Indian Patent Law – Intellectual Property Rights Laws and Practices Important Questions

Indian Patent Law – Intellectual Property Rights Laws and Practices Important Questions

Question 1.
With reference to the relevant legal enactments, write short notes on the following :
(i) Company Secretary as a patent agent.
Answer:
A person shall be qualified for a patent agent if the person is

• Citizen of India
• Completed the age of 21 years
• Has obtained a degree in science, engineering, or technology
• Passed the prescribed qualification exams or worked for not less than ten years as an examiner or discharged the functions of the controller. In the light of the above legal provisions, if a Company Secretary who fulfills the above conditions, satisfy the condition then he will be eligible to act as a patent agent.

Question 2.
With reference to the relevant legal enactments,’ write short notes on the following :
(ii) Element of ‘novelty’ in an invention
Answer:
One of the pre-requisite for anything to be regarded as an invention is something having an inventive step. Novelty means anything new or strange which is thus an indispensable part of anything to be construed as.

Question 3.
With reference to the relevant legal enactments, write short notes of the following :
(vi) Contents of the complete specification
Answer:
The specification is the description of the invention. The specification can be provisional or complete. The contents of the complete specification are

1. Describe the invention, its operation, its use, and methods.
2. It must disclose the best method of performing the invention.
3. Ends with a claim defining the scope of the invention.
4. Must provide technical information on the invention.
5. A declaration as to the inventorship of the invention.

Question 4.
With reference to the relevant legal enactments, write short notes on the following:
(iii) Term of patents
Answer:

1. Provisions relating to the term period of patents are covered under section 53 of the Patents Act 1970.
2. The term period of patents is 20 years from the date of filing the application for the patent.
3. However, nonpayment of renewal fees may result in the cessation of the patent.

Question 5.
With reference to the relevant legal enactments, write short notes on the following :
(iv) Restoration of lapsed patents
Answer:
Section 60 to 62 deals with provisions relating to the restoration of lapsed patent, it provides that where the patent has ceased to have effect by reasons of failure to pay any renewal fees within the period prescribed then the patentee may within eighteen months from the date on which the patent ceased to have an effect, make an application for restoration of the patent. If the controller is satisfied that the failure to pay fees was unintentional he may advertise the application. Any person interested may oppose the restoration and after considering the opposition, the controller will make appropriate orders.

Question 6.
With reference to the relevant legal enactments, write short notes on the following:
(v) Patent agent
Answer:
A person shall be qualified for a patent agent if the person is

• Citizen of India
• Completed the age of 21 years
• Has obtained a degree in science, engineering, or technology
• Passed the prescribed qualification exams or worked for not less than ten years as an examiner or discharged the functions of the controller. In the light of the above legal provisions, if a Company Secretary who fulfills the above conditions, satisfy the condition then he will be eligible to act as a patent agent.

Question 7.
With reference to the relevant legal enactments, write short notes on the following:
(v) Inventive step
(vii) General principles applicable to working of the patented invention.
Answer:
(v) Inventive step

• The inventive step has been defined in Section 2(1) (ja) of the Patents Act, 1970.
• Inventive step means a feature of an invention, that involves technical advance as compared to the knowledge or having economic significance or both that makes the invention which is not obvious to a person skilled in the art.

(vii) General principles applicable to working of patented invention Some of the principles applicable to working of the patented invention covered in Section 83 of the Patents Act, 1970 are as under:

• Patents are granted to encourage inventions.
• Patents are not granted to merely enable patentees to enjoy a monopoly.
• Patents granted do not prohibit Central Government from taking measures to protect public health.
• The benefit of the patented invention should be available at reasonable prices to the public.
• Patents granted should act as an instrument to promote public interest especially in sectors of vital importance.
• Patent rights should not be abused by the patentee.

Question 8.
(a) Distinguish between the following :
(iii) ‘Invention’ and ‘patentable invention’ under the Patents Act, 1970.
Answer:
Section 2(j) of the Patent Act defines an invention as to mean a new product, or process involving an inventive step and capable of Industrial application. The term ‘inventive step’ has been defined under the Patent Act as to mean. a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art.

Any invention or technology which has not been anticipated by publication in any document or used in the country or elsewhere in the world before the date of filing of a patent application with complete specification, i.e. the subject matter has not fallen into the public domain or that it does not form part of the state of the art, which is registered with Controller of Patent is a patentable invention.
Section 3 enumerated the list of inventions that are not patentable.

Question 9.
(a) Distinguish between the following :
(iii) ‘Invention’ and ‘patentable invention’ under the Patents Act, 1970.
Answer:
Please refer 2008 – June [3] (a) (iii) on page no. 86

Question 10.
(a) Distinguish between the following :
(iii) ‘Provisional specification’ and ‘complete specification’ under the Patents Act, 1970.
Answer:
A provisional specification is a document, which contains a description regarding the nature of an invention. The description, however, does not contain the details regarding the invention. Also, it does not contain the claims. The provisional specification is filed to claim the priority date of an invention. The advantage of a provisional specification is that it can be filed as soon as the patent is conceived and for the recorded priority date. But the application is only examined after the complete specification has been filed.

Section 9 of the Patents Act, 1970 stipulates that where an application for a patent (not being a convention application or an application filed under PCT designation India) is accompanied by a provisional specification, a complete specification shall be (filed within twelve months from the date of filing of the application, and if the complete specification is not so filed, the application shall be deemed to be abandoned.

The complete specification is the document, which contains a detailed, description of the invention along with the drawings and claims. Also, the description regarding prior art is included in the complete specification. Section 10 dealing with contents of Specifications provides that every specification, whether provisional or complete, shall describe the invention and begin with a title sufficiently indicating the subject matter to which the invention relates. Every complete specification is required to

1. fully and particularly describe the invention and the operation or use and I the method by which it is to be performed;
2. disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim protection;
3. end with a claim or claims defining the scope of the invention for which protection is claimed; and
4. be accompanied by an abstract to provide technical information on the invention.

Question 11.
(a) Distinguish between the following:
(iii) ‘Patent’ and ‘patent of addition’.
Answer:

• Patent means a patent granted under the Patent Act, 1970.
• A patent is a grant from the government that confers on the grantee, for a limited period of time, the exclusive privileges of making, selling, and using the invention for which the patent has been granted and also of authorizing others to do so.
• A patent gives its owner a monopoly right to make & sell the subject matter of the patent for a defined period of time.

Patent of addition:

• Patent of Addition is a patent for an improvement in, or modification of an invention for which invention, a patent has already been applied for or granted.
• A patent of addition will remain in force as long as the patent for the original invention remains in force.

Question 12.
(a) Distinguish between the following :
(iv) ‘Patent’ and ‘patent of addition’.
Answer:
Please refer 2010 – June [3] (a) (777) on page no. 88

Question 13.
(a) Distinguish between the following:
(iii) ‘Invention’ and ‘patentable invention’.
Answer:
Please refer 2008 – June [3] (a) (iii) on page no. 87 .

Question 14.
(a) Distinguish between the following:
(ii) ‘Surrender of a patent’ and ‘revocation of a patent ‘ under the Patents Act, 1970.
Answer:
Surrender of patents:

• A surrender of patents has been provided in Section 63 of the Patents Act, 1970.
• As per the provisions of the Act, the patentee of the patentee can offer to surrender his patent, at any time by giving notice to the controller.
• The Controller shall publish the offer in the prescribed manner, once the offer is made by the patentee.
• Any person within the prescribed period after such publication may give notice of opposition to the controller.
• If the controller is satisfied after hearing the patentee & any opponent, he may accept the offer & by order revoke the patent.

Revocation of Patents:

• ‘Revocation of patents’ has been covered in Section 64 of the Patents Act, 1970.
• As per the provisions of the Act, a patent may be revoked by any person, Central Government.
• If the Central Government is satisfied that a patent is for an invention relating to atomic energy for which no patent can be granted, it may direct the controller to revoke the patent.

Question 15.
Attempt the following :
(ii) Explain the provisions of the Patents Act, 1970 regarding the restoration of lapsed patents.
Answer:
Please refer 2010- Dec [1 ] [C] (iv) on page no. 84

Question 16.
(a) Mention any five inventions which are not patentable under the Patents Act, 1970.
Answer:
Inventions not patentable under The Patents Act, 1970
Section 3 of the Patents Act, 1970 provides that the following are not inventions and hence not patentable:

• 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 a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any property or mere 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 or employs at least one new reactant;
• a substance obtained by a .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 the 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 micro¬organisms but including seeds, varieties, and species and essentially biological processes for production or propagation of plants and animals;
• a computer program per se other than its technical application to industry or a combination with hardware;
• 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 the game;
• a presentation of information;
• 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 components or components.

Section 4 prohibits the grant of patent in respect of an invention relating to atomic energy falling within Sub-section (1) of Section 20 of the Atomic Energy Act, 1962.

Question 17.
(a) Mention five important grounds for opposition to the grant of patents.
Answer:
Section 25 provides that any person, can apply for the opposition of grant of a patent on the following ground:

1. That the applicant had wrongfully obtained the whole or part of invention 1 from him or the person from whom he claims.
2. That the invention has been published before the priority date of the claim.
3. That the invention claimed is publicly known or used.
4. That the invention claimed does not involve any inventive step.
5. That the invention is not patentable under the Act.
6. That the complete specification does not describe the invention properly.
7. That the complete specification is provided after the specified time.

Question 18.
Client XYZ has approached you for getting a patent on a drug for curing insomnia. What are the steps involved ¡n registering the patent? Describe with examples.
Answer:

1. Prior art on the subject must be examined to find out the “novelty”. Patent searches have to be organized.
2. Similarly, the innovative part has to be seen along with .with usefulness.
3. Disclosures and publication of the discovery must be in place.
4. Claims must be prepared along with detailed specifications, drawings, and manufacturing process.
5. The drug must also be physically available to establish its identity.
6. The patent office will examine the claims and publish the results for objections.
7. Finally, the patent will be granted and duly registered.

Question 19.
‘There are two kinds of opposition in the grant of patent.’ Discuss the provisions of Pre grant opposition and procedure followed in such situation as per the Patent legislation.
Answer:
There are two types of opposition to the grant of a patent as per the Patent Amendment Act, 2005. They are:

• Pre-Grant Opposition
• Post-Grant Opposition.

Pre-Grant Opposition
Section 25 of the Act deals with opposition to the grant of a patent and provides that where an application for a patent has been published but a patent has not been granted, any person may, in writing, represent by way of opposition to the Controller against the grant of a patent on the following grounds and the Controller on request of such person shall hear him and dispose of the representation in the prescribed manner and specified time. The grounds of the Pre-Grant opposition are as follows :

(1) That the applicant for the patent or the person under or through whom he claims, wrongfully obtained the invention or any part thereof from him or from a person under or through whom he claims;

(2) That the invention so far as claimed in any claim of the complete specification has been published before the priority date of the claim –

1. In any specification filed in pursuance of an application for a patent made in India on or after the 1 st day of January 1912; or
2. In India or elsewhere, in any other document:
   Provided that the ground specified in sub-clause (ii) shall not be available where such publication does not constitute an anticipation of the invention by virtue of sub-section (2) or sub-section (3) of section 29;

(3) That the invention so far as claimed in any claim of the complete specification is claimed in a claim of a complete specification published on or after the priority date of the applicant’s claim and filed in pursuance of an application for a patent in India, being a claim of which the priority date is earlier than that of the applicant’s claim;

(4) That the invention so far as claimed in any claim of the complete specification was publicly known or publicly used in India before the priority date of that claim.

Explanation:
For the purposes of this clause, an invention relating to a process for which a patent is claimed shall be deemed to have been publicly known or publicly used in India before the priority date of the claim if a product made by that process had already been imported into India before that date except where such importation has been for the purpose of reasonable trial or experiment only;

(5) That the invention so far as claimed in any claim of the complete the specification is obvious and clearly does not involve any inventive step, having regard to the matter published as mentioned in clause (b) or having regard to what was used in India before the priority date of the applicant’s claim;

(6) That the subject of any claim of the complete specification is not an invention within the meaning of this Act, or is not patentable under this Act;

(7) That the complete specification does not sufficiently and clearly describe the invention or the method by which it is to be performed;

(h) That the applicant has failed to disclose to the Controller the information required by section 8 or has furnished the information which in any material particular was false to his knowledge

(8) That in the case of convention application, the application was not made within twelve months from the date of the first application for protection for the invention made in a convention country by the applicant or a person from whom he derives title;

(9) That the complete specification does not disclose or wrongly mentions the source or the geographical origin of biological material used for the invention;

(10) That the invention so far as claimed in any claim of the complete specification is anticipated having regard to the knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere.

The grounds for both pre and post-grant opposition are identical and there is nothing to preclude a pre-grant opponent from subsequently filing a post-grant opposition. However, despite the similarities, there are also several procedural differences between the two types of opposition. The primary difference between pre-grant and post-grant opposition is that though pre-grant proceedings may be initiated by “any person”, but only a “person interested” can institute a post-grant opposition.

The Indian Patents Act defines a “person interested” as including a person engaged in, or in promoting, research in the same field as that to which the invention relates. Moreover, the Indian Patents Act does not explicitly allow the opponent to be heard in a pre-grant opposition. The opponent has to make a request for a hearing and the rules do not detail how a hearing is to be conducted. The opponent’s right to be heard solely depends upon the discretion of the Controller, who decides the same based upon the merit of the opposition. Additionally, the rules are also not clear whether the opponent will be heard in the presence of the applicant.

Opposition Proceedings
Rule 55 dealing with opposition by representation against the grant of a patent requires the representation for opposition under section 25(1) to be filed at the appropriate office within a period not exceeding three months from the date of publication of the application under section 11A of the Act, or before the grant of a patent, whichever is later and includes a statement and evidence, if any, in support of the representation and a request forbearing if so desired.

The Controller has been empowered to consider such representation only when a request for examination of the application has been filed. On consideration of the representation, if the Controller is of the opinion that application for patent shall be refused or the complete specification requires amendment, he shall give notice to the applicant to that effect. On receiving the notice the applicant shall, if he so desires, file his statement and evidence if any in support of his application within one month from the date of the notice.

On consideration of the statement and evidence filed by the applicant, the Controller may either refuse to grant a patent on the application or require the complete specification to be amended to his satisfaction before the patent is granted. After considering the representation and submission made during the hearing if so requested, the Controller shall proceed further simultaneously either rejecting the representation and granting the patent or accepting the representation and refusing the grant of a patent on that application, ordinarily within one month from the completion of above proceedings.

In the case of Novartis Ag v. Natco Pharma Ltd. on 25 January 2006, an application for the patent was filed in India on 17th July 1998 by Novartis AG, Switzerland, claiming Switzerland’s priority date of 18th July 1997. Upon publication, the grant of the patent was opposed by Natco Pharma Ltd., India on 26,h May 2005.

The grounds for opposition were:

• Anticipation by prior publication
• Lack of inventive step
• Non-patentability under section 3(d)
• Wrongfully claiming the priority

The title compound was already known in a US patent (filed in 1993). The US patent claimed a pharmaceutically acceptable salt of the base compound. Another Document, “Nature Medicine” (5th May 1996) also described the title compound. Also, the claimed salt inherently existed in the most stable form of salt. Hence, the claims of the application for the product and process in respect of the title compound stood anticipated by prior publications.

Additionally, based on section 3(d) the product claim amounted to a mere discovery of the new form of the known substance. Further, the application had claimed Swiss priority, but Switzerland was not a convention country on the date of filing in Switzerland. Hence, no priority of Swiss application could be claimed in respect of the Indian application. In view of the above findings and arguments, the Controller ruled that the above patent application cannot proceed for grant of patent.

Question 20.
To qualify for the grant of a patent under the Patents Act, 1970, the invention must be non-obvious. But determining whether an invention is non-obvious is one of the most difficult tasks in patent law. Discuss.
Answer:
For the purposes of grant of a Patent to an invention, determining as to whether an invention is non-obvious or not, i.e. determining whether it involves an inventive step or not, is one of the most difficult tasks in the Patent law. The mere coalition of two or more things without the exercise of inventive ingenuity is not a subject matter for a patent. It is an invention if the process or manufacture of an article requires some ingenuity or has an inventive step.

However, simplicity is not necessarily an objection to securing a patent for an invention. Even if the product and/or the process may be perfectly simple and very common, yet there may be an invention, if the inventor has developed a variant, which will render it more useful. After all, a disposable razor, a safety pin, and a retractable tape measure all seem obvious now, yet none of these items were obvious at the time they were invented. The point of view from which it needs to be ascertained as to whether a particular invention is ‘non-obvious’ or not is that of a person skilled in the particular art to which the invention relates.

An invention which has an inventive step, however small, but having regard to the condition of the state-of-the-art in-the particular field on the date of filing or the priority date of the application for patent, whichever is earlier constitutes a step forward and maybe a subject matter for a patent. Thus, one must review the score and content of the prior art existing in the particular field to determine if the invention is non-obvious. Secondly, consideration must be given to the differences or enhancement carried out between the Prior Art and the Invention at hand. Thirdly, as already stated, if the invention would be obvious to a person having primary skill in the art to which the invention pertains, it cannot be patented.

The Supreme Court in the case of Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries interpreted the term inventive step. In this case, the Court opined that ‘obviousness’ has to be strictly and objectively judged. The test laid down by the Court to determine obviousness was: ‘Had the document been placed in the hands of a competent craftsman (or engineer as distinguished from a mere artisan), endowed with the common general knowledge at the ‘priority date’, who was faced with the problem solved by the patentee but without knowledge of the patented invention, would he have come up with the invention in question

Simply put, according to the test, what has to be determined is whether at the time the invention was made, any other person skilled in the same field as the invention could have come up with the same invention if faced with the same problem.

Question 21.
Many life-saving drugs are patented by multinational pharmaceutical companies and many times there is a shortage of these medicines in the market. In this context explain the working of the patented invention and can government issue license for the protection of the general public.
Answer:
Section 83 of the Patents Act, 1970 deals with general principles applicable to working of Patented Invention. It provides that in exercising the powers conferred for working of Patents and Compulsory Licenses, regard shall be had to the following general considerations, namely:

(1) That patents are granted to encourage inventions and to secure that the inventions are worked in India on a commercial scale and to the fullest extent that is reasonably practicable without undue delay;

(2) That they are not granted merely to enable patentees to enjoy a monopoly for the importation of the patented article;

(3) That the protection and enforcement of patent rights contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations;

(4) That patents granted do not impede protection of public health and nutrition and should act as an instrument to promote public interest especially in sectors of vital importance for socio-economic and technological development of India;

(5) That patents granted do not in any way prohibit Central Government in taking measures to protect public health;

(6) That the patent right is not abused by the patentee or person deriving title or interest on patent from the patentee, and the patentee or a person deriving title or interest on patent from the patentee does not resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology;

(7) That patents are granted to make the benefit of the patented invention available at reasonably affordable prices to the public.

Compulsory Licenses
The provisions for Compulsory Licenses are made in the Patents Act, 1970 to prevent the abuse of grant of Patent as a monopoly and to make the way for commercial exploitation of the invention by any interested person. According to Section 84 of the Patents Act, 1970, any person interested can make an application for grant of a compulsory license for a Patent after three years from the date Of grant of that Patent on any of the following grounds:

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

An application for Compulsory License may be made by any person notwithstanding that he is already the holder of a license under the Patent and no person shall be estopped from alleging that the reasonable requirements of the public with respect to the patented invention are not satisfied or that the patented invention is not worked in the territory of India or that the patented invention is not available to the public at a reasonably affordable price by reason of any admission made by him, whether in such a license or otherwise or by. reason of his having accepted such a license.

Thus, while law confers some exclusive monopoly rights upon the individuals (Patent Holders) in respect of their inventions as a credit or reward for the time, efforts, and capital spent by them in coming up with such an invention, it equally draws a balance by making provisions thereby ensuring that grant of such a right does not run counter to the interest of society / general public and thus in case there is a shortage of any life-saving drug which is a subject matter of Patent by a Multinational Corporation, the Government is entitled to direct such Patent Holder or itself grant the right to a potential player to carry on production of such life-saving product to ensure that there is no short supply of it in the public.

Question 22.
(a). Ajit developed a method of hedge against price fluctuation in the energy market. He used a simple concept of mathematics and a familiar statistical approach to achieve the above purpose. Ajit termed it as an innovative procedure to calculate the risk at this competitive time. Advise him on the patentability of his innovation (6 marks)
Answer:
As per the Patents Act, 1970 the condition of patentability has to be satisfied. The criteria are threefold, i.e., Novelty, Inventive Step and Industrial Applicability. However, section 3 of the Act list out the invention’s nonpatentable subject matter.

Section 3 (k) provides that mathematical or business methods or a computer program perse or algorithms are not inventions and therefore not patentable. Mathematical methods are considered to be the act of mental skill. A method of calculation, formulation of equations, finding square roots, cube roots and all other methods directly involving mathematical methods are therefore not patentable.

With the development in computer technology, mathematical methods are used for writing algorithms and computer programs for different applications and the claimed invention is sometimes camouflaged as one relating to the technological development rather than the mathematical method itself. A mathematical method is one which is carried out on numbers and provides a result in numerical form and not patentable.

If low-quality business methods or mathematical methods are allowed to be patentable, it may damage the public perception of the patent system. It may create enormous monopoly power much more than the cost of so-called invention. In the given problem since it is a simple concept of mathematics and familiar

Question 23.
Sitca Healthcare (hereinafter referred as ‘Applicant’) filed a divisional patent application on 11,h May, 2007 numbered as 00077/NP/2007 for an invention “CRYSTAL MODIFICATION OF ACTIVE PHARMACEUTICAL INGREDIENT’ for the patent application number 00072/N P/2007 having German Priority patent application number 1404/97dated 10th June, 2003.

It was observed during the substantial examination that claims 1-10 of parent application were reproduced verbatim in the claimed invention as claims 1-10. If the subject matter of any claimed invention relates to more than one invention, applicant can file further application any time before the grant of patent u/s 16(1) of the Patents (Amendment) Act, 2005.

Since claims of the claimed invention and claims of the parent application are verbatim, hearing was offered to the applicant to decide the allowability of divisional status to the claimed invention u/s 16 of the Act. The Applicant replied that the Controller can offer hearing for deciding the divisional status only after sending a gist of objections to the applicant and giving him an opportunity to file a reply. He further stated that the Controller cannot decide the divisional status unless examined and passed through sections 12,14 and 15 of the Patents Act. There is no such direction or any other guiding principle laid down in the Act as to how a Controller should proceed with divisional status of an application.

The Controller observed that application shall define distinct subject matter when compared with claims of parent Application, which is first and foremost requirement to qualify as divisional application u/s 16 of the Act. Once claims of the claimed invention fulfil the requirement forthe divisional application u/s 16, it can be further allowed for substantial examination, which will save time and effort of the patent administration and also it is logical to approach as well. Since the subject matter of claims 1 -10 is verbatim with claims 1 -10 of the parent application, there is no need for conducting a substantial examination to assess the novelty, inventive step and other patentability criteria for the present application.

The applicant claims the same set of claims submitted in the parent application in different multiple further applications. The Controller further observed that the reason for filing such a divisional application is to prosecute once again the same set of claims already claimed in the abandoned parent application and also to extend the life of the application.

If the subject matter of claims of the further application is not distinct with the claims of the parent application, the divisional status shall not be granted. It is, therefore, wilful attempt to obtain multiple patents for a single subject matter through many further applications by misusing the provision of section16 of the Act. Even though each and every component of the claims 1-10 of the divisional application is verbatim with the claims 1-10 of parent case, the intention of the applicant by hook or crook is to extend the life of the application utilizing divisional route, that too, on the last date of submitting a reply to first examination report (FER) of the parent case.

There were 10 claims at the time of filing the claimed invention where claims 1-9 related to ‘modification A of the compound’1-(2, 6-difluorobenzyl) – 1H- 1,2,3-triazole-4-carboxamide (namide)’ (hereinafter referred as ‘product Claims’) and claim 10 related to a pharmaceutical preparation.

On 15th July 2011, the applicant amended originally filed 10 claims into 12 claims by filing Form-13 u/s 57 and u/s 81(1) of the Act and Rules. The applicant amended ‘modification A of the compound name in all the claims 1-10 into ‘crystal modification A of the compound named and also added two new claims relating to ‘method of preparing A of the compound named which is neither claimed in the International application nor in the National Phase application.

In response to the FER, the applicant further amended claim 11 by incorporating many additional features including identity and quality of the solvent for recrystallization, filtration conditions necessary to generate a suspension with initial crystal, stirring time, and temperature. The patent application was opposed by way of pre-grant representation u/s 25(1) of the Act, by Indian Pharmaceutical Alliance, a Society registered under Societies Registration Act, 1860 (hereinafter referred as ‘Opponent’). After the hearing notice was served, the Applicant further amended all the ‘product claims’ into ‘21 method claims as a method for preparing crystal modification A of the compound named. In the earlier amendment, the applicant introduced new matter in claims 11 & 12 ‘method of preparing A of the compound named but the later amendment converted all the claims into ‘method for preparing crystal modification A of the compound name, the principal claim.

The applicant submitted a set consisting of 13 method claims which they desired to rely on during the hearing, (hereinafter referred to as ‘amended claims’). The patent agent for the applicant submitted that Rule 55 (5) of the Patents Rules, 2003 gives power to the Controller to require the complete specification to be amended to his satisfaction during the opposition, before proceeding to refuse the application. The patent agent for the applicant submitted that amendment of claims is a primary right conferred upon the applicant by the Patents Act and it is possible to amend the claims to avoid overlapping with the citations, and the Controller should require the same rather than proceeding to reject the application. It is further submitted that the amended claims on file now fall well within the scope of Section 59.

The patent agent submitted that it is well-accepted fact that ‘product claims’ cover in its scope the process of its manufacture as well and therefore the amendment made to claims of this application satisfies Section 59 of the Act in that the amendment is made by way of ‘disclaimer1 wherein the scope of the product is disclaimed and the claims are now restricted to the process of its preparation. Also that the scope of the claims is not extended and no new subject matter is added. The process claims are well supported by the description especially on page 2 and last 3 lines, page 3 and 2nd para, and in examples 1,2, 3, 4, and 5.

Keeping the above in view, prepare your arguments for opponents of the patent, covering division of patent, right of opposition under the Patents Act, and the legal provisions applicable to modification of specification.
Answer:
Issues in the present case

1. Can the Applicant Impose, upon Controller to have and accept the division application?
2. Does the applicant have the right to amend the patent specification and how?
3. Can the applicant amend the specification by replacing product claims into process claims in compliance with the provisions of the Patent Act 1970?

The opponents would respectfully like to draw the kind attention of the Learned Controller towards the following findings and facts in the matter of the finally amended claims. Section 16 of Patent Act, 1970 dealt with the power to Controller to make orders respecting the division of application. A person who has made an application for a patent under this Act may, at any time before the grant of the patent, if he so desires, or with a view to remedying the objection raised by the controller on the ground that the claims of the complete specification related to more than one invention, file a further application in respect of an invention disclosed in the provisional or complete specification already filed in respect of the first-mentioned application.

Since claims of the claimed invention and claims of the patent application are verbatim. There is no such direction or any other guiding .^principle laid down in the Act, as to how the controller should proceed with the divisional status of an application. The further application shall define distinct subject matter when compared with claims of parent application, which is the first and foremost requirement to qualify as divisional application u/s 16 of the Act.

Applicant cannot claim the same set of claims claimed in the parent application in different multiple further applications. It is observed that the reason for filing such a divisional application is to prosecute once again the same set of claims. If the subject matter of claims of the further application is not distinct from the claims of the parent application, the divisional status shall not be granted.

The case of LG Electronics Inc. Vs Controller of Patents, Hon’ble Intellectual Property Appellate Board (IPAB) held that the applicant cannot take undue advantage of Section16 for extending to prosecute the same subject matter. Section 57 deals with the Amendment of application and specification or any document relating thereto before the Controller.

1. Subject to the provisions of Section 59, the Controller may, upon application made under this section in the prescribed- manner by an applicant for a patent or by a patentee, allow the application for the patent or the complete specification or any document relating thereto to be amended subject to such condition, if any as the Controller thinks fit: Provided that the Controller shall not pass any order allowing or refusing an application to amend an application for a patent or a specification or any document relating thereto under this section, while any suit before a Court the infringement of the patent or any proceeding before the High Court for the revocation of the patent in pending, whether the suit or proceeding commenced before or after the filing of the application to amend.

2. Every application for leave to amend an application for a patent or a complete specification or any document relating thereto under this section shall state the nature of the proposed amendment and shall give full particulars of the reasons for which the application is made.

3. Any application for leave to amend an application for a patent or a complete specification or a document related thereto under this section made after the grant of patent and the nature of the proposed amendment may be published.

4. Where an application is published under sub-section (3), any person interested may, within the prescribed period after the publication thereof, give notice to the Controller of opposition thereto and where such a notice is given within the period aforesaid, the Controller shall notify the person by whom the application, under this section is made and shall give to the person and to the opponent, an opportunity to be heard, before he decides the case.

5. An amendment under this section of a complete specification may be or include, an amendment of the priority date of a claim.

6. The provisions of this section shall be without prejudice to the rights of an applicant for a patent to amend his specification or any other document related thereto comply with the directions of the Controller issued before the grant of a patent.

In general amendments to patents and application are governed by Section 57 of The Indian Patents Act, which stipulates that the applicant should state the nature of the proposed amendment and shall give full particulars of the reasons for which the amendment is made without the addition of new subject matter. The applicant of subject application has never stated in their reply why they wish to amend the claims and applicant addition of the claims which are not filed initially or originally can not be allowed.
Therefore, the new final set of claims was filed.

Section 59 provides Supplementary provisions as to amendment of application or specification.

1. No amendment of an application for a patent or a complete specification or any document relating thereto shall be made except by way of disclaimer correction or explanation and no amendment thereof shall be allowed except for the purpose of incorporation of actual fact and no amendment of a complete specification shall be allowed, the effect of which would be that the specification as amended would claim or describe matter, not in substance disclosed or shown in the specification before the amendment, or that any claim of the specification as amended would not fall wholly within the scope of a claim of the specification before the amendment.

2. Where after the date of grant of patent any amendment of the specification or any other documents related thereto is allowed by the Controller or by the Appellate Board or the High Court, as the case may be.

• The amendment shall for all purposes be deemed to form part of the specification along with other documents related thereto;
• The fact that the specification or any other documents related thereto has been amended shall be published as expeditiously as possible; and
• The right of the applicant or patentee to make amendment shall not be called in question except on the ground of fraud;

3. In construing the specification as amended, reference may be made to the specification as originally accepted.
Section 59 is quite clear that first whatever amendments made by the applicant shall fall within the scope of a claim of the specification before the amendment.

Further, no amendment shall be made except by way of disclaimer, correction, or explanation and no amendment thereof shall be allowed, except for the purpose of incorporation of actual fact. Now question is that the weather, the further addition of the claims which have not been filed initially or originally can be allowed.

Further, According to the Intellectual Property Appellate Board (IPAB) decision (Order No. 189/201, M/s Diamcad N V Vs. The Assistant . Controller of Patents and Design, Chennai) dated 3rd August 2012, amendment of claims which is not within the scope of the claimed filed initially are not allowed.

Therefore, the present set of claims which are different and additions over the claims as originally filed cannot be allowed in accordance with the provisions of Section 57 and 59 of the Indian Patent Act 1970.

Hence it is respectfully submitted that the subject application should be straight away rejected on the basis of the non-compliance with the mandatory provisions of Section 57 of the Indian Patent Act for not providing reasons for the amendment.

Also, Section 59 provides that no effect of amendment can be given of any part of the specification including claims if the amended matter would not fall wholly within the scope of the original claims filed.

Question 24.
Sorafenib Tosylate is a compound patented by Bayer Corporation (Bayer), a renowned USA-based developer and manufacturer of innovative drugs. It is marketed as NEXAVAR (the Drug) and is used in the treatment of advanced stages of kidney cancer and liver cancer. The drug is a life-extending drug and not a life-saving drug. It can increase the life of a kidney cancer patient by 4-5 years and that of a liver cancer patient by 6-8 months.

Bayer was granted a patent as well as regulatory approval for importing and marketing the Drug in India in the year 2008. Bayer does not hold manufacturing approval in Indian but has only a marketing and import license. Natco Pharma (Natco) filed an application in July 2011 under section 84(1) of the Patents Act, 1970 for grant of Compulsory Licence (CL) in respect of Sorafenib Tosylate covered under Bayer’s patent. In its application, Natco proposed to se|l the drug at a price of INR 8,800 (about USD 175) for one month of therapy as against Bayer’s INR 2,80,428 (about USD 5,600) for one month therapy.

The Controller of Patents (Controller), upon noting that 3 years had elapsed since the grant of patent and being satisfied that a prima facie case existed, issued an order for publishing the CL application in the official journal. Upon this, Bayer filed its opposition to the CL application. Each party filed its respective evidence. The parties were given a hearing by the Controller.

Natco urged that as per GLOBOCAN 2008, there were 20,000 patients of liver cancer and 8,900 cases of kidney cancer in India. Assuming 80% of patients needed the Drug treatment, approximately 23,000 patients required the Drug. According to the Form – 27(statement of working of Patents) filed by Bayer, they imported no units in 2008 and approximately 200 bottles in 2009 and no further units in 2010. Hence, the reasonable demand or requirement of the public was not being met. Natco argued that Bayer did not manufacture the Drug in India but imported it and that it was exorbitantly priced and usually out of stock and available only in pharmacies attached to a few hospitals in metro cities. Bayer launched the product worldwide in 2006 and made thumping sales to the tune of USD 2,454 million dollars. Thus, the insignificant number of bottles imported in India showed Bayer neglectful conduct.

Bayer responded by demonstrating that the actual number of patients of kidney and liver cancer requiring treatment was 8,842 and not 23,000. The Drug was being made available by Bayer to all cancer treatment centers in India. This objection was dismissed by the Controller on the basis that as per Form-27 filed by Bayer at the Patent Office, Bayer had imported grossly inadequate quantities of NEXAVAR in the previous 3 years, which was ample material that a prima facie case had been made out. Furthermore, the Controller observed that the number of patients needing the Drug would be much higher than 8,842 and that as per Bayer’s own numbers they had been able to supply the Drug to not more than 200 patients which is a mere 2% of the 8,842 patients who, according to Bayer’s own estimate needed the Drug. He ruled that Bayer’s conduct was not justifiable as it was already marketing the drug worldwide since 2006.

The next argument advanced by Natco was that the price of the patented product was too high and therefore, the patented invention was not available to the public at reasonably affordable prices. The exorbitant pricing was an abuse of its monopolistic rights and amounted to unfair and anti-competitive practice. Bayer countered this by contending that innovative drugs cost significantly more than generics since the innovator’s costs included R&D expenses which generics did not incur as they merely copied the drugs. The higher price included the costs of failed projects also which accounted for nearly 75% of total R&D cost. According to Bayer, it took an investment of more than €2 billion to bring a new medical entity (NME) to the market.

Also, the price being charged by Bayer was comparable to other oncology drugs of innovation-based companies. Replacing innovative drugs with generics would in the long – run damage, patients as originators also provided for the education of doctors and pharmacovigilance which generics did not. Only the patentee, being the innovator and having invested in the R&D would be able to determine what would constitute a ‘reasonably affordable price’ for the Drug. The term ‘reasonable’ should be construed as to mean reasonable for both the patients and the patentee and a ‘reasonable’ price is needed to factor in R&D costs and reasonable commercial gain.

Bayer argued that ‘public’ denoted different sections of the public – rich class, middle class, and poor class. A blanket CL-that gave the patented product at the same price to all sections of the public was not reasonable, amounted to treating ‘unequal as equal’, and was discriminatory. A CL would lower the price of a patented product even for people who could pay – which could not be the intention of the Legislature. One of the ways by which people afford medical treatment is medical insurance. ‘Affordability’ should be determined by asking whether the patient could afford insurance coverage or not. ‘ The Controller in his decision agreed with Bayer that public included different sections of the public, but also observed, that Bayer was free to have offered differential pricing to different classes, but chose not to. The Controller partially disagreed with Bayer that in determining reasonableness, both the Patentee and the public needed to be factored in, but observed that “reasonably affordable price has to be construed predominantly with reference to the public”.

The Controller added that the sales by Bayer during the previous 4 years constituted only a fraction of the requirement of the public and came to the conclusion that lower sales had been due to the high price of the patented product. Therefore, the Controller held that the Drug was not available to the public at a ‘reasonably affordable price’. Natco advanced another argument that the patented invention was not worked by Bayer in the territory of India. Natco pointed out to the Controller that since the Drug was being imported, it was not being commercially worked in India. Bayer responded by contending that the ‘working’ requirement of

Section 84(1 )(c) of the Patents Act, 1970 did not mean that the patented product had to be locally manufactured. According to Bayer ‘working’ of a patent would mean that there should be a supply of the patented product in the territory of India. Bayer also argued that it had centralized its manufacturing in Germany for reasons of economies of scale and for maintaining high quality.

The Controller relied on the Paris Convention, TRIPS Agreement, the unamended Patents Act of 1970, and in particular Sections 84(7), 83(b) and 90(2) thereof to come to the conclusion that importation would not amount to working of a patented product. He observed that the term ‘work the invention’ did not include imports as a CL holder had to necessarily work the patent by manufacturing the patented invention in India.

The Controller granted a non-exclusive and non-assignable CL to Natco, solely for the purpose of making, using, offering to sell and selling the Drug for the purpose of treating kidney and liver cancer patients within the territory, of India, adding that the Drug would have to be manufactured by Natco in its own manufacturing facility only and not outsourced.

Thereafter, Bayer filed an appeal challenging the order of the Controller before the Intellectual Property Appellate Board (IPAB). The IPAB, in March 2013, dismissed the appeal and upheld the decision of the Controller. However, in the order, IPAB raised the rate of royalty to be paid by Natco to Bayer from 6% to 7%. Bayer challenged IPAB’s order before the High Court of Bombay by way of a writ petition.

The High Court examined the relevant provisions of the Act and upheld IPAB’s order and ruled that in respect of medicine the adequate extent for meeting the demand of the drug should be 100%. It further held that dual pricing could be applied to meet the requirement of the public and not for making available the drug at a reasonably affordable price.
In the light of the aforesaid case and the relevant provisions of the Indian Patent Act (as amended), answer the following:

1. Under what circumstances can CL be granted?
2. In considering the application for CL, what factors are required to be taken into account by the Controller?
3. While settling the terms and conditions of a CL, what factors does the controller secure?
4. Is manufacture in India the sole method of working a patent in the territory of India? Do you agree with the Controller’s decision on this question?
5. Under what exceptional circumstances can CL be granted for the export of patented pharmaceutical products?

Answer:
(1) The provisions for compulsory licenses are made to prevent the abuse of patent as a monopoly and to make the way for commercial exploitation of the invention by an interested person. According to Section 84 of the Patents Act, 1970, any person interested can make an application for grant of a compulsory license for a patent after three years from the date of grant of that patent on any of the following grounds:

• that the reasonable requirements for the public with respect to the patented invented have not been satisfied or
• that the patented invention is not available to the public at a reasonably affordable price or
• that the patented invention is not worked in the territory of India.

An application for a compulsory license may be made by any person notwithstanding that he is already the holder of a license under the patent and no person shall be estopped from alleging that the reasonable requirements of the public with respect to the patented invention are not satisfied or that the patented invention is not worked in the territory of India or that the patented invention is not available to the public at a reasonably affordable price by reason of any admission made by him, whether in such a license or otherwise or by reason of his having accepted such a license.

The Controller on being satisfied that the reasonable requirements of the public with respect to the patented invention have not been satisfied or the patented invention is not worked in the territory of India or the patented invention is not available to the public at a reasonably affordable price may grant a license upon such terms as he may deem fit.

(2) The factors which are required to be taken into account by the Controller while considering the application for Compulsory Licence are as under:

• the nature of the invention, the time which has elapsed since the sealing of the patent, and the measures already taken by the patentee or any licensee to make full use of the invention.
• the ability of the applicant to work the invention to the public advantage;
• the capacity of the applicant to undertake the risk in providing capital and working the invention, if the application were granted.
• as to whether the applicant has made efforts to obtain a license from the patentee on reasonable terms and conditions and such efforts have not been successful within a reasonable period as the Controller may deem fit.

Still, the Controller is under no obligation to take into account matters subsequent to the making of the application. It has been clarified that the reasonable period shaH be construed as a period not ordinarily exceeding a period of 6 months.

(3) Section 90 of Patents Act, 1970 provides that in settling the terms and conditions of a compulsory license, the Controller shall endeavor to secure that:

• the royalty and other remuneration, if any, reserved to the patentee or other person beneficially entitled to the patent, is reasonable having regard to the nature of the invention, the expenditure incurred by the patentee in making the invention; or in developing it and obtaining a patent and keeping it in force and other relevant factors;
• the patented invention is worked to the fullest extent by the person to whom the license is granted and with reasonable profit to him;
• the patented articles are made available to the public at reasonably affordable prices;
• the license granted is a non-exclusive license;
• the right of the licensee is a non-assignable;
• the license is for the balance term of the patent unless a shorter term is consistent with the public interest;
• the license is granted with a predominant purpose of supply in the Indian market and the licensee may also export the patented product if need be in accordance with Section 84 (7) (a) (iii) of the Act.
• in the case of semiconductor technology, the license granted is to work the invention for public non-commercial use.
• in case the license is granted to remedy a practice determined after the judicial or administrative process to be anti-competitive, the licensee shall be permitted, if need he, to export the patented product.

Section 90 (2) provides that no license granted by the Controller shall authorize the licensee to import the patented article or an article or substance made by a patented process from abroad where such importation would, but for such authorization, constitute an infringement of the rights of the patentee.

(4) The Controller is of the view that the patented product will be considered to be worked in India only if the patentee manufactures the patented product in India within a reasonable time. But an issue arises as to whether the import of a patented product can also be considered, as working the patent in the territory of India.

Article 27 of the TRIPS provides that there would be no discrimination in respect of patented products whether legally manufactured or imported. The same view is also apparent from Form 27 prescribed under the Act and the Patent Rules. The patentee has to file a statement in Form 27 with the Controller regarding the working of the patent in India. In the aforesaid form the patentee while giving details of working of the patented drug in India, has to make a declaration of working in India of the patented product under two classifications namely manufacture in India and imported from other countries.

The working of a patented invention in the territory of India has to be considered by reading Section 83 of the Act which provides for legislative guidelines to predict the meaning of the words “worked in the territory of India”. The following guidelines of Section 83 are germane to the discussion:

• the patent is not granted to enable the Patentee to enjoy a monopoly for the importation of the patented article;
• the technological knowledge must be transferred and disseminated to the mutual advantage of producers and users of technological knowledge;
• the patent right should not be abused by the patentee by indulging in activities that unreasonably restrain trade or adversely affect the international transfer of technology.

The legal position is that the patentee is required to make some efforts to manufacture the patented product within the territory of India. Manufacture in India is not the sole method of working a patent in India. A patent can be worked in India by importing the patented article in adequate quantity and supplying it. Still, working by import can be accepted only after the patentee provides satisfying reasons for not manufacturing the patented product in India.

(5) Section 92 A of the Patents Act, 1970 inserted by The Patents (Amendment) Act, 2005 postulates compulsory license for the export of patented pharmaceutical products in certain exceptional circumstances. It states that CL shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems, provided CL has been granted by such country or such country has, by notification or otherwise allowed the importation of the patented pharmaceutical products from India Sub-section (2) authorizes

the Controller, on receipt of an application in the prescribed manner, to grant, on such terms and conditions as he may specify, a CL solely for manufacture and export of the concerned pharmaceutical product to such country under such terms and conditions as may be specified and published by him. Explanation appended to Section 92A defines the pharmaceutical products as to mean any patented product or product manufactured through a patented- process, of the pharmaceutical sector needed to address public health problems and shall be inclusive of ingredients necessary for their manufacture and diagnostic kits required for their use.

Question 25.

Read the case given below and answer the questions given at the end: This case is between US-based multinational Bristol-Myers Squibb and a mid-sized Mumbai-based company BDR Pharma over ‘Dasatinib’, an anticancer drug.

Bristol-Myers is the exclusive owner of Dasatinib and its derivatives by the claims of Patent No. IN203937 In India. The patent is valid and subsisting and has a term of 20 years from 12,h April 2000 in India. It enjoys patent protection in several other countries such as United States, Australia, New Zealand, Japan, etc. Chronic Myeloid Leukemia (CML), one of the most common forms of leukemia, arises from the excessive production of abnormal stem cells in the bone marrow which eventually suppress the production of normal white blood cells. The development of imatinib mesylate, a small-molecule tyrosine kinase inhibitor (TKI), was the first rationally designed drug for CML.

Bristol-Myers product Dasatinib was approved by the US Food and Drug, Administration on 28th June 2006. It is presently sold in approximately 50 countries throughout the world. Marketing approval for Dasatinib was also granted by the Drug Controller General of India (DCGI) on 30th August 2006. Apart from the above patent, Bristol-Myers also made a patent application. in India for crystalline monohydrate form of Dasatinib. The said application is numbered 4309/DELNP/2006 dated 4th February 2005 and is currently pending before the Indian Patent Office. The monohydrate form of Dasatinib has been granted patents in 45 countries and is an improvement patent of the Indian Patent No. IN203937.

Cause of Action and Grounds: In December 2008, Bristol-Myers received ( information that Mumbai-based company, BDR Pharma had applied to the DCGI for the marketing approval for Dasatinib. It sent a ‘cease and desist letter to BDR Pharma on 12th January 2009 asking them to restrain from infringing its Patent No. IN203937. In view of the apprehension that the defendant may infringe the plaintiff’s exclusive right of the patent, the plaintiff j filed a suit in the nature of a quia timet action against the defendant on 3rd December 2009 for the infringement of IN203997.

The defendant has not launched the product in the market, hence, no loss or irreparable harm will be caused to BDR Pharma if it is restrained from doing activities that they have not yet commenced. BDR Pharma admitted that the defendant is intending to launch the generic version of Dasatinib only if the DCGI grants license to the defendant to manufacture under the provisions of Drugs and the Cosmetics Act, 1940. Patent Licencing: On 5th May 2013 the Controller of Patents considered the compulsory license application filed by BDR Pharma arid opined that the BDR Pharma had not made out a prima facie case for grant of a license as the applicant (BDR Pharma) did not make efforts to obtain a license from the patentee on reasonable terms and conditions and relegated the applicant to approach the plaintiff for a voluntary license.

By letter dated 13th March 2012, Bristol-Myers, the patentee raised certain queries on BDR Pharma’s application for voluntary license such as ‘facts which demonstrate an ability to consistently supply a high volume of the API, Dasatinib, to the market’, ‘facts showing your litigation history or any other factors which may jeopardize Bristol-Myers Squibb’s market position’, ‘quality-related facts and in particular compliance with local regulatory standards and basic GMP requirement’, ‘quality assurance system due diligence’, ‘commercial supply terms’, ‘safety and environmental profile’ and ‘risk of local corruption’;

BDR Pharma argued that the drug in question is important in the treatment of Leukemia and is exorbitantly priced at? 1,67,000 for a month’s course, putting it beyond the reach of the majority of the Indian population. Therefore, the public interest lies in compulsory licenses with a royalty being given to Bristol-Myers. Blood cancer patients have a right to get the drug at a low price.

Ever since the launch of Dasatinib in India. Bristol-Myers has addressed the access and affordability needs of the patients by an aggressive commercial Patient Access Program (PAP) through which prices of the drug are reduced to a fraction of the MRP. This has evolved over time thereby consistently reducing the cost of drugs to patients. The program is available through a third-party service provider, for the self-paying patients prescribed ‘Dasatinib’ by an Oncologist. The service provider through a centralized call center delivers the drug to the prescribed patients at their doorstep anywhere in India with no additional delivery cost.

BDR Pharma Defense:
BDR Pharma claimed that the Dasatinib patent is invalid as it doesn’t pass the non-obviousness test and that in any event, the public interest lies in granting an alternative remedy such as ongoing royalties instead of an injunction. The arguments for invalidity of the patent were stated under section 3(d). Under section 3(d) of the Patents Act, 1970, BDR Pharma said that Dasatinib is a mere derivative of a previously-known compound and that Bristol-Myers is ‘evergreening’ the patents by patenting minor modifications to previously patented inventions. The other aspect is that of efficacy. The compound should display enhanced efficacy over the previously known compound.

BDR Pharma further contended that it is a quia timet injunction, i.e. based on an expectation of harm rather than actual harm. A quia timet action is a bill in equity. It is an action preventive in nature and a species of precautionary justice intended to prevent apprehended wrong or anticipated mischief. According to Section 83 read with Section 90(d) of the Patents Act, 1970, the patent has to be worked in India by the manufacture and not by import.

BDR Pharma submitted that the same principles would apply in respect of the Indian law and thus, in the absence of a definition of commercial scale, natural and ordinary meaning should be given to the expression. It said that in terms of the said treaties the general principles set out are that, a patentee must manufacture the product in that country and it should not also be a mere improvement.

In light of the above, answer the following questions:

(1) In this case, BDR Pharma has not actually infringed the Bristol-Myers patent by way of manufacture or trade. The Court has, nevertheless, given an injunction against BDR Pharma not to work the patent. Explain the provisions under which the injunction was given.

(2) The question of public interest in compulsory licensing on grounds of the high price of the drug is relevant. How can BDR Pharma work the Bristol- Myers patent to undercut the high prices of Dasatinib? Give suggestions.

(3) What do you understand by ‘evergreening’? Discuss this in the above case in the context of efficacy.

(4) Who grants patents? What is the role of the Drug Controller General of India (DCGI) in the patent process, does it grant patents? While giving approval for marketing a drug, does it consider patent status?

Answer:
(a) Provisions of Patents Act, 1970 under which injunction was granted are as under:
Section 106 of the Patents Act, 1970 deals with the power of the Court to grant relief in cases of groundless threats of infringement proceedings.

Section 106 states that:
(1) Where any person (whether entitled to or interested in a patent or an application for a patent or not) threatens any other person by circulars or advertisements or by communications, oral or in writing addressed to that or any other person, with proceedings for infringement of a patent, any person aggrieved thereby may bring a suit against him praying for the following reliefs, that is to say:

1. a declaration to the effect that the threats are unjustifiable;
2. an injunction against the continuance of the threats and
3. such damages, if any, as he has sustained thereby;

(2) Unless in such suit the defendant proves that the acts in respect of which the proceedings were threatened constitute or if done, would constitute, an infringement of a patent or of rights arising from the publication of a complete specification in respect of a claim of the specification not shown by the plaintiff to be invalid, the Court may grant to the plaintiff all or any of the reliefs prayed for.

Explanation: A mere notification of the existence of a patent does not constitute a threat of proceeding within the meaning of this section. Section 108 of the Patents Act, 1970 deals with reliefs in suits for infringement.

Section 108 provides that:
(1) The reliefs which a Court may grant in any suit for infringement include an injunction (subject to such terms, if any, as the Court thinks fit) and, at the option of the plaintiff either damages or an account of profits.

(2) The Court may also order that the goods which are found to be infringing and materials and implement, the predominant use of which is in the creation of infringing goods shall be seized, forfeited or destroyed, as the Court deems fit under the circumstances of the case without payment of any compensation.

Section 114 of the Patents Act, 1970 deals with relief for infringement of partially valid specifications.

Section 114 states that:
(1) If in proceedings for infringement of a patent it is found that any claim of the specification, being a claim in respect of which infringement is alleged, is valid but that any other claim is invalid, the Court/Tribunal may grant relief in respect of any valid claim which is i infringed:
PROVIDED that the Court shall not grant relief except by way of 1 injunction save in the circumstances mentioned in sub-section(2).

(2) Where the plaintiff proves that the invalid claim was framed in good faith and with reasonable skill and knowledge, the Court shall grant relief in respect of any valid claim which is infringed subject to the discretion of the Court as to costs and as to the date from which damages or an account of profits should be reckoned, and in exercising such discretion the Court may take into consideration the conduct of the parties in inserting such invalid claim in the specification or permitting them to remain there.

(b) The grounds which are available for the person interested while seeking an application for the compulsory licensing or revocation of the patent on the ground of nonworking of the patent could be argued before the relevant authority as a matter of defense to the suit for infringement as the civil court hearing the suit for infringement cannot transgress within the domain of the authority/controller/Central Government which are | distinct functionaries having their powers and consideration specially defined under the specific provisions of the Act.

Under the World Trade Organization TRIPs Agreement, Compulsory Licenses are recognized in order to overcome barriers in accessing affordable medicines and on other grounds of non-workable of suit patent as per conditions prescribed under Section 83 and 84 of the Act. This is a case of quia timet. There is a fear that BDR will infringe in the future since they have made applications for a compulsory license to DGCI.

Quia Timet Action, it is settled law that such action is maintainable. If a party fears or apprehends, who may obtain an injunction to prevent some threatened act being done which if done, would cause him substantial damage and which money would not be an adequate or sufficient remedy. In a quia time action, in the absence of evidence if a strong case is made out against the defendants, after valid justification, the interim order may be passed by the Court. BDR should apply to a patent authority for compulsory license in the public interest on grounds of high price. The license will, however, be given to all Indian parties and not just BDR.

It is an admitted position that BDR has not yet launched the generic version of Dasatinib commercially in the market. This may be another option. Hence, if the patent is valid and BDR has not been able to establish the prima-facie credible defense, the case of infringement is made out. Under the said, circumstances, the public interest is an exception to the patent; otherwise, the rights granted under Section 48 by the Sovereign towards monopoly would be undermined. The plea of public interest may be invoked once the Court would find that prima-facie the case of credible defense is made out.

(3) In the case of Novartis AG Vs. Union of India & Ors (Civil Appeal Nos. 2706-2716 of 2013 Arising out of SLP(C) Nos. 20539-20549 of 2009, decided by Supreme Court on 1st April 2013, AIR 2013 SC 1312,1313), the Supreme Court held that the primary purpose of Section 3(d), as is evidenced from the legislative history, is to prevent “evergreening” and yet to encourage incremental invention.

“Evergreening” is a term used to label practices that have developed in certain jurisdictions wherein a trifling change is made to an existing product, and claimed as a new invention. The coverage/protection afforded by the alleged new invention is then used to extend the patentee’s exclusive rights over the product, preventing competition. By definition, a trifling change, or in the words of the section “a mere discovery of a new form of a known substance”, can never ordinarily meet the threshold of novelty and inventive step under clauses(j) and (ja) of Section 2(1). An invention cannot be characterized by the word “mere”. The word “invention” is. distinct from the word “discovery”.

As per Section 3(d) of the Patents Act, the mere discovery of a new form of a known substance which does not result in the 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, the machine or apparatus unless such known process results in a new product or employs at least one new reactant is not an invention.

Section 3(d) provides an explanatory clause to make it more clear which reads as follows:

Explanation:
For the purposes of this clause, “salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers complexes, combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy”. In a case in relation to a pharmaceutical substance, the Madras High Court held that efficacy means therapeutic efficacy. It was held that:

• going by the meaning for the word “efficacy” and “therapeutic”…. what the patent applicant is expected to show is, how effective the new discovery made would be in healing a disease having a good effect on the body? In other words, the patent applicant is definitely aware as to what is the “therapeutic effect” of the drug for which he had already got a patent and what is the difference between the therapeutic effect of the patented drug and the drug in respect of which patent is asked for.”

“Due to the advanced technology in all fields of science, it is possible to show by giving necessary comparative details based on such science that the discovery of a new form of a known substance had resulted in the enhancement of the known efficacy of the original substance and the derivatives so derived will not be the same substance, since the properties of the derivatives differ significantly with regard to efficacy.” (Novartis AG Vs. Union of India, W.P. No. 24760/06). Efficacy means “the ability to produce a desired or intended result”. Hence, the test of efficacy in the context of Section 3(d) would be different, depending upon the result the product under consideration is desired or intended to produce. In other words, the test of efficacy would depend upon the function, utility, or purpose of the product under consideration.

(4) Controller of Patents grants patent.
Drug Controller General of India (DCGI) does not grant patents. It lays down the standards and quality of manufacturing, selling, import, and distribution of drugs in India as well as acting as an appellate authority in case of any dispute regarding the quality of drugs. There is no linkage between Patents Act and the Drugs and Cosmetics Act in India.

The objective of the Drugs and Cosmetics Act is to regulate the import, distribution, manufacture, and sale of drugs and the Act does not impose any obligation under any provision on the Drug Controller General to deny marketing approval to a person based on the existence of Patent rights. Patents Act and Drugs and Cosmetics Act are two independent statutes and no linkage can be established between them in the absence of an express provision. Indian legislature stayed away from bringing about a Patent linkage with respect to regulatory approval of drugs.

CS Professional Intellectual Property Rights Laws and Practices Notes