Ipr Project.docx

DR. RAM MANOHAR LOHIYA NATIONAL LAW UNIVERSITY

2017-18 Final Draft IPR-II Reading efficiency out of its box of ‘therapeutic’ colour?- a case analysis of Pharma Chem and Ors. v. Rajnikant Devidas Shroff and Anr. Under Guidance of:

Submitted by

Ms. Priya Anuragini

Srijan Jha (143)

Assistant Professor (Law)

Enrol. No- 140101145

Dr. Ram Manohar Lohiya

VIIth Semester

National Law University

Section- ‘B’

Acknowlegdement

A research project of such great scope and precision could never have been possible without great co-operation from all sides. Contributions of various people have resulted in this effort. Firstly, I would like to thank God for the knowledge he has bestowed upon me. I would also like to take this opportunity to thank Priya Anuragini ma’am without whose valuable support and guidance, this project would have been impossible. I would like to thank the library staff for having put up with my persistent queries and having helped me out with the voluminous materials needed for this project. I would also like to thank my seniors for having guided me and culminate this acknowledgement by thanking my friends for having kept the flame of competition burning, which spurred me on through the days.

-sd Srijan Jha

Contents Acknowlegdement ..................................................................................................................... 2 Structure of the law .................................................................................................................... 4 Structure of Case ........................................................................................................................ 7 Nature of the patent ............................................................................................................ 7 Timeline of the Patent......................................................................................................... 8 Intricacies of the Case......................................................................................................... 8 The High Court Decision .................................................................................................... 9 The Supreme Court’s stance ............................................................................................. 10 Therapeutic efficacy and beyond ............................................................................................. 11 Is PCL5 a Pharmaceutical substance? .............................................................................. 12 Widening the Scope of Section 3(d) of the Patent Act, 1970. .......................................... 13 Indian Judicial Understanding .......................................................................................... 14 Lesson learnt? ................................................................................................................... 15 Conclusion ............................................................................................................................... 17

Cases - S. Shammugadel Nadar v. State of Tamil Nadu, (2002) 8 S.C.C. 361.................................. 11 Board of Trustees of the Leeland Stanford junior University v. Roche Molecular Systems,(2011) S.C.C. OnLine U.S. S.C. 52, part IIA. ........................................................ 14 Dhanpat Seth v. Nil Kamal Plastic Crates Ltd. ....................................................................... 11 Farbwerke Hoechst Aktiengesellschaftvormals Meister Lucius &Burning Corporation v. Unichem Laboratories ......................................................................................................... 10 Golchan Industries ltd v. Cadila Health and Others ............................................................... 12 Novartis A.G. v. Union of India (2007) S.C.C. OnLine Mad. 658. ......................................... 12 Pharma Chem v. Rajnikant Devidas Shroff ............................................................................. 11 Rajnikant Devidas Shroff v. Pharma Chem, (2009) S.C.C. OnLine Guj. 790 ........................... 8 Shillito v. Larmuth and Co., 1885 (II), Reports of Patent Cases, Page 1, Chancery Court of the County Palatine of Lancaster, Manchester District. ........................................................ 9 Tianjin Dishlin Investment Holding v. Controller General (2012) S.C.C. OnLine I.P.A.B. 101 .............................................................................................................................................. 14 Statutes The Patents (Amendment) Act, 2005......................................................................................... 5 The Patents Act, 1970 ................................................................................................................ 5 Other Authorities - New Jersey Department of Health and Senior Services, ‘Hazardous Substance Fact Sheet’, (last accessed on 12/10/2017) http://nj.gov/health/eoh/rtkweb/documents/fs/1525.pdf ....... 9 Black’s law dictionary ............................................................................................................. 12 E Buchdunger and J Zimmerman, “The .................................................................................... 6 Ghaiyur Alam, Patent Eligible Products and Processes: Legal Perspective and Reforms, 3-5 R.M.L.N.L.U.J. (2011-2013) 66 .......................................................................................... 14 Harekrishna Ashar,The Supreme Court on Therapeutic Efficacy and Section 3(d) of The Patents Act, 1970, Volume 1, Issue 1, RGNUL Student Law Review 172, at page 178-179. .............................................................................................................................................. 12 Phosphorous

Pentachloride

(accessed

on

15th

October,2017)

https://pubchem.ncbi.nlm.nih.gov/compound/phosphorus_pentachloride#section=Patents, 8

Structure of the law What does a patent protect? The simple answer to this question is that a patent protects an invention, which is a new product1 or process involving an inventive step and capable of industrial application.2” The present law provides the meaning of nearly all but one elements of invention, which is nature of ‘product or process’. This silence of the Patents Act, 1970 as to meaning of “product” or “process” seems to be problematic. This legislative silence has not been noticed either by the judiciary or by the academia. The most famous attempt in this regard, Novartis AG v. Union of India3came on April 1, 2013. Not only has a lot of time and effort passed after this landmark judgement was decided, but also the answers sought have been so sought in the light of either public welfare4 or economic liberalisation for foreign players5, and has clearly missed the point of why or why not evergreening be considered or not considered by using an equitable yardstick which has three thresholds, namely novelty, inventive step and utility. Section 3 stipulates all the conditions, falling under which a subject matter could not be considered as an invention and hence cannot be granted patent. Section 3(d), which seeks to eradicate the aspect of evergreening6, currently reads as under: “3. What are not inventions:- the following are not inventions within the meaning of this act: (d) 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.”

1

The Patents (Amendment) Act, 2005 § 4. The Patents Act, 1970 §2(1)(j). 3 Supreme Court Civil Appeal No. 2706-2716 of 2013. 4 See- Shamnad Bhasheer and T Prashant Reddy, The “Efficacy” of Indian Patent Law: Ironing out the Creases in Section 3(d),(2008) 5:2 SCRIPT-ed, at page 265. 5 See- Tatum Anderson, Rejected Novartis Cases Leave India’s TRIPS Compliance Unchallenged (Aug 8,2007, last accessed on Oct 27, 2017) https://www.ip-watch.org/2007/08/07/rejected-novartis-cases-leave-indias-tripscompliance-unchallenged/. See also- Harsha Jeswani, Analysis Of Novartis A.G. vs. Union Of India, (Feb 5,2016 last accessed Oct 24, 2017) 6 “Evergreening” is referred to a situation where the pharmaceutical companies extend their patent by another 20 years for mere reformulations or other itineries of the drug, without necessarily increasing the therapeutic efficacy of the drug, 2

Section 3(d) stipulates that a new form of a known substance would be patentable only when the new substance shows enhanced efficacy comparing with known substance. The key issues in interpreting section 3(d) could be: 1. What the word “efficacy” mean? 2. Factor realized which would qualify as enhanced “efficacy”? 3. Definition of “known substance”? The hoopla over section 3(d) of the Indian patent act is that the word enhanced efficacy is not backed by strong procedure to determine the efficacy of a particular drug. It depends on the whims and fancies of the patent controller to determine the efficacy of a particular drug. When the question arises to decide the efficiency of a life-saving drug like in the case of Novartis’ Glivec, the decision of the controller seems to go into the favour of public health although this biasness is obvious because the main aim of a state is welfare of its denizens. But this at some point seems arbitrary as the pharma companies invest lot of funds in their research and development department to develop lifesaving drugs. As in this case Novartis did, the Zimmermann’s drug Imatinib was a freebase which had anti-tumoural properties that can be used to cure cancer basically leukemia (blood cancer) and it was decided that the betacrystalline imatinib mesylate was the enhanced version of the freebase as the PHOSITA in this case could not make the beta-crystalline using the freebase. So, Novartis stands true on the ground of novelty, merely rejecting the Novartis’ application on the ground of the enhanced efficacy was not the correct decision, but we can’t deny the fact that when Novartis got the EMR (exclusive marketing rights) it increased the price of the drug by 20 times which in itself vitiated the aim, for which such drugs are manufactured i.e. public welfare, this objection of increasing prices destroyed the claims of Novartis. Although the company who has invested such a huge amount of funds in its r&d shall have the right to get the money back and make profits as at the end of the day earning profit is the main target of such companies.7

See R Capdeville “Glivec (STI571, Imatinib), A Rationally Developed, Targeted Anticancer Drug” Nature Reviews Drug Discovery 1, 493-502 (July 2002). See also E Buchdunger and J Zimmerman, “The Story of Gleevec” (last accessed 20th Oct, 2017) http://www.innovation.org/index.cfm/StoriesofInnovation/InnovatorStories/The_Story_of_Gleevec. 7

Structure of Case The only one time that Gujarat High Court gave a decision on s3(d) of The Patents Act, 1970 was in the case of Rajnikant Devidas Shroff v. Pharma Chem8, and the same was by the virtue of s. 104 of the Patents Act, 19709. The plaintiff had alleged a violation of the patent it had by the hands of the defendant, and then went on to claim (i) injunction from using the patent, (ii) either a decree of Rs 1,00,00,000 or to render a faithful accounts of the profits earned, and (iii) appointment of a Court’s Commission to look into the matter. Against this the defendant filed a counter-claim alleging that the patent should have never been given in the first place, and that no interim or final action should be taken against him. Nature of the patent The patent10 is on a crystalline form of phosphorous pentachloride (PCL5). The United States have registered 1,426 patents on PCL511. It was first patented in 1970s in the USA, but the Indian Patent Controller had granted Patent to the plaintiff for the reason that the same was in crystalline form, as against the fluid form in all other cases. Defendant 12 (Rajnikant Devidas Shroff) invented the process and apparatus for the production of free flowing dry PCL5. The invention of defendant was with the object of manufacturing PCL5 directly in the form a line, free flowing powder devoid of any lump formation which can be readily used for binding with the medicines for greater efficiency, without requiring further processing after the completion of the reaction. He also invented an apparatus for carrying out the process according to the said invention, and therefore, invented a process to achieve the said objects by a novel route by synthesizing PCL5 using a vapour phase reaction between phosphorus trichloride with chlorine gas and by devising an apparatus to carry out the said process with a view to eliminate the disadvantages and the drawbacks in the conventional method.13 PCL5 is a white to pale yellow powder or fine granular fuming mass with a pungent odour which reacts violently with water. In the presence of moisture, it decomposes with heat. Prior to this invention, the following procedures were used for manufacturing PCL5: a) By reacting stoichiometric quantities of chlorine with Phosphorus Trichloride in a solvent medium, or 8

Rajnikant Devidas Shroff v. Pharma Chem, (2009) S.C.C. OnLine Guj. 790. Jurisdiction of Suits Concerning Infringement of Parties. 10 Patent No- 172459. 11 Phosphorous Pentachloride (accessed on 15th https://pubchem.ncbi.nlm.nih.gov/compound/phosphorus_pentachloride#section=Patents, 12 Defendant with respect to the case we are analyzing. 13 Id. at para 5. 9

October,2017)

b) By direct chlorination of Phosphorus Trichloride with chlorine gas or liquid chlorine, or c) By passing chlorine gas in suspension of red phosphorus in a suitable solvent medium, or d) By reaction between Phosphoryl chloride carbonyl chloride and carbon at higher temperatures, say in the region of 300 to 500 Deg. C, or e) By reaction of phosphorus trichloride and chlorine under pressure in an autoclave.14 Timeline of the Patent The patent application was filed on 15/05/1991 and granted. Hence, the monopoly over the patent was supposed to last till 15/05/201115. The patent in speculation had already been termed as a good patent16 as in previous litigations, this patent was given validity, and at the time of the arrival of this case it already was 18 years old. Intricacies of the Case We have been talking about PCL5, which in itself even if is not a medicine, but is one of the major ingredients in production of medicines and pharmaceuticals17. The defendants put forward a notion that the particular substance has been in use since 1970s and because of such an availability of prior art, the same was not liable for grant of patent in the first place, and hence, the patent should have been revoked. This is the major ground of application of s. 3(d), as it is just a polymorphous form of an existing material, and the only way out of this deadlock is to analyse the efficiency of the crystalline form over the usual form. The defendants even came up with a method of production of PCL5, that was done by a series of reaction of phosphorous trichloride, using the catalyst of carbon tetrachloride and thereby producing a form of PCL5 which resembled the patented object. The same was being carried out since around 2004. These two parties, the plaintiff and the defendant happen to be the only producers of such an object in the area of Valsad, Gujarat.

14

Id. at para 4. The Patents Act, 1970, §53. 16 Old patents are termed ‘good patents’ if they have well held their sanctity and utility in the industrial arena, and the courts have a lenient approach favouring them when it comes to decisions on infringement and injunctions. See- Shillito v. Larmuth and Co., 1885 (II), Reports of Patent Cases, Page 1, Chancery Court of the County Palatine of Lancaster, Manchester District. 17 It includes posttraumatic stress disorder medicines. See- New Jersey Department of Health and Senior Services, ‘Hazardous Substance Fact Sheet’, (last accessed on 12/10/2017) http://nj.gov/health/eoh/rtkweb/documents/fs/1525.pdf . 15

The crystalline form as provided by the learned advocates in the cause is better than the fluid form for the reason that the same can be easily mixed and integrated into medicines. It was also alleged that the defendants were in close contact with one of the chemists of the plaintiffs and the same had been the bridge between the infringement of the patent and changing of hands of the patent process. The High Court Decision The High court held that all the other methods that were being pointed out by the defendants were not the same or even similar to that of the plaintiff, and the plaintiff’s patent was indeed more efficient than the other crystalline forms of the same compound, and this aspect was used to increase the therapeutic efficacy of the object. Hence, the court held that there was infringement of the patent18, but however gave a stay for the implementation of 3 weeks if the defendants wanted to approach a higher forum. Interim Decision

This discussion was greatly moulded by the discussions on injunction to be laid or not. Mr. Thakore, learned advocate of the defendant relied on the decision of Farbwerke Hoechst Aktiengesellschaftvormals Meister Lucius &Burning Corporation v. Unichem Laboratories19, wherein it is held that in an action for infringement of plaintiff's patent in respect of the process of manufacture of a medicinal product where the defendants admit that the drug which they manufacture under different trade name is the very drug in respect of which the plaintiffs have obtained their patent, a presumption that the defendants drug has been produced by the patented process of which it is alleged to be an infringement can be drawn against the defendants under the general provision contained in Section 114 of the Evidence Act. Moreover, though the general burden of establishing the case of infringement undoubtedly rests on the plaintiffs in accordance with Section 101 of the Evidence Act, the burden of providing a particular fact, viz., the process by which the defendant's product is being prepared by the defendants would be on the defendants, since that is a fact “especially” within their knowledge within the terms of Section 106 of the Evidence Act. It is impossible for the plaintiffs to know by what precise process that product is being prepared by the defendants and it is precisely to that sort of a case that Section 106 is intended to apply. The Court therefore took the view that in view of the admissions made by the defendants, it 18 19

Supra 9 at para 8. A.I.R. 1969 Bombay 255.

became unnecessary for the defendant to lead any evidence at all to prove infringement on the part of the defendants. As stated in Section 58 of the Evidence Act, facts which are admitted need not be proved.20 On the other hand Mr. Joshi, counsel for the petitioner21 relied on the decision of Dhanpat Seth v. Nil Kamal Plastic Crates Ltd.22, wherein it was held that mere fact that the device is made of polymeric material instead of bamboo is not an inventive step involving any novelty. There is nothing new about the process of manufacturing. Therefore mere grant of patent in favour of the plaintiffs by itself does not mean that plaintiffs were entitled to any injunction. This factor can be taken into consideration and would be a relevant factor but grant of patent would not ipso facto entitle defendant to grant of an junction without taking into consideration other relevant factors. In fact, Section 107 clearly provides that in any suit for infringement of patent every ground on which it may be revoked under Section 64 shall be available as a ground for defence.23 The Supreme Court’s stance Following its 3 week stay on the injunction, the defendant approached the Supreme Court24. Till now, the Supreme Court has only granted the leave and ordered a conclusion of all the matters aligned to this cause. This was done in 2014, when the case reached the Supreme Court in the form of a SLP25. For the lack of comment on this case, the Supreme Court has applied the doctrine of merger26 in this case.

20

Supra 9 at para 23. With respect to the Supreme Court decision. 22 A.I.R. 2008 Himachal Pradesh 23. 23 Supra 9 at para 31. 24 O.J. Appeal No.12 of 2009 in Civil Suit 1 of 2005 decided on March 3, 2009 (Gujarat). 25 Pharma Chem v. Rajnikant Devidas Shroff (2014) 16 S.C.C. 380. 26 When a higher court’s judgement is limited, the operative part of the lower court’s judgement is merged in the final judgement. This is known as Doctrine of Merger. See- S. Shammugadel Nadar v. State of Tamil Nadu, (2002) 8 S.C.C. 361, para 10. 21

Therapeutic efficacy and beyond Dictionary meaning to efficacy means “effectiveness” i.e. likelihood of achieving desired end by expending effort. In medicine, it means a treatment’s or vaccine’s effectiveness in curing, preventing or lessening the effect of disease.27 The sections 3(d) circumnavigate the word efficacy as u will get the result, what interpretation u put to this word. More specifically the issues is whether the word efficacy should be interpreted to mean “therapeutic efficacy” or it should be give a wider interpretation to include any kind of advantageous property attributable to the new form. According to Novartis, Section 3(d) contravenes the TRIPS Agreement. We see following reasons as potential reasons of computability. Firstly, Section 3(d) may render the Indian patentability system more stringent than what Article 27 of TRIPs requires, Secondly, by focusing on chemicals and pharmaceuticals products, Section 3(d) may be considered discriminatory as to the field of technology. After the Madras High Court decision28, which said that efficacy can only be read under the head of ‘therapeutic efficacy’29 and thereby turning this provision into a law restricted for pharmaceutical industry, there was a tiff to redefine the stance. The Supreme Court in that case did not do so as it had bigger problems to answer in a very short span of time. But the present case at hand can be one of liberating and widening standards that puts this provision back on to being a general provision. In the case of Golchan Industries ltd v. Cadila Health and Others30, the court opined that s.3(d) is not a mere reproduction of the provision in the ordinance, but a result of Parliamentary Debates31 and hence has a value that shall not be so judiciously interpreted to restrict it to a certain field. It takes all fields of technology and not just pharmacology and the only restriction is the requisite of ‘efficacy’ 32. This case even saw a general statement made as a direction to the Assistant Controller of Patents to look beyond the point of law provided for efficacy, for a proper enquiry, if the condition speaks highly of inventive steps. 33 Since this case the Bombay High Court has not decided upon the merits of s. 3(d).

Black’s law dictionary Novartis A.G. v. Union of India (2007) S.C.C. OnLine Mad. 658. 29 Id. at para 181. See also- Harekrishna Ashar,The Supreme Court on Therapeutic Efficacy and Section 3(d) of The Patents Act, 1970, Volume 1, Issue 1, RGNUL Student Law Review 172, at page 178-179. 30 (2009) S.C.C. OnLine Bom. 1701. 31 Id. at para 11. 32 Id. at para 11 and 13. 33 Id. at para 16. 27 28

Basically, the efficacy explained in section 3(d) cannot be limited to only pharmaceuticals industries as it has already been cleared by the Indian government in 2007 at WTO Trade Policy Review(TRP) that the amendment act 2005 seeks to balance IP Protection with public health, national security, and the concerns of public interests. So limiting the interpretation only to pharmaceutical patents does not suffice the intention behind enacting it, as the interpretation given by various courts around the country is that the word efficacy used in this section means only therapeutic efficacy but it will narrow down the interpretation as (some foreign court decision.), which should be widen up to include efficacy of any substance which has been granted patent and there is some enhancement in its properties rather just improvement in its physical properties. Is PCL5 a Pharmaceutical substance? There is a requirement of discussing things in the broader light and broader perspectives. After the Novartis AG cases at the Supreme Court and the High Court of Madras, a provision was inserted in the Patents Act, 1970, which has defined ‘pharmaceutical substance’ 34, which is highly regulated35 and a ‘pharmaceutical substance’36 is one which comes with the assumption of patent grant. Even though these are not clear to define a pharma product, it’s safe to assume that one product is pharmaceutical if it has some value for the aspects of good health regulation and one will be industrial product/chemical when it’s a chemical that has an industrial use, whether or not it also has an excluded use.- this is the Australian definition of the term. PCL5 though is used in manufacturing of medicines and that is the main business of the plaintiff and the defendant provides chemicals for the same, but it rather fits into the definition of an industrial chemical37, for it is needed for a further production and has got no direct therapeutic value38. In a very centric condition, we can even say that crystalline form of PCL5 is better only because it gets mixed and formulate easily into the medicines.The same does not add on to

34

The Patents Act, 1970 § 2(ta)- "pharmaceutical substance" means any new entity involving one or more inventive steps”. 35 The Patents Act, 1970,§ 92A(3) 36 The Patents Act, 1970, § 92A(3), See-Explanation. 37 Which is defined in the USA and Australia. The Australian definition, as taken from Section 5 of Industrial Chemicals (Notification and Assessment) Act 1989, has been provided in the preceding paragraph. 38 See- New Jersey Department of Health and Senior Services, ‘Hazardous Substance Fact Sheet’( last accessed Oct 12, 2017) http://nj.gov/health/eoh/rtkweb/documents/fs/1525.pdf.

the ‘therapeutic’ value as much as it adds on to the industrial process of its production and value of its product. To point that there is a higher degree on the head of the defendant as well to prove that section 3(d) applies and hence the same becomes difficult to be proved, an example can be taken. In order to realise the therapeutic efficacy IPAB has held that applicants of revocation of any patent are required to prove experimental data of clinical nature, done on human beings in support of therapeutic efficacy.39 Hence, it is not required to read PCL5 under the head of a medicine to attach a theory of medicinal value and then implicate s.3(d) of the Patents Act, 1970. The provision is broad and can well take industrial chemicals, a better object for the grant of patent and also was the first US patent.40 Widening the Scope of Section 3(d) of the Patent Act, 1970. Patent Act, 1952 of the United States America does not have statutory provisions corresponding to the provisions of Sections 3 and 4 of the Patents Act, 1970 which are like “first gate keepers” who may or may not allow a product or process to enter the empire of patent. There are no such statutory gate keepers under the US Act. Further, the US Act identifies four patentable subject matters: process, machine, manufacture, and composition of matter.41 The US Act defines “process” as process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material but does not define “machine,” “manufacture,” and “composition of matter.”42 Now that there are provisions relating to the gatekeeping, we need to look at two aspects. First is the one of restrictions on a wider approach. There is a widespread and growing concern that patents hinder access to life saving drugs in developing countries. The same is because of lack of R&D and parlance of generic drugs,

39

Tianjin Dishlin Investment Holding v. Controller General (2012) S.C.C. OnLine I.P.A.B. 101, para 5. “In the US Law, the first Patent was granted to Samuel Hopkins in 1790, who had devised an improved method of making Potash, America’s first industrial chemical. This was signed by President George Washington, Secy of State Thomas Jefferson and Attorney general Edmund Rudolph.”- Board of Trustees of the Leeland Stanford junior University v. Roche Molecular Systems,(2011) S.C.C. OnLine U.S. S.C. 52, part IIA. 41 US Patent Act, 1952 §101. 42 Ghaiyur Alam, Patent Eligible Products and Processes: Legal Perspective and Reforms, 3-5 R.M.L.N.L.U.J. (2011-2013) 66 at page 68. 40

which implicate higher rates from the manufacturers.43 Such a gatekeeping will be beneficial as it will be more difficult to indulge in evergreening in India.44 The amended S. 3(d) appears to be limited to only new forms that demonstrate an increase in known efficacy. It does not, therefore, apply to a case where the new form is found to have a completely different use (and not just an increased efficacy vis-à-vis the known use). If the intention behind this provision is to heighten the obviousness standard and weed out frivolous and fairly obvious patents, this seems a rather illogical result, as a new use for a new form is certainly more inventive than a mere showing of an increase in known efficacy.45 But this will keep leading us to the same question as that we had in the Novartis AG and are having right now. Even the landmark judgment could not a middle path and gave the scope for the same cause to heard again in the same court.46 Indian Judicial Understanding We have seen a dearth in the understanding of this aspect of what a patent is and what is not when we talk about the evergreening constraint. The Bombay High Court has not decided on any matter on s.3(d) and its merits after the Novartis judgement47. Before this judgment, only once the Hon’ble High Court dealt with such an intricate question in the case of Golchan Industries ltd v Cadilla Health48which we have dealt previously. This still is better than a lot other High Courts which have not discussed this matter, including the Allahabad High Court, Jabalpur High Court and since its decision, even the Madras High Court. Delhi High Court on the other hand can be seen to be directly influenced by the two Novartis judgements, and have very clearly dealt a few instances. The principle the judges have opined is that a derivative of a known substance/compound cannot be patented49. This is believed to be the effect of a very simple case that any derivative will certainly have some new effects, which are beneficial but not clearly out of the box, considering the attributes of the substance/compound it is a derivative of, and unless the rules constructing this setup are not stringent, evergreening cannot be done away with. The first question that arises in regard to Prof. A. Lakshminath and Dr. Ajay Kumar, ‘Evergreening of Patents’, 16 (1stedn, Satyam Law International 2014). 44 Ibid. page 21. 45 Shamnad Bhasheer, India's Tryst with Trips: The Patents (Amendment) Act, 2005, 1 I.J.L.T. (2005) 15 at page 25. 46 “Inventive step”. Press Trust of India, Natco Opposes Novartis' Patent Claim, (last visited Oct 18, 2017) http://inhome.rediff.com/money/2005.jun/20natco.htm . 47 Novartis A.G. v. U.O.I., (2013) 6 S.C.C. 1. 48 (2009) S.C.C. OnLine Bom. 1701. 49 Roche v. Cipla (2012) S.C.C. OnLine Del. 4704, para 11. 43

the subject of the utility of a patent understands the quantum of utility required to support a patent. Reference may be made to the effect that in the absence of any promise in the specification that a definite degree of advantage would result from the use of the invention, the amount of utility required to support a patent is very small.50 It is further stated in the said passage that it is, in particular, not necessary that the invention as described should be commercially useful, unless the specification promises that it would be, and that it is sufficient that that invention should, by reason of the features that distinguish it from earlier proposals, be of some use to the public.51 Strikingly in Tianjin Dishlin Investment Holding v. Controller General of Patents, Designs, Trademarks and Geographical Indications at Dwarka, New Delhi52 the tribunal spoke of the requisite of clinical data on therapeutic efficacy, done on humans, as a way of increasing the threshold of the sanctity of new found effects. Lesson learnt? Patent Application No.1577/Del/1996 was refused, inter alia under the provisions of s3(d). The Controller in his decision dated 12th June, 2007 held that “the present invention provided a new form of a known substance either in anhydrous form or hydrated form III of Atorvastatine having the same therapeutic activity in the same field. It only creates more improvement in physical property. Hence it could not be provided a patent.53 Clearly, a stance, similar to the PCL5 has appeared and the Patent office has understood a minor mistake it had done earlier. It has denied the patent protection of a chemical which is used as a medicine for controlling of the total Cholesterol and preventing cardiovascular diseases54, and is another important life-saving drug, a patent on which could have been against the cause of the patients. This has been done for the reason that one is just a nextlevel form of pre-existing cause and the result will not change the position as it will still be a new use of a known substance.55 Similarly, combination of two compounds is also not

50

Farbewerke Hoechst v. Unichem Laboratories A.I.R. 1969 Bom. 255. Bristol Myers SuibbCompany v. JD Joshi (2015) S.C.C. OnLine Del. 10109, para 51. 52 (2012) S.C.C. OnLine I.P.A.B. 101, page-5. 53 Draft Manual of Patent Practice and Procedure, by the Controller General of Patents, Designs and Trademark, India (3rdedn, 2008) page-63. 54 ‘Atorvastantine 10 mg film coated tablets’, www.medicines.org.uk/emc/medicine/33640, ( accessed 30th Oct, 2017). 55 Mosanto Technology v. The Controller of Patents and Designs, (2013) S.C.C. OnLine I.P.A.B. 106, para 26. 51

permissible to be provided patent. In cases of combinations, the authorities can go forward with ignoring the application if there is some particular new innovation and novelty.56

56

Ajanta Pharma v. Allegram Inc. (2013) S.C.C. OnLine I.P.A.B. 127, para 11.

Conclusion Just one conclusion comes out of this arrangement and that is the recognition of the problem at hand. The problem is hotly debated and seldom answered, and this is the best chance that the Supreme Court has had in a while to answer the question of when to patent and when to not. Such a decision is not just the characterization for the judicial bodies, but would rather form an integral aspect in the analysis of each application that claims patent. As to what the answer should be, clarity could be found only by construing the structure of the foreign bodies trying to regulate impartially. TRIPS agreement should be referred to and dealt more seriously than before. Such constructions would be beneficial for the sole cause of ease of trade in India and respect to the R&D works that other Companies have taken. Lastly, the word’ efficacy’ has been read very restrictively and the same is the root cause of all the problems. Efficacy should be left back to its literal meaning and not be restricted to only pharmaceuticals.