Striking the Balance in Pharma Patents: Timely Filing vs. Filing of Comprehensive Data
In the pharmaceutical industry, there is a classic inventor’s dilemma when it comes to figuring out the perfect timing for filing a patent application. On one side, the invention needs to meet novelty requirements, which drives the inventor to file the invention promptly to secure a priority date. On the flip side, the inventor must gather enough data to showcase the technical advancement, which can sometimes delay the filing process.
However, missing out on data demonstrating technical advancements at the time of filing isn’t catastrophic; it’s just a plot twist in the patent saga. Thus, patent prosecution in the pharma industry demands not only strategic amendments but procedural details, specifically for situations in which data plays a very important role in obtaining the grant of the patent.
Moreover, patenting of pharmaceutical products and processes in India usually necessitates overcoming objections under section 2(1)(ja): inventive step and section 3(d) of the Indian Patents Act, 1970 (hereinafter “the Patents Act, 1970”). Under section 3(d) of the Patents Act, 1970, the patenting of “mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant is not an invention” is barred.
For securing a patent for pharmaceutical products or processes by overcoming section 3(d), it is important to provide compelling evidence demonstrating enhanced therapeutic efficacy or significant technical advancement over existing parameters. This evidence includes information in the form of adequate clinical data demonstrating therapeutic efficacy, elaborative experimental details, and compliance with the regulatory standards.
Inventors often omit the addition of critical data related to technical advancements or efficacy when filing their patent applications. The occurrence of this omission is plausible as product or drug development is an ongoing process that requires additional time for necessary experiments and clinical data collection.
Nevertheless, the core challenge lies in identifying the extent of data/information that can be added without altering the scope of the claimed invention and the timelines for its introduction. Fortunately, certain provisions (section 57, section 59 & section 79) in the India Patent Act allow pharmaceutical companies to submit evidence, additional data, and information on experiments and clinical data during prosecution.
This flexibility allows applicants to strengthen their patent applications by providing supplementary information supporting their invention’s novelty and inventive steps. However, this must be done within the boundaries set by the patent law to ensure that the scope of the claimed invention remains unchanged. Adhering to these regulations ensures that the application remains robust and minimizes the risk of future challenges to the patent’s validity.
One can overcome objection effectively by leveraging provisions under section 59 of the Patents Act, 1970 to amend the complete specification:
Section 59 of the Patents Act, 1970 delves into the intricacies of amendments to patent specifications, ensuring that amendments are procedurally sound and in line with established rules. Under this section, patents cannot be amended “except by way of disclaimer, correction or explanation, and no amendment thereof shall be allowed, except for incorporation of fact.”
Here, disclaimer refers to limiting or narrowing the scope of a claim, positive disclaiming and/or negative claiming; correction refers to rectifying obvious mistakes or clerical errors; explanation relates to the rationale provided to clarify a claim or description along with incorporating facts. It is necessary that the amendments made to the claims or specification remain within the scope of the originally filed application and that no new matter gets introduced.
In July 2022, a patent was granted by the Delhi High Court, permitting the conversion of product-by-process claims to process claims (Nippon A and L Inc. v. The Controller of Patents) without expanding the scope of the original claims as per Section 59 of the Act. The basis for the grant was the process sought to be claimed in the amended claims has been disclosed in the patent specification.
One can also submit efficacy data seamlessly through provisions under section 79 of the Patents Act, 1970 – filing evidence by way of Affidavit/Declaration:
When it comes to providing additional information related to efficacy while prosecution, Section 79 plays a crucial role in detailing how evidence should be presented. This section outlines the submission of evidence in any proceedings must be given by way of affidavit and self-declaration to verify the authenticity of the evidence.
Evidence can be furnished at various stages before the patent office, or in infringement or revocation actions at the Courts. (as shown in the figure provided below)
In one such case of Oyster Point Pharma Inc v. The Controller of Patents and Designs (2023), the decision of the Calcutta High Court on an appeal filed by Oyster Point Pharma, a biopharmaceutical company, challenging the refusal order of the Controller of Patents and Designs under sections 2(1)(ja) and 3(d) of the Act lends some guidance.
Appellant’s Stance:
To address the objection under section 3(d), the appellant amended the claims and submitted an affidavit and annexure containing the additional data demonstrating improved properties such as purity, stability, solubility, and bioavailability of the claimed product. Despite this, the Controller overlooked the efficacy data and ultimately rejected the grant of patent.
Court’s Analysis and Judgment:
The court agreed with the appellant and directed the Ld. Controller to assess the additional data provided by the appellant. The court stressed the necessity of considering the detailed experiments, comparative studies, and their conclusive results to accurately determine the efficacy of the claimed product.
“The details of the experiments conducted, comparative studies made and their conclusive results had been discussed in Appendix A, B and C in support of the claimed invention and the same ought to have been considered before passing of the order. There is no substance in the contention that the additional documents could not be considered after filing of the patent application at a later stage. No specific time bar has been provided in the Act which prevents an applicant from filing additional documents after the filing of the patent claim.
Drug development is a lengthy and complex process. It may not be possible to provide all data at the time of filing of the application. Further screening may be required to be carried out before a prospective compound ultimately makes it to clinical trials.”
Given the above judgment, the court accepted the additional data provided by the way of evidence and set aside the rejection order. Moreover, the Controller was instructed to thoroughly review the additional data and re-evaluate the application on merits resulting in its grant.
In the above matter, the court also placed reliance on the decision by a Single Judge in AstraZeneca AB and Ors. v. Intas Pharmaceuticals Limited and Ors., 2020/DHC/3125, which had also considered the relevance of post-filing data in the context of technical advancement u/S 2(1)(ja).
Similarly, the IPAB has upheld an appeal in the case of University of Miami Vs Controller Of Patent, ultimately granting a patent to the University of Miami. Notably, various amendments were made to the claims during the prosecution process, which included the elimination of the method of treatment claims in response to the objection raised by the Controller. Furthermore, the appellant submitted Affidavits from experts containing data supporting the invention, along with post-hearing written submissions to counter the objection and provide supporting results. Despite this, the Controller erred in disallowing the post-filing data submitted by the appellant in support of the patentability of the claimed invention.
To this, the IPAB board stated that,
“Filing of additional documents, data and evidence in support of the invention, to overcome the objection raised and to attack a specific objection is something which is allowed under the Patent Law of not only India but also other foreign jurisdictions.”
Thus, the IPAB recognized the University of Miami’s right to submit additional documents, data, and expert affidavits in support of its patent application and stressed its permissibility, citing the Patent Law of India and other international jurisdictions. Therefore, this decision underscores the significance of considering post-filing evidence in evaluating the patentability of the application, ensuring that applicants have the opportunity to address objections and provide comprehensive support for their claims.
Not Everything Flies at the Indian Patent Office
Recently in February 2024, the High Court upheld the refusal of a patent in Ovid Therapeutics, Inc. v. Assistant Controller of Patents and Designs. Ovid Therapeutics claimed a method of using a composition including 4,5,6,7- tetrahydroisoxazolo (5,4-c) pyridin-3-ol (THIP) for treating diseases and disorders. In response to the examination report (FER), applicants filed an amended set of claims 1-20. However, the amended claims 1-8 were not within the scope of the invention as defined by the originally filed claims, which were limited to a ‘composition for treating diseases’, whereas the amended claims were related to a composition pertaining to a “pharmaceutical salt”, thereby broadening the scope of the invention. Hence, the amended claims 1-8 were not allowable under section 59 of the Patents Act, 1970. The Court concurred with the Ld. Controller and stated that,
“In the present case the field of description clearly describes that this method and composition is to be used for the purpose of treating secondary insomnia and the fact that the medical condition is not written in the amended claims show that the same has gone beyond the specification as also the description of the invention.”
Furthermore, even if the court were to permit the appellant to reintroduce limitations of disease in claim 1, the modified claim could still encounter objection under section 3(d) unless significant therapeutic efficacy is established. Therefore, the Appellant must expressly assert and support enhanced efficacy through comprehensive research data; merely showing increased bioavailability is insufficient. Thus, the appeal in the instant case lacked merit due to both the expansion of the claim scope and insufficient evidence of significant therapeutic improvement.
Thus, addressing the complexities of patent prosecution and section 3(d) objections requires a holistic approach and expert guidance. Ensuring that your patent applications are meticulously prepared and strategically amended can significantly impact the outcome. For pharmaceutical companies seeking to master these challenges, expert advice and thorough preparation can make all the difference. A skilled techno-legal team can provide the necessary insights and support to help you achieve successful patent protection and safeguard your innovations effectively.
Global Perspectives: A Snapshot of Alternative Jurisdictions
Filing additional documents, data, and evidence to address objections or strengthen a patent application is permissible under Patent Law in India. However, this option is not universally available. For instance, the
- The European Patent Office (EPO) allows post-filing data, particularly when evaluating the inventive step using the “problem-solution” approach.
- The consideration of post-filing additional data in the USPTO has shown increased likelihood when the filed patent specification includes teachings that establish a connection between the claimed subject matter and the technical effect achieved.
- The post-filing option in China is considerably limited, and the courts demonstrate logical and reasonable evaluation regarding the use of post-filing data. Notably, if a technical effect was not originally asserted within an application, post-filing data cannot remedy the lack of disclosure. However, if the specification clearly describes the assertion of the technical effect of specific examples, post-filing data to confirm these effects is permissible.
Therefore, although jurisdictions such as the EPO, China, the United States, Japan, Korea, and Canada permit post-filing data under specific conditions, the criteria and acceptance standards vary by region. This article was compiled in August 2024, based on the jurisprudence available. This is a dynamic subject, and you are requested to reach out to us at ip@stratjuris.com for further information.
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