PHARMACEUTICAL PATENTS – INDIAN SCENARIO 

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Patentability of pharmaceutical inventions in India has been a topic of intense debate since 1970. In India, the patentability of pharmaceutical inventions is understood and interpreted in light of Section 2(1)(j), Section 2(1)(ja) and Section 3 [specifically, Sections 3(d), 3(e) and 3(i)] of the Patents Act, 1970 [hereinafter referred to as the Act]. Further, the ‘Guidelines for Examination of Patent Application in the field of Pharmaceuticals’, published by the Office of the Controller General of Patents, Designs and Trademarks assist the Examiners in examination of pharmaceutical inventions.

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BACKGROUND (Back to top)

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In the 1970s, India quickly became a major supplier of cheap drugs to a number of developing and under developed countries. During the period 1970 - 1994, the Indian pharmaceutical industry became nearly self-sufficient and one of the largest exporters of generic medicines. A large number of developing countries depended on India for the supply of cheaper generic medicines. However, since Indian patent laws did not allow patenting of pharmaceutical products at the time, innovation was discouraged.

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The WTO agreement, of which India is a signatory, came into force from January 01, 1995. TRIPs (Trade Related Aspects of Intellectual Properties) agreement (Annexure 1C of the WTO agreement) under Article 27, required introduction of both product and process patenting in all fields of technology including drugs, foods, products of chemical reactions and micro-organisms. In order to become TRIPS compliant, India needed to revise its patent laws to provide product patent protection for pharmaceuticals. While traversing the history of the development of the legislation related to pharmaceuticals, Honourable Supreme Court of India referred to a letter written by the HIV/ AIDS Director of the WHO, dated December 17, 2004, to the then Minister of Health and Family Welfare, Government of India. A part of said letter is quoted herein below:

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“As India is the leader in the global supply of affordable antiretroviral drugs and other essential medicines, we hope that the Indian government will take the necessary steps to continue to account for the needs of the poorest nations that urgently need access to anti-retrovirals, without adopting unnecessary restrictions that are not required under the TRIPS Agreement and that would impede access to medicines”.

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Accordingly, the Indian Parliament amended section 3(d) of the Act in the year 2005 in order to strike a balance between the patent laws in India becoming TRIPS compliant vis-à-vis ensuring that such patentability does not have an adverse effect on public health and interest.

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The same is reflected in the fact that as per the data provided in the Annual Reports published by the Indian Patent Office [hereinafter referred to as the IPO], the grant rate of pharmaceutical inventions has increased by a phenomenal 60.17% in the duration of 2012 to 2017.

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SECTION 3 OF THE ACT

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Section 3 of the Act stipulates, “What are not inventions” as per the Act. The main aim of the amendments of the Patents (Amendment) Act of 2005 is to prohibit ever-greening of drug patents and bring within the ambit of patentability, the patents on variants of those chemical compounds that show significant enhancement in therapeutic efficacy.

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Section 3(d) of the Act recites as follows:

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“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, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

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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”.

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Thus, Section 3(d) of the Act stipulates that in an invention claiming an already known substance, having established medicinal activity, such substance shall be deemed to be treated as a same substance, and thus, shall fall foul of patentability, unless the invention is able to demonstrate significantly improved therapeutic efficacy with respect to that known compound.

 

Often misunderstood, Section 3(d) of the Act, does not in fact act as an impediment in the patentability of pharmaceutical inventions. The Supreme Court of India in a landmark judgement[1] in 2013, has emphasized on the positive construction of Section 3(d) in the patentability of pharmaceuticals as a second-tier of qualifying standards for pharmaceutical products in order to leave the door open for true and genuine inventions, but at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds.

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The provision of Section 3(d) of the Act is adjudicated meticulously and with utmost care by the IPO. To enable Applicants to substantiate the therapeutic efficacy of their invention, in various matters, Controllers have permitted the Applicants to produce additional data and experimental results during the proceedings, even in cases where said data and results were not directly referenced in the specification of the application.

 

Section 3(e) of the Act recites as follows:

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“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”.

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It is a well-accepted principle of Patent Law that mere placing side by side of old integers so that each performs its own proper function independently of any of the others is not a patentable combination, but that where the old integers when placed together has some working interrelation producing a new or improved result, then there is patentable subject matter in the idea of the working inter relations brought about by the collocation of the integers.

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According to Section 3 (i) of the Act, 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 is not an invention. Patent may however be obtained for surgical, therapeutic or diagnostic instrument or apparatus. Also the manufacture of prostheses or artificial limbs and taking measurements thereof on the human body are patentable.

 

With respect to patenting of pharmaceutical inventions in India, Section 3(d) of the Act takes the spotlight of the debate. The purpose of the above-said provision has been time and again explained by the IPO as well as the Indian Courts as to ensure that for an invention to obtain a patent for the second and subsequent use of a medicament, the therapeutic efficacy must be enhanced or at least a new reactant must be employed in its manufacture.

 

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Landmark Cases with respect to Section 3(d) of the Act (Back to top)

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Below is a timeline of the landmark cases decided by the IPO, Intellectual Property Appellate Board [hereinafter referred to as IPAB] and the Indian Courts with respect to Section 3(d) of the Act.

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A landmark and vastly debated case in the development of the pharmaceutical patent regime in India is the Novartis AG vs. Union of India (UOI) and Ors.[2], commonly referred to as the ‘Glivec case’. The judgement pronounced by the Supreme Court of India has time and again been analysed and commented upon by critics and commenders alike. The following is a brief analysis of the above-said judgement.

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NOVARTIS AG VS. UNION OF INDIA (UOI) AND ORS.[3] (Back to top)

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By way of a special leave petition filed before the Supreme Court of India, Novartis appealed the decision of the IPAB of rejecting the patent application[4] “Crystal Modification of a N- Phenyl-2-Pyrimidineamine derivative, processes for its manufacture and its use” on the ground that the subject matter claimed in the patent application was non-patentable under the provision of Section 3(d) of the Act.

 

Though the Supreme Court rejected the patent application and upheld the decision of the IPAB, the findings in the matter are pertinent to be noted for applicants of pharmaceutical inventions.

 

One imperative clarification made by the Hon’ble Court is with respect to incremental inventions. The Court clarified that the provision of Section 3(d) of the Act should not be interpreted to bar patent protection for all incremental inventions of pharmaceutical substances. The Court held that, “We have held that the subject product, the beta crystalline form of Imatinib Mesylate, does not qualify the test of Section Atomic En of the Act but that is not to say that Section Atomic En bars patent protection for all incremental inventions of chemical and pharmaceutical substances. It will be a grave mistake to read this judgment to mean that Section Atomic En was amended with the intent to undo the fundamental change brought in the patent regime by deletion of Section 5 from the Parent Act. That is not said in this judgment”.

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Further, the Hon’ble Court clearly and repeatedly clarified that the findings of the Court were based on the material/ data provided before it by the Applicant, said material/ data failing to substantiate the therapeutic efficacy of the claimed invention. It is imperative to note that the Hon’ble Court did not deny or disregard the fact that increase in bioavailability may lead to an enhancement of therapeutic efficacy, but on the other hand, held that much like any other claim of enhancement of therapeutic efficacy, such claims must be supported by research data. Since the Applicant was unable to substantiate its claim that the beta crystalline form of Imatinib Mesylate has 30 percent increased bioavailability as compared to Imatinib in free base form by way of any research or evidence, the Court did not find the claimed invention as disclosing enhanced therapeutic efficacy. Accordingly, the Hon’ble Court held that, “… the position that emerges is that just increased bioavailability alone may not necessarily lead to an enhancement of therapeutic efficacy. Whether or not an increase in bioavailability leads to an enhancement of therapeutic efficacy in any given case must be specifically claimed and established by research data. In this case, there is absolutely nothing on this score apart from the adroit submissions of the counsel. No material has been offered to indicate that the beta crystalline form of Imatinib Mesylate will produce an enhanced or superior efficacy (therapeutic) on molecular basis than what could be achieved with Imatinib free base in vivo animal model.

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Thus, in whichever way Section Atomic En may be viewed, whether as setting up the standards of "patentability" or as an extension of the definition of "invention", it must be held that on the basis of the materials brought before this Court, the subject product, that is, the beta crystalline form of Imatinib Mesylate, fails the test of Section Atomic En, too, of the Act”.

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Thus, to understand the above judgment as being discouraging with respect to pharmaceutical related inventions would have a contrary result as that intended by the Hon’ble Court. Since 2013 i.e. post the Glivec judgement, the IPO as well as the Indian Courts have time and again upheld the sanctity of Section 3(d) of the Act, while at the same time maintaining the interests of innovators. The below decisions are reflective of the pro-patent and pro-innovation stand taken by the IPO and the Indian Courts alike, while deciding upon pharmaceutical related inventions.

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F. HOFFMANN-LA ROCHE LTD. AND ORS. VS.  CIPLA LTD. (Back to top)

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Hoffman-La Roche Ltd. [hereinafter referred to as Roche] filed a suit for infringement of Indian Patent bearing number 196774 [hereinafter referred to as IN ‘774] against Cipla in 2008. The suit patent protected ‘A NOVEL [6, 7-BIS(2- METHOXYETHOXY) QUINAZOLIN-4-YL]- (3-ETHYNYLPHENYL) AMINE HYDROCHLORIDE’ also known as ‘Erlotinib Hydrochloride’ which was licensed to Roche. Roche had been manufacturing ‘Erlotinib Hydrochloride’ as an anti-cancer drug under the brand name ‘Tarceva’ across the world.

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The Single judge of the Delhi High Court decided against the interests of Roche with respect to the interim relief claimed by Roche, following which Roche appealed said decision before a Divisional Bench of the Delhi High Court.

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Single Judge[5]

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The Single Judge primarily held the following:

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i. Section 3(d) of the Act –

 

The Single Judge denied Cipla’s contention that the requirement under Section 3(d) of the Act was unfulfilled as the ‘increased efficiency’ criteria was not met forth. The Hon’ble judge followed the observations of the Controller [in the pre-grant opposition filed against Roche in the prosecution stage] with respect to the therapeutic efficacy of the patented drug and held that the invention cannot be held to be non-patentable under Section 3(d) of the Act. It is pertinent to note herein that the Controller in the above-mentioned pre-grant opposition had accepted the efficacy data submitted by Roche during the course of the pre-grant proceedings. Though the Opponent in the matter objected to acceptance of such data, the Controller rejected said objection and held the same to be sufficient for establishing enhanced therapeutic efficacy of the invention and accordingly granted the patent to Roche.

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ii. Balance of convenience & interim relief

 

While adjudicating the issue of balance of convenience, the Hon’ble Judge took note of the decisions of the Court of Appeal in the matter of Roussel Uclaf vs. G.D. Sarle[6] and Company Ltd.  and Cordis Corporation vs. Boston Scientific Corporation[7].

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The Hon’ble Judge took note that a month’s dosage of Tarceva [Roche’s drug] for a patient undergoing treatment for cancer was Rs.1.4 lakh whereas the equivalent cost of Erlocip [Cipla’s drug] would be Rs. 46,000. The Hon’ble Judge denied the relief of interim injunction against Cipla and held that “… as between the two competing public interests, that is, the public interest in granting an injunction to affirm a patent during the pendency of an infringement action, as opposed to the public interest in access for the people to a life saving drug, the balance has to be tilted in favor of the latter. The damage or injury that would occur to the plaintiff in such case is capable of assessment in monetary terms. However, the injury to the public which would be deprived of the defendant's product, which may lead to shortening of lives of several unknown persons, who are not parties to the suit, and which damage cannot be restituted in monetary terms, is not only uncompensatable, it is irreparable. Thus, irreparable injury would be caused if the injunction sought for is granted.”

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However, the single judge, being mindful to the losses that may be caused to Roche, directed Cipla to take an undertaking to pay the damages in the event of the suit being decreed and to maintain faithful accounts and file quarterly accounts with the Court along with an annual statement of the sales figures of the impugned drug.

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Thereafter, Roche appealed the decision of the Single Judge before a Divisional Bench of the High Court at Delhi. 

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Divisional Bench[8]

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While discussing the provision of Section 3(d) of the Act, the Divisional Bench luminously noted,

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“62. … Section 3(d) assumes that structurally similar derivatives of a known 'substance' will also be functionally similar and hence ought not to be patentable. What is of crucial importance is that this is not a provision that merely bars certain subject matter from patentability. On the contrary, it provides that if the new form of the known substance is found despite a structural similarity to demonstrate a better functionality i.e. 'enhancement of the known efficacy', it would qualify for assessment under Section 2(1)(j) as if it were a new product involving an inventive step and it would thereafter be up to the applicant for the patent to demonstrate the patentability of this substance in accordance with Sections 2(1)(j) and (ja). This provision is not a patent term extension or an evergreening provision but in fact recognizes incremental innovations in pharmaceutical patents. The use of the words 'product' and 'substance' in Section 2(1)(j) and Section 3(d) is therefore telling, in that, the legislative intent appears clearly to demonstrate that all 'substances' may not qualify as 'products' under the Act, where the latter are only those substances that are patent-eligible. In fact, Section 2(1)(ta) provides the bridge between Section 3 and Section 2(1)(j), in that, it defines a 'pharmaceutical substance' as 'any new entity involving one or more inventive steps'. Thus, the discovery of an entity or substance may not involve an inventive step. Insofar as there is no inventive step involved in its formation it is merely a substance even though its structural form may be hitherto unknown. A new chemical entity (NCE) that is structurally dissimilar but functionally similar to an existing chemical entity is thus merely a substance under Section 3(d). If the substance has an added layer of enhanced efficacy then it would be treated as a 'new product' and would be eligible for assessment under Section 2(1)(j) to ascertain whether its formation involved an inventive step. If the new product involved one or more inventive steps, then it would qualify as a pharmaceutical substance. Thus, graphically represented, the same would be:--

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The Hon’ble Court further held:

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“We understand Section 3(d) as a positive provision that in fact recognizes incremental innovation while cautioning that the incremental steps may sometimes be so little that the resultant product is no different from the original. The inherent assumption in this is that an infringement of the resultant product would therefore be an infringement of the original i.e. the known substance and by no stretch of imagination can Section 3(d) be interpreted as constituting a defence to infringement.”

 

Conclusively, the Divisional bench held Cipla liable for infringement of the suit patent and consequently, liable to pay damages [to be submitted before the Joint Registrar and decided at a later date] along with costs on INR 5,00,000 [approx. USD 7200].

 

It is imperative to commend the High Court for intensively and concretely adjudicating issues that had been left vague by the earlier judgments. This well-reasoned judgment also does the essential job of reanalyzing the perspective and purpose of Section 3(d) of the Act.

 

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AJANTA PHARMA LIMITED vs. ALLERGAN INC., ALLERGAN INDIA PVT. LTD. AND THE CONTROLLER OF PATENTS[9] (Back to top)

 

In a revocation petition filed by Ajanta Pharma Limited before the IPAB, against the granted patent of Allergan Inc. bearing patent no. 219504, the provisions of Section 3(d) of the Act were discussed at length by both parties. The IPAB agreed with the perspective of the patent holder and clarified a distinct line between an attempt to claim derivatives of compounds vis-à-vis an invention comprising of a combination of compounds. The IPAB held as follows:

 

“The section explained that a mere discovery of which is not to be considered as an invention if it is a new form of a known substance, new property of new use of known substance or a known process or the use of a known process, machine or apparatus. But this discovery would be considered as an invention if the new form results in enhancement of known efficacy of that substance and so on as described in the section. The explanation to the section enumerates various derivatives of the known substance which shall be considered to be the same substance unless, there is significant difference in therapeutic efficacy. Therefore all forms of the known substance that are mentioned are derivatives of the known substance which could be salts, esters, ethers and so on. Combination is also mentioned here. The respondent (patent holder) had argued that this cannot be considered as a form of a known substance. The respondent is right. This invention is a combination of Brimonidine and Timolol. The applicant perhaps wants us to consider it either as a derivative of Brimonidine or as a derivative of Timolol. It is not a derivative. The combination mentioned in the Explanation can only mean a combination of two or more of the derivatives mentioned in the Explanation or combination of one or more of the derivatives with the known substance which may result in a significant difference with regard to the efficacy. A combination of two active drugs like Brimonidine and Timolol cannot be considered derivatives of each other. This ground is rejected.”

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It is significant to note that the IPAB protected Allergan’s patent from the ambit of non-patentability under Section 3(d) of the Act by going to great lengths to understand and give justice to the scope of the invention and the true intent of the patent holder with respect to the compounds claimed in the invention. The efforts undertaken by IPAB to thoroughly discuss the facts of the case and the merits of the arguments presented by both parties, is appreciable. No stone was left unturned by the Appellate Board as it conducted an in-depth discussion and thorough review of the complete specification of the patent to understand the scope of the invention.

 

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GLOCHEM INDUSTRIES LTD. VS. CADILA HEALTHCARE LTD.[10] (Back to top)

 

Glochem Industries Ltd. [hereinafter referred to as Glochem] filed a pre-grant opposition against the grant of the patent application filed by Cadila Healthcare Ltd. [hereinafter referred to as Cadila/ the Applicant], titled “crystalline clopidogrel besylate and process for preparation thereof”. Said opposition was disposed of in January 2009 and all the grounds taken up by Glochem i.e. anticipation by prior publication, anticipation by prior claiming, anticipation by prior use, lack of inventive step, non-patentable subject matter, insufficiency of disclosure were rejected by the Controller. Particularly, the Controller intensively debated the ground under Section 3(d) of the Act taken up by the Opponent.

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The Controller while adjudicating the pre-grant opposition took note of the contents of the complete specification of the application along with further data submitted by the Applicant during the course of the pleadings. The Controller held that:

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“The claims 1 to 3 of the alleged invention are directed to Crystalline Clopidogrel besylate. The besylate salt of Crystalline Clopidogrel is pure, free flowing, easy to handle and chemically stable (nor hygroscopic) which can be utilized on an Industrial scale (pages 2, 3 & 5 of Complete Specification). To support this and also to meet the requirements of Section 3(d) of Patents Act, 1970 the applicants with their reply statement, have submitted the Stability study data sheet of bisulphate (Enclosure 5 & 9) and besylate (Enclosure 6); along with Stability and Comparative Pharmaceutical characterization Report of solvated (toluene and diozane) and Crystalline Clopidogrel besylate (Enclosures 13 & 14).

 

The stability study data for the Clopidogrel bisulphate salt reveals that there is increase in the concentration of the inactive metabolite which in the long term reduces the efficacy of bisulphate salt by reduction of therapeutic dose (Enclosure 5). Further in tablets of bisulphate salt there is an increase in acid impurities (Enclosure 9). Whereas the Crystalline Clopidogrel besylate of present invention surprisingly is not detected with inactive metabolite for over six months in any of the three batches (Enclosure 6). Hence, the Crystelline Clopidogrel Besylate of instant invention is advantageous in terms of increased shelf life of the Clopidogrel bisulphate salt.

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The stability report given in the Enclosure 13 shows that the Crystalline Clopidogrel besylate of instant invention is more free flowing and stable even after two month period in comparison to the solvated (toluene and dioxane) forms of Crystalline Clopidogrel besylate (cited by the opponent).

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The comparative Pharmaceutical Properties data provided in Enclosure 14 shows that the solvated (toluene and dioxane) forms of Crystalline Clopidogrel besylate are more cardiotoxic compared to the Crystalline Clopidogrel besylate of present invention. The Crystalline cop besylate is non-toxic till 50 uM concentration, whereas the toluene solvated form showed toxicity at 5uM and dioxane solvated form showed toxicity at 25uM. Hence it shows that the Crystalline Clopidogrel besylate is better and advantageous in matters of toxicity in comparison to solvated forms.

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In view of the advantageous effects of Crystalline Clopidogrel besylate of instant invention over the known clopidogrel bisulphate and also over the solvated forms of Clopidogrel besylate in different characterization aspects, it can be held that the Crystalline Clopidogrel besylate of present invention compound is patentable and cannot be rejected under Section 3(d) of the Patents Act, 1970”.

 

The Controller took note of the contents of the complete specification, submissions made during the pleadings and the further evidence/ research data submitted by the Applicant, and accordingly observed that the test of patentability laid down by Section 3(d) of the Act had been sufficiently met by the application.

 

In light of the same, the Controller rejected the opposition.

 

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IND SWIFT LABORATORIES LTD. VS. CADILA HEALTHCARE LTD.[11] (Back to top)

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Ind Swift Laboratories Ltd. [hereinafter referred to as Ind] also filed an opposition against the grant of the patent application filed by Cadila, titled “crystalline clopidogrel besylate and process for preparation thereof”. Said opposition was disposed of in September 2009 and all the grounds taken up by Glochem i.e. anticipation by prior publication, anticipation by prior claiming, anticipation by prior use, lack of inventive step, non-patentable subject matter, insufficiency of disclosure were rejected by the Controller. Since Ind did not cite any new documents, the Controller reiterated the contents of the decision in the Glochem opposition with respect to Section 3(d) of the Act taken up by the Opponent and accordingly, granted the patent.

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Thereafter, Ind filed a petition[12] for review of the order granting a patent to Cadila and submitted four new annexures to substantiate the challenge to the patentability of the subject matter claimed in the invention.

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However, the Controller reiterated its decision of granting a patent to Cadila and held that “in view of the advantageous effects of Crystalline Clopidogrel besylate of instant invention over the known clopidogrel bisulphate and also over the solvated forms of Clopidogrel besylate in different characterization aspects, it can be held that the Crystalline Clopidogrel besylate of present invention compound is patentable and cannot be rejected under Section 3(d) of the Patents Act, 1970”.

 

Thus, the Controller refused the ground taken up by the Opponent in light of the enhancement of therapeutic efficacy established by the Applicant.

 

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RANBAXY LABORATORIES LTD. VS. PFIZER HEALTH AB.[13] (Back to top)

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In 2007, the Indian Patent Office refused the pre-grant opposition filed by Ranbaxy Laboratories Ltd. [hereinafter referred to as Ranbaxy] against the grant of a patent to Pfizer Health AB [hereinafter referred to as Pfizer] for the invention claimed in the patent application titled “A PHARMAXCEUTICAL FORMULATION”.  

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Dealing with the arguments put forward by Ranbaxy under Section 3(d) of the Act, the Controller held that the therapeutic efficacy was established by the Applicant by way of reduction in the number of urge incontinence episodes per week by 71% in relation to placebo. Further, the Controller addressed the ground raised by the Opponent under Section 3(e) of the Act and held that the invention is patentable on account of the synergistic effect disclosed in the specification. Accordingly, the Controller granted the patent to Pfizer. Relevant excerpts from the order are reproduced hereinbelow:

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“The opponent has further argued and stated that the various processes as laid in the examples provided in the instant application for the preparation of formulation as oral and other dosage forms comprises the well known active ingredients and other well known excipients. Under Section 3(d) of the Patents Act, combination of known substances, unless they differ significantly in properties with regard to efficacy, is not patentable; and also no patent can be granted for a composition which does not exhibit any synergistic effect under Section 3(e) of the Patents Act. Since the claims are related to a composition showing neither enhancement in known efficacy nor any synergistic effect, the invention falls under Sections 3(d) &(e) of the Patents Act, the patent should not be granted.

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The agent for the applicant in his reply stated that the present invention is Novel, Inventive and Industrially applicable. The composition as claimed therein is not a mere admixture but it is a synergistic composition. In support of their arguments, the applicant was referring to the Exhibit “I” referred to in the affidavit of Paul Abrams, wherein in the paper presented by Kerrebroeck et al., it was shown that Tolterodine controlled release formulation according to the present application has significantly reduced the number of urge incontinence episodes per week by 71% in relation to Placebo. It was further stated that the description with respect to the efficacy is already provided in pages 14 & 15 of the complete specification. Therefore it is prayed to grant the Patent right to the applicants.

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Admitting the view of the applicant and also the results provided in the specification, I conclude that the amended claims do not contradict the provisions Section 3(d) and Section 3(e) of the Patents Act and hence are allowable”.

 

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NATCO PHARMA LIMITED VS. PFIZER PRODUCTS INC.[14] (Back to top)

 

 

A Pre-grant opposition was filed by Natco Pharma Limited [hereinafter referred to as Natco] against the grant of a patent to Pfizer Products Inc. [hereinafter referred to as Pfizer] for the patent application titled “Quinazoline Derivatives Compounds and Composition Thereof”. The Controller rejected the grounds taken up by Natco including but not limited to Section 3(d) of the Act and granted a patent to Pfizer.

 

The order of the Controller in the matter is significant as the Controller recognized and acknowledged that data establishing therapeutic efficacy and synergistic effect of a pharmaceutical invention may not be available with the Applicant at the time of filing such application. In light of the fact that the research and development of pharmaceutical inventions is a long and gradual process, and that the purpose of examination under Section 3(d) of the Act is not to scrutinize the Applicant for the contents of the specification, but instead to evaluate the true intent and efficacy of a pharmaceutical invention, the Controller allowed the Applicant to submit further data and evidence to rebut the challenges made by the Opponent under Section 3(d) of the Act.

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The Controller inspected and analysed the evidence submitted by the Applicant and on account of sufficient establishment of enhancement of therapeutic efficacy of the claimed invention by way of said data given by the Applicant, the Controller was pleased to grant the patent. Relevant excerpt from the order of the Controller is reproduced hereinbelow:

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“…The applicants submit that the providing of efficacy data at filing was not possible. However, the same has been given as and when asked by Controller. The data regarding survival rate increase has been significant as indicated in the Journal The Oncologist, Feb 5th 2007. In view of the fact that the opponents have not substantiated and elaborated this ground of objection. And further once the invention has been found inventive, the invention cannot be held non-patentable under section 3(d) of the Patents Act. Therefore, the invention cannot be held non-patentable under section 3(d) of the Patents Act, 1970”.

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“.. in order to be successful on this ground the opponent has to prove beyond doubt that the alleged invention is either a mere discovery of any new property or new use for a known substance or it is a 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 it is a 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. Since the opponents have proved neither clearly nor explicitly, this ground fails”.

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– Indian Patent Office

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M/S FDC LIMITED, INDIA VS. VENUS REMEDIES LIMITED, INDIA[15] (Back to top)

 

 

In 2009, in a matter of a pre-grant opposition filed by M/S FDC Limited, India [hereinafter referred to as FDC] against the grant of a patent to M/s Venus Remedies Limited [hereinafter referred to as Venus] for "ANTIBIOTIC COMBINATIONS FOR PROVIDING TOTAL SOLUTION TO THE TREATMENT OF INFECTIONS", the IPO discussed the extent of the onus on the Applicant of establishing enhancement of therapeutic efficacy and synergistic effect of the claimed invention. In the present matter, the Controller relied on the opinion of the EPO in the matter of SUMITOMO/Yellowdyes[16] wherein the Board of Appeal held that “An invention which relates on substantial and surprising improvement of a particular property need not also show advantages over the prior art with regard to other properties relevant to its, use, provided, the latter are maintained at a reasonable level so that the improvement is not completely offset by disadvantage in other respect.....”

 

The Controller agreed with the above decision of the EPO and accordingly granted a patent to Venus. Relevant excerpt from the order of the Controller is reproduced hereinbelow:

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“Aminoglycoside cause oxidative stress when administered individually separately either alone or in combination with other antibiotic & causes toxicity, which has been reduced in the fixed dose combination of cefepime & amikacin along with the stabilizing agent L-arginine. Therefore, the combination the individual component & its feature mentionally influence each other to achieve a technical advancement by way of efficacy. Therefore I feel that the combination of cefepime & amikacin enhances the synergism and qualifies the requirement of section 3(d)”.

 

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E.I. DU PONT DE NEMOURS AND COMPANY, USA VS. GHARDA CHEMICALS LIMITED, THANE (Back to top)

 

 

In 2010, the IPO adjudicated a pre-grant opposition filed by E.I. Du Pont De Nemours And Company, USA [hereinafter referred to as the Opponent] against the grant of a patent to Gharda Chemicals Ltd. [hereinafter referred to as the Applicant] for “A PROCESS FOR LARGE SCALE MANUFACTURE OF INDOXACARB”[17]. The challenge raised by the Opponent under Section 3(d) of the Act was that the invention claimed a mere use of a known process. The Controller rejected said ground taken up by the Opponent and held that:

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“… I have been convinced as per the discussion above that the claimed invention is novel as well as inventive over the prior art cited by the opponent. The Applicant seeks protection for an invention “Process for large scale manufacture of Indoxacarb” as contained in claims (1-3). As the claimed process is novel and inventive it cannot be a mere use of a known process rather the said process employs a solvent mixture in the reaction scheme which is new. Accordingly, such a ground of opposition is not validly established by the opponent”.

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Accordingly, the Controller granted a patent to the Applicant.

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INDIAN PHARMACEUTICAL ALLIANCE VS. CHIESI FARMACEUTICI S.P.A. OF VIA PALERMO[18] (Back to top)

 

In 2018, the IPO granted a patent to Chiesi Farmaceutici [hereinafter referred to as the Applicant] for “PRESSURIZED METERED DOSE INHALER COMPRISING FORMOTEROL AND BECLOMETASONE DIPROPIONATE” thereby rejecting the pre-grant opposition filed in the matter by Indian Pharmaceutical Alliance [hereinafter referred to as the Opponent]. The opposition comprised of objections under several grounds, including but not limited to the claimed invention being non-patentable subject matter under Sections 3(d) and 3(e) of the Act. It is pertinent to note that said grounds had also been taken up by the Controller in the First Examination Report [office action]. However, in light of the examples provided in the specification of the application and the submissions made by the Applicant, the Controller held all the objections to be met by the Applicant and granted the patent in the matter. Relevant excerpt from the order of the Controller is reproduced hereinbelow:

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“Regarding 3(e ) of the Patents Act, it is observed that the claimed inhaler comprising the formulation according to the present invention undeniably exhibits unforeseen synergistic effect as explained under Example 2, Comparative Example 3 and Comparative Example 4 of the complete specification starting from page 14, which is summarized below for your ease of reference. In the Example 2 and Comparative Examples 3 & 4 of the complete specification, the solubility of formoterol fumarate dihydrate in the presence and in the absence of each of the ingredients of the claimed composition was estimated. It is further observed that, the presence of BDP in the mixture of HFA134a : ethanol at 2.7 % w/w significantly decreases the solubility of formoterol fumarate dihydrate suspended in the formulation, thereby hindering the occurrence of unwanted Ostwald ripening process, thus improves stability over longer period of time. In addition, Example 5 of the complete specification shows that the excellent aerosol performance of the claimed inhaler, which is capable of providing upon actuation of the inhaler, a fine particle fraction (FPF) much higher than 50% for both the active ingredients that lead to improved therapeutic efficacy. This evidences that every ingredient of the inhaler has not been arbitrarily chosen, but is the useful range for having formoterol fumarate dihydrate in suspension and beclometasone dipropionate (BDP) in solution and exhibiting technical advancement/synergistic effect. Therefore, the Opponent fails to establish such a ground of opposition yet again; whereas the objection raised under Non-Patentability u/s 3 of the hearing notice is also met”.

 

Similarly, in 2018, the IPO granted a patent to Apex Laboratories Private Limited for “A NOVEL CREAM AND A PROCESS TO MANUFACTURE THE SAME”  bearing Indian Patent number 302376. The Controller had cited Sections 3(d) and 3(e) of the Act, among other grounds, as objections in the First Examination Report [office action]. However, the Controller held that the objections had been met in light of the enhancement of therapeutic efficacy and synergistic effect of the claimed invention being established by the Applicant in its response to the Report.

 

A patent was granted by the IPO to HEIDELBERG PHARMA GMBH, a German Company, for “METHODS FOR SYNTHESIZING AMATOXIN BUILDING BLOCK AND AMATOXINS” bearing Indian Patent number 310496. The Controller had cited Section 3(d) of the Act, among other objections in the First Examination Report [office action]. However, the Controller granted the patent in light of the submissions made by the Applicant in its response to the Examination Report in merely 9 days from the date of submission of the Reply to the Examination Report by the Applicant.

 

Another patent was granted by the IPO to HEIDELBERG PHARMA GMBH for “AMATOXIN CONJUGATES WITH IMPROVED LINKERS” bearing Indian Patent number 310961. The Controller had cited Sections 3(d), 3(e) and 3(i) of the Act, among other objections in the First Examination Report [office action]. However, the Controller granted the patent in light of the submissions made by the Applicant in its response to the Examination Report.

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A patent was granted by the IPO to ADVERIO PHARMA GMBH, a German Company, for “METHOD FOR PRODUCING SUBSTITUTED 5-FLUORO-1H-PYRAZOLOPYRIDINES”  bearing Indian Patent number 303187. The Controller had cited Sections 3(d) and 3(i) of the Act, among other objections in the First Examination Report [office action]. However, the Controller granted the patent in light of the submissions made by the Applicant in its response to the Examination Report.

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COMPULSORY LICENCE (Back to top)

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The Indian Patents Act does not define the term compulsory licensing. However, a common interpretation of the term compulsory licensing is when a government allows someone else to produce a patented product or process without the consent of the patent owner or plans to use the patent-protected invention itself[19]. The grant of compulsory licence is often misconstrued to mean the relinquishment of a patent holder’s rights over the patented invention. However, in reality, the patent holder continues to have rights over the patent, including a right to be paid for copies of the products made under the compulsory licence[20].

 

Chapter XVI of the Act stipulates the relevant provisions with respect to compulsory licensing in India. Specifically, Sections 84 and 92 of the Act provide the imperative conditions to be fulfilled to the grant of a compulsory licence.

 

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

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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; or

3. the patented invention is not worked in the territory of India.

 

Further, compulsory licences can also be issued suo motu by the IPO under Section 92(1) of the Act, 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’.

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The main objective of Section 84 of the Act is to prevent the abuse of patent as a monopoly and to cut way for the commercial exploitation of an invention by an interested person. In addition to the three conditions mentioned above, Section 84(6) of the Act enunciates the key factors considered by the IPO while granting a compulsory licence, said factors including but not limited to:

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1. the nature of the invention;

2. any measures already taken by the Patentees or any Licencee to make full use of the invention;

3. ability of the Applicant (requesting the compulsory licence) to work the invention to the public advantage;

4. the capacity of the Applicant to undertake the risk in providing capital and working the invention, if such application for compulsory licence were granted;

5. time elapsed since the grant of the patent i.e. worked or not worked.

6. 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 [‘reasonable period’ construed as a period not ordinarily exceeding a period of six months].

 

The provisions in the Act related to compulsory licence finds its’ roots in the endeavour of the Indian Parliament to strike the right balance between the interests of innovators and the wider public interest in order to foster an environment in which creativity and innovation can flourish.

 

As stipulated in Section 83 of the Act, patents are not granted merely to enable patentees to enjoy a monopoly on a patented article. Said provision emphasizes the general consideration 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, among other considerations.

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The IPO, while deciding an application for compulsory licensing, noted that “from its very nature, a right cannot be absolute. Whenever conferred upon a patentee, the right also carries accompanying obligations towards the public at large. These rights and obligations, if religiously enjoyed and discharged, will balance out each other. A slight imbalance may fetch highly undesirable results. It is this fine balance of rights and obligations that is in question in this case”.

 

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Landmark Compulsory Licensing Cases  (Back to top)

 

The provisions related to Compulsory licensing in India are often misconstrued as deprivative and intrusive by patent holders. The monetary investments made by patent holders for the research, development and prosecution of patented inventions, specifically pharmaceutical inventions, are a common concern. Critics are usually of the view that patent laws have been enacted to encourage innovation, technical advancement, technological progress, transfer of technology and thereby ultimately attain the common cause of development. Innovative drugs are significantly more expensive than generic medicines on account of  complex processes which are required to make the invention. It may be after thousands of trials in several permutations and combinations that a molecule reaches the market and then to the patients.

 

The concerns of patent holders in this regard, specifically pharmaceutical companies, have not fallen on deaf ears. On various occasions, the IPO and the Indian Courts have acknowledged and appreciated the investments in terms of time, money and efforts made by pharmaceutical companies for the development of pharmaceutical inventions. Both, the patent office and the Courts have aligned their practice in matters of compulsory licensing, taking a pro-patent stand by interpreting the relevant provisions with a view to protect and uphold the rights of the Patentee. A stern and severe test has been observed for the Applicants filing for compulsory licences. The same is evident from the fact that in the duration of 2012 – 2017, merely 3 applications requesting a compulsory licence have been filed with the IPO, out of which only one of said applications has been granted. It is also pertinent to note that in the case where a compulsory licence was in fact granted, all three conditions stipulated in Section 84 were satisfied and the same is attributed by experts to be a vital reason behind the expeditious passage of the judgement.

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Below is a timeline of the cases decided by the IPO with respect to Compulsory Licensing.

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