Additional experimental data in patent applications refers to supplemental information provided by inventors after their initial patent application. This data plays a pivotal role in establishing the uniqueness and technological advancement of inventions. Demonstrating how an invention works and its advantages is essential for securing patent rights. In this legal context, the significance of experimental data cannot be overstated. It not only bolsters the credibility of the patent application but also aligns with the requirements of patent offices in different countries, including India, Europe, and Japan. Understanding the role of such data is crucial for patent applicants seeking to protect their innovations effectively.
The Role of Experimental Data in Patent Applications
Experimental data in patent applications serves two primary purposes:
- Demonstrating technological advancement: One crucial role of experimental data is to showcase that the invention represents a technological advancement or, in other words, possesses a quality that positions the invention as an upgrade from the existing solutions to the same requirement. This data substantiates the claim that the invention is not obvious and brings something new, non-trivial and economically significant to the field.
- Ensuring sufficiency of the patent application: Experimental data also plays a vital role in ensuring the sufficiency of the patent application. It provides comprehensive details about the invention, making it understandable and reproducible for someone skilled in the relevant field.
It is important to note that in India, however, bridging the sufficiency gap with experimental data can be challenging, as its acceptance remains discretionary under the Controller's judgement. Hence, while experimental data primarily supports the concept of displaying technological advancement, its utility in addressing sufficiency issues should be approached cautiously, especially within the Indian patent landscape.
Indian Perspective
In India, there are currently no established principles within the guidelines or manual of the Indian Patent Office (IPO) that govern the acceptance or rejection of post-filing data in a general context. Additionally, there is a lack of consistent judicial precedent on this matter, leaving the decision to accept such data at the discretion of the Controller.
Specifically, regarding the use of post-filing data to establish technical advancement, the Intellectual Property Appellate Board (IPAB) has weighed in on this matter on two occasions. The IPAB's interpretation is that the Patents Act 1970[1] does not permit the consideration of post-filing data to establish technical advancement. Under this Act, a patent is nullified if an invention is deemed obvious, and this determination cannot be altered by relying on secondary considerations[2].
In the case of Oyster Point Pharma Inc. v. The Controller Of Patents and Designs[3], an appeal was made under section 117A of the Patents Act 1970 against the rejection of a patent application by the Assistant Controller of Patents and Designs. The rejection was based on sections 2(1)(ja)[4] and 3(d)[5] of the Act, referencing three prior art documents. The appellant argued that the Controller overlooked the improved efficacy shown in amended claims. The Court stressed the need to consider experiment details and comparative studies to assess efficacy. It clarified that the Act has no specific time limit for submitting additional documents and thus set aside the order, instructing a fresh review by the Controller.
Recently, the Delhi High Court addressed the issue of admitting post-filing data in support of technical advancement in a case involving Astrazeneca AB & Anr. v. Intas Pharmaceutical Ltd[6]. The Court noted that such evidence could only be considered to confirm the existence of a technical effect already disclosed in the patent's specification. It cannot be used to establish this effect for the first time. The Court emphasised that this approach aligns with the relevant sections of the Patents Act, 1970.
The current situation at the Indian IPO involves examiners and Controllers assessing the connection between as-filed data and post-filing data when determining their acceptability. If there is a significant disparity between the two or a lack of linkage, the examiner may decline to consider the post-filing data. However, if the data serves to validate the information in the patent's specification, demonstrating unexpected results not found in prior art references, it is possible to persuade the patent office to admit such data.
European Perspective
In Europe, there is a willingness to accept post-filing data to substantiate patent applications, particularly when it serves to demonstrate that the invention functions as claimed. European patent authorities understand the evolving nature of innovation and permit inventors to provide supplementary data to support their claims.
Crucially, any post-filing data in Europe must align seamlessly with the original application. It should directly relate to the invention's description, ensuring that the additional information complements what was initially disclosed. This alignment is imperative to maintain the integrity and coherence of the patent application.
While post-filing data is accepted, it's advisable to exercise conciseness. Therefore, applicants should aim to provide relevant data that reinforces their claims without overwhelming the patent application with excessive information. Clarity and relevance remain the guiding principles in European patent practice.
Japanese Perspective
The Japan Patent Office (JPO) allows applicants to respond to a notice of refusal regarding inventive step by providing post-filing data in a certificate of experimental results. However, it's crucial to note that this certificate can't replace the detailed invention description in the initial application. The certificate's purpose is to clarify or verify what was already mentioned in the original description.
A 2010 ruling by the Intellectual Property High Court affirmed that if the initial application contains statements enabling someone skilled in the field to understand the invention's effect, post-filing experiment results can be considered unless they go beyond these statements[7]. Furthermore, the JPO permits considering post-filing factors like commercial success as secondary evidence supporting an inventive step.
Regarding enablement and written description issues, applicants can use post-filing data in a certificate of experimental results to argue that common knowledge at the time of filing justifies expanding or generalising details in the description to cover the claimed invention's scope.
It's important to remember that a certificate of experimental results can't compensate for inadequate initial description when the description can't reasonably cover the claimed invention's scope. In Japan, using post-filing data for technical advancement or sufficiency claims is less common compared to other places, but it can be a useful option when appropriate.
The Importance of Experimental Data
Experimental data stands as an aid to bridge the technical effect gap in the context of patent applications, substantiating an invention's uniqueness and functionality. It serves as evidence for technological advancement, demonstrating that the invention is not obvious and brings genuine innovation to the relevant field.
Incorporating experimental data from the outset is paramount. It ensures a strong foundation for your patent application, cementing its credibility and comprehensiveness. The initial submission should ideally encompass data supporting the invention's advantages and how it contributes to technical advancement.
While some jurisdictions accept post-filing data, it's subject to limitations. Inventors should be aware of restrictions on its use, and must focus on submitting a thorough initial submission to reduce reliance on post-filing data. Clarity, precision, and adherence to legal requirements remain pivotal in this process.
Specific Legal Provisions in India
With regard to experimental and post-filing data, two critical provisions under Indian patent law come into play: Section 3(d) and Section 3(e)[8].
Section 3(d)
Section 3(d) of the Patents Act, 1970 restricts the patenting of new forms of known substances, like salts, esters, or polymorphs, unless they show improved effectiveness compared to the known substance. To obtain a patent for such new forms, applicants must provide experimental data demonstrating this enhanced efficacy. The Indian Supreme Court, in the Novartis v Union of India case[9], emphasised that any increase in bioavailability must be specifically claimed and supported by research data, whether submitted during the initial application or afterwards. The Intellectual Property Appellate Board (IPAB), in Pfizer Products v. The Controller of Patent and Designs[10], stressed the need for a reasonable opportunity to present experimental data before a patent application is rejected.
Section 3(e)
Section 3(e) of the Act prohibits patents for substances created by merely mixing components without a functional interaction resulting in a greater combined technical effect. This means that applicants must demonstrate a synergistic effect through either experimental evidence or comparative data, such as improved efficacy, stability, dissolution, or reduced toxicity. A post-grant opposition case involving Diclofenac injections[11] highlighted the necessity of concrete evidence to support claims of reduced pain.
In Willowood Chemicals Private Limited v Assistant Controller of Patents & Designs[12], the IPAB overturned a refusal order because the applicant could explain the synergistic data provided in their patent specification.
To secure patents in India under these sections, it's crucial to provide robust experimental data showcasing technical effects by either a) comparative data distinguishing claimed invention vis-a-vis closest prior art; b) improved efficacy or synergistic effects. This data should ideally be part of the initial patent application or submitted in response to examination notices. Subsequent submissions on synergism or efficacy must be backed by the patent specification.
In summary, experimental data is pivotal in patent applications, highlighting an invention's uniqueness and functionality. Understanding country-specific practices is imperative to navigate patent procedures effectively. It is advisable that patent applicants diligently provide comprehensive data in the specification from the outset, ensuring their inventions are well-supported and can cross the patent eligibility hurdles.
[1] https://ipindia.gov.in/writereaddata/Portal/IPOAct/1_31_1_patent-act-1970-11march2015.pdf
[2] https://kilpatricktownsend.com/en/Blog/MEMO/2021/3/Late-But-Not-Too-Late-Submitting-Post-Filing-Data-During-Patent-Prosecution-in-Selected-Jurisdictions; Fresenius Kabi Oncology Ltd. v. Glaxo Grp. Ltd., (2013) IPAB Order No. 161 (India); Ajanta Pharma Ltd. vs. Allergan Inc., (2013) IPAB Order No. 172 (India)
[3] https://indiankanoon.org/doc/104264429/
[4] https://indiankanoon.org/doc/1348840/
[5] https://indiankanoon.org/doc/1845556/
[6] https://indiankanoon.org/doc/60901055/
[7] Chiteki Zaisan Kōtō Saibansho [Intellectual Prop. High Ct.] July 15, 2010, 2009 (Gyo-Ke) 10238 (Japan)
[8] https://indiankanoon.org/doc/1675745/
[9] https://indiankanoon.org/doc/165776436/
[10] Pfizer Products v. The Controller of Patent and Designs (OA/30/2011/PT/DEL)
[11] https://www.allindianpatents.com/patents/231479-injectable-preparations-of-diclofenic-and-its-pharmaceutically-acceptable-salts
[12] Willowood Chemicals Private Limited v Assistant Controller of Patents & Designs (OA/53/2020/PT/DEL)