Appeal and Reexamination in Indian Patent Law!

When an Indian patent application is rejected, the applicant has two important legal remedies: submitting a request for review or filing an appeal. These two approaches each have their own characteristics, and choosing the appropriate remedy is crucial for successfully obtaining patent protection. This article will systematically analyze the specific characteristics, applicable situations, and selection criteria of these two programs based on our company's years of practical experience.

A request for re examination is a formal procedure of applying to the original examiner for a re examination. The original intention of this program design is to provide applicants with a relatively fast and economical means of relief. The specific points are as follows:

• Reason for review：The applicant needs to provide sufficient and convincing reasons, mainly including: providing new key facts or evidence that can overturn the rejection decision; Or clearly indicate any obvious errors or important omissions in the review process; Or provide other substantial persuasive reasons.

• time limit：The rejection decision must be submitted within one month from the date of formal delivery. In case of special circumstances, an extension of one month can be applied for through Form 4, but it is recommended to prepare as early as possible to ensure sufficient preparation time.

• cost：The official fee is only $30, which is more cost-effective compared to other relief channels.

• process：We need to prepare a request for re examination, detailing the reasons for the re examination, participate in the hearing process, and submit written statements.

• file：A complete copy of the power of attorney is required to ensure the authenticity and validity of the document.

• advantage：The procedure is relatively simple, the processing cycle is short, the cost is relatively economical, and it is suitable for simple cases with sufficient evidence.

• disadvantage：Due to the fact that the trial is still conducted by the original examiner, if the original examiner has formed an inherent understanding of the case, the possibility of changing the original decision is relatively limited, especially when it comes to complex issues such as legal interpretation.

The appeal procedure needs to be initiated to the High Court and comprehensively reviewed by an independent judicial institution. Although the procedure for this relief pathway is relatively complex, it can provide a more comprehensive and fair review. Its main features are as follows:

• Legal basis for appeal：The situations in which patent applications are rejected mainly include two types: (1) rejection decisions made by the Patent Office in accordance with Article 15 of the Patent Law; (2) The decision made by the Patent Office to maintain, modify or revoke in the pre grant objection procedure in accordance with Article 25 (4) of the Patent Law. The rejection decision in these situations can seek relief through the appeal process.

• time limit：The rejection decision must be submitted within three months from the date of formal delivery, which is relatively flexible and provides sufficient preparation time for the applicant.

• cost：Higher fees are required, including an appeal fee of $130 and a rejection decision authentication copy fee of $68. These are only basic fees, and there may be other fees incurred during the actual process. Additionally, the service fee for the agent is higher than that for the review.

• process：Relatively complex, including professional preparation and formal submission of the appeal, requiring participation in a series of hearings (usually 4-6 online meetings), which may incur additional travel expenses and other related costs.

• file：More stringent documents need to be submitted, including: (1) the original notarized power of attorney, which must be signed and stamped with an official seal by an authorized representative (preferably a company director). If it is not signed by a director, additional authorization documents need to be provided; (2) Certified copy of the rejection decision officially issued by the Patent Office.

• advantage：Providing a new perspective by the High Court is particularly suitable for handling cases involving creative judgment and complex legal disputes such as Article 3 (d), which can result in a more fair and professional trial.

• disadvantage：The program cost is significantly high, the requirements for documents are strict, and the entire hearing process has a long and uncertain cycle.

When choosing specific relief channels, it is recommended that applicants focus on the following key factors:

• Nature of rejection decision：For cases involving complex technical issues, it is recommended to choose the appeal channel to obtain a more comprehensive review; If there is strong new evidence to support it, the review process may be more effective. For issues involving the interpretation of legal provisions, it is usually recommended to choose the appeal channel; For cases mainly involving factual disputes, resolution can be sought through the review process.

• Time factor:If the statutory deadline is approaching, the time pressure of the review process will be relatively high; Although the appeal process has a relatively long overall cycle, the preparation time in the early stage is relatively sufficient, making it easy to make sufficient preparations.

• Resource investment：Although the appeal process incurs significantly higher costs and requires more time and effort, it often leads to more ideal outcomes for technically complex or legally contentious cases.

• Feasibility of appeal after re examination：It is generally not recommended to adopt the strategy of first reviewing and then appealing, as the appeal deadline is still three months from the date of delivery of the original rejection decision, and waiting for the review result may result in missing the statutory appeal deadline. In this case, it is necessary to submit a pardon application and provide detailed reasons for the delay, but there is still a significant risk of being rejected by the judge.

In a classic case we handled, the applicant's invention involvedlanosterolA new crystal form of prodrug.

lanosterol（Lanosterol），It is an important sterol compound and an important intermediate product in cholesterol synthesis, commonly used in various aspects of the pharmaceutical industry. 

approveMoentropy Medicine（https://pharma.bcpmdata.com/）andEntropy API Database（https://api.bcpmdata.com/）According to the query, there are hundreds of approvals for this substance and its downstream associated drugs, which have a wide range of uses as raw materials and excipients. In recent years, the total annual sales of related products have reached hundreds of millions or even billions of yuan.

In this application, the substantive examiner rejected the application on the grounds of lack of creativity and being an unauthorized subject matter under Article 3 (d) of the Patent Law. At that time, the probability of convincing the original examiner during the review process was relatively low, and due to various reasons, it took nearly a month to receive the rejection decision. It was estimated that by the time the review result was received, it was likely that the deadline for submitting an appeal had already passed. Therefore, the applicant ultimately decided to submit an appeal.

After submitting an appeal and undergoing multiple hearings, the Madras High Court ultimately revoked the rejection decision of the Patent Office, remanded the case back to the Patent Office for retrial, and requested a change of examiner for examination.

In the subsequent examination of this case, the examiner first argued based on the appeal judgment that the prodrug of the drug had not been disclosed, and pointed out that the new forms stipulated in Article 3 (d) of the Patent Law cannot be superimposed. Specifically, Article 3 (d) of the Indian Patent Law states as follows:

Discovering only a new form of a known substance without increasing its known efficacy, or discovering any new characteristics or uses of the known substance, or using only known processes, machines, or instruments, unless the known process produces a new product or at least uses a new reactant.

Explanation - For the purposes of this clause, esters, ethers, polycrystals, metabolites, pure forms, particle sizes, isomers, mixtures of isomers, complexes, combinations, and other derivatives of known substances shall be considered as the same substance unless they differ significantly in their functional characteristics. "

In this case, the drug in question is known, but the specific prodrug is not a known substance, therefore the new crystal form of the prodrug is no longer subject to the provisions of Article 3 (d). This case was ultimately successfully authorized.

But in another case, if the protection requested in this case is for a prodrug, it belongs to a new form of a known substance. In this case, it is necessary to carefully consider whether the new form leads to an enhancement of the known efficacy (therapeutic efficacy) of the known substance. This will undoubtedly increase the difficulty of authorization in this case.

The provision of Article 3 (d) is a characteristic of India's patent protection system, which poses a challenge to the protection of patents for old drugs, new uses or crystal forms in India. When receiving a rejection decision based on similar reasons, taking timely action, preparing sufficient arguments and evidence are key to successfully obtaining relief, regardless of the chosen approach.

Although the cost of the review process is relatively low and the processing efficiency is high, for cases involving complex technical issues or important legal interpretation issues (such as disputes related to Article 3 (d)), the appeal process often provides a more effective and comprehensive remedy.

It is worth noting that the intellectual property legal system in India is constantly improving, and relevant procedures and regulations may be adjusted. It is advisable for applicants to consult experienced patent lawyers before taking action to determine the best course of action for each specific case.