IPO VS USPTO- Remarkable differences in prosecutions for Pharmaceutical and Software Patents - Prometheus IP

February 6, 2019by Dr.Poornima Chandran0


This article aims to demarcate the pertinent differences in the Indian and US Patent systems that have influenced as to how inventions can be patented in both these jurisdictions. Be it in any part of the world, these criteria must always be satisfied

1) The invention must be novel

2) The invention must be non-obvious. However, variable definitions of these criteria have been applied by different countries(here IPO vs USPTO) based on their respective legal systems, cultural and business environments.

ipo vs uspto

Picture source: https://patentbusinesslawyer.com/blogs/global-legal-post-indian-patent-office-backlog/global-legal-post-indian-patent-office-backlog-2/

The following table provides the country-wise feature that differs in both the jurisdictions. (IPO vs USPTO)

Patentable subject matter New product or process involving an inventive step and capable of industrial application. Invention or discovery of a new & useful process/ machine/ manufacture/ composition of matter or improvement thereof.
Patentability Criteria Novelty; Inventive step; Industrial applicability. Novelty; Non-obviousness; Usefulness.
Specific restrictions on the patentability of polymorphs/new forms in the governing law/ rules Under Section 3(d) of the Patents Act, to be patentable a new form of a known substance must exhibit enhanced efficacy when compared to the existing substance. No specific restrictions.
Medical method/method of treatment inventions Any invention claiming to treat a human /animal i.e., aiming to make the entity disease-free is not patentable. No such restrictions.
Plant Patents Not patentable but under the sui generis option, planta and plant varieties are protected under The Plant Variety Protection and Farmers Rights Act (PPVFRA), 2001. No such restrictions. Whoever invents or discovers and asexually reproduces any distinct and new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings, other than a tuber propagated plant or a plant found in an uncultivated state, may obtain a patent therefor, subject to the conditions and requirements of this title.
Specific restrictions on the patentability of software/algorithm per se Indian Patent Law excludes programs that do not provide a technical solution to a technical problem. A program which simply exemplifies a theory, a mathematical method, a method of doing business and an algorithm are excluded, as the matter falls within non-patentability Section 3(k) of Indian Patents Act, 1970. A process (including software-related inventions or computer code) is patentable only if “(1) it is synchronized to the particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.” This “machine-or-transformation test” is intended to identify and exclude abstract ideas that are not eligible for a patent. For instance, a device that makes a video game controller to vibrate is likely to survive the “machine-or-transformation test”, because its software component is entwined or integrated with a physical/ hardware component.
Case Laws pertaining to patent prosecution The term “efficacy” in Section 3(d) refers to “therapeutic efficacy”. The new form shall not be a result of routine “experimentation”; it shall not be “obvious to try”; and it shall not be “inherently disclosed” in the prior art; “unexpected results” or “advantages over the existing prior art” may be used to rebut obviousness.
Filing Requirements By virtue of corresponding address mentioned at the time of application the jurisdiction of the IPO’s in Kolkata, Delhi, Chennai or Mumbai is determined; or via e-filing. By virtue of physical filing at USPTO or via e-filing.
Option to preclude publication Not available. Available.
Supplemental examination Not available. Available.

IPO vs USPTO- Requirements


The following requirements must comply in order to expedite prosecution of the filed application at the Indian Patent Office. The first examination report (FER) or the first statement of objections (FSO) issued by the Controller of Patents is divided into two parts. (1) Summary of the technical report and (2) Detailed technical report. The summary of the technical report provides concise information regarding the objections under novelty, inventive step, and other requirements.

The detailed technical report provides in-depth details regarding the documents and the technical reasoning of objections raised in the FER such as novelty, inventive step and sufficiency of disclosure. Non-compliance with respect to formal requirements is an essential part of the FER. There is disclosure with respect to the forms such as POA (Power of Attorney), assignment details, form 3 (details with respect to foreign or other jurisdiction applications.

With respect to the above-mentioned objections, care must be taken to ensure that the title, detailed description, claims, drawings and abstract have been properly described. The claims must have proper support in the detailed description, clearly articulated to convey the novel and inventive features over the prior art. If need be, two-part claim construction can be adapted to impart clarity and conciseness. The drawings need to be furnished in the prescribed format as mentioned in the Indian Patent Act.

The title of the Specification must be clear and concisely point out to the features of the invention in less than fifteen words, abstract of the specification should be a concise summary of the matter contained in the specification and the summary shall indicate clearly the technical field to which the invention belongs, technical advancement of the invention as compared to the prior art and principal use of the invention excluding any speculations.

The abstract shall contain the chemical formula, which characterizes the invention. Further, the claims need to be drafted in a way to preclude rejections under:

  • 3(d) which usually is to prevent evergreening of patents or to grant patents for secondary pharmaceutical constituents or compounds,
  • 3(e) which is usually to preclude patenting of a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance and
  • 3(j) to prevent patenting of a plant and plant variety etc.
  • Appropriate disclosure of applying for permission from the National Biodiversity Authority (NBA) under the Biodiversity Act to include in its ambit the transfer of research results and application for intellectual property rights (IPRs) relating to Indian biological resources.

As described above, if these requirements are complied with then the patent application can have smooth sailing at the Indian Patent Office.


Similarly, in the case of US patent prosecution, appropriate care must be taken to draft the claims and specification in line with each other.

In order to avoid rejections under section 35 U.S.C § 112, the claims must have proper support in the specification, avoid ambiguous and indefinite terminology in the claim construction, lexicon needs to be properly defined in the specification, means plus function claim construction needs to be avoided. Specific claim construction with respect to the software-related invention with due diligence to avoid to fall under patent in-eligible subject matter i.e., under section 35 U.S.C § 101 (Abstract Idea, natural phenomenon and does not amount to significantly more)     and merely does not use the computer hardware as a tool but has specific advantages/unexpected results associated with it.

With reference to the 35 U.S.C § 102 (Novelty), 35 U.S.C § 103 rejections (Obviousness), double patenting rejections, the claim as whole needs to be considered while comparing the claimed elements /features in the subject claim with the features disclosed in the prior arts. Further, when one or more prior arts either alone or in combination are alleged to disclose the features of the subject claim, effective reasoning with respect to the rationale behind the allegation must be clarified, amended and argued to overcome the said rejections.

Improper hindsight, presumption to arrive at the claimed features by merely showing different claim features in different prior arts or how the subject invention could not be contemplated by a person having ordinary skill in the art without additional experimentation needs to be established during prosecution. The decision must be taken in a rational manner to overcome the said rejections within the purview of the US patent law.

With reference to the biotechnology/life sciences inventions, it becomes crucial to incorporate the market claim structure appropriately and also specify a range of conditions that affect a process claim. Avoiding phrases such as “less than about”, “more than about”, “greater than about”, “approximately” to broaden the claim scope or impart ambiguity. The above-mentioned points are some of the key points that need to be considered while drafting patent applications under US Patent law.

Read More: https://www.gov.uk/government/news/heads-of-ipo-epo-and-uspto-discuss-global-patents-system

More from Prometheus: https://www.prometheusip.com/conferences-and-meetings/intellectual-property-rights-management/

Dr.Poornima Chandran

Dr.Poornima Chandran is Senior Strategic Planner - IP Project Management at Prometheus Patent Services. She comes with a total work experience of around ten years. With an academic research experience spanning around seven years and three years in the corporate field she has a holistic overview of both academic and non-academic backgrounds.

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Plot No:438, SPR Arcade,
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Gachibowli, Hyderabad-500032
Telangana, India.
Our locationsWhere to find us?
Get in touchPrometheus IP Social

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Copyright Prometheus IP. All rights reserved.