Patent Subject Matter Eligibility – A Global Guide – Globe Law & Business
A great compendium of subject matter eligibility requirements across various jurisdictions and a handy reference for developing a prosecution strategy across jurisdictions for inventions in a given technical domain. - Nitin Sharma, Director, Engineering and Patent Counsel, Qualcomm India
Patentees file applications in more and more countries every year, with nearly four million PCT applications filed since the Patent Cooperation Treaty came into force in 1978. Yet prosecuting patents in different countries can be challenging. Each country has its own laws for pursuing patent applications and achieving enforceable patents, and local patent law varies widely on the issue of patent eligibility.
This title explores patent-eligible subject matter across major jurisdictions and technologies. With succinct discussions of case law, patent office practices, and practical prosecution strategies, this guide is intended to help patent practitioners determine where to consider filing applications, the risks and benefits of certain claim types and language, and how to increase the strength of their clients’ global patent portfolios.
The India Biological Diversity Act: A review of the Amendment Bill 2021
When the Intellectual Property Appellate Board was suddenly abolished in April, lawyers across India were taken by surprise. Espie Angelica A. de Leon finds out just what lawyers are thinking of its abolition in this eulogy to the IPAB.
It is important for countries like India, with diverse biological resources, to have regulations on access and use of biological resources. At the same time, the applicability of these regulations becomes equally important. The “Biological Diversity Act” [henceforth referred to as “Act”] enacted in 2002, has gained a lot of attention in recent years in view of the National Biodiversity Authority’s (NBA) active enforcement of the key provisions of the Act. Currently, all foreign entities engaged in research and commercialisation involving any Indian biological resource, have to sign benefit-sharing agreements even before initiating research. Further, if any intellectual property (IP) rights are sought involving such research, both Indian and foreign entities must enter into benefit sharing agreements in lieu of permission by the NBA. Any such patent will remain pending until such time as the necessary permission from NBA is submitted to the Indian Patent Office. In addition, contravening the provisions attract criminal penalties. All this has led to widespread discussions on possible simplification and clarity in the Act.
Role of IPR in Forming Legal Strategies for Pharma Industry
Pharmaceutical industry currently has an evolving IPR strategy requiring a better focus and approach in the coming era. This article chalks out the evolving role of IPR in framing legal strategies for pharmaceutical industry.
In the era of globalisation, there is a constant technological race especially in the field of pharmaceuticals to develop new/improvised drugs. Due to this, pharmaceutical companies are making huge investments on R&D and hence, it is imperative to protect the Intellectual Property (IP) associated therein and obtain returns by its commercialization. Accordingly, it is no surprise that IP, particularly patents have become important in framing legal strategies for pharmaceutical companies, right from the commencement of research till the expiry of patents. Frequently, pharmaceutical companies strategise on procuring and enforcing their patents, however, such strategies are not focused on how to maintain their patents when challenged for validity. On the other hand, economic liberalisation has seeded a competitive market pressurising the competitors to come out with generic or biosimilar versions for which suitable strategies have to be formulated.
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Patent working statement obligation in India – Life sciences sector implications
What is the working statement obligation?
The Indian Patents Act 1970 requires every patentee and licensee to commercially “work” their patents in India to the fullest extent. This is to encourage inventions and ensure that Indian patents are commercially worked in India to the fullest extent possible, within reasonable and practical limits, so that the Indian public benefits from them. A patent is considered “worked” in India if it has been commercially exploited – that is, the patented product must be available to the public either by manufacturing the product in India, by importing it into India, or both.
Section 146(2) of the Act requires all patentees and licensees to submit an annual “working” statement to the Indian Patent Office (IPO) regarding the working of their patents in a given financial year. This requirement is known as the “working statement obligation”. The Patents (Amendment) Rules 2020 (the 2020 Rules) made certain changes to the working statement form (form 27), to simplify the required information and online submission thereof.
The 2020 Rules also:
- removed the need to provide the quantum of patented product disclosures;
- added the possibility to combine and file a single consolidated statement for related patents;
- eliminated the compulsory disclosure of information regarding the country of import and licensee; and
- removed the requirement to respond to whether the Indian public’s requirements have been met.
Patent working statement obligation in India – Life sciences sector implications
What is the working statement obligation?
The Indian Patents Act 1970 requires every patentee and licensee to commercially “work” their patents in India to the fullest extent. This is to encourage inventions and ensure that Indian patents are commercially worked in India to the fullest extent possible, within reasonable and practical limits, so that the Indian public benefits from them. A patent is considered “worked” in India if it has been commercially exploited – that is, the patented product must be available to the public either by manufacturing the product in India, by importing it into India, or both.
Section 146(2) of the Act requires all patentees and licensees to submit an annual “working” statement to the Indian Patent Office (IPO) regarding the working of their patents in a given financial year. This requirement is known as the “working statement obligation”. The Patents (Amendment) Rules 2020 (the 2020 Rules) made certain changes to the working statement form (form 27), to simplify the required information and online submission thereof.
The 2020 Rules also:
- removed the need to provide the quantum of patented product disclosures;
- added the possibility to combine and file a single consolidated statement for related patents;
- eliminated the compulsory disclosure of information regarding the country of import and licensee; and
- removed the requirement to respond to whether the Indian public’s requirements have been met.