ECO 500 - IPR

Prescribed Course Structure #

1. Relevance of “Laws relating to Intellectual Property (IP) and Patents” for the students of Science and Technology.
2. Meaning and Characteristics of IP Rights.
3. Types of IP Rights.
4. Meaning and characteristics of patent
5. Substantive Patent Law:
   • Patentable Subject Matter
   • Novelty
   • Inventive Step
   • Capability of Industrial Application
6. Procedural Patent Law:
   • When to go for a patent?
   • Where to go for a patent?
   • How to go for a patent?
     • Patent Application
     • Specification
       • Written Description
       • Enablement
       • Rest Mode
       • Claim(s)

Lecture 1 #

Richard Thoman is the CEO of Xerox Corporation. When asked how would he intend to increase the value of the company?

• Increasing sales
• Creating new leading-edge product lines.
• Creating Physical Assets to the company
• Mergers and acquisitions.

But Thoman wasn’t content with such conventional strategies. He believes one of the strategic keys to Xerox’s future is something so intangible, so invisible to traditional corporate practice.

He focused on Intellectual property and its management at Xerox. Companies that are good at managing IP will win. The ones that aren’t will lose.

What is a Patent? #

• A patent is an exclusive right granted by the Government to the inventor to exclude others to use, make and sell an invention.
• Right is given for a specific period of time, typically 20 years.
• The main aim to enact a patent law is to encourage inventors to contribute more in their field by awarding them exclusive rights for their inventions.
• In modern terms, the patent is usually referred to as the right granted to an inventor for his Invention of any new, useful, non-obvious process, machine, article of manufacture, or composition of matter.

Three basic tests for any invention to be patentable:

• The invention must be NOVEL, must not be in existence.
• The invention must be NON-OBVIOUS, i.e. a significant improvement to the previous one; mere change in technology will not give the right of the patent to the inventor.
• The invention must be USEFUL in a bonafide manner, meaning thereby that the Invention must not be solely used in any illegal work and is useful to the world in a bonafide manner.

What is Intellectual Property (IP)? #

• IP may include original ideas; research results; critical business information
• IP emanates from human creative labor
• IP is different from real property
• Real property is tangible, has defined boundaries

There are different kinds of IPR, for e.g., inventions are protected by patents. Literary works are protected by copyright. IP is different from IPR

Meaning of ‘right’ in IPR #

What is a ‘right’:

A legal entitlement which is recognized and can be protected and the violation of which is deemed as ‘unlawful’ and leaves the right- holder with a remedy.

Rights can be used in 2 ways:

• as a liberty (gives the right-holder freedom to do certain acts)
• as a licence (right to do something because someone has given you the consent)

Certain rights manifest are inherent in a human being (Eg: human rights, right to vote, right to privacy), while certain rights manifest themselves outside human beings (Eg: rights in property).

A right must be recognized by law. Rights can be general i.e. claimed by every citizen (e.g. right to protection by the State) or exclusive i.e. the right-holder can stop others from doing certain acts without his consent (e.g. right to property)

IPR refers to rights which emanate from IP which are capable of being protected (Eg: copyright, patent). Violation of IPR refers to ‘infringement’. Patent law protects the right to use/make/sell/import the invention.

Property is a form of regulation. Property can be of 2 kinds: public and private:

Public property is property which is held in common (also known as ‘the commons’),whereas, private property is owned by an individual.

Real property (land) has physical boundaries & can be distinguished from the property of another. The owner of land & its boundaries can be ascertained from the property deed.

Meaning of ‘intellectual’ in IPR #

• ‘Intellectual’ refers to ‘products that come out of our intellect’
• Intellect is our ability to think and understand ideas
• An idea is a product of careful thinking

Common Characteristics of IP #

• Protectable by law i.e. enforceable right
• Intangible
• Capable of being described and registered (copyright does not require compulsory registration).

Lecture 2 #

The Paris Convention for the Protection of Industrial Property #

Paris Convention for the protection of Industrial Property adopted in 1883. The Paris Convention, was revised several times between 1900 and 1979.

The substantive provisions of the Paris Convention fall into three main categories:

• National treatment
• Right of priority
• Common rules

Under the national treatment, each Contracting State must grant the same protection as its own national to nationals of other Contracting States or nationals of non-Contracting States if they are domiciled or have a real and effective industrial or commercial establishment in a contracting state.

The right of priority means that on basis of a regular first application filed in one of the Contracting States, the applicant may, within a certain time apply for protection in any other Contracting States. These subsequent applications will be regarded retrospectively from the same day as the first application.

The common rules for patents granted in different Contracting States for the same invention are independent: Patent grants in one Contracting State don’t oblige others to grant a patent, nor a patent can be refused or terminated for being refused or terminated in any other Contracting State.

A patent may not be refused because domestic law restricts or limits sale of patented product, or product obtained through the patented process.

The inventor has the right to be named as such in the patent.

Patent Cooperation Treaty #

The Patent Cooperation Treaty (PCT) provides patent protection for an invention simultaneously in large number of countries by filing an "international" patent application. The PCT was concluded in 1970, amended in 1979 and modified in 1984 and in 2001. It is open to States party to the Paris Convention (1883). The Treaty regulates in detail the formal requirements with which international applications must comply. Filing a PCT application has the effect of automatically designating all Contracting States bound by the PCT on the international filing date.

Under PCT, an international application is subjected to an international search carried out by one of the competent International Searching Authorities (ISA) under the PCT. A preliminary and non-binding written opinion on the invention meeting the patentability criteria. Based on the international search report and written opinion, applicant may decide to withdraw or amend amend the claims in the application. If not withdrawn, the International Bureau, together with the international search report, publishes it along with the written opinion made available on PATENTSCOPE.

Strasbourg Agreement Concerning the International Patent Classification #

International Patent Classification (IPC) – 8 technology divisions with approximately 70,000 subdivisions. IPC Agreement – was concluded in 1971 and amended in 1979 and It is open to all states party to the Paris Convention (1883). The appropriate IPC symbols are indicated on patent documents published by the national or regional industrial property office.

Patent Law Treaty #

The PLT was concluded in 2000, and entered into force in 2005, with the aim of harmonizing and streamlining formal procedures with respect to national and regional patent applications, making such procedures more user-friendly.

The PLT is open to States members of WIPO and/or States party to the Paris Convention certain inter-governmental organizations. With the significant exception of filing date requirements, the PLT provides the maximum sets of requirements the office of a Contracting Party may apply.

Under the PLT, a filing date is accorded upon compliance with three simple formal requirements:

• an indication that the elements received by the office are intended to be an application for a patent for an invention
• indications that would allow the office to identify or to contact the applicant
• a part which appears to be a description of the invention.

A set of formal requirements for national and regional applications was standardized by incorporating into the PLT the requirements relating to form or content of international applications under the PCT.

The standardized Model International Forms that have to be accepted by the offices of all Contracting Parties were established.

A number of procedures before patent offices were simplified, which contributes to a reduction in costs for applicants as well as for offices.

The PLT provides procedures for avoiding the unintentional loss of substantive rights resulting from failure to comply with formality requirements or time limits.

Substantive Patent Law Treaty #

Standing Committee on the Law of Patents (SCP) was created in 1998 as a forum to discuss issues, facilitate coordination and provide guidance concerning the progressive international development of patent law.

The need for patent law harmonization beyond formalities initiated work on a Substantive Patent Law Treaty (SPLT).

The SCP initially focused on issues directly relevant to patenting - like, definition of prior art, novelty, inventive step, industrial applicability, drafting and interpretation of claims, and sufficient disclosure of the invention.

In Nov. 2000, the SCP, at its 4th session, decided to initiate work on SPLT.

It’s first draft, including the draft Regulations and Practice Guidelines was considered in its 5th session in May 2001.

In 6th session in Nov. 2001, the draft provisions were revised, and an approach to establish a seamless interface between the SPLT, the PLT and PCT was agreed upon.

It also agreed to create a Working Group on Multiple Invention Disclosures and Complex Applications that includes issues such as:

• unity of invention
• linking of claims
• number of claims
• the requirement of "clear and concise" claims and
• special procedures to treat complex applications

During the subsequent sessions of the SCP the contents of the draft SPLT were progressively broadened.

At the 10th session, USA, Japan and the European Patent Office submitted a joint proposal to focus on an initial package of priority items including definition of prior art, grace period, novelty and inventive step.

No consensus was reached at the 2005 session in Casablanca, Morocco, and subsequently, the SPLT negotiations were put on hold in 2006.

Lecture 3 #

Indian Pharmaceutical Market #

India’s pharmaceutical industry is considered as the 3rd largest volume wise and 14th in terms of value. India led a group of 17 high-growth pharmaceuticals markets also called “pharmerging countries”. India also stands as “the 2nd leading provider of medicines distributed by UNICEF in developing world” India’s pharmaceutical industry was estimated at over USD $10-billion in 2010 Generic pharma manufacturers dominate the Indian market, accounting for up to 90% of product sales.

Patents & Pharmaceutical Market #

For over 30 years, the Indian government did not allow product patents for pharmaceutical inventions. Process patents were recognized as an incentive for domestic manufacturers to develop cheaper methods of expensive patented products, keeping the drug prices low. In 1995, as India joined WTO, it was compelled to revise its patent laws following a 10-year transition period. Since 2005, India has been obliged pursuant to the TRIPS Agreement to integrate patent laws with global standards. A per TRIPS, the pharmaceutical corporations have the rights to gain protection for its innovation of medicine. Jan. 1, 2005 saw “implementation of substantially enhanced patent protection for pharmaceuticals” in India. Protests fuelled claiming that the TRIPS is not consistent with the economic and social conditions of India. The Indian Government adopted a strategy to interpret its TRIPS obligations in a manner that still permits the production of generic medicines, keeping prices as low as possible to facilitate access to essential medicines. This brought serious market challenges for the research- based pharmaceutical industry.

Novartis AG vs. Union of India #

• Glivec (imatinib mesylate), produced by Novartis, is used to treat Chronic Myeloid Leukemia (CML) and Gastrointestinal Stromal Tumours (GIST)
• It is Patented in 35 countries across the world.
• Price gap between the patented version of Glivec ($5000 monthly dose) and its generic copy ($200 monthly dose)
• In 2006, the Indian Patent Office rejected Novartis’ patent application for Glivec under Section 3(d) of the Indian Patents Act under grounds of ‘evergreening’.
• Sec. 3(d) make reformulation of pre-existing drug without improving efficacy ineligible for extended patents.
• Indian patent statute or implementing rules do not define ‘efficacy’ - No guidelines for companies like Novartis seeking second-generation patents.
• Novartis filed 2 legal challenges against Indian govt. – (i) appealing the rejection of its patent request, (ii) contesting Sec. 3(d), claiming that it did not comply with TRIPS.
• In August 2007, the Madras High Court ruled against Novartis’s attempt to overturn Section 3(d)
• In 2009, Intellectual Property Appellate Board rejected it’s appeal against the rejection of its patent application.
• Novartis filed a new case in the Supreme Court, which also went against it in its April 2013 final verdict.
• India argued for rejection of Glivec patent as the modified version of the drug did not exemplify a significant change in therapeutic effectiveness over its previous form.
• “… the selection of a salt of the active ingredient with the purpose of improving bioavailability (also referred to as ‘evergreening’) is well-known in pharmaceutical art”.
• India has also argued that under the Doha Declaration on the TRIPS Agreement and Public Health of 2001 its actions are legal.
• The Indian government argue that Sec. 3(d) allows them the ability to interpret patent laws in favour of national public health interests.
• It represents critical issues related to IPR and access to medicines.
• It impacted business of pharma MNCs to conduct business in India and India’s role as the “Pharmacy of the Developing World”.
• Model for developing countries in terms of interpreting their obligations pursuant to the TRIPS.

Lecture 4 #

Turmeric #

Medicinal uses #

Turmeric (Curcuma longa) - known to cure a lot of diseases like Alzheimer’s, arthritis, cancer and ulcer. It has proved useful in traditional Ayurveda and now in the modern conventional development of medicine. Turmeric latte has immense anti-bacterial and anti-fungal properties beneficial for keeping an individual healthy. It helps in reducing skin damage, combating sinus problems and bronchitis, and also purify blood keeping body organs like skin, lung, breast, prostrate healthy.

Patent #

In 1995, 2 scientists at U. of Mississippi, applied for a patent for the method of healing by application of grounded turmeric on the wound. 6 patent claims covered oral and topical use of turmeric powder to heal surgical wounds and ulcers. It confers exclusive rights to specific formulations of turmeric the wound-healer, turmeric the anti-inflammatory agent, and turmeric the food additive.

Patent Opposition #

CSIR opposed the turmeric patent. CSIR argued – turmeric being native to India, has been used for centuries for wound healing, and so lacked the “novelty” criterion required for patenting. CSIR supported it argument with “prior art” - documents ranging from scientific publications to books on home remedies and ancient Ayurvedic texts on Indian systems of medicine.

Patent revoked #

USPTO disqualified the patent in August 13, 1997 on ground that the use of turmeric for which the patent was filed is well known.

Neem Patent #

• In 1994, European Patent Office (EPO) granted a patent to the US Corporation W.R. Grace Company and US Department of Agriculture for a method for controlling fungi on plants using hydrophobic extracted Neem oil.
• Opposition against the patent, and evidence was submitted that the fungicidal effect of Neem seed extracts have been in used for centuries in Indian agriculture.
• The EPO revoked the patent in May 2000 for lack of inventive step. In 2006, the EPO rejected the challenge to revocation made by the applicants.

Traditional Knowledge #

• Traditional knowledge (TK) can be protected by – (i) defensive protection (ii) positive protection.
• A case of defensive protecion is India defeating wrongful patent claim of foreign countries by making available all the historic texts in leading international languages.
• Positive protection involves preventing unauthorized usage and active exploitation of TK.
• India’s failure to protect ‘Jeevani’ from bio-piracy. Jeevani is an Ayurveda drug from Arogyapacha, plant native to Kerala and known to Kani community over ages, later developed in form of a drug.

Traditional Knowledge Digital Library #

Traditional Knowledge Digital Library (TKDL) was set up as a collaboration between CSIR and Ministry of Ayush) to transcribe and make available various ancient texts and books of India dealing in TK into leading international languages.

• It covers Indian TK related to Ayurveda, Unani, Siddha and Yoga. (0.29 million medicinal formulations).
• It has created 200 sub-groups under A61K 36/00 in International Patent Classification.
• It is searchable with Boolean operators using Keywords, IPC and disease names.
• The Indian Patent Office presented a proposal for inclusion of TKDL in the PCT Minimum Documentation.
• A WIPO Committee on IP and Genetic Resources, TK and Folklore has taken an initiative to formulate and legislate a law for TK (currently under negotiation).

Lecture 5 #

Benefits of Patents to patentee ‐ I #

to make, use, exercise, sell or distribute an Invented Article or Process in India.

• Right can be shared , licensed or sold
• Right to initiate Legal Proceedings against Infringement.
• The Invention can be commercially exploited without fear of copying, imitation or unauthorised use during Term of Patent.

Benefits of Patents II #

• Published patent specifications: An ocean of scientific Knowledge and technological information
• Patented inventions ‐ Open to public for free use after the term expires or ceases to be in force
• Avoids duplication of Research and acts as a stepping Stone for further Research.
• “You need not reinvent the wheel”
• Patents give valuable guidance for‐
  • Planning R & D
  • Planning strategic protection for IP‐ assets
  • Forging strategic alliances
  • Identifying possible collaborators /competitors

Benefits of Patents III #

• Helps industry to improve existing technology to give cheaper and better products
• Identifies emerging technologies, research areas and business opportunities
• Patent Portfolio‐ Measure of Company’s Success
• Tool for increasing negotiating power
• Establishes as a Pre‐eminent Player in the market
• Patent ‐ A Tool for International Trade