PATENTS

The origination or birth of the patents took place way back in the fourteenth and sixteenth century. The word ‘patent’ was derived from the Latin word ‘patere’ which means ‘to lay open.’ The history of Patent law in India starts from 1911 when the Indian Patents and Designs Act, 1911 was enacted. The present Patents Act, 1970 came into force in the year 1972, amending and consolidating the existing law relating to Patents in India. The Patents Act, 1970 was again amended by the Patents (Amendment) Act, 2005, wherein product patent was extended to all fields of technology including food, drugs, chemicals and micro- organisms. After the amendment, the provisions relating to Exclusive Marketing Rights have been repealed, and a provision for enabling grant of compulsory license has been introduced. The provisions relating to pre- grant and post- grant opposition have been also introduced.

1.What is Patent?

A patent is a statutory right for an invention granted for a limited period of time to the patentee by the Government, in exchange of full disclosure of his invention for excluding others, from making, using, selling, importing the patented product or process for producing that product for those purposes without his consent.

2. What is the term of a Patent in the Indian system?

Under the Indian Patent law the term of every patent granted is 20 years from the date of filing of application. However for an application filed under national phase under Patent Cooperation Treaty (PCT), the term of patent will be 20 years from the international filing date accorded under PCT.

 3. What can be patented?

An invention relating either to a product or process that is new, involving inventive step and capable of industrial application can be patented. However it must not fall into the categories of invention that are non- patentable under Section 3 & 4 of the Act.

4. What is the criteria for Patentability?

Section 3 & 4 of the Indian Patents Act list out non- patentable subject matters. As long as an invention does not fall under provisions of Section 3 & 4 it means it has patentable subject matter (subject to other criteria).

i. Novelty: Section 2(l) of the Patent Act states that any invention or technology which has not been anticiapated by publication in any document or used in the country or elsewhere in the world before the date of filing of Patent application with complete specification, i.e., the subject matter has not fallen in public domain or that it does not form part of the state of the art.”

ii. Inventive step or non- obviousness

iii. Capable of Industrial application

5. What types of inventions are not patentable in India?

An invention may satisfy the condition of novelty, inventiveness and usefulness but it may not qualify for a patent under the following situations:

• an invention which is frivolous or which claims anything obviously contrary to well established natural laws;
• an invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human , animal or plant life or health or to the environment;
• the mere discovery of scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature;
• the mere discovery of a new form of a known substance which does not result in enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product
• a substance obtained by mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance;
• the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way;
• a method of agriculture or horticulture;
• any process for medicinal, surgical, curative, prophylactic (diagnostic, therapeutic) or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products;
• plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals;
• a mathematical or business method or a computer program per se or algorithms;
• a literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever including cinematographic works and television productions;
• a mere scheme or rule or method of performing mental act or method of playing game;
• a presentation of information; xv. topography of integrated circuits;
• an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components;
• inventions relating to atomic energy;

6. Will a Patent granted in India give protection worldwide?

A patent granted in India doesn’t give protection worldwide. Patents are granted by individual countries and not by any international authority. Different countries have different patent laws.

7. The law governing Patents in India?

The patent system in India is governed by the Patents Act, 1970 (No.39 of 1970) as amended by the Patents (Amendment) Act, 2005 and the Patents Rules, 2003. The Patent Rules are regularly amended in consonance with the changing environment, most recent being in 2016.

8. When should an application for Patents be filed?

For the purpose protecting an invention by way of Patents it is important that the application seeking Patent should be filed at the earliest possible without delay. An application filed with provisional specification, disclosing the essence of the nature of the invention helps to register the priority of the invention. Delay in filing of patent application comes with risk involved i.e. (i) some other person may file a patent for same invention OR (ii) there may be an inadvertent publication of the patent either by inventor or by another person.

9. Can any invention be patented after publication or display in the public exhibition?

Generally, an invention which has been either published or publicly displayed cannot be patented as such publication or public display leads to lack of novelty. However, under certain circumstances, the Patents Act provides a grace period of 12 months for filing of patent application from the date of its publication in a journal or its public display in an exhibition organised by the Government or disclosure before any learned society or published by applicant. The detailed conditions are provided under Chapter VI of the Act

10. Does the Patent Office keep information of the invention secret?

Yes all patent applications are kept secret for a period of 18 months from the date of filing or priority date whichever is earlier and thereafter they are published in the Official Journal of the Patent Office.

11. Filing of Application for grant of Patent in India by Foreigners.

India being a signatory to the Paris Convention for the Protection of Industrial Property, 1883 and the Patent Cooperation Treaty (PCT), 1970, a foreign entity can adopt any of the aforesaid treaties for filing of application for grant of patent in India.

Where an application for grant of patent in respect of an invention in a Convention Country has been filed, then similar application can also be filed in India for grant of patent by such applicant or the legal representative or assignee of such person within 12 months from the date on which the basic application was made in the Convention Country, ie, the home country. The priority date in such a case is considered as the date of making of the basic application.

12. Pre- grant opposition

A representation for pre-grant opposition can be filed by any person under s 11A of the Patents Act, 1970 within six months from the date of publication of the application, as amended (the “Patents Act”) or before the grant of patent. The grounds on which the representation can be filed are provided under section 25(1) of the Patents Act. There is no fee for filing representation for pre-grant opposition. Representation for pre-grant opposition can be filed even though no request for examination has been filed. However, the representation will be considered only when a request for examination is received within the prescribed period.

13. Post Grant Opposition

Any interested person can file post-grant opposition within twelve months from the date of publication of the grant of patent in the official journal of the patent office.

14. Grounds for Opposition

Some of the grounds for filing pre-and post-grant opposition are as under:

• Patent wrongfully obtained;
• Prior publication;
• The invention was publicly known or publicly used in India before the priority date of that claim;
• The invention is obvious and does not involve any inventive step;
• That the subject of any claim is not an invention within the meaning of this Act, or is not patentable under this Act;
• Insufficient disclosure of the invention or the method by which it is to be performed;
• That in the case of a patent granted on convention application, the application for patent was not made within twelve months from the date of the first application for protection for the invention made in a convention country or in India;
• That the complete specification does not disclose or wrongly mentions the source and geographical origin of biological material used for the invention; and
• That the invention was anticipated having regard to the knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere.

 15. Patent of Biological Material

If the invention uses a biological material which is new, it is essential to deposit the same in the International Depository Authority (IDA) prior to the filing of the application in India in order to supplement the description. If such biological materials are already known, in such a case it is not essential to deposit the same. The IDA in India located at Chandigarh is known as Institute of Microbial Technology (IMTECH).

16. What are the modes of filing a Patent application in foreign countries?

Since there is no worldwide patent, the applicant has to file his patent application in respective countries separately to obtain protection on his invention. The following are the routes available to the applicant to file his International application in foreign country. Paris Convention: The Paris Convention for the Protection of Industrial Property, established in 1883, provides for 12 months time to file the patent application in the member countries from the date of filing of the earliest application. Patent Cooperation Treaty System: PCT is a system which allows an applicant to file in PCT contracting states within 30-31 months from priority date instead of 12 months. Not only does the PCT enable extended time period, it also simplifies filing procedure through a single application. The PCT system also provides for publication of application, International Search and International Preliminary Examination before entering the national phase .

17. What is the Patent Cooperation Treaty (PCT)?

The PCT is an international treaty with more than 150 Contracting States which are bound with certain formal requirements set out in the Treaty and Regulations. The PCT makes it possible to seek patent protection for an invention simultaneously in a large number of countries by filing a single ―international‖ patent application instead of filing several separate national or regional patent applications however, granting of patents remains under the control of the national or regional patent offices after the corresponding ―national phase‖ application has been filed and the national phase application is assessed as per patent law of that jurisdiction.

As per Indian Patent Act 1970 as amended and the Patents Rules 2003 as amended by (amendment) rules 2016, any PCT international application may be filed designating India and it shall deemed to be an application if the corresponding national phase application has also been filed.

18. Compulsory Licensing

a. What are Compulsory Licenses under the Patents Act?

Compulsory licenses are authorizations given to a third-party by the Controller General to make, use or sell a particular product or use a particular process which has been patented, without the need of the permission of the patent owner. This concept is recognised at both national as well as international levels, with express mention in both (Indian) Patent Act, 1970 and TRIPS Agreement. There are certain pre-requisite conditions, given under sections 84-92, which need to be fulfilled if a compulsory license is to be granted in favour of someone.

As per Section 84, any person, regardless of whether he is the holder of the license of that Patent, can make a request to the Controller for grant of compulsory license on expiry of three years, when any of the following conditions is fulfilled –

1. the reasonable requirements of the public with respect to the patented invention have not been satisfied
2. the patented invention is not available to the public at a reasonably affordable price
3. the patented invention is not worked in the territory of India.

Further, compulsory licenses can also be issued suo motu by the Controller under section 92, pursuant to a notification issued by the Central Government if there is either a “national emergency” or “extreme urgency” or in cases of “public non-commercial use”.

The Controller takes into account some more factors like the nature of the invention, the capability of the applicant to use the product for public benefit and the reasonability, but the ultimate discretion lies with him to grant the compulsory license. Even after a compulsory license is granted to a third party, the patent owner still has rights over the patent, including a right to be paid for copies of the products made under the compulsory licence.

b. Advantages of Compulsory Licensing

• Compulsory licence stops the abuse of Intellectual property rights. It gives reward to the owner of the patent keeping in mind the limitation for the owner. It helps in rewarding the patentee for their invention and making the product available to the society at reasonably affordable rate. Compulsory licensing sometimes becomes unavoidable as to save lives of the populace by ensuring accessibility of the products at affordable rate. It also helps to break the monopolies and cartel which are some of the abuses of patent rights.
• It is very important for the government to keep a control over the use of dominant position of the companies. Compulsory licensing will help in Indian industrial sectors development. The size of the Indian market is one of the biggest in the world, compulsory licensing will help to make the products more accessible to public and it will beneficial for public welfare.
• Sometimes the patentee of the products delays in development of important technology which give rise to a deadlocks between the improver and the original patentee. Compulsory Licensing can be used as an effective tool to resolve these deadlocks by pressurizing the original patentee to come to the terms of an agreement with the improver. It can therefore help in generating rapid technical progress.

c. Cases dealing with grant of Compulsory Licence in India

• India’s first ever compulsory license was granted by the Patent Office on March 9, 2012, to Hyderabad-based Natco Pharma for the production of generic version of Bayer’s Nexavar, an anti-cancer agent used in the treatment of liver and kidney cancer. It was established in the Bayer vs Natco case that only 2% of the cancer patient population had an easy access to the drug and that the drug was being sold by Bayer at an exorbitant price of 2.8 lakh INR for a month’s treatment. Further, on the ground that Nexavar was being imported within the territory of India, the Indian Patent Officeissued a compulsory license to Natco Pharma, which assured that the tablets would be sold for Rs. 8,880/- per month. It was settled that 6% of the net sales of the drug would be paid to Bayer by Natco Pharma as royalty.
• In the second case of Compulsory licensing in India, the Controller rejected BDR Pharmaceuticals’ application for compulsory license (made on March 4, 2013) for BMS cancer drug, SPRYCEL. The Controller rejected the compulsory license application made by BDR for stating that BDR has failed to make prima facie case for the making of an order under section 87 of the Act. Controller in the said case observed that BDR Pharmaceuticals had not made any credible attempt to procure a voluntary license from the Patent holder and the applicant has also not acquired the ability to work the invention to the public advantage.
• In another case Lee Pharma, a Hyderabad based Indian pharma company, filed an application for compulsory license (dated 29.06.2015) for the patent covering AstraZeneca’s diabetes management drug Saxagliptin. In order to make a prima facie case, Lee Pharma strived to show that their negotiations for a voluntary license with the patent owner were not rewarding as they did not receive any response from the Patent owner within a reasonable period. The grounds alleged by Lee Pharma were that:

• the patentee has failed to meet the reasonable requirements of the public,
• the patented invention is not available to the public at a reasonably affordable price, and
• the patented invention is not worked in India.

However, all the three grounds of Lee Pharma were rejected by the Controller General and the Compulsory license application was refused. The application was rejected on the basis that Lee Pharma failed to demonstrate what  the reasonable requirement of the public was with respect to Saxagliptin and further failed to demonstrate the comparative requirement of the drug Saxagliptin vis-a-vis other drugs which are also DPP-4 inhibitors. Further, Controller General held that all the DPP-4 inhibitors were in the same price bracket and the allegation that Saxagliptin alone was being sold at an unaffordable price was unjustified. The Controller General also stated that Lee Pharma failed to show the exact number of patients being prescribed the patented drug and how many of them were unable to obtain it due to its non-availability and consequently it was difficult to hold whether manufacturing in India was necessary or not.

19. Border Control Measures

The Central Government has formulated the Intellectual Property Rights (Imported Goods) Enforcement Rules, 2007 in consonance with the TRIPS and World Customs Organisation Model. The Customs department of India has the Customs Recordal system, where the right holder records his right. After the rights holder records their right, the Custom Authorities helps to stop the cross- border movement of counterfeit or infringing goods. However, an amendment in June 2018 to the said rule has omitted the work ‘patent’ from the definition of Intellectual Property. Therefore after the amendment of Intellectual Property Rights (Imported Goods) Enforcement Rules, 2007, the Custom Authorities no longer have jurisdiction to scrutinise the import of any product/ goods on the ground of patent infringement. The enforcement of patent rights at the border is now only possible through an order of the Court whereby specific injunction to import infringing products is granted.

20. Antitrust Law and Patents

• India enacted its Competition Act in 2002 to eliminate practises that have an adverse effect on competition, promote and sustain competition, protect the interests of consumers and ensure freedom of trade carried on by other participants. In matters of dispute between Competition Act and Patents Law the Courts have held that a complaint against a patentee’s abuse of dominant position is an independent proceeding and does not affect any relief in a suit for infringement.
• The Competition law puts reasonable restrictions on patent licensing. The limitations on terms of licensing under the Competition Act, 2002 may include those that prevent exorbitant and non- uniform royalty rates, any discriminatory terms that violate FRAND terms, a bar on the jurisdiction etc.

21. Infringement of Patents

a. Effective ways for a patent owner to enforce its rights in India:

The most effective way to enforce patent rights in India includes a civil action seeking the following remedies:

• a temporary injunction – the court can impose a temporary restraining order on the defendant until final disposal of the civil suit or for such time as stated in the court order;
• a permanent injunction – the court can issue a final order restraining the defendant from carrying out activities constituting patent infringement in India;
• damages or account of profits;
• delivery up or destruction of infringing articles; or
• legal costs.

A patent owner also has the following options to enforce its rights in India:

• an Anton Piller order – the court can appoint a local commissioner on the request of the plaintiff or otherwise to hold or seal infringing materials or accounts in the defendant’s premises;
• a Mareva injunction – the court can restrain the defendant from disposing of its assets within India until the trial ends or judgment in the patent infringement action is passed; or
• a John Doe order – the court can order search and seizure in respect of an unknown defendant with the cooperation of the local commissioner and police, if required, to raid any premises where infringing activities are suspected to be carried out.

b. Stages in Litigation process leading up to a full trial?

The following stages lead to a full patent trial:

        Pleadings A suit is instituted before the court in the appropriate jurisdiction by the plaintiff, including a plaint (containing the facts, grounds, claims, arguments and relief claimed) and supporting documentary evidence. The plaint must comply with Orders IV (institution of suits), VI (pleadings) and VII (plaint) of the Code of Civil Procedure.

• In addition to the plaint, the plaintiff often files separate interim applications seeking:
• a temporary injunction in conjunction with an ex parte ad interiminjunction;
• the appointment of a local commissioner; or
• the appointment of a scientific adviser.

The court will consider the interim applications and issue any necessary orders. In exceptional cases an ex parte ad interim injunction order can be passed on the first day of the hearing where the plaintiff can prove, based on the documents available on record:

• a prima faciecase;
• irreparable loss and injury; and
• the balance of convenience in its favour.

Pursuant to institution of the suit, if a court prima facie finds merit in plaintiff’s claims, it can issue a court notice to the defendant to appear before the court on a given date. The plaint is then also served on the defendant. On receiving the notice, the defendant can appear before the court to seek time to file a written reply. The plaintiff may then reply to the defendant in writing.

       Admission and denial of documents At this stage the parties must produce before the court all of the documents in their possession on which they intend to rely. Thereafter, the parties must notify the court as to whether they admit or deny the documents filed by the other side. The court marks the exhibits accordingly.

        Framing of issues Based on the pleadings filed by both the parties, the documents and the preliminary hearing, the court frames the main issues to be dealt with.

        Discovery (optional) Discovery is the process by which a party may obtain information or documents from the opposing party before trial, through a request from the court. At this stage, depositions, requests for admission and requests for the production of documents, objects and entry may be filed.

       Evidence At the evidence stage, the parties must provide evidence and confirm the veracity and genuineness of the evidence filed by an affidavit under oath. In order to prevail in a civil trial, the plaintiff may introduce competent evidence with respect to each disputed allegation, if already not filed.

       Examination and cross-examination of witnesses The parties’ witnesses give statements under oath which may be questioned by the other party’s counsel. At this stage, an expert witness may be asked to appear before the court to validate the parties’ arguments or his or her own report.

       Final arguments At this stage, each party’s counsel presents its case, with supporting arguments, evidence and precedents. Written arguments or submissions may also be given to the court at its discretion.

       Judgment The court then pronounces its judgment.

22. Defenses available to an alleged infringer

The following defences are available to an alleged infringer:

• Challenge to the title of claimant: Defendants can argue that the claimant is not entitled to sue for infringement due to reasons such as defective title.
• Grounds for revocation.All the grounds available to challenge the validity of a patent are available as grounds for defending an infringement action
• “Gillette” defence.Indian courts recognise the Gillette defence as a valid defence in an infringement action. The defendant can prove that the act complained of was merely what was disclosed in a prior publication (which can also be relied on against the validity of the patent), without any substantial or patentable variation made (Hindusthan Lever Ltd v Godrej Soaps Ltd [1996] AIR Cal 367; Raviraj Gupta v Acme Glass Mosaic Industries (1994) 56 DLT 673). Therefore, either the defendant does not infringe or the patent is invalid, if the patent covers prior art.
• Bolar exemption.India recognises the concept of Bolar exemption and borrows from Bolar provisions under US law. Under section 107A (a) of the Patents Act 1970 the act of making, constructing, using, selling, or importing a patented invention solely for uses related to the development and submission of information required under any law in force in India will not amount to infringement. In Bayer Corporation & Anr. v Union of India & Ors., 2010 (43) PTC 12 (Del), the Division Bench of the Delhi High Court held that a patent owner cannot seek to prevent the Drug Controller General of India from processing applications for licences to manufacture and/or market a generic version of a patented drug (generally referred to as “patent linkage”).
• Parallel import.The import of a patented product by any person duly authorised under the law to produce and sell or distribute this product is not considered to be an infringement.
• Patent applications made before 1 January 2005.Enterprises that have made significant investments and were producing and marketing the product covered by a patent application under the old Patent Act (before 1 January 2005) will continue to manufacture the product even after the grant of a patent. No infringement proceeding can be instituted against these enterprises. A patent holder can only be entitled to receive a reasonable royalty from the enterprises. This provision is applicable until the patent applications that were made before 1 January 2005 are disposed of by the Patent Office.
• Innocent infringement.Although the fact that the defendant was an innocent infringer is not a factor for determining liability, it plays a role in determining whether an account of profits and damages should be granted in favour of the claimant. The Patents Act 1970 expressly states that damages or accounts of profits will not be granted against a defendant that proves that he/she was not aware and did not have reasonable grounds to believe that the patent existed at the date of the infringement.
• Experimental use.Any uses of a patented invention for the sole purposes of experimentation or carrying on research, including for educational purposes, are not considered as acts of infringement.

23. On what grounds can a patent be invalidated?

A patent can be revoked on the following grounds (section 64, Patents Act 1970):

• The invention is claimed in the specification of another patent registered in India.
• The patent holder was not entitled to apply for the patent.
• The patent was wrongfully obtained, in contravention of the rights of the person applying for revocation.
• The subject of the claim is not an invention.
• The invention was anticipated through prior public knowledge, prior use or prior publication in India.
• The invention is obvious or does not involve an inventive step due to prior public knowledge, prior use or prior publication in India.
• The invention is not useful.
• The invention is not sufficiently described.
• The scope of the claim is not defined clearly, or the claim is not based on the matter contained in the specification.
• The patent was obtained as a result of a false suggestion or misrepresentation.
• The subject is not patentable under the Patents Act 1970.
• The invention has been used secretly in India before the date of the claim.
• The applicant has failed to disclose information about foreign applications or has provided materially false information in this respect.
• The applicant has violated certain secrecy obligations or, if a resident of India, has made a foreign application without seeking the permission of the Controller General of Patents.
• Leave to amend the specification was granted fraudulently.
• The specification contains an incorrect indication of source or geographical origin of biological material used for the invention.
• The invention was anticipated through the knowledge of any indigenous or local community in India or elsewhere.

24. Is it possible to amend patent claims during proceedings.

It is possible to amend patent claims during the following types of proceedings:

• Prosecution of a patent application.
• Pre- Grant opposition.
• Post- grant opposition.
• Suit for Infringement or connected counterclaim.
• Revocation proceedings before the Intellectual Property Appellate Board.

25. Current Developments

The IPO has granted a patent in 81 days, under an expedited examination procedure, a time period less than what it is normally required for initial publication in many jurisdictions. This is not only the exception for the IPO, rather there is a significant increase in the percentage of patent applications examined and disposed over the preceding year. Some of the other significant developments are:

• Operationalisation of India- Japan bilateral agreement for expedited patent prosecution.
• The IPO has come up with revised Guidelines for Examination of Computer related Inventions (CRISs) that do away with the complexity associated with determining patentability of the CRIs.
• The IPO has also come up with the Draft Patent Rules 2019 which, apart from streamlining procedures, expands the list of potential applicants that could avail the benefits of expedited examination and/ or start- up status.
• In 2019, the IPO has also come up with the revised Draft Manual of Patent Office Practise and Procedure.
• The IPO adapted WIPO DAS and WIPO CASE systems to facilitate the submission of digitally secure documents within different IP Offices and to release the applicant from the duty of providing documents related to the prosecution of a patent application for participating countries.
• The Supreme Court of India set aside an order of the Division Bench of the Delhi High Court holding a Monsanto’s Patent invalid.
• Madras High Court upholds Kibow’s probiotic Patent.