The Indian Patents and Designs Act, 1911, was enacted in 1911, marking the beginning of the country's patent law. The current Patents Act, 1970, came into effect in 1972, amending and consolidating the existing patent law in India. The Patents Act, 1970 was amended again in 2005 by the Patents (Amendment) Act, which expanded the scope of product patents to include food, drugs, chemicals, and microorganisms. The provisions relating to Exclusive Marketing Rights (EMRs) have been repealed due to the amendment, and a provision allowing for the grant of a compulsory licence has been added. Pre-grant and post-grant opposition provisions have also been added to the law.
In India, a patent can be applied to a new product or process that involves an inventive step and is capable of industrial application. However, it must not fall into the category of non-patentable inventions as defined by sections 3 and 4 of the (Indian) Patents Act, 1970. A patent application can be filed in India by the true and first inventor or his assignee, either alone or jointly.
Section 2 of the Patents Act, 1970 contains all the important Definitions and interpretations related to the patents law in India. They are:
Section 2 (a)– Assignee –This section defines an assignee as any legal representative of a deceased assignee and references to a person's assignee, including references to that person's legal representative or assignee.
Section 2 (f)– Exclusive License–An exclusive licence is an agreement between the licensor and the licensee prohibiting the licensor from practising under the Patent or granting other exclusive licences to third parties.
Section 2 (j) –Invention –Any new and useful art, process, method, or manner of the manufacturing machine, apparatus, or other article is considered an invention. It also encompasses any manufactured substance and any new and valuable improvement to any of them.
Section 2 (m)– Patent – Patent as per this section means a patent granted under this Act. A patent is the government's exclusive right to prevent others from using, making, or selling an invention for a set period of time. The main goal of patent legislation is to encourage inventors to contribute more to their fields by giving them exclusive rights to their inventions. A patent is a right granted to an inventor for his Invention of any new, useful, non-obvious process, the machine, article of manufacture or material composition.
Section 2 (n) –Patent Agent – Patent Agent refers to a person who is currently registered as a patent agent under the provisions of this Act.
Section 2 (o) – Patented Article and Patented Process – A Patent Article or Process is defined as an article or process for which a patent is currently granted or in effect.
Section 2 (p) – Patentee – The term "patentee" refers to the person listed on the patent register as the grantee or proprietor of the Patent.
Section 2 (t) –Person Interested – A Person Interested in the Invention includes anyone engaged in or promoting research in the same field as the Invention's subject matter.
Section 2 (y) –True and First Inventor – True and First Inventor, as defined in this section, does not include either the person who imports an invention into India for the first time or the person who receives an invention for the first time from outside India.
What can be patented
Exclusions to what can be patented in India are clearly stated in Sections 3 and 4 of the Indian Patents Act, 1970. In order to obtain a patent in India, certain requirements must be met. They are:
Patent subject:Anessential factor to consider is whether or not the Invention relates to a patentable subject matter. The non-patentable subject matter is listed in Sections 3 and 4 of the Patents Act. Unless the Invention falls under one of the provisions of Sections 3 or 4, it is a patentable subject.
Novelty:When it comes to determining the patentability of an invention, innovation is a critical factor. A novelty or new Invention is defined as "no invention or technology published in any document before the date of filing of a patent application, anywhere in the country or the world," according to Section 2(l) of the Patent Act.
To put it another way, the novelty requirement states that an invention should never have been released into the public domain. It must be the most recent, with no prior arts that are identical or similar.
Inventive steps or non-clarity:An inventive step is defined in Section 2(ja) of the Patents Act as a feature of an invention that involves technological advancement, economic importance, or both, as compared to existing knowledge and is not obvious to a person skilled in the art.
This means that the Invention should not be obvious to someone with experience in the same field as the Invention. For someone with experience in the same field, it should not be inventive and obvious.
Capable of industrial application:The term "industrial applicability" is defined in Section 2 (ac) of the Patents Act as "the ability to make or use the invention in an industry." This essentially means that the Invention can't exist in a vacuum. It must be able to be used in any industry, which means it must be of practical utility in terms of patents.
These are legal requirements for obtaining a patent for an invention. In addition, the disclosure of a competent patent is an important criterion for obtaining a patent. A qualified patent disclosure is one in which the Invention is sufficiently disclosed in a patent draught specification to allow a person skilled in the same field to carry out the Invention without undue effort.
Rights and obligations of the patentee
Rights of Patentee
Right to exploit Patent:The patentee has the exclusive right to use, exercise, sell, or distribute the patented article or substance in India or use or exercise the method or process. This right can be exercised by the patentee himself, as well as his agents and licensees. The patentee's rights are only exercisable during the Patent's term.
Right to grant license:The patentee has the option of transferring rights, granting licences, or entering into another arrangement for a fee. To be legitimate and valid, a licence or assignment must be in writing and registered with the Controller of Patents.
The document assigning a patent is not admissible as evidence of any person's title to a patent unless it is registered. This applies to the assignee, not the assignor.
Right to Surrender:A patentee has the option of surrendering his Patent, but before doing so, a notice of surrender is sent to all persons whose names are listed in the patent register as having an interest in the Patent, and their objections, if any, are considered. The surrender application is also published in the Official Gazette so that anyone who is interested can object.
Right to sue for infringement: The patentee has the right to file a lawsuit in a District Court with jurisdiction over the case for patent infringement.
Obligations of patentee
Government use of patents:A patented invention may be used or even acquired by the government solely for its purposes; however, the government may restrict or prohibit the Patent's use in certain circumstances.
If medicine or drug has a patent, the government may import it for its use or distribution in any dispensary, hospital, or other medical facility run by or on behalf of the government. This use is permissible without the patentee's permission or payment of royalties. Aside from that, the government may sell the product made using a patented process for royalties or require a patent in exchange for a suitable payment.
Compulsory licenses:The Controller may grant compulsory licences to any applicant to work the Patent if it is not worked satisfactorily to meet the reasonable requirements of the public at a reasonable price.
Under the Indian Patent Act, the government can require a generic drug maker to produce low-cost medicine in the public interest, even if the product is patentable. Compulsory licences can also be obtained in the case of related patents where one Patent cannot be worked on without the other.
Revocation of Patent: A patent may be revoked if no work has been done or if the public's demand for the patented Invention has not been met satisfactorily.
Invention for defence purposes:Certain secrecy provisions may apply to such patents, i.e., publication of the Invention may be restricted or prohibited by Controller directives. The application is debarred from using the patented Invention if the order or prohibition of publication or communication of the patented Invention continues, and the Central Government may use it in exchange for royalties paid to the applicant.
Restored Patents: Once lapsed, a patent may be restored, provided that few limitations are imposed on the right of the patentee. When the infringement was made between the period of the date of infringement and the date of the advertisement of the application for reinstatement, the Patent has no authority to take action for infringement.
The procedure of getting a Patent registered
Chapter III of the Patents Act, 1970 deals with the Application for Patents.
- Step 1: All about the inventions (ideas or concepts) must be written in great detail. All the relevant information about the Invention is to be gathered, such as the Invention's field of application, the description of the Invention, its's function and the advantages of the Invention.
- If one has worked on the Invention during the research and development phase, then they should present some call lab records signed by themselves as well as the appropriate authority and dated.
- Step 2:It is required to include a diagram, drawing, or sketch that explains the Invention. Drawings and diagrams should be created in such a way that the visual work can be better explained in conjunction with the invention work. In patent applications, they play a crucial role.
- Step 3: To determine whether or not the Invention is patentable. Not all inventions are patentable, and some inventions have not been declared patentable under the Indian Patent Act (inventions are not patentable).
- Step 4: The next step will be to determine whether the Invention meets all of the patent criteria outlined in the Indian Patent Act, including the requirement that it be novel. The Invention has to be obscure. Industrial applications are also required for the Invention.
- Step 5: A provisional application can be filed if the Invention is still in its early stages of research and development. It has advantages such as filing date, a 12-month time limit for filing full specifications, and a lower cost.
The filing date is secured after filing a provisional application, which is very important in the patent world. One also has 12 months to develop a complete specification; after that time, the patent application will be removed.
When all required documents have been completed, and the research work has progressed to the point where prototypes and experimental results can be used to demonstrate the inventive move, the complete specifications can be filed with the patent application. If one has complete knowledge of the Invention and wants to move straight to the full specification, filing the provisional specification is optional.
- Step 6: The application is published 18 months after the first filing when the complete specification is filed with the patent application. An initial publication request can be made with the prescribed fee if one does not wish to wait until the patent application has been published for 18 months from the filing date. As a one-month form request, the patent application is usually published early.
- Step 7: Only after receiving a request for an RFE examination is the patent application examined. Following this request, the Controller assigns the patent application to a patent examiner who reviews it. The patent subject, newness, lack of clarity, inventory steps, and industrial application are the various patent eligibility criteria examined.
After reviewing the patent application for the conditions mentioned above, the examiner issues the first examination report. This process is known as patent prosecution. Patent prosecution refers to everything that happens in the lead up to a patent application being granted. The examiner's first examination report usually includes prior art (documents that existed before the filing date) similar to the claimed Invention and is also reported to the patent applicant.
- Step 8: The majority of patent applicants will face objections based on the examination report. The best course of action is to discuss the examination report with a patent professional (patent agent) and respond to the examination report's objections. In examination reports, this is an opportunity for an investor to communicate his novelty over the prior art. Inventors and patent agents prepare and send a test response in order to demonstrate that their Invention is patentable and meets all patent requirements.
- Step 9: The Controller and the patent applicant are linked to ensure that all objections to the Invention or application are addressed and that the inventor has a fair chance to establish novelty and inventive steps over other existing arts. It is a patent applicant's first grant after receiving a patent application in order to grant.
- Step 10: The application for the grant will be submitted once all patent requirements have been met. The Patent Journal, which is published regularly, notifies the grant of a patent.
Foreign Filing License
No person residing in India may file any application for the grant of a patent outside of India unless the following conditions are met:
- A patent application for the same Invention was filed in India at least six weeks before the application was filed elsewhere.
- Either no secrecy direction was given in relation to the application in India under Section 35(1), or all such directions were revoked.
- A request for a foreign filing licence can be made on a prescribed form, along with a detailed description of the Invention and, if applicable, drawings, as well as the prescribed fee.
Every application is normally published after 18 months has passed from the date of filing or priority of the application, whichever comes first. The applicant can request that his application be published earlier than the normal period by filling out a form and paying a fee.
The rule against early publication does not apply if:
- Section 35 of the Act mandates the issuance of secrecy orders.
- The application has been withdrawn in accordance with Section 9(1) of the Act.
- The applicant withdrew his application three months before the prescribed period of 18 months expired.
The early publication can result in a faster substantive review of the application and a faster grant. In cases where the applicant anticipates infringement, the early publication is also critical for obtaining provisional protection.
Grounds for opposition
A prior grant or a subsequent grant by any person on the grounds specified in sections 25 (1) and 25 (2) of the former Act may be used to oppose a patent application. There are no other grounds in the Act that can be used to challenge the Patent. The following are some of the most common pre-grant and post-grant grounds for opposition:
- The Invention had previously been published in India or elsewhere or had previously been claimed in India.
- The Invention is creating a portion of a community's prior public knowledge, prior public use, or traditional knowledge.
- The Invention is self-evident and devoid of an inventive step.
- The Invention does not meet the definition of an invention under the Act, or it is not patentable under the Act.
- The applicant's failure to disclose information or providing false information about a foreign country.
Pre-Grant Opposition:The procedure for pre-grant opposition is outlined in Section 25 (1) of the Patent Act and Rule 55 of the Patent Rules, 2003. Anyone can file a pre-grant opposition after the application is published but before the Patent is granted.
The Controller only considers representation if a request for examination is filed to oppose the application. Suppose the applicant has not filed a request for examination. In that case, the opponent as an interested person may file a request for examination under Section 11B before filing a pre-grant opposition.
Post-grant opposition: Under Section 25 (2) of the Patents Act, 1970, and Rules 55A to 70 of the Patent Rules, 2003, the procedure for opposing the grant is followed. Any person who is interested in any of the specific grounds can file a post-grant opposition within one year of the date of publication of the patent grant.
A post-grant opposition, unlike a pre-grant protest, must be filed by an individual and not by a person. Section 2(t) of the Patents Act, 1970 defines the expression, people interested as a person/party who is engaged in, or researching in, the same field as the Invention (which is to be opposed).
The compulsory licencing of a patent subject to the fulfilment of certain conditions is one of the most important aspects of the Indian Patents Act, 1970. Compulsory licencing is addressed in Section 24C of the Act. Any person interested may apply to the Controller of Patents for a compulsory licence of a patent at any time after the expiration of three years from the date of the Patent's sealing, provided that the following conditions are met:
- The public's reasonable expectations in relation to the patented Invention have not been met;
- The patented Invention is not reasonably available to the general public;
- The patented Invention is not used in India's territory.
It's also worth noting that anyone can file a compulsory licencing application, even if he already has a licence under the Patent. No person can be prevented from alleging that the public's reasonable requirements for the patented Invention are not met or that the patented Invention is not available to the public at an affordable price for the purposes of compulsory licencing by any admission made by him, whether in such a licence or by his acceptance of such a licence.
If the Controller determines that the public's reasonable requirements for the patented Invention have not been met or that the patented Invention is not available to the public at a reasonable price, he may order the patentee to grant a licence on whatever terms he sees fit. However, the Controller of Patents must consider the following factors before issuing a compulsory licence:
- The Invention's nature;
- The amount of time that has passed since the Patent was sealed;
- The steps are taken so far by the patentee or licensee to fully exploit the Invention;
- The applicant's ability to use the Invention for the benefit of the public;
- If the application for a compulsory licence is granted, the applicant's ability to take on the risk of providing capital and working the Invention;
- If the applicant has made reasonable efforts to obtain a licence from the patentee on reasonable terms and conditions;
- National emergency or other situation requiring immediate action;
- Public non-commercial use; and the establishment of ground for the patentee's anti-competitive practises.
Compulsory licences cannot be claimed as a matter of right because they are subject to the above conditions and the Controller of Patents' discretion. Any arbitrary or illegal order of the Controller of Patents for the grant of compulsory licence can be challenged in Court.
Commercial Working of Patents
Section 146(2) requires every patentee and licensee to provide a periodic statement to the Controller detailing the extent to which the patented Invention has been used commercially in India. These statements must be submitted in the manner outlined in Rule 131. As a result, filing a statement about how a patented invention works commercially in India is a legal requirement. Penalties are imposed if the patentee or licensee fails or refuses to comply. False information submission is punishable by up to six months in prison, a fine, or both. The most important point is that failure to use the Invention in India is grounds for granting a compulsory licence under section 84(c).
It appears that commercial use of a patent is defined as using a patent process to produce an article for general sale. Working commercially means meeting a specific item's demand in India at a reasonable price.
Authorities concerning a Patent
The Controller of Patents is the principal officer in charge of administering the patent system in India. The Controller is the chief executive officer of the four Patent Offices in Chennai, Delhi, Mumbai, and Kolkata. Because the Controller also serves as the Registrar of Trademarks at the Trade Office's Head Office in Mumbai, he acts as a patent from that location. The Patent's official headquarters are in Kolkata (Calcutta). Patents granted under the Patents Act and other officers of the Patent Office are subject to the Controller's direction and regulation.
Infringement of a Patent
Patent infringement is when someone uses, produces, sells, or offers to sell the subject matter or Invention of another person's Patent without their permission. Patents come in a variety of forms, including utility patents, design patents, and plant patents. Patent infringement is based on the principle that unauthorised parties are not permitted to use patents without the owner's permission.
When a court determines that a patent has been infringed, the Court compares the Patent's subject matter to the subject matter used by the "infringer." Infringement occurs when the infringer uses patent material in its exact form. Any unauthorised manufacture, sale, or use of a patented invention is considered patent infringement. Patent infringement can take place either directly or indirectly.
Direct patent infringement:Direct infringement is the most common type of infringement. The infringing Invention is described or performs substantially the same function as the patent claims.
Indirect patent infringement:Indirect infringement, divided into two types, is another type of patent infringement.
Infringement by inducement – It is any action taken by a third party that directly causes another person to infringe on a patent. This could include selling parts that can only be used in a patented invention, selling an invention with instructions to use in a specific method that infringes on a method patent, or licencing an invention covered by another's Patent. The inducer must aid intentional infringement, but the infringer doesn't need to have the intent to infringe on the Patent.
Contributory infringement - It is the sale of material components explicitly made for use in a patented invention and has no other commercial application. While there is a lot of overlap with indications, contributor violations necessitate a lot of time. The seller's violations must have a direct intent to infringe. A direct violation must also be an indirect act in order to be an obligation for indirect violations.
Remedies for Patent Infringement
When it comes to financial losses, patent infringement lawsuits can be far more costly than other types of lawsuits. There are laws that allow plaintiffs to recover damages, like the Patent Act. When someone else's Invention or subject matter is infringed upon without the owner's consent, patent infringement occurs. This consent can come in the form of consent, licence, or waiver.
In the event of infringement, patent owners have a number of options for redress. In patent infringement lawsuits, you may be able to get monetary compensation, equal relief and costs, and legal fees.
Monetary Relief:To prevent patent infringement, monetary relief in the form of compensatory damages is available:
- Indemnity compensation – When determining the Patent's value, a patent owner may have lost profits due to infringement.
- Increased damage – Compensation charges can be charged up to three times in cases of will or violation of will.
- The time period for damages – Only six years after the Patent is issued and only after the infringement claim is filed can the right to damages be asserted.
Equitable relief:The Court can issue an order to prevent someone from doing something or acting in a certain way. There are two types of injections:
- Preliminary injunction – Orders issued in the early stages of lawsuits or lawsuits prevent parties from performing a disputed act (making a patent product).
- Permanent injunction – A court order that permanently halts certain activities or takes a variety of other actions.
Term of Patent
It does not matter whether the patent application is filed with a provisional or complete specification; in India, the term of a patent is 20 years from the date of filing the patent application. When applications are filed under the Patent Cooperative Treaty (PCT), the term of 20 years begins on the date of the international filing instead of the date of the domestic filing.
Payment of Renewal Fee
It's worth noting that a patentee must renew their Patent every year by paying a renewal fee, which can be paid annually or in one lump sum.
Restoration of Patent
A request for patent restoration must be filed within eighteen months of the Patent's expiration date, along with the required fee. The matter is notified in the official journal for further processing of the request after it is received.
Patent of Biological Material
If the Invention uses a novel biological material, it is necessary to deposit it with the International Depository Authority (IDA) before filing the application in India so that the description can be supplemented. It is not necessary to deposit biological materials if such materials are already known. Institute of Microbial Technology is the name of the IDA in Chandigarh, India (IMTECH).
Maintainability of Secrecy by the Indian Patent Office (IPO)
All patent applications are kept secret for eighteen months from the date of filing or priority date, whichever comes first, before being published in the Patent Office's Official Journal, which is published weekly. Following the publication of the patent application, the public is entitled to inspect the documents and obtain a photocopy for a fee.
Licensing and Assignment of Patent
It is legal to assign a patent or a share in a patent or to mortgage, licence, or create any other interest in a patent. In the case of patents, an assignment is only valid if it is made in writing and the agreement is reduced to the form of a document that contains all of the terms and conditions governing the parties' rights and obligations. The transferee must submit an application for registration in the prescribed format.
Important Case Laws
In Cipla Ltd. v. Hoffmann-La Roche Ltd. &Anr., the legal battle began in January 2008, following media reports that Cipla, the Respondent, planned to launch Erlocip, a non-proprietary version of Roche's drug, Tarceva, based on Roche's Indian Patent 196774. Roche filed an injunction with the Delhi High Court to prevent Cipla from marketing Erlocip. The Single Judge dismissed the complaint. Roche's appeal to the Supreme Court for Special Leave was also denied, and the case went to trial. The trial was conducted by a single judge, who ruled in favour of Roche, stating that Cipla was not infringing on Roche's Patent. Thus, any request for an injunction was denied. In this case, the most interesting study is judgment. The distinction between product and substance is thoroughly explained. The Court also pointed out that a deed of assignment of a patent does not have to be registered because it is an immovable property, according to the Registration Act.
In the case of CTR Manufacturing Industries Limited v. Sergi Transformer Explosion Prevention Technologies Pvt. Ltd. &Ors., An explosion and fire detection technology used in electrical transformers was patented by Plaintiff, CTR Manufacturing Industries Limited. On appeal, the High Court ruled in favour of the plaintiff, stating that its pith and marrow are integers working together to produce explosion detection. It was interesting to note that a Court is not required to maintain the validity of a patent at an interim stage, even if granted.
It was observed in Merck Sharp & Dohme Corporation &Anrv. Glenmark Pharmaceuticals Ltd., A lack of consideration will not invalidate a licence agreement. A trademark for the same can be granted for a nominal fee of Rs. 1 or USD 1. The Plaintiffs sought a permanent injunction against any salt of Sitagliptin, in combination or alone, that infringed their Patent No. 209816. Defendant filed a written statement and counterclaim, requesting the cancellation of the suit patent. The defendant was permanently compelled from making, selling, distributing, or using Sitagliptin Phosphate Monohydrate with one or more drugs, infringing the plaintiff's suit patent No. 209816.
The case of Dr Snehlata C. Gupte v. Union of India &Ors. (W.P. (C) 3516 AND 3517 OF 2007) Delhi High Court) set a precedent for when a patent is considered granted. It stated that a patent must be granted as soon as possible (u/s 43). Still, it did not specify what would happen if the Patent violated the Act. In essence, the case demonstrates that the Controller's Intention to Grant on file is a date of patent grant.
Another case highlighting when a patent is said to be granted Chemtura Corporation v. Union of India (C.S. (OS) No. 930 of 2009. It was stressed that regulatory requirements must be met and facts must not be changed. The case demonstrated how Section 8 of the Act is mandatory and must be followed regularly.
The Supreme Court's decision in Novartis AG v. Union of India is regarded as a watershed moment in the Indian patenting system. Novartis had been fighting for the Patent for Gilvec, a drug for treating chronic myeloid leukaemia, since 2006. It had been promoting the Patent with the argument that if investors' rights are not protected, research and development will suffer.
In the case of Natco Pharma Ltd. v. Bayer Corporation, Natco Pharma Ltd. was granted India's first compulsory patent licence for the production of Nexavar, a medicine used in the treatment of kidney and liver cancer. The medicine was a generic version of a patented medicine by Bayer Corporation. The latter was offering it for Rs. 2.80 lakhs for a month's course, while the former promised to offer it for Rs. 8,800. The Bayer Corporation demanded that Natco pay them 6% of its net sales.