No Incentive To Innovator Prior To 1st January 2005

• Prior to 1st January 2005, the Indian Patent Act (1970) allowed only for process patents in all areas of high technology viz., food, agrochemicals, pharmaceuticals etc.

• This hardly gave protection to the innovator as the generics could easily make copycats through reverse engineering and thus, avoid facing infringement.

• Since, the onus of proving infringement was on the patent holder, that made life all the more easier for the infringer.

• Trade-Related Intellectual Property Rights Agreement (TRIPs)

• The TRIPs Agreement is another one of the new agreements adopted as part of the Uruguay Round

• The rationale for the WTO adopting rules on intellectual property minimum standards on rights and enforcement obligations was that intellectual property is inherent in many/most goods that are traded.

• IP and Development• There are long standing disagreements between

developed and developing countries over the value of strict or high IP standards.

• Developing countries tend to see these as benefiting those capable of creating and the obtaining the rights (most often foreign parties) over its own consumers.

• (Illustration: Lack of patentability pre-TRIPs for pharmaceuticals and agricultural chemicals.)

What does the TRIPS Agreement do?

• Recognizes categories of intellectual property rights — seven in all:

• — Patents• — Trademarks• — Copyrights• — Trade Secrets• — Industrial Designs• — Lay-out Designs/Integrated Circuits• — Geographical Indications• Defines minimum standards for these rights• (including scope of the right, the term, how they can be• exploited, exceptions)

• Applies principles of MFN and National Treatment and existing IP treaty rules

• Sets out granting and enforcement obligations of Member States

• (Setting up of IP administrative offices, judicial procedures,establishing the border and internal measures that most be taken to counter infringement — seizures, civil and criminal procedures).

• All obligations have to be undertaken by certain dates — phase-in system

• Developed countries — 1/96• Developing — 1/2000 and 1/2005 for

categories considered unpatentable before)

• Least Developed — 1/2006 — but extended under 2000 Doha

• Declaration until 1/2016.

• Design of TRIPs Agreement

• Part 1 — General Provisions and Basic Principles

• • Scope

• • Adoption of Existing Intellectual Property Conventions

• • National Treatment

• • Most Favored Nation

• Part II — Standards (on availability, scope and use) for each of the Seven IP

• rights• (Illustration: Patents)• Art. 27 Patentable subject matter• Art. 28 Rights Conferred• Art. 29 Conditions on Patent Applicants• Art. 30 Exceptions to Rights Conferred

• Art. 31 Other use without Authorization• (Compulsory licensing, emergencies and response to

anticompetitive uses)• Art. 32 Revocation/Forfeiture• Art. 33 Term• Art. 34 Process Patents: Burden of Proof and Section 8

— Control of Anti-Competitive Practices in Contractual Licenses.

• (Art. 40 recognizes the link between IP protection and anti-competitive licensing practices and gives Member States the right to determine what constitutes an abuse of IP rights and to ban certain licensing practices.)

• Part III — Obligations of members to provide procedures/Remedies for IP

• rights.

• Part IV — Transitional Arrangements

• Part V — Dispute Settlement

TRIPS Agreement –The Primary International Instrument

For The Purpose Of Patent Law In India

• India became a party to the WTO, including the TRIPS Agreement, w.e.f 1st January 1995.

• The TRIPS Agreement recognizes the fundamental importance of fostering and protecting innovation. It does not characterize innovations as large or small, incremental or pioneering, but establishes a framework for assessing the inventive quality of an invention against what is already known.

Conditions Under TRIPS Agreement- For An Invention To Be Patentable

• Article 27 of TRIPS Agreement establishes the following conditions for an invention to be patentable.

• The product or process must be “new”, involve an “inventive step” (non-obvious) and should be “capable of industrial application” (useful).

• Patents shall be available irrespective of the place of invention, the field of technology and whether products are imported or locally produced.

Exceptions To Patenting

• Under Article 65.1 and 65.2 of TRIPS Agreement, developing countries (including India) had 5 years to comply with the TRIPS provisions. Under Article 65.4, a further 5 years were provided to comply with the requirement of granting product patents in areas where such protection was not granted.

• The developing countries thus got a leeway of 10 years to introduce product patent regime in all areas of technology.

• Article 27.2 permits a member state to exclude inventions from patentability only where it is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment.

• Article 27.3 permits exclusion of (a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals; and (b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof.

Changes UnderThe Indian Patent Act (1970)

• India availed of the 10 years exemption (provided under Article 65.1, Article 65.2 & Article 65.4) to fully comply with the TRIPS provisions.

• Vide the first amendment to the Patent Act from 1st January 1995, the GOI provided for EMR (exclusive marketing rights) and set up a mail box facility to accept product patent applications.

• EMR was intended to give exclusivity to the innovator for marketing of the product embodying the innovation; it was given subject to an applicant holding a process patent, market approval in other countries and the innovation pertaining to post January 1, 1995 period.

• Since 1995, 13 applications for EMR – mostly in pharmaceutical sector - were filed. Of these, EMRs were granted in 3 cases including one in agrochemicals.

• The second amendment to the Indian Patent Act (1970) - applied from January 1, 2000 - introduced a “uniform” patent term of 20 years for innovations in all areas; rationalized time lines to reduce time taken for grant of patent.

• Other positive features like giving innovations abroad the same treatment as given to the innovations made in India and shifting the onus of patent violation on the infringer were also added. The amendment also provided safeguards for protection of public interest, nation security, bio-diversity, traditional knowledge etc.

Patent (Amendment) Act 2005 Key Provisions

• The Patent (Amendment) Act 2005 effective from 1st January 2005

• provides for grant of product patents in food, agrochemicals, bio-technology and pharmaceuticals. With this, the EMR provision (introduced vide first amendment) has become redundant.

• However, all pending applications for grant of EMR will be treated as request for examination. Also, applications for which EMR were granted before 1st January 2005 shall be examined for grant of patent immediately.

• Every EMR granted before January 1, 2005 shall continue to be effective for a period of 5 years (from the date of its grant) or the date of patent grant or rejection whichever is earlier

• The Patent (Amendment) Act 2005 also contains important provisions in regard to the patentability criteria;

• treatment of mail- box applications,• pre-grant opposition,• parallel importation; • obtaining patent abroad;• compulsory licensing,• Bolar provision etc.