ppti.info Lifestyle Indian Patent Act Pdf


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2, The Patents Act, (incorporating all amendments till ), PDF file that opens in new window. To know how to open PDF file. The e-Version incorporates all the amendments in the Patents Act, .. (b) an undertaking that, up to the date of grant of patent in India, he would. “invention”, “discovery” and “improvement” respectively shall mean any manner of new manufacture or new mode of manufacture the subject of Letters Patent.

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The philosophy of India's Patents Act of varies enormously from the framework being .. ppti.info /issues/08/ppti.info visited on An Act to amend and consolidate the law relating to patents. Be it enacted by Parliament in the Twenty first Year of the Republic of India as follows: CHAPTER I . PDF | This article examines whether the amendment to the Indian Patents Act, has taken advantage of the provisions available under the TRIPS agreement.

The section 3 enlists what does not amount to inventions and sub- 1 6 SCC 1 Page 6 section d was incorporated in by way of an amendment. The Novartis challenged the constitutionality of this provision by stating that it violates Article 14 of the constitution of India and contravenes with the principles of equality enshrined therein.

Thus the authorities may exercise their wide discretionary powers in relation to grant of patent, which is against the very principle of equality. Now, to look into the issue closely we need to observe two important aspects.

As stated earlier, the primary motive of section 3 d is to prevent the ever greening of patents in pharmaceutical industry.

Page:Patents Act 1970 (India).pdf/1

This could be stated as a pre-domestic industry measure as the big pharmaceutical companies are capable of getting patent for their minor improvements and inventions also. This section is incorporated to prevent such practices which may adversely affect the competition within a particular territory. Thus it serves the public purpose and yet maintain the higher standards of patentability in India.

As far as the constitutionality of the section is concerned the explanation provided as quoted above serves as a guiding principle for the interpretation. Hence when such guidelines are 2 The Patent Amendment Act, Page 7 itself provided with the section, the enforcing authorities are bound to act within the scope and limits of such guiding principles. Also the explanation is clear and elaborative to mitigate any confusion arising so as to judge whether invention is there or not.

Therefore, in the light of above discussions it would be safely concluded that the incorporation of section 3 d is constitutionally valid and does not grant scope to act arbitrary and exercise their discretionary powers.

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However, the committee also recognised that the real function of this section is to support innovations which result in enhanced efficacy and therefore setting a higher standard of patentability. Thus this committee has indirectly supported the incorporation of section 3 d and held that such incremental development should essentially be protected in a country like India where most of the pharmaceutical inventions result through incremental inventions only.

Article 27 leaves some flexibility in the hands of member states to define patentability criteria as per their domestic conditions. Even though it has incorporated words like new and inventive but has not defined these terms.

It should also be noted that countries like US and Germany has also refined the patentability criteria as per their domestic set up.

If a substance by virtue to incremental changes results in enhanced efficacy of the product then it can be protected and a patent can separately be granted to that product. This section also consists of an explanation which says that salts, esters, ethers, polymorphs, particle size, polymorphs, complexes, combinations and other derivatives of already known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy. Hence the section makes it quite clear that if a known substance needs to be protected than enhanced efficacy is a deciding factor.

But the problem arises when we contemplate as to what exactly would amount to enhanced efficacy. This is the paramount reason of lack of clarity on this issue. The court in the case of Novartis Ag v.

This means that if we have to prove that a drug is capable of showing increased efficacy, it is expected of you to show that how effective the new drug is in terms of healing capacity without having any lowered side effects. Generally, bio-availability factor comes into play to determine therapeutic effect of a drug. Bio-availability6the degree and rate at which a substance as a drug is absorbed into a living system or is made available at the site of physiological activity.

For instance, if drug A is more bio-available than drug B this means that drug A can be consumed in lower quantity to achieve same effect as drug B.

Indian Patent Office

But it cannot be said that drug A has enhanced therapeutic effect as compared to B, unless it is proved that drug A is less toxic also i. To prove that a substance possess significantly enhanced efficacy, the existence of prior art is a must.

Thus this section presumes that there is a prior art for comparison of efficacy. Unless there is a prior art, we cannot determine the enhanced efficacy. If prior art is not there than there may be chances of arbitrary actions on the part of patent authorities.

However, if prior art is in existence than it is difficult to say that patent authorities has sufficient scope of arbitrariness since they are guided by the above mentioned principles. There is a strong need to define the scope of this term in context of Section 3 d in order to save higher cost of litigation. The Novartis case could be traced back to when Novartis, a multinational pharmaceutical giant filed a patent application in India for its drug Glivec.

Glivec is a drug for the treatment of blood cancer and has obtained patent in 40 countries. Meanwhile various pharmaceutical companies like Ranbaxy, Hetro Drugs and Cipla were selling generic versions of Glivec in India.

In when product patent for pharmaceuticals were introduced in India, the mailbox application of Novartis was consequently examined by the Assistant Controller of Patents. Several generic drug manufacturing companies strongly opposed granting of patent to Novartis on the basis of lack of novelty, enhanced efficacy and wrongful priority.

The patent application of Novartis was rejected by the Assistant Controller after examining then pre-grant objections. With regard to this particular issue the court held that the explanation accompanied with the section acts as a guiding principle for the patent authorities hence the authorities are bound to act accordingly. Therefore, there is no scope of exercising arbitrary powers by the authorities.

The question relating to efficacy was to be decided by the IPAB. The IPAB failed to give sufficient reasons as to why the drug lacked efficacy.

This is particularly appreciable in Indian scenario where generic drug manufacture needs protection so as to promote innovations and safeguard their economic interest. At the same time, much clarity was expected from the Apex Court on this issue of efficacy as various multinational pharmaceutical companies was keeping an eye on the judgment.

I would most humbly like to submit here that despite section 3 d being the most controversial provision in the entire act, it has not come in the way of patenting incremental inventions which meet the criteria of patentability.

This is quite evident from the statistics. There was a steep increase in the grant of patents during from to 18, overall grant of patents. Since, section 3 d works on a presumption of existence of prior art.

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So in cases where no prior art exist, I recommend that increased efficacy should be accessed with reference to the views of skilled persons in the relevant art. On September 2, DePenning, submitted the Specifications for his invention along with drawings to illustrate its working.

These were accepted and the invention was granted the first ever Intellectual Property protection in India. Amendments in , , were necessitated by India's obligations under TRIPS , allowing product patents in drugs and chemicals.

A pre-grant representation in addition to the existing post-grant opposition has been re-introduced. The amendment in [3] focused on change in marks of Patent Agent Examination. Indian Patent Rules were amended in ,,,,,, and The amendment of rules introduced reduced time lines and a fee structure based on specification size and number of claims, in addition to a basic fee.

Indian Patent amendment rules was for amendments in criteria for patent agent exam qualification. Gazette Notification of Patent Amendments Rules has made necessary provisions for recognising Patent office as Examining authority and Searching authority [5] on international level for filing, searching and examination of patent along with necessary fees.

Patent amendment rules introduced a third category of applicant for small entities and revised the basic fee for filing a patent application. In addition, video conference has been introduced for hearing the patent matters. Gupta is the current CG and took charge on 16 November Although the designations of the Controllers differ, all of them with the exception of the Controller General have equal authority in administering the Patents Act.

An Indian Patent Examiner is mandated to search for prior art and for objections under any other ground as provided in the Patent's Act, then to report to the Controller, who has the power to either accept or reject Examiners' reports.

Examiners' reports to the Controller are not open to the public unless courts allow it section of the Patents Act. A Parliamentary committee has recommended repealing S Term of every patent in India is 20 years from the date of filing of patent application, irrespective of whether it is filed with provisional or complete specification.

Since the rights granted by an Indian Patent Office extends only throughout the territory of the India and ceases to have effect in a foreign country, an inventor who wishes patent protection in another country must apply for a patent in a specific country according to its law either through: PCT route or through conventional filing of application.

The GI tag ensures that none other than those registered as authorised users or at least those residing inside the geographic territory are allowed to use the popular product name.

In , Darjeeling tea became the first GI tagged product in India and since then by July , had been added to the list.

The Indian Patent Office has implemented a modernisation program according to an Indian govt website. As per an Indian patent attorney, patents which were beyond the Act were granted by the office. Knowledge commission, an Indian Government appointed body has recommended measures regarding the functioning of the office. The controversial promotion of examiners as assistant controllers has led to an imbalance in the set-up with more controllers than examiners.Such documents include "legislative enactments, judicial decisions, administrative rulings, public ordinances, or similar types of official legal materials" as well as "any translation prepared by a government employee acting within the course of his or her official duties.

Now, to look into the issue closely we need to observe two important aspects. The Indian Patent Office has implemented a modernisation program according to an Indian govt website. The GI tag ensures that none other than those registered as authorised users or at least those residing inside the geographic territory are allowed to use the popular product name.

Retrieved 1 March Thus it serves the public purpose and yet maintain the higher standards of patentability in India. This error rate corresponds exactly to the percentage of all pharmaceutical patents that have come before the IPO that can be classified as secondary patents, and that the IPO has, in turn, granted.

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