novartis in India in 1998, after India had agreed to enter the World Trade Organization and to abide by worldwide intellectual property standards under the TRIPS agreement. As part of this agreement, India made changes to its patent law; the biggest of which was that prior to these changes, patents on products were not allowed, while afterwards they were, albeit with restrictions. These changes came into effect in 2005, so Novartis' patent application waited in a "mailbox" with others until then, under procedures that India instituted to manage the transition. India also passed certain amendments to its patent law in 2005, just before the laws came into effect, which played a key role in the rejection of the patent application.

The patent application claimed the final form of Gleevec (the beta crystalline form of imatinib mesylate). In 1993, during the time India did not allow patents on products, Novartis had patented imatinib, with salts vaguely specified, in many countries but could not patent it in India. The key differences between the two patent applications, were that the 1998 patent application specified thecounterion (Gleevec is a specific salt - imatinib mesylate) while the 1993 patent application did not claim any specific salts nor did it mention mesylate, and the 1998 patent application specified the solid form of Gleevec - the way the individual molecules are packed together into a solid when the drug itself is manufactured (this is separate from processes by which the drug itself isformulated into pills or capsules) - while the 1993 patent application did not. The solid form of imatinib mesylate in Gleevec is beta crystalline.

As provided under the TRIPS agreement, Novartis applied for Exclusive Marketing Rights (EMR) for Gleevec from the Indian Patent Office and the EMR were granted in November 2003. Novartis made use of the EMR to obtain orders against some generic manufacturers who had already launched Gleevec in India. Novartis set the price of Gleevec at USD 2666 per patient per month; generic companies were selling their versions at USD 177 to 266 per patient per month. Novartis also initiated a program to assist patients who could not afford its version of the drug, concurrent with its product launch.

When examination of Novartis' patent application began in 2005, it came under immediate attack from oppositions initiated by generic companies that were already selling Gleevec in India and by advocacy groups. The application was rejected by the patent office and by an appeal board. The key basis for the rejection was the part of Indian patent law that was created by amendment in 2005, describing the patentability of new uses for known drugs and modifications of known drugs. That section, Paragraph 3d, specified that such inventions are patentable only if "they differ significantly in properties with regard to efficacy." At one point, Novartis went to court to try to invalidate Paragraph 3d; it argued that the provision was unconstitutionally vague and that it violated TRIPS. Novartis lost that case and did not appeal. Novartis did appeal the rejection by the patent office to India's Supreme Court, which took the case.

The Supreme Court case hinged on the interpretation of Paragraph 3d. The Supreme Court decided that the substance that Novartis sought to patent was indeed a modification of a known drug (the raw form of imatinib, which was publicly disclosed in the 1993 patent application and in scientific articles), that Novartis did not present evidence of a difference in therapeutic efficacy between the final form of Gleevec and the raw form of imatinib, and that therefore the patent application was properly rejected by the patent office and lower courts.

Although the court ruled narrowly, and took care to note that the subject application was filed during a time of transition in Indian patent law, the decision generated widespread global news coverage and reignited debates on balancing public good with monopolistic pricing and innovation with affordability. Had Novartis won and gotten its patent issued, it could not have prevented generics companies in India from continuing to sell generic Gleevec, but it could have obligated them to pay a reasonable royalty under a grandfather clause included in India's patent law.

Initial patent prosecution and litigation

As mentioned above, Novartis' patent application on the beta crystalline form of imatinib mesylate was filed in India in 1998 and put in a "mail-box" as per the TRIPS agreement.The application was processed in 2005 once the law in India allowed for product patents. The Assistant Controller of Patents and Designs rejected the application on 25 January 2006 as failing to satisfy requirements for novelty and non-obviousness. As the appellate board was not yet convened, Novartis filed several appeals before the Madras High Court in 2006.

Novartis mounted a separate and concurrent litigation before the Madras High Court arguing that section 3(d) of the Indian Patents Act is violated Article 14 of the Indian constitution because the definition of "enhanced efficacy" was too vague and left too much power in the hands of the patent examiner, and was in violation of India's obligations under the TRIPs agreement because it rendered inventions that should be patentable, unpatentable, and argued that the Court was the proper venue for hearing the claim concerning violation of TRIPS. Counsel for the Indian government argued that any violation of TRIPS belonged before the Dispute Settlement Board established by TRIPS, not before the Court, and that in any case, TRIPS allowed national laws to address the needs of its citizens; with respect to the claim that the amended law was arbitrary, counsel argued that "enhanced efficacy" is well understood in the pharmaceutical arts. In 2007 the High Court decided, agreeing with Novartis that it had the right to hear the case, and agreeing with counsel for the Indian government that the law was not vague, and that the law complied with TRIPS, and observed that section 3(d) aims to prevent evergreening and to provide easy access for Indian citizens to life saving drugs. Novartis did not further challenge this order.Before the High Court could decide on the issue of patentability, the Intellectual Property Appellate Board (IPAB) was formed and in 2007 the case was transferred before the IPAB in line with section 117G of the Indian Patent Act. The IPAB on 26 June 2009 modified the decision of the Assistant Controller of Patents and Designs stating that ingredients for grant of patent novelty and non obviousness to person skilled in the artwere present in the application but rejected the application on the ground that the drug is not a new substance but an amended version of a known compound and that Novartis was unable to show any significant increase in the efficacy of the drug and it, therefore, failed the test laid down by section 3(d) of the Indian Patents Act.

After IPAB rejected the patent application in 2009, Novartis appealed directly before the Supreme Court through a Special Leave Petition (SLP) under Article 136 of the Indian Constitution; under normal circumstances, an appeal from IPAB should have been before one of the High Courts before it could proceed to the Supreme Court. However the patent if granted on appeal would expire by 2018 and thus any further appeal at that stage would be pointless. Considering this urgency and the need for an authoritative decision on section 3(d) (other cases on this issue were pending before various High courts), the Supreme Court granted special leave to bypass the High Court appeals process and come directly before it.

Novartis

The legal team of Novartis was led by ex-Solicitor General of India Gopal Subramaniam and senior advocate T. R. Andhyarujina. Novartis had attempted to patent imatinib mesylate in beta crystalline form (rather than imatinib or imatinib mesylate), thus they sought to prevent extant literature on imatinib or imatininb mesylate from being considered as prior art. The thrust of the arguments by Novartis' legal team was two-fold: firstly, that the Zimmerman patents and the journal articles published by Zimmerman et al. do not constitute prior art for the beta crystalline form as it is only one polymorph of imatinib mesylate, thereby providing the required novelty and inventive step; and secondly, that imatinib mesylate in beta crystalline form has enhanced efficacy over imatinib or imatinib mesylate to pass the test of section 3(d).

To prove novelty and inventive step it was argued that the Zimmermann patent did not teach or suggest to a person skilled in the art to select the beta crystalline form in preference to other compounds of which examples were given in the Zimmermann patent. Further, even if the beta crystalline form was selected, the Zimmermann patent did not teach a person to how to prepare that particular polymorph of the salt. Having arrived at the beta crystal form of methanesulfonic acid addition salt (mesylate salt) of imatinib, Novartis contended that the inventors had to further research to be able to ensure that particular salt form of imatinib was suitable for administration in a solid oral dosage form. Hence, the coming into being of the beta crystalline form of imatinib mesylate from the free base of imatinib was the result of an invention that involved technical advance as compared to the existing knowledge and brought into existence a new substance. Research was required to define and optimise the process parameters to selectively prepare the beta crystalline form of imatinib mesylate. As the Zimmermann patent contains no mention of polymorphism or crystalline structure, the relevant crystalline form that was synthesized needed to be invented. There was no way of predicting that the beta crystalline form of imatinib mesylate would possess the characteristics that would make it orally administrable to humans without going through the inventive steps.^[

To prove that the beta crystalline form enhanced efficacy over other polymorphs, it was stated that beta crystalline form has (i) more beneficial flow properties, (ii) better thermodynamic stability, (iii) lower hygroscopicity, and (iv) increasedbioavailability.

Respondents

There were seven named respondents who were represented before the court along with two Intervenor/Amicus. The respondents were led by Additional Solicitor General of India Paras Kuhad.

Various arguments were brought before the court but primarily focussed on proving imatinib mesylate in beta crystalline form is neither novel nor is it non-obvious due to publications about imatinib mesylate in Cancer Research and Nature in 1996, disclosures in Zimmerman patents, disclosures to FDA and finally that efficacy as referred to in section 3(d) should be interpreted as therapeutic efficacy and not merely a physical efficacy.

The respondents quoted extensively from Doha Declaration, excerpts from parliamentary debates, petitions from NGOs, WHO, etc. to highlight the public policy dimension of arguments in regards to easy affordability and availability of life saving drugs.

Supreme Court decision

Supreme Court decided the matter de novo looking into matters of both fact and law.

The court first analysed the question of prior art by looking into Zimmerman patent and the related academic publications. It was clear from the Zimmerman patent that imatinib mesylate itself was not new and did not qualify the test of invention as laid down in section 2(1)(j) and section 2(1)(ja) of the Patents Act, 1970. The court then examined the beta crystalline form of imatinib mesylate and wrote that it, "for the sake of argument, may be accepted to be new, in the sense that it is not known from the Zimmermann patent. (Whether or not it involves an “inventive step” is another matter, and there is no need to go into that aspect of the matter now). Now, the beta crystalline form of Imatinib Mesylate being a pharmaceutical substance and moreover a polymorph of Imatinib Mesylate, it directly runs into section 3(d) of the Act with the explanation appended to the provision".

In applying 3(d) of the Act, the Court decided to interpret "efficacy" as "therapeutic efficacy" because the subject matter of the patent is a compound of medicinal value. Court acknowledged that physical efficacy of imatinib mesylate in beta crystalline form is enhanced in comparison to other forms and that the beta crystalline form of imatinib mesylate has 30 per cent increased bioavailability as compared to imatinib in free base form.However as no material had been offered to indicate that the beta crystalline form of imatinib mesylate will produce an enhanced or superior efficacy (therapeutic) on molecular basis than what could be achieved with imatinib free base in vivo animal model, the court opined that the beta crystalline form of imatinib mesylate, does not qualify the test of Section 3(d).

Thus in effect, Indian Supreme Court upheld the view that under Indian Patent Act for grant of pharmaceutical patents apart from proving the traditional tests of novelty, inventive step and application, there is a new test of enhanced therapeutic efficacy for claims that cover incremental changes to existing drugs.

The Court took pains to point out that the subject patent application was filed during a time of transition in Indian patent law, especially with regard to striking Section 5, which had barred product patents and adding section 3(d), for which there was no case law yet. The Court also took care to state the decision was intended to be narrow: "We have held that the subject product, the beta crystalline form of Imatinib Mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances. It will be a grave mistake to read this judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Parent Act. That is not said in this judgment."

Reference

https://en.wikipedia.org/wiki/Novartis_v._Union_of_India_%26_Others

Patent Infringement

Patent infringement is the commission of a prohibited act with respect to a patented invention without permission from the patent holder. Permission may typically be granted in the form of a license. 

The scope of the patented invention or the extent of protection is defined in theclaims of the granted patent. In other words, the terms of the claims inform the public of what is not allowed without the permission of the patent holder.

Patents are territorial, and infringement is only possible in a country where a patent is in force. For example, if a patent is granted in the United States, then anyone in the United States is prohibited from making, using, selling or importing the patented item, while people in other countries may be free to exploit the patented invention in their country. The scope of protection may vary from country to country, because the patent is examined -or in some countries not substantively examined- by the patent office in each country or region and may be subject to different patentability requirements.

In response to allegations of infringement, an accused infringing party typically asserts one or more of the following:

• that it was not practicing the patented invention, i.e. the invention claimed in the patent (the claims define the extent of protection conferred by a patent);
• that it was not performing any infringing act in the territory covered by the patent (patents are indeed territorial in nature);
• that the patent has expired (since patents have a limited patent term, i.e. a limited lifetime);
• that the patent (or the particular claim(s) alleged to be infringed) is invalid, because the invention in question does not meet the patentability requirements or includes a formal defect, this rendering the patent invalid or unenforceable;
• that it has obtained a license under the patent.

The parties may also resolve their dispute in a settlement, which may involve a licensing agreement, such as a cross-licensingagreement. Private settlements may not always serve the public interest, "because litigating patent disputes to completion tends to generate positive externalities, by clarifying the limits of patent protection if the patent is upheld or encouraging wider use of the innovation if the patent is invalidated".

EXceptions to infringement:

1. Government use : Government whether central or person authorized in this matter can do activities prohibited otherwise by patent act.

2. Research: Making product and exploiting for the purpose of research are allowed.

3.Supply the patented things to government health institutes.

4. Allow to made and evaluate patented product for the purpose of submit report to govenmetor concern  authority.

Reference 

http://www.ssrana.in/Intellectual%20Property/Patents/Patent-Infringement-in-India.aspx
https://en.wikipedia.org/wiki/Patent_infringement

Maibox System

Maibox system is important provision which had to accept by Indian as Indian is member of WTO ,and according to TRIPS agreement it is mandatory to accept mailbox system by developing country from 1995.

Indian patent law didn't allowed product patent which most of the develop country did,and it was needed to comply with TRIPS agreement to be member of   WTO India accepted   mail box provision.

According to this provision since 1995 all the applications claiming product patent had to kept unopened till India makes necessary changes/amendment to its patent law.It was year of 2005 when India made necessary changes to include product patent system.So all the applications were opened  in 2005 and accordingly product patent or EMR (ExclusiveMarketing Rights )were granted.