W R Grace And Co Conn vs Controller Of Patents

Introduction:

The case under consideration revolves around a patent application pertaining to the “CRYSTALLINE FORM OF NICOTINAMIDE RIBOSIDE.” Initially facing objections under Section 3(d) of the Indian Patents Act during the First Examination Report (FER), the patent claims focused on crystalline Form II of nicotinamide riboside chloride. Despite efforts to clarify its distinctive properties, the Controller of Patents rejected the application. Subsequently, the Appellant challenged this decision before the Hon’ble Delhi High Court. The core issue at hand lies in the admissibility of the Appellant’s amended claims post-rejection, particularly concerning their compliance with the patentability criteria outlined in Section 3(d). This case unfolds against the backdrop of the delicate balance required to incentivize pharmaceutical innovation while preventing unjust monopolies, with potential implications for the broader landscape of pharmaceutical patent prosecution in India.

Facts of the Case:

The Appellant filed a  public phase patent  operation in India, seeking protection for “ liquid FORM OF NICOTINAMIDE RIBOSIDE ”. The original claims were directed to a crystalline Form II of nicotinamide riboside chloride and a  system of preparing the same. In the First Examination Report( FER), the Controller  expostulated to Sections 3( d) by characterising the subject matter of the invention as falling under a” new form of known  composites and same process” along with the other  expostulations,  similar as Sections 2(1)(ja), 3(e).  The Appellant filed a reply to the FER and submitted an amended set of claims along with the explanation that crystalline Form II nicotinamide riboside chloride has particular characteristics used to identify the crystalline form. For  illustration, besides  numerous  salutary physical features, the crystalline Form II of nicotinamide riboside chloride has a particular greasepaintX-ray diffraction pattern and a particular IR diapason. 

In addition, the crystalline Form II nicotinamide riboside chloride can also be characterised by its  discriminational scanning calorimetry thermogram.  Still, in the  hail notice, the Controller maintained the  expostulation under Section 3( d) along with other  expostulations. The Appellant filed apost-hearing written submission whereby the Appellant had amended  former claim 12 to define the polar detergent and all the essential parameters for performing the claimed  system. 

The Appellant further submitted that the subject matter of the impugned patent  operation is  similar to Ind Swift LaboratoriesLtd.v. Cadila HealthcareLtd., where the Learned Controller has granted a patent to a crystalline form of Clopidogrel Besylate against a Section 3( d) challenge because the crystalline form had superior  salutary characteristics which greatly enhanced its  marketable value,  similar as an increased shelf life. 

 Still, the Controller of Patents refused the patent  operation on Section 3( d) ground, stating that the crystalline form of a known substance is the same  emulsion unless the crystalline form of that  emulsion differs significantly in  parcels with regard to  efficacity. still, the Appellant submitted in the  hail submission that nicotinamide riboside chloride crystalline Form- II has advanced thermodynamic stability than Crystallin Form- I and Crystallin form- II is less hygroscopic than Form- I as well as  unformed form. still, the Controller held that patent  aspirants must prove the increase in  remedial  efficacity and just increased thermodynamic stability alone, and  lower hydroscopic property may not  inescapably lead to an  improvement of  remedial  efficacity. 

 The Appellant filed an appeal against the  turndown order of the Controller before the Hon’ble Delhi High Court. The Appellant also moved an  operationI.A. 17000/ 2023 along with the appeal for allowing claim  emendations post-refusal of the operation.  

Issue before the Court:

 -The issue before the Court was whether the Appellant’s amended set of claims filed at this stage should be allowed and if the  amendments are allowed? 

• whether the amended set of claims passes the test of patentability under Section 3( d) of the Act.

Contentions of the Appellant:

• Distinctiveness of Crystalline Form II: The Appellant strongly emphasized the uniqueness of crystalline Form II of nicotinamide riboside chloride, arguing that this particular form exhibited properties that warranted patent protection.
• Precedents Supporting Patentability: Drawing parallels with precedents where patentability was upheld based on the superior properties of the invention, the Appellant sought to establish a basis for the acceptance of their claims.
• Addressing Controller’s Objections: The Appellant contended that the amended claims adequately addressed the objections raised by the Controller during the examination process, showcasing a commitment to meeting the requirements set forth by patent authorities.
• Maintaining Scope while Amending: There was a notable emphasis on the importance of maintaining the overall scope of the patent application even as amendments were introduced. This underscored the Appellant’s strategy to navigate through objections without compromising the broader innovation.

Contentions of the Respondent:

• Stringent Requirements under Section 3(d): The Respondent adhered to a stance rooted in the stringent requirements outlined under Section 3(d) of the Indian Patents Act. According to them, the identification of a new form of a known substance should not automatically confer patentability unless there is a demonstrable enhancement in therapeutic efficacy.

• Skepticism about Benefits: The Respondent expressed skepticism about the direct correlation of purported benefits associated with crystalline Form II with therapeutic efficacy enhancement. This skepticism formed a critical aspect of their argument against the patentability of the claimed crystalline form.

 Judgment:

The Hon’ble Court, after careful consideration, sided with the Appellant. The amended claims were allowed to proceed within the scope of the patent application. The decision was grounded in the recognition of the distinctive properties of crystalline Form II highlighted by the Appellant. Acknowledging the importance of addressing objections post-refusal, the Court ordered a fresh examination by the Patent Office. This approach signaled a progressive stance, allowing for a more comprehensive evaluation of the amended claims.

 Analysis:

The Court’s ruling signifies a significant milestone in the landscape of pharmaceutical patent prosecution. By allowing post-refusal amendments, the decision underscores the importance of flexibility in the patent system to accommodate advancements and address objections raised during examination. The balanced approach adopted by the Court is evident in its nuanced consideration of the distinct properties of crystalline Form II, aligning with the evolving understanding of scientific advancements in the pharmaceutical sector.

Furthermore, the decision reflects a balanced approach towards reconciling the imperative of preventing evergreening (extending the exclusivity of a patent beyond what is justified) with the need to incentivize genuine innovation in the pharmaceutical sector. This nuanced approach ensures that the patent system serves its purpose of encouraging innovation while preventing abuse.

 Conclusion:

In conclusion, this case serves as a noteworthy example of the dynamic interplay between legal frameworks and technological innovation, particularly within the pharmaceutical industry. The ruling, allowing post-refusal amendments and recognizing the distinctive properties of crystalline Form II, is poised to shape the trajectory of pharmaceutical patent prosecution in India. This decision contributes to establishing a balanced patent system that fosters innovation and serves the broader interests of society. As the industry continues to push the boundaries of scientific discovery, legal decisions such as this one contribute to the establishment of a robust and balanced patent system that encourages genuine innovation.

REFERENCES 

1.https://www.courtkutchehry.com/Judgement/Search/t/5125299-w-r-grace-and-co

2.https://www.lexology.com/library/detail.aspx?g=1244eec5-ff0f-46c8-894e-05030f0c5f79#:~:text=Decision%20of%20the%20Court%3A&text=The%20Hon’ble%20Court%2C%20after,the%20date%20of%20the%20order.

THIS ARTICLE IS WRITTEN BY AARTHI.A OF B.S.Abdur Rahman Crescent Institute of Science & Technology

Disclaimer: The materials provided herein are intended solely for informational purposes. Accessing or using the site or the materials does not establish an attorney-client relationship. The information presented on this site is not to be construed as legal or professional advice, and it should not be relied upon for such purposes or used as a substitute for advice from a licensed attorney in your state. Additionally, the viewpoint presented by the author is of a personal nature.

Admin