The Journey of a Patent: From Publication to Opposition and Grant

Section 11A and Section 11B in The Patents Act, 1970

PUBLICATION AND EXAMINATION OF APPLICATIONS

11A. Publication of Applications

1. An Application is Published After 18 Months:

a) According to the Patents Act, a patent application is published only after 18 months have passed from the priority date. This period allows inventors the time and opportunity to refine their invention, gauge market potential, and seek financial or legal support.

b) Why are patent applications typically published 18 months after the initial filing date unless early publication is requested? This 18-month waiting period helps balance the inventor’s interests and public awareness. It gives inventors a head start to test or develop their invention while ensuring that, eventually, the invention details are made public for the benefit of the scientific and industrial community.

c) Although the standard timeline for publication is 18 months from the priority date, applicants have the option to expedite the process through early publication procedures.

2. The Process of Expedited Publication:

a) The expedited publication process allows applicants to request earlier disclosure of their patent applications. Under Section 11A of the Patents Act, this enables bypassing the standard 18-month waiting period.

b) To initiate expedited publication, the applicant must submit Form 9 along with the prescribed fee. This results in faster public availability of the application, granting provisional rights and the possibility to commence commercialization sooner.

c) What are the fees associated with expedited publication? The fee structure for early publication is outlined in Schedule I of the Patents Rules. The cost varies depending on the applicant type (individual, small entity, or large organization).

d) What is early publication, and how can it benefit a patent applicant? Early publication refers to making the patent application public before the standard 18-month period. This allows the inventor to claim provisional rights earlier, potentially attracting investors, initiating licensing discussions, and taking a strategic lead in the market. Early publication also promotes transparency and fuels further innovation in related fields.

One of the most prominent advantages of a patent is the right to license it, which opens up commercial opportunities and helps reduce long-term development costs. A granted patent ensures 20 years of exclusive rights from the date of filing, safeguarding the patentee’s interests and preventing unauthorized usage.

11B. Request for Examination

1. Examination Request: A patent application will not be examined unless the applicant or an interested party submits a formal request for examination. This mechanism ensures that only those inventions with actual interest move forward in the grant process.

2. Examination Process for Pre-2005 Patent Applications: a) For applications filed under Section 5(2) before January 1, 2005, a request for examination must be made either by the applicant or any interested person. This request should follow the manner prescribed under Rule 24B(1), Clause II.

b) Section 11B(3) mandates that the examination request must be made within 48 months from the date of priority or the actual date of filing, whichever applies.

c) For post-2005 filings, publication generally occurs automatically after the 18-month window, though actual examination may take longer due to procedural backlogs and examiner workloads.

3. Timelines for Patent Examination Requests: a) If the examination request is not made within the specified time, the application is considered withdrawn.

b) Exceptions:

• The applicant may voluntarily withdraw the application at any point before the patent is granted by submitting a request in the designated format.

• In case a secrecy direction has been issued under Section 35, the timeline for requesting examination starts from the date such direction is revoked.

25(1) Subsection (b) – Prior Publication

Case 1: Glochem Industries Ltd vs Cadila Healthcare Ltd (AIR 2010 Bombay 76)

Brief Summary: This case centered around a patent dispute concerning Clopidogrel Besylate, a salt of Clopidogrel used as an antiplatelet agent in cardiovascular treatments. Cadila Healthcare Ltd (Respondent No. 1) filed a patent application for Clopidogrel Besylate on April 25, 2003. Glochem Industries Ltd opposed the grant on grounds that the invention did not meet Section 3(d) criteria.

Section 3(d) of the Patents Act mandates that new forms of known substances must demonstrate enhanced therapeutic efficacy to qualify for patent protection.

Judgment:

• The Bombay High Court overturned the Assistant Controller’s decision and reinstated the opposition by Glochem Industries for fresh evaluation.

• The matter was sent back to the Controller to assess whether Clopidogrel Besylate demonstrated enhanced therapeutic efficacy as mandated by Section 3(d).

• The Court clarified that this order should not prejudice the Controller’s fresh assessment.

Section 3(d) Requirements: The Court reaffirmed that for a modified form of a known compound to be patentable, it must possess enhanced therapeutic efficacy. Improvements in shelf life, stability, or physical form alone are insufficient. The Respondent’s failure to establish superior therapeutic effect led to a reconsideration.

Relevant Excerpt: Para 5 of the judgment references Section 25(1)(f) read with Section 3(d), stating that no admissible evidence was provided by Respondent No. 1 in support of their claims.

Para 6 highlights the availability of alternative remedies to the petitioner, including:

• Post-grant opposition under Section 25(2),

• Suo moto revocation under Section 64, and

• Filing a counterclaim under Section 104 of the Act.

This case underscores the critical requirement that enhanced therapeutic efficacy must be demonstrated for patenting known substances in new forms.

Case 2: 25(1) Subsection (d) – Publicly Known

Boehringer Ingelheim International vs The Controller of Patents (12 July 2022)

Brief Summary: The Delhi High Court invalidated a pharmaceutical patent under Section 25(1)(d) due to prior public use in India. The Court found that the compound was in public use before the priority date, thereby disqualifying it from patent protection.

Relevant Excerpts:

Para 17 noted that the applicant attempted to file a divisional application to claim monopoly over DPP IV inhibitors, which were not part of the original application.

Para 35 stated that there was no “plurality of inventions” in the parent application. The divisional claims, concerning pharmaceutical products, differed from the method or use claims in the parent application. Since the product claims had not been included in the original application, they were deemed disclaimed. Thus, the parent application could not be interpreted to support a divisional filing.

Judgment: The Court dismissed the appeal, citing lack of merit, and imposed a cost of Rs. 50,000 on the applicant. This penalty was due to the prolonged litigation from 2008 to 2017 and the questionable timing of the divisional filing.

Conclusion: The Indian Patents Act, 1970, prescribes clear procedural stages in the patenting process, particularly regarding publication under Section 11A and examination under Section 11B. While standard publication occurs after 18 months, applicants can opt for expedited publication to gain early advantages. The examination ensures compliance with legal requirements before a patent is granted.

Sections like 25(1) empower stakeholders to challenge patent validity on grounds like prior publication or public use. Judicial decisions such as Glochem Industries Ltd v. Cadila Healthcare Ltd and Boehringer Ingelheim International v. Controller of Patents demonstrate the judiciary’s role in ensuring patent integrity. They reinforce the importance of thorough scrutiny and maintaining the delicate balance between innovation protection and public interest.

References: Indian Patents Act, Section 25(1)(b), (d) (1970). Retrieved from Manupatra: https://www.manupatra.com