Non-statutory double patenting is a crucial aspect of U.S. patent law, designed to prevent the undue extension of patent terms. This doctrine tackles the issue of multiple patents being granted for essentially the same invention or its obvious variations. By requiring either disclaimers or amendments to address these rejections, the doctrine ensures a healthy balance between fostering innovation and preventing monopolies that could stifle competition and further innovation.

Patent practitioners must thoroughly understand and navigate the complexities of non-statutory double patenting to effectively manage patent portfolios. This knowledge is key to securing robust patent protection while adhering to the principles of U.S. patent law.

Example of Use:
The Indian Patent Office (Controller) denied Boehringer Ingelheim International GmbH's second patent application, citing double patenting. This decision stemmed from the determination that the claims in the second application were merely obvious modifications of the claims already granted in their first patent. The applicant's intent was to prolong their exclusive rights by filing a subsequent application with minor tweaks to the original invention.

The Novartis AG v. Union of India case not only delved into the patentability of new forms of known substances under Section 3(d) of the Indian Patents Act but also confronted the issue of double patenting. Novartis' attempt to patent a new form of the existing compound imatinib mesylate was perceived as an effort to extend the patent protection of an already patented invention.

In the 2010 case of Cipla Ltd. v. Controller of Patents, Cipla challenged a patent application on the grounds of double patenting, arguing that the new application's claims were not sufficiently distinct from those in a previously granted patent. This case underscored the crucial requirement that subsequent patent applications should not claim inventions that are not patentably distinct from those in prior applications.

An inventor possesses a patent for a chemical compound and subsequently submits an application for a closely related compound. The U.S. Patent and Trademark Office (USPTO) responds with a non-statutory double patenting rejection. To align the expiration dates, the inventor submits a terminal disclaimer.

A company obtains a patent for a mechanical device and later files an application for an enhanced version. To address a non-statutory double patenting rejection, the company submits a terminal disclaimer, guaranteeing that the expiration dates of both patents coincide.

Rule Change Proposed by the United States Patent and Trademark Office (USPTO):

The United States Patent and Trademark Office (USPTO) proposes a rule change that would significantly impact patent practice in the U.S., especially continuation patent practice. This rule addresses the complex legal concept of non-statutory double patenting, which non-practitioners may not be familiar with.

The proposed rule targets a legal strategy commonly employed to overcome non-statutory double patenting: the terminal disclaimer. This strategy involves limiting the scope of a later-filed patent to avoid infringement on an earlier-filed patent held by the same inventor. The proposed rule would potentially alter the use and effectiveness of the terminal disclaimer in patent practice.

A terminal disclaimer serves as a crucial legal mechanism within the U.S. patent system, addressing the issue of non-statutory double patenting rejections. By employing a terminal disclaimer, an applicant for a patent acknowledges the potential for overlapping claims between two patents. This acknowledgement triggers an agreement to truncate the duration of the subsequent patent, ensuring its expiration coincides with the earlier patent.

Moreover, a terminal disclaimer imposes the maintenance of a uniform ownership structure for both patents. This stipulation prevents a patent holder from abusing the rights granted by the exclusivity period. In essence, a terminal disclaimer safeguards against the unwarranted extension of exclusive privileges for inventions that share significant similarities, thus upholding the principle of fair competition and preventing the monopolization of innovative concepts.

Indian Scenario:
In India, the issue of double patenting, although not explicitly termed as 'non-statutory double patenting,' is addressed within the framework of its patent laws. The concept of double patenting arises when two patents are granted for the same invention or for inventions that lack sufficient distinctiveness. This practice can potentially hinder innovation and create an unfair advantage for patent holders.

To address these concerns, the Indian Patent Act, 1970, incorporates provisions that indirectly combat double patenting. These provisions focus on ensuring that patents are granted for genuinely novel inventions and that they do not unfairly overlap with existing patents. The Act emphasizes the requirement for inventions to be new, inventive, and industrially applicable, thereby implicitly deterring the granting of patents for inventions that are not sufficiently distinct from previously granted patents.

Preventing Patent Evergreening and Double Patenting in the Indian Patent Act:

• Section 3(d): This provision safeguards against granting patents for minor modifications of existing substances unless they significantly improve the known effectiveness. This crucial measure tackles the issue of 'evergreening,' where patents are extended for minor changes, and addresses concerns about double patenting.
   
• Sections 10(5) and 13: To avoid multiple patents for identical or substantially similar inventions, these sections mandate comparing patent applications with existing prior art, including earlier Indian patent applications.
   
• Section 16: Division of Application: This section allows applicants to split their application into multiple applications if it covers multiple inventions. However, it prevents applicants from securing multiple patents for essentially the same invention, thereby preventing double patenting.
   
• Sections 25(1) and (2): Opposition Proceedings: This section enables the public to challenge the grant of a patent on various grounds, including prior applications or patents for the same invention, addressing concerns of double patenting.
   
• Section 104: Jurisdiction and Proceedings for Infringement: This section establishes the legal framework for challenging the validity of a patent, including grounds related to double patenting.

Judicial Interpretations:
Indian courts have played a vital role in shaping the legal landscape surrounding double patenting. Through numerous landmark rulings, the judiciary has provided invaluable guidance on the interpretation and application of relevant provisions. These rulings have effectively clarified the parameters within which the issue of double patenting is addressed, ensuring consistency and predictability in patent adjudication.

Moreover, Indian courts have adopted a nuanced approach when assessing patent claims, focusing on the substance of the invention rather than mere technicalities. By scrutinizing the core inventive concept, the judiciary has strived to prevent applicants from obtaining multiple patents for substantially similar inventions. This approach has not only fostered innovation but has also safeguarded the integrity of the patent system, ensuring that patents are only granted for genuine and distinct advancements.

Conclusion:
To prevent double patenting, the Indian Patent Office rigorously scrutinizes patent applications. This comprehensive review encompasses a thorough examination of prior art, including previously filed and granted patents, to ensure that applicants do not receive multiple patents for the same invention. While the Indian Patent Act may not explicitly mention 'non-statutory double patenting,' its provisions and the practices of the Indian Patent Office effectively address and prevent this issue.

Written By: Md.Imran Wahab, IPS, IGP, Provisioning, West Bengal
Email: [email protected], Ph no: 9836576565