This article is written by Pankhuri Bhatnagar pursuing Diploma in Intellectual Property, Media, and Entertainment Laws from LawSikho.

Introduction

The patent refers to the exclusive right which is granted to an inventor for inventing a new product or process, which offers a new method of doing something or provides a technical solution to a problem. The owner of the patent acquires monopoly rights and can prevent others from commercially exploiting the invention without his consent. These rights are granted in exchange for a full disclosure of the technical ‘know how’ of the invention, so that others may learn from it and there is the encouragement of creativity and innovation in the society. 

Due to the monopoly nature of a patent, it is important to ensure that it is awarded only to those innovations which fulfill the criteria for a valid patent. There may be certain cases where the person applying for a patent (the applicant) has wrongfully obtained another person’s invention, or the invention is obvious or is already publicly used in the territory. In such circumstances, there must be a system in place which allows third parties to oppose the grant of an invention. The same is known as “opposition proceedings”. The Intellectual Property laws of different jurisdictions have laid down a procedure for invalidation of patents: ranging from costly and time-consuming litigation proceedings to a formal, administrative process of opposition.

Opposition proceedings refer to the administrative procedure available in most jurisdictions that enable third parties to formally challenge the granted patent or the pending application for a patent. The purpose is to filter frivolous, incomplete, or false claims. In this manner, “opposition proceedings can be said to be a litmus test for inventions claiming the protection of a patent.” Recognizing the significance of these proceedings in the grant of a patent, this article seeks to analyse the opposition procedure prevalent in India and the USA, their procedure, and grounds for challenging the patent and concludes with a comparative analysis of the efficacy of opposition proceedings of both jurisdictions. 

Opposition proceedings in India

The Indian Patent Act, 1970 provides a mechanism that allows the public to raise objections against the grant of a patent by filing an opposition with the Patent office. There are 2 types of opposition proceedings in place depending on the stage of grant of the patent:

1. Pre-grant opposition: Where the opponent can challenge a pending application prior to the grant of a patent.
2. Post-grant opposition: Where the opponent challenges the validity of a patent that has already been granted. 

Before 2005, only the ‘pre’ grant opposition system prevailed and there was no way of challenging a patent once it had been granted. However, the Indian patent system underwent a significant transformation on 1st January 2005 in pursuance of the TRIPS agreement (Trade-Related Aspects of Intellectual Property Rights). In order to comply with the International agreement, India amended its Patent Act and a post-grant opposition system was introduced in Section 25 of the Act. 

Pre-grant opposition in India

Section 25(1) of the Indian Patent Act, 1970 along with Rule 55 of Patents Rules, 2003 lays down the law relating to pre-grant opposition in India. The opposition can be filed by any person in writing, any time after the publication of the patent application and before it is granted. It is necessary to obtain the complete specification from the official website as opposition cannot be made solely based on the abstract. The purpose of this mechanism is to act as a defensive shield that verifies the validity of the application before the actual grant of patent rights. The opposition is known as making a “representation.” 

Grounds for pre-grant opposition

Section 25(1) clauses (a) to (k) of the Patent Act lays down an exhaustive list of the grounds based on which the patent application can be opposed. These grounds are:

1. Wrongful obtainment: The invention or any part thereof was wrongfully obtained from the opponent. 
2. Prior publication: The invention was published before the priority date (earliest filing date which discloses the invention). This objection is subject to Section 29 of the Act, which talks about situations where the publication does not constitute an anticipation of the product or process.
3. Prior claim: The invention was previously claimed in another Indian patent application, which was published on or after the priority date of the applicant’s claim but whose priority date is earlier than that of the applicant.
4. Prior knowledge or use: The invention is known or used by the public before the priority date. In the case of a process that is being patented, it is deemed to have been publicly known or used if a product made by that process was imported in India, before the first date of filing of the application.
5. Obviousness: The invention is obvious and does not involve any inventive step. This means that no advancements have been to the existing use or literature on the subject.
6. Non-patentable subject matter: The subject of the application is not considered to be an invention under the Patent Act or falls in the category of “non-patentable inventions”.
7. Insufficient description: The patent specification does not properly explain the invention or the method of performing it.
8. Non-disclosure: The applicant has failed to disclose all the details which were required under Section 8 of the Act.
9. False disclosure: The applicant has provided materially false information.
10. Time limit: The conventional application was not filed within the specified period of 12 months from the date of the first patent application made in a conventional country.
11. Biological material: The specification failed to disclose the origin or source of the biological material, if any, used in making the invention or has mentioned the incorrect source.
12. Traditional knowledge: The invention was anticipated taking into consideration the knowledge possessed by indigenous communities anywhere in the world.

Procedure for pre-grant opposition

The procedure for filing the opposition is given in Rule 55 of the Patent Rules. The rule states that all representations for opposition must be made in accordance with Form 7A of the Act to the Controller General of Patents. The Indian legislature has intentionally made a provision that prohibits the grant of patents until a period of 6 months from the date of publication has gone by. This gives a sufficient window to third parties who wish to oppose the patent. If the examiner believes that the arguments put forth in the statement of opposition are without merit, he will reject the opposition by passing a speaking order. On the other hand, if the statement is found to have merit, the Examiner shall send a notice to the applicant. The applicant is then required to submit his own statement and evidence, if any, within a 3-month time frame from the date of the notice. The Controller considers the statements and issues a speaking order, which may:

• Grant the patent,
• Refuse the patent, and
• Require the amendment of the patent specification or other documents after which the patent can be granted.

Post-grant opposition in India

Once the patent has been granted, there is still a way for third parties to oppose the grant. This was done by way of a ‘notice of opposition’. The notice has to be filed with the Controller of the appropriate patent office at any time within 12 months from the date on which the grant of the patent was published in the Indian Patent Journal. 

Unlike pre-grant opposition, this type of opposition can only be filed by an “interested party”. Section 2(1)(t) of the Patent Act, 1970 gives an inclusive definition of the term “person interested. ” It includes an individual involved in or promoting research in the field to which the patent pertains. It may also refer to an entity that has a manufacturing, trading, or financial interest in the patented goods. 

Grounds for post-grant opposition

Under the Act, there is no difference in the grounds on which pre-grant and post-grant oppositions can be made. Section 25(2) specifies the same grounds which were listed in subsection 1 of the provision. Nevertheless, there are substantial differences in the procedures of both the oppositions, which will be discussed in the following sections. 

Procedure for post-grant opposition

Rules 55A to 70 of Patent Rules, 2003 lay down the procedure for a post-grant opposition. The notice of opposition under Section 25(2) has to be filed with the Controller of the appropriate office in accordance with Form 7. 

Constitution of the board

Rule 56 provides that once the Controller receives the notice of opposition, he shall establish an ‘Opposition Board’ comprising 3 members. The duty of the board is to examine the notice filed, along with statements and evidence of both parties, and issue a report with reasons regarding each ground challenged by the opponent.

Hearing

Rule 62 states that any party who wishes to be heard must send a notice and the prescribed fees to the Controller. After hearing both parties and taking into consideration the recommendation made by the Opposition Board, the Controller shall decide the case. 

Appeal

The Controller’s decision of both pre and post-grant opposition can be appealed to the IPAB (Intellectual Property Appellate Board) with a period of 3 months from the date of order. However, if the Controller grants a patent after refusing a pre-grant opposition, an appeal can only be made to the High Court and not to IPAB.

Differences between pre-grant and post-grant opposition

Re-examination procedure in the US

Re-examination refers to proceedings conducted by a Patent Office after a patent has been granted. It is conducted upon the request of a third party or the patent holder himself and the purpose is to “re-examine” the validity of a patent. The purpose is similar to post-opposition proceedings: to verify the validity of a patent that has already been granted using an inexpensive and speedier approach, as compared to traditional litigation. 

Ex parte re-examination(EPR)

This type of re-examination is said to be “ex-parte” as there is minimal participation of the opposing party. The person seeking to verify the patent’s validity is only involved in sending the initial request and replying to the patent holder’s statement.

Grounds for ex parte re-examination

EPR can be conducted only when there is a “substantial new question of patentability” with respect to at least 1 claim given in the patent specification. In order for this substantial question to be present, 2 criteria must be fulfilled:

1. The prior art comprising of patents or printed publications must raise a substantial question regarding the patentability of at least one claim, i.e. the examiner must deem that prior art important in determining whether the claim can be patented.
2. This substantial question of patentability must not have been already decided during the previous examination or decision of a federal court. 

Procedure for ex parte re-examination

The proceedings can be initiated by any person, including the patent holder himself, by filing a request for re-examination with the USPTO (United States Patent and Trademark Office). The process has been codified in 35 U.S.C. § 302-307. The USPTO Director shall determine within 3 months whether the request involves any “substantial question of patentability” on the basis of the prior art cited by the opposer or discovered by him. If no such substantial question is found, the re-examination fees will be partially refunded to the requestor. This decision shall be final and cannot be appealed. If there are grounds affecting the patentability of the claim, an order for re-examination shall be made. The Director shall publish a certificate for:

• Cancelling any patent claim which is found to be unpatentable;
• Confirming the claim;
• Substituting any amended or proposed claim in the patent; or
• Adding a new claim which is patentable

Inter partes review

This form of re-examination was introduced in the year 2000 and its purpose was to expand the available options for challenging an issued patent. This process allows further participation of the opposing party as compared to the ex-parte procedure and is thus known as “inter partes”. In 2012, Inter partes reexamination process was further modified and replaced by a new process called inter partes review (IPR). This change was brought about by the passing of the Leahy-Smith America Invents Act, 2011. The review process is carried out by the Patent Trial and Appeal Board of the USA. 

Grounds for inter partes review

• Obviousness: If the differences between the invention being claimed and the prior art are such that the invention would have been obvious on the date of filing to a person skilled in the art.
• Novelty: There must have been some new advancements made which go further than the existing literature.
• Both these grounds can only be raised on the basis of prior art consisting of patents or printed publications.

Procedure for inter partes review

The procedure for inter partes review has been codified in 35 U.S.C. § 311.  A person other than the patent holder can file this petition before the USPTO Director. The burden of proof is on the petitioner to prove that the claim is unpatentable by a preponderance of the evidence. The patent holder shall have the right to file a preliminary response to the petition, giving reasons as to why the inter partes review should not be instituted. The patent holder can also:

• Cancel any claim which has been challenged,
• Propose substitute claims (without enlarging the scope or introducing new matter), or
• Enter into a settlement agreement with the petitioner.

Upon entering into a settlement, the review process can be terminated on the joint request of both parties. If it is not so terminated, the Board shall issue its final decision. The Director publishes a certificate either confirming, cancelling, or amending the challenged claims. This decision shall be final and non-appealable.  

Comparison and analysis of opposition procedure in India vs. re-examination in the US 

Both jurisdictions have laid down detailed procedures and requirements for challenging a patent and both countries are parties to the TRIPS Agreement. However, there are substantial differences between the opposition process in India and the re-examination procedure which prevails in the US. The key differences are:

1. Under Indian law, post-grant opposition can only be filed by an “interested party” which refers to an individual researching in, or an entity trading in the same field to which the patent pertains. Under US law, any third party can oppose a patent after it has been granted. They do not need to have a specific financial interest or be directly affected by the patent.
2. The US allows the patent holder to himself initiate re-examination proceedings. Such a provision is unheard of in Indian law.
3. In India, the patent can be opposed through an administrative process only before the grant, or 1 year after the patent is granted. Once this period expires, any individual who wishes to invalidate the patent will have to institute revocation proceedings in a court of law. In the US, however, re-examination is not time-bound. Opposition can be made throughout the lifetime of the patent. In the opinion of the author, this is an unnecessarily long period. Even if the subject matter of the patent lacks novelty and has been published earlier, the opposing party should not be allowed to sleep on its rights for such a long period. The patent holder would never feel secure in owning the exclusive rights without any possibility of invalidation of the patent. It may even pave the way for his competitors to file malicious requests for re-examination throughout the lifetime of the patent and harass him, causing a stoppage of work or losses to his business.
4. Grounds: The Indian Patent Act, 1970 gives a list of more than 10 grounds on the basis of which the patent can be challenged. In comparison, the US law simply lays down that there must be a “substantial question of patentability” which can only be raised on the basis of prior art consisting of patents or printed publications. This is a very restrictive provision and there can be a number of other circumstances where the patent holder does not deserve to enjoy monopoly rights, such as; where the person has wrongfully obtained the invention, or the invention forms a part of traditional knowledge. In the opinion of the author, the grounds in US law can be made broader. Conversely, the USA believes that the Indian Patent laws are very strict regarding the criteria of patentability and has been making demands for relaxation of certain provisions such as Section 3(d) which prohibits grant of patents for incremental works which do not improve the efficiency of the product or process.
5. The pre-grant process in India is handled solely by the Controller and the post-grant process may involve the constitution of an Opposition Board. In the US, opposition matters are handled by a single examiner (Director). If the Director finds merit in the inter partes review request, then a Patent Trial and Appeal Board shall conduct the same. 
6. India follows a two-tier system: pre-grant for opposition before the grant of patent and post-grant for a period of 12 months after such grant. The grounds of opposition are the same for both and the procedure laid down is simple and straightforward. In contrast, the US has 2 re-examination procedures and a post-grant review option. The provisions of inter-partes and post-grant review are quite similar. All of these methods are used to invalidate a patent after it has been granted and invalidation proceedings can also be initiated in a Federal court. As such, there may be overlapping timelines and confusion as to which method to opt for. 

Conclusion

Patent opposition plays an important role in the prevention of grant of monopoly rights to frivolous, inaccurate, bogus, or petty claims. It also goes a long way in protecting the rightful owner of the invention and prevents others from enjoying the fruits of his labour. Third-parties who wish to challenge the grant of such rights no longer have to rely on the expensive and time-consuming method of litigation. They can quickly get their concerns heard through the formal and administrative process of opposition and re-examination, as it is called in the United States. 

As per statistics, the majority of opposition requests are filed by pharmaceutical companies but lately, other industries have also woken up and have realized the advantages of nipping a frivolous patent in the bud! The two-tier systems in place Actas an additional filter to give optimum security to the inventor and stop false claims from being granted. However, there is a possibility of misuse of these low-cost opposition procedures by businesses to deliberately cause harm to their competitors. Nevertheless, there are ample checks and balances in the procedure and each application is examined for merit. All in all, the patent laws of both jurisdictions, India and the US, are in compliance with the TRIPS Agreement and have looked after the interests of the general public while also ensuring that there is no multiplicity of suits. 

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