7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015 BEFORE THE HIGH COURT OF MUNAIN, REPUBLIC OF BHARANESIA. O.S. No.

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1 Team code SK39 BEFORE THE HIGH COURT OF MUNAIN, REPUBLIC OF BHARANESIA O.S. No. 707/ B.Z. Mate University.. Plaintiff v. 1. Bristo Pharmaceuticals Pvt. Ltd. and Bristo Pharmaceuticals Inc....Defendants BEFORE THE INTELLECTUAL PROPERTY APPELLATE BOARD (IPAB) OF BHARANESIA OA/7/2014/PT/DH 1. Bristo Pharmaceuticals Pvt. Ltd......Appellant v. 1. B.Z. Mate University 2. Controller of Patents, Bharanesia......Respondents AND ORA/14/2014/PT/DH 1. Bristo Pharmaceuticals Pvt. Ltd....Applicant v. 1. B.Z. Mate University...Respondent

2 TABLE OF CONTENTS Table of Contents 1. List of Abbreviations Index of Authorities Statement of Facts Issues Presented Statement of Jurisdiction Summary of Arguments Before the High Court of Munain, Republic of Bharanesia i. If a pre-grant opposition is filed and dismissed, is the aggrieved party stopped from filing a post-grant opposition on primarily the same grounds?...12 ii. Can a quia timet injunction be granted to a party for a patent whose validity is under challenge before various bodies?...14 Before the Intellectual Property Appellate Board (IPAB) of Bharanesia i. The obligation to provide a Proof of right if the assignment is not in place and if the inventors are not traceable. Whether the Patent Office can conclude on ownership of a patent from other circumstances?...18 ii. Obviousness in case the level of skill is high iii. Whether prior publication by the inventors can defeat novelty?...28 iv. If a Post Grant opposition has been filed, can the same party file for a revocation and also challenge the patent in a counter claim for infringement Prayer

3 LIST OF ABBREVIATIONS List of Abbreviations 1. AIR All India Reporter 2. Anr Another 3. Ch Chapter 4. Corpn. Corporation 5. CTC Current Tamil Nadu Cases 6. Del Delhi 7. DLT Delhi Law Tribunal 8. IPAB Intellectual Property Appellate Board 9. JIPR Journal of Intellectual Property Rights 10. Ltd Limited 11. Mad. Madras 12. Nag Nagpur 13. OA Original Application 14. Ors Others 15. OS Original suit 16. PTC Patent & Trade Marks Cases 17. RPC Reports of Patent, Design and Trade Mark Cases 18. SC Supreme Court 19. SCC Supreme Court Cases 20. v. Versus 3

4 INDEX OF AUTHORITIES Index of Authorities CASES: 1. Aloys Wobben and anr. v. Yogesh Mehra and ors, A.I.R S.C American Cyanamid Co v. Ethicon Ltd. 3. Andhra Pradesh Financial Corporation v. Gar Re-rolling Mills, 1994 (2) S.C.C Beloit Technologies Inc.; Beloit Walmsley Limited v. Valmet Paper Machinery Inc. and Valmet pazper Machinery (U.K.) Limited, (1997) E.W.C.A. Civ Bilcare v. Amartara Pvt. Ltd., M.I.P.R (2) Biswanath Prasad Radhey Shyam v. Hindustan Metal Industries, A.I.R S.C (8) 7. B.T.H. v. Metropolitan Vickers, (1928) 45 R.P.C Canadian general electric company v. Fada radio, A.I.R P.C F. Hoffmann-La Roche Ltd. and anr. v. Cipla Limited, 148 (2008) D.L.T Flour Oxidising v. Carr, (1908) 25 R.P.C General Tire & Rubber Company v. The Firestone Type and Rubber Company Limited and ors., (1972) R.P.C Helitune Ltd v. Hughes Ltd, [1991] F.S.R. 171, Hills v. Evans, (1862) 4 De G.F. & J J. Mitra and Co. Pvt. Ltd. v. Asst. Controller of Patents and Design and ors, A.I.R S.C K. Manivannan, Proprietor, Trading as Kumar Industries v. Shri M. Mani, Proprietor Valasumani Lathe Works, 2009 (41) P.T.C. 561 (I.P.A.B.) 4

5 Index of Authorities 16. Manicka Thevar v. Star Ploro Works, A.I.R Mad Mars Incorporated v. Kumar Krishna Mukerjee and ors, 2003 (26) P.T.C. 60 Del 18. Motor Corpn v. Hollister Inc, [1993] R.P.C. 7, 13 (C.A.) 19. National Research and Development Corporation of India v. Delhi Cloth and General Mills, A.I.R Del Pope Alliance Corporation v. Spanish Siver Pulp & Paper Mills Ltd., A.I.R P.C Smith v. Grigg Ltd., (1924) 1 K.B. 655) 22. Surendra Lal Mahendra v. Jain Galzers, 1981 P.T.C Transcore v. Union of India, (2008) 1 S.C.C Valensi v. British radio corpn, [1973] R.P.C. 337 BOOKS: 1. Pharmaceutical, Biotechnology and chemical Inventions: World protection and exploitation (Duncan Bucknell ed., Oxford University Press). 2. V.K. Ahuja, Intellectual Property Rights in India 934 (LexisNexis 2009). STATUTES: 1. Indian Patents Act, Manual of Patents Practice and Procedure, The Code of Civil Procedure, Patent Rules, ARTICLES: 1. Sindhura Chakarvarty, Importance of Assignment Agreement under Intellectual Property laws in India, 14(6) J.I.P.R. 513 (Nov. 2009). 2. Employer v. Employee invention: IPR issues in R&D organizations, 5(5) J.I.P.R 246 (Sept. 2000). 5

6 STATEMENT OF FACTS Statement of Facts 1. B.Z. Mate University (hereinafter referred to as Mate) is a University based in the Republic of Bharanesia. Its Constitution, Laws, Institutions and Social Ethos are substantially similar to that of Union of India. Bristo Pharmaceuticals Pvt. Ltd. (hereinafter referred to as Bristo) is a company registered under the laws of Bharanesia. Bristo is a wholly owned subsidiary of Bristo Pharmaceuticals Inc., registered under the laws of Federation of Pandora whose constitution, laws and social ethos are substantially similar to that of the United States of America. 2. Mate filed patent application 8456/MN/2009 on June 5, 2009 titled Abc receptor antagonist for the treatment of chronic pain. The inventors named in the application were Vaidya M. and Bhattacharya P. both employed by Mate. On objection to the grant of patent, Mate, responded to the First Examination Report. It stated that the inventors whereabouts are not known. The Standing Rules of the Contract of Employment (which has the force of law) specifically stipulates that only the University will be the owner of any IP generated by their employees in the course of their employment. Subsequently, Bristo filed a pre-grant opposition against the grant of a patent. 3. Mate responded with similar submissions as before. A hearing was held and both parties argued. Based on Mate s submissions, the Controller of Patents dismissed the pre-grant opposition proceedings filed by Bristo. A patent was granted which was given the Patent No on January 11, Bristo filed a post grant opposition to the Patent claiming that the piperidine derivates were obvious to a person skilled in the art. Meanwhile an RTI application by Mate revealed that Bristo had applied for a manufacturing licence manufacturing abc bulk 6

7 Statement of Facts drug. Also, their website listed abc in their product list under developed antagonist APIs. Mate, sent a letter through their Attorneys to Bristo and Bristo Inc. which inter alia stated that Mate is the owner of the patent, the impugned product is identical to the one under challenge and that they should abstain from such advertising or production. 5. After receiving no response, subsequently Mate filed a quia timet suit for infringement before the District Court of Suriya for restraining Bristo and Bristo Inc. from using in any way the impugned product. The Hon ble District Court, granted a quia timet ex-parte injunction restraining Bristo and Bristo Inc. from manufacturing, marketing or in any way using the impugned product in and exporting the same outside Bharanesia. 6. In the opposition proceedings, the Controller of Patents constituted an Opposition Board. Both parties made their submissions along with evidence by experts. The Opposition Board accepted relative novelty. Nonetheless, the Controller, maintained the patent. 7. Bristo further appealed the decision at the IPAB. Simultaneously, it also filed for a revocation of the patent at the IPAB on grounds that it was prior art and lacked inventive step - the issue of missing signatures was also raised wherein Bistro provided the actual whereabouts of the Inventors who were claimed to be untraceable by Mate. 8. Since the appeal and the application for revocation involved the same patent, both the matters were taken up simultaneously at the IPAB. Bristo also challenged the claims of the patent in a counter-claim of infringement. The suit, along with the counter- claim got transferred to the High court of Munain. 7

8 Issues Presented ISSUES PRESENTED Before the High Court of Munain, Republic of Bharanesia 1. If a pre-grant opposition is filed and dismissed, is the aggrieved party stopped from filing a post-grant opposition on primarily the same grounds? 2. Can a quia timet injunction be granted to a party for a patent whose validity is under challenge before various bodies? Before the Intellectual Property Appellate Board (IPAB) of Bharanesia 1. The obligation to provide a Proof of right if the assignment is not in place and if the inventors are not traceable. Whether the Patent Office can conclude on ownership of a patent from other circumstances? 2. Obviousness in case the level of skill is high. 3. Whether prior publication by the inventors can defeat novelty? 4. If a Post Grant opposition has been filed, can the same party file for a revocation and also challenge the patent in a counter claim for infringement. 8

9 STATEMENT OF JURISDICTION Statement of Jurisdiction Before the High Court of Munain, Republic of Bharanesia The High Court exercises its jurisdiction conferred on it by the virtue of S. 104 of the Patents Act, 1970 wherein if a counter-claim for revocation of the patent is made by the defendant, the suit, along with the counter-claim, shall be transferred to the High Court for decision. Before the Intellectual Property Appellate Board (IPAB) of Bharanesia The IPAB exercises its jurisdiction to hear all cases against any order or decision of the controller and all cases pertaining to revocation of patent other than on a counter claim in a suit for infringement and rectification of registers and all such cases which were pending before the High Court stood transferred to the IPAB by virtue of S. 117-G of the Patents (Amendment) Act,

10 SUMMARY OF ARGUMENTS Summary of Arguments Before the High Court of Munain, Republic of Bharanesia 1. If a pre-grant opposition is filed and dismissed, is the aggrieved party stopped from filing a post-grant opposition on primarily the same grounds? If a pre grant opposition is filed and dismissed, the aggrieved party is not stopped from filing a post grant opposition on the same grounds because, pre grant opposition and post grant opposition are two different stages in Patent Procurement procedure, they only differ in the procedural aspects. Further, under pre grant opposition it is not necessary for the controller to hear both the parties, whereas he is obliged to do so in the post grant opposition. Hence, it is only logical to conclude that the grounds for opposition in pre grant and post grant opposition for a party in a genuine case would not change. Post grant opposition is merely an additional shield to aid better scrutiny in the grant of patent, change in the very grounds of such opposition will only indicate a vexatious defence as opposed to a genuine one. Lastly there is also no express provision in the Indian Patents Act, that bars such an action. 2. Can a quia timet injunction be granted to a party for a patent whose validity is under challenge before various bodies? A quia timet injunction cannot be granted to a party whose patent is under challenge before various bodies. The standard for granting a quia timet injunction was laid down in F. hoffmann-la Roche Ltd. and anr v Cipla Ltd. which stipulates three preconditions - firstly, the approach indicated in American Cyanamid, secondly, a rule of caution whereby presumption of validity must not be based on the mere fact that the defendant is challenging it, and lastly the defence must be genuine. All three preconditions have been summararily 10

11 Summary of Arguments satisfied. Finally, the grant will not succeed because of the "presumption of invalidity" that has became the standard with the courts. Before the Intellectual Property Appellate Board (IPAB) of Bharanesia 1. The obligation to provide a proof of right if the assignment is not in place and if the inventors are not traceable. Whether the patent office can conclude on ownership of a patent from other circumstances? The counsel humbly submits that If the assignment is not in place and inventors are not traceable, there must not be an obligation to provide a proof of right specifically, providing credible proof of proprietary interest would suffice or else the purpose of protecting the true owner gets defeated. In absence of any provision under Indian law, reliance can be placed on U.S. law wherein it is sufficient to show the proprietary interest, non-traceability, promise or obligation to assign patent and probability of irreparable damage. Moreover, as a matter of practice employment contracts in India are considered sufficient proof of ownership. 2. Obviousness in case the level of skill is high. The claimed invention is not obvious because it is structurally and functionally different from the known compounds and technically advanced. Not only the efficacy of the compound has substantially improved but has economic significance too. Also the inventive step is not obvious to the person skilled in the art. The obviousness of an invention is to be tested on the standards of a "person skilled in the art". The personal level of skill of the inventors should not affect the standards of examination. 3. Whether prior publication by the inventors can defeat novelty? 11

12 Summary of Arguments Prior publication by the inventors can defeat novelty only if it can be anticipated. The defendant s claim is not equivalent to what has been disclosed in prior publication by the same inventors. For anticipation to occur the antecedent document must contain clear and unmistakable directions to do what the patentee has claimed in the claim under consideration. It is not enough to prove that an apparatus described in an early specification could have been used to produce this or that result. It must also be shown that the specifications contain clear and unmistakable directions as to use it. While in the present case the inventors had only comprehended the possibility of such a product. 4. If a post grant opposition has been filed, can the same party file for a revocation and also challenge the patent in a counter claim for infringement. The counsel humbly submits that if a post grant opposition has been filed by a party and the same is still pending, it will eclipse all or any other remedy available under section 64(1). In fact, section 64 is applicable only after proceedings under section 25(2) culminate. If the same has been dismissed, it will still attract the doctrine of matter sub-judice. Moreover, the revocation application and counter claim of infringement suit are clearly disjunctive remedies indicated by the term or used in the provision. Furthermore, the doctrine of election would also apply here and thus, both the remedies cannot be taken simultaneously. 12

13 ARGUMENTS ADVANCED BEFORE THE HIGH COURT OF MUNAIN, REPUBLIC OF BHARANESIA 1. IF A PRE-GRANT OPPOSITION IS FILED AND DISMISSED, IS THE AGGRIEVED PARTY STOPPED FROM FILING A POST-GRANT OPPOSITION ON PRIMARILY THE SAME GROUNDS? The Counsel humbly submits that if a pre grant opposition is filed and dismissed, the aggrieved party is not stopped from filing a post grant opposition on the same grounds as: Different Stages in Patent Procurement Procedure It is humbly submitted that pre grant opposition and post grant opposition are two different stages in Patent Procurement procedure. Although, the grounds for the two are same, they differ in procedural aspect as explained by the Hon'ble Supreme Court of India, in the case of J. Mitra and Co. Pvt. Ltd. v Asst. Controller of Patents and Design and ors. 1 "The ground of challenge under Section 25(1) is identical to Section 25(2) of the said 1970 Act. However, Section 25(1) is wider than Section 25(2) as the latter is available only to a "person aggrieved". The main difference between Section 25(1) and Section 25(2), as brought about by Patents (Amendment) Act, 2005, is that even after a patent is granted, "post-grant opposition" can be filed under Section 25(2) for a period of one year. The reason is obvious. In relation to patents that are of recent origin, a higher scrutiny is necessary. Moreover, under pre grant opposition it is not necessary for the controller to hear both the parties, whereas he is obliged to do so in the post grant opposition. Thus, it can be rightly said that it is a two tier protection system to ensure better scrutiny of the patents to be granted as 1 A.I.R S.C

14 well as the interests of the interested parties, that the post grant opposition was introduced post 2005 amendment wherein post grant opposition was introduced. Therefore, the same party has been given the right under statute to pre grant as well as post grant opposition. Grants for opposition in these two levels remain unchanged in genuine petition Moreover, it is humbly submitted that it is only logical to conclude that the grounds for opposition in pre grant and post grant opposition for a party in a genuine case would not change. An analogy to this effect would satisfy the Hon'ble court - i.e. an insanity plea in a defence for murder will remain the same in an appeal at a higher adjudicatory forum, It is submitted that post grant opposition is an additional shield to aid better scrutiny in the grant of patent, change in the very grounds of such opposition will only indicate a vexatious defence as opposed to a genuine one. No Express Prohibition in the Act It is pertinent to note that there is no provision provided in the Act that precludes a party from filing a post grant opposition on same grounds after an unsuccessful attempt at pre grant opposition. Thus, in absence of such express prohibition the parties cannot be denied the independent statutory remedy of filing post grant opposition. Also, it can be concluded from the case of Surajmal Rambux & Ors v Laxminarayan Raghunath 2 that if there are two proceedings of different levels and in absence of an express prohibition, an unsuccessful attempt at one of the proceedings would not bar the party from initiating other proceeding. 2. CAN A QUIA TIMET INJUNCTION BE GRANTED TO A PARTY FOR A PATENT WHOSE VALIDITY IS UNDER CHALLENGE BEFORE VARIOUS BODIES? 2 A.I.R Nag

15 The counsel humbly submits that a quia timet injunction cannot be granted to a party whose patent is under challenge before various bodies. Injunctions are granted as relief in suit for infringement under Section 108(1) of the Indian Patents Act, Definition of Quia Timet Injunction In Mars Incorporated vs. Kumar Krishna Mukerjee and ors 4, it was held by the Delhi High Court that:- "This is a Quia Timet suit i.e. action against apprehended or threatened invasion... In legal terminology it has been defined in Osborne's Concise Law Dictionary (London: Sweet and Maxwell, 8th edn. 1993, Bone and Rutherford) as an action by which a person may obtain an injunction to prevent or restrain some threatened act being done which, if done, would cause him substantial damage, and for which money would be no adequate or sufficient remedy..." (emphasis supplied) The Counsel would like to draw the attention of the Hon'ble court to the phrase - "for which money would be no adequate or sufficient remedy" (emphasis supplied) as held by the Hon'ble Delhi HC. The counsel contends that, in the present circumstances any damage can easily be made good (monetary compensation as the honourable court deems fit) by the defendants, in the off chance of the case falling in the plaintiff's favour. Standard Test for granting a Quia Timet Injunction - F. Hoffmann-La Roche Ltd. and anr. v Cipla Limited The celebrated 2008 judgement of the Delhi High Court - F. Hoffmann-La Roche Ltd. and anr. v Cipla Limited 5 laid down a standard test for the grant of a Quia Timet injunction :- "To summarize, on the issue of interlocutory injunctions: 3 Indian Patents Act 108(1). 4 (2003) 26 P.T.C. 60 (Del). 5 (2008) 148 D.L.T

16 (i) In patent infringement actions, the courts should follow the approach indicated in American Cyanamid, by applying all factors; (ii) The courts should follow a rule of caution, and not always presume that patents are valid, especially if the defendant challenges it; (iii) The standard applicable for a defendant challenging the patent is whether it is a genuine one, as opposed to a vexatious defense. Only in the case of the former will the court hold that the defendant has an arguable case." The American Cynamide Approach Relying upon the celebrated English decision reported as American Cyanamid Co v Ethicon Ltd. 6 to say what are the guiding principles which courts have to adopt in cases involving infringement of patent and copyright cases held as follows: "As to that, the governing principle is that the court should first consider whether, if the plaintiff were to succeed at the trial in establishing his right to a permanent injunction, he would be adequately compensated by an award of damages for the loss he would have sustained as a result of the defendant's continuing to do what was sought to be en joined between the time of the application and the time of the trial. If damages in the measure recoverable at common law would be adequate remedy and the defendant would be in a financial position to pay them, no interlocutory injunction should normally be granted, however strong the plaintiff's claim appeared to be at that stage. Bristo in the present case being competent enough to make good any loses in the unlikely event of the suit falling in favour of the plaintiff, it would be unwise to attempt even to list all 6 [1975] A.C

17 the various matters that may need to be taken into consideration in deciding where the balance lies, let alone to suggest the relative weight to be attached to them. Presumption in favour of Invalidity The Counsel also urges that the nature of presumption that can be drawn in cases of patent infringement is limited. The court can ask the defendant in the case of infringement action involving process patent, to prove or disprove any fact, prescribed, under Section 104A. The absence of such condition in relation to product patents was a significant omission. This had to be viewed with the opening expression in Section 48 'subject to provisions of the Act' to mean that unlike in the case of trademarks and copyrights, the grant itself did not guarantee per se protection. The Act, after amendment, envisions scrutiny of the patent at five different stages It is submitted that, in several judgments in India, it has been consistently held that where the patent is of recent origin and its validity has not been tested, the courts should not grant injunctions where infringement is alleged; it has also been held that if the defendant alleges that the patent cannot be sustained, the injunction should be refused (See Manicka Thevar v. Star Ploro Works 7 ; Surendra Lal Mahendra v. Jain Galzers 8 ; National Research and Development Corporation of India v. Delhi Cloth and General Mills 9 ) This rule, or practice, which appears to have been consistently followed stems from the English decision in Smith v. Grigg Ltd. 10 This Court has also indicated, in National Research and Development Corporation's case 11 that if the patent is not less than six years old, injunction should not be granted. The present case clearly fails the six year test. 7 A.I.R Mad P.T.C A.I.R Del (1924) 1 K.B National Research Development Corporation v. Commissioner of Patents, (1959) 102 C.L.R

18 The counsel hence submits that the Hon'ble court kindly consider the 'six-year' rule preventing courts in India from granting interim injunction. The six-year rule can be traced back to the V. Manicka Thevar v Star Plough Works 12 and subsequently picked up in other judgments to be developed into a universal rule. The rule can be explained to be one of caution that patent infringement actions stand on a slightly different footing, (from other cases) where the courts should not automatically grant injunction on prima facie satisfaction of infringement, since patents can be challenged, even in defence. Furthermore in a recent Delhi HC judgment Bilcare v Amartara Pvt. Ltd. 13 it has been observed by the Hon'ble Court that the mere grant of a patent doesn t guarantee its validity; in case an opposition is filed by the defendant and that if the counter claim of the defendant is based on that opposition, there can t be any presumption in favour of validity of the patent. Genuine Challenge It is contended that the present case can be well envisaged under the peculiarities which comes in the way of the grant of such an injunction. In a suit alleging patent infringement, the court ought not to grant any interim injunction in cases where the defendant presents a credible challenge to either the validity of the patent or to the factum of infringement. Rather, the matter ought to go to the trial for a final decision on the merits. This suggestion stems from the counsel's assumption that in most IP cases, the interim stage decision seals the fate of the dispute. Any wrong decision at this stage has colossal consequences, making it imperative that courts try and get the right result at the interim stage. However, in a complicated patent dispute, it is virtually impossible to make the right assessment within the short window normally available during an interim phase. Particularly so, when Indian courts 12 A.I.R Mad (2007) 2 M.I.P.R

19 are relatively inexperienced with patent disputes, increasing the likelihood of wrong decisions at the interim stage; a fact borne out by the Roche vs Cipla 14 case. To summarise the counsel contends with respect to the above cited facts that granting a quia timet injunction when there is a prima facie presumption of invalidity is not only irregular but a highly utopian demand and hence should not be granted. The counsel thus maintains submission on the issue. BEFORE THE INTELLECTUAL PROPERTY APPELLATE BOARD (IPAB) OF BHARANESIA 1. THE OBLIGATION TO PROVIDE A PROOF OF RIGHT IF THE ASSIGNMENT IS NOT IN PLACE AND IF THE INVENTORS ARE NOT TRACEABLE. WHETHER THE PATENT OFFICE CAN CONCLUDE ON OWNERSHIP OF A PATENT FROM OTHER CIRCUMSTANCES? The Counsel humbly submits that if the assignment is not in place and the inventors are not traceable, there must not be an obligation to provide a proof of right but merely giving sufficient evidence of such a right of inventor would suffice and ownership of Patent can thus also be concluded from other circumstances or any other document. Purpose of Proof of right It is humbly submitted that the purpose for proof of right like assignment deed etc is that the rightful owner of the Intellectual Property so generated must be protected against being defrauded 15 and to ensure that the inventors of a particular patent are recognised and given due credit for their work. Thus, what in fact must be proven is the right to apply and not the proof of right to apply which would serve the same purpose. 14 (2008) 148 D.L.T Sindhura Chakarvarty, Importance of Assignment Agreement under Intellectual Property laws in India, 14(6) J.I.P.R. 513 (Nov. 2009). 19

20 Under the Indian Patent Filing system and as per the Manual of Patent Office practice and procedure, a proof of right can be provided in form of an endorsement in the Application Form i.e. Form 1 or by way of an assignment deed. 16 However, difficulty arises when the inventors are ex-employees and more so when they are not traceable and the assignment deed is not in place. In such a situation, patent cannot be simply refused if the applicant provides enough evidences to show that the applicant in has a right to apply but does not have required documents or else the whole purpose of protecting the rights of the real owner. Under patent laws of other countries, it is permitted It is humbly submitted that the Indian Patent laws do not have any provision to deal with a situation where the inventors are missing or not traceable or refuse to sign the assignment in great detail and thus reliance must be placed on certain relevant provisions from the Manual of Patent Examination Procedure, Chapter 0400, Section 409 that read as follows: Unavailability of Inventor - Application Filed Before September 16, 2012 [R ] 35 U.S.C. 118 pre-aia Filing by other than inventor Whenever an inventor refuses to execute an application for patent, or cannot be found or reached after diligent effort, a person to whom the inventor has assigned or agreed in writing to assign the invention or who otherwise shows sufficient proprietary interest in the matter justifying such action, may make application for patent on behalf of and as agent for the inventor on proof of the pertinent facts and a showing that such action is necessary to preserve the rights of the parties or to prevent irreparable damage; and the Director may grant a patent to such inventor upon such 16 The Manual of Patent Office Practice and Procedure,

21 notice to him as the Director deems sufficient, and on compliance with such regulations as he prescribes Application for Patent by an Assignee, Obligated Assignee, or a Person Who Otherwise Shows Sufficient Proprietary Interest Application Filed On or After September 16, 2012 [R ] 37 C.F.R Application for Patent by an Assignee, Obligated Assignee, Or a Person who otherwise shows sufficient Proprietary Interest in the matter. (a) A person to whom the inventor has assigned or is under an obligation to assign the invention may make an application for patent. A person who otherwise shows sufficient proprietary interest in the matter may make an application for patent on behalf of and as agent for the inventor on proof of the pertinent facts and a showing that such action is appropriate to preserve the rights of the parties. 17 Thus, as per these provisions if any of the inventors is not traceable, a person to whom the inventor has assigned or was under an obligation to assign the invention can make the application for patent. However, the applicant needs to prove the following: 1. The inventors could not be reached even after diligent efforts. 2. Inventors had assigned or agreed to assign or were under obligation to assign their patent. 3. Applicant has sufficient proprietary interest in the matter. 4. Proof of pertinent facts and that such an action is appropriate to preserve the rights of parties or to prevent irreparable damage. Although there are few differences in the application filed before and after September 16, 2012, however, the basic criteria remains the same and if the abovementioned elements are proved, the applicant can be granted patent on behalf of the inventors. 17 Ownership/Assignability of Patents and Applications, The United States Patent and Trademark office, (last updated March 27, 2014). 21

22 In the present case as well, Mate University had tried to reach the inventors but they were untraceable as they had terminated their respective employment with the University and moved to a company outside Bharanesia and their whereabouts were not known. 18 The patent application was in fact originally filed by the researchers only 19 and the non- signing of Form- 1 was only due to an oversight. Also, the inventors were the employees of the University and were on its rolls when the medicine was invented. They had also signed the employment contract and the standing rules of the Contract of Employment (which has force of law) specifically stipulated that any IP generated by the employees in the course of their employment would belong to the University 20. It is in fact a general principle that if the invention was done in the course of employment and the employee had agreed to transfer the ownership of such by virtue of an employment contract 21. Thus, the applicant here i.e. the Mate University has sufficient proprietary interest and is the rightful owner of the patent and there are documents available with the Patent Office to the fact that the same inventors, during the past, had assigned all their inventions to the Mate University. 22 Moreover, it is necessary that the Applicant must be allowed to file the application as a lot of money, time and years of research of the professors of the University has been invested in this invention and if the patent is not granted only on the ground of want of proof of right, it will cause grave injustice to the applicant as it will lose out on revenue, market share, reputation etc if it fails to get a patent and other companies would try to copy and launch this medicine. Bristo Pharmaceuticals Inc. has in fact already applied for marketing approval with the FDA of Pandora and has even advertised its intention of launching the product abc in India and 18 Moot Proposition Moot Proposition Moot Proposition Employer v. Employee invention: IPR issues in R&D organizations, 5(5) J.I.P.R 246 (Sept. 2000). 22 Moot Proposition 6. 22

23 Pandora through various media 23 thus, there is a risk of irreparable damage that it can suffer. Therefore, by all standards the ownership can be concluded from all these circumstances and the University need not provide any other proof of Right. A General Practice It is relevant to note that even in India, as a matter of practice the ownership is concluded through documents and circumstances other than the Assignment Deed or an endorsement in Form 1. Various articles written by practicing advocates are a proof of the same. Following are excerpts from a few of them: In the case of inventors who are ex-employees, filing of the certified copy of the employment contract may usually be sufficient provided that the contract states in clear terms that any invention made by the employee during the period of the contract is the property of the employer. This employment contract can be supported by any other recordal of right such as under the PCT or in the application filed in the priority country. 24 Usually Form-1 signed by inventors in favor of applicant is sufficient or else file certified/ notarized copy of assignment deed/ employment contract/ national law copy is acceptable if the same provides rights to inventions/ patents vest in employer, then we can file national law copy with certified/ notarized copy of employment agreement). 25 The issue of the proof of right can be overcome by submission of an executed Form 1 or by the submission of an assignment. It is expected that a certified copy of the employment agreement stipulating that the rights to the Intellectual Property 23 Moot Proposition Dr Neeti Dewan, Inventorship and proof of right to apply, R. K. Dewan & Co., (accessed Jan. 14, 2015). 25 Patent, Chadha & Chadha IP, (accessed Jan. 10, 2015). 23

24 including the rights to file an application for a Patent are assigned to the employer, may be acceptable as the proof of right. 26 Reference to Manual of Patent Office Practice and Procedure and the Patent Rules, 2003 Moreover, it is humbly submitted that when the Examiner vide his letter December 12, 2011 objected the grant of patent on the ground that no credible proof of ownership was supplied by the applicant, the University replied to the same supporting its contention with the Contract of Employment and the documents proving that all the past patents were filed by the inventors in the name of University and the patent was granted to Mate University as the applicant himself 27 had sought the withdrawal of the objection. Again, when the Opposition Board raised the opposition, the Controller concluded that the fact that the original inventors have not objected on the grounds of wrongful obtaining in Patent Office and thus, the Patent Office may well within its rights hold that the fact and duration of full employment is proved and thus, no other proof of right is required. This is permissible because the act or the rules does not provide that proof of right must be furnished in form of an endorsement in Form 1 or an assignment deed. This is provided by the Manual of Patent Office Practice and Procedure, which expressly states that It must only be considered as a practical guide for effective prosecution of patent application in India but it does not constitute rule making and hence does not have the force and effect of law. Also, Rule 91 of the Patent Rules, 2003 identifies that even the documents other than the assignment can be an evidence of transfer of a patent or affects the proprietorship of a patent. 26 Proof of right for filing patent application in India, IP Newsletter, Mondaq&utm_medium=syndication&utm_campaign=View-Original (accessed Jan. 10, 2015). 27 Exhibit C 1. 24

25 Thus, in circumstances like the case at hand, the ownership can be concluded from other circumstances and documents provided they give credible proof of such interest and employment contract and past patent application would rightly fall under this ambit. 2. OBVIOUSNESS IN CASE THE LEVEL OF SKILL IS HIGH. The respondents humbly submit that the Patent No does involve an inventive step as has been accepted by the Hon ble court in pre grant as well as the post grant proceedings. The contention of the appellant that since the inventors Vaidya M and Bhattacharya P were working on pain receptor antagonists for many years and hence their level of skill in the art was high, it was obvious for them to come up with the claimed piperidine derivatives when earlier compounds were known, is frivolous and should be rejected. It is contended by the appellant that the Patent No should be revoked on the grounds of obviousness as provided in sec 3 (d) of the Indian Patents Act. Also Section 2(ja) defines inventive step. On conjoint reading of the Section 64 read with Section 2 (ja), it is clearly discernible that there are certain essential ingredients of Section 2 (ja) in order to call any invention to qualify the threshold of inventive step. The said ingredients are a) That the said invention involves a technical advancement as compared to existing knowledge or economic significance or both; and b) That makes the invention non obvious to the persons skilled in art. 28 These are conjunctive requirements under Section 2 (ja) which means that not merely there should be a technical advancement in the invention but at the same time, it should not be obvious to the person skilled in art. Therefore, both the requirements are to be satisfied conjunctively. It is noteworthy here again that beyond the said two ingredients, there is no 28 Biswanath Prasad Radhey Shyam v. Hindustan Metal Industries, A.I.R S.C

26 further ingredient which should be read into in order to enlarge or limit the scope of the Section. The said view propounded by Hon ble Supreme Court in Biswanath Prasad 29 holds the field till date and has been followed from time to time by this Court till recently without any variance. It is in consonance with the observations of Court of appeal that the obviousness has to be tested on the basis of technological advancement and what has been known to the person skilled in art and nothing beyond the same. The Patent No fulfils both the conditions as explained below: The said invention involves a technical advancement as compared to existing knowledge or economic significance or both. Structural and functional difference The line of pharmaceutical products claimed in the patent application is much more technically advanced than the present knowledge in the concerned field. Compound I is different from Compound T as they are composed of different compounds, different properties and Compound I is more efficacious. Compound T does not have methylbenzene attached with the cyclopentane ring. The methylbenzene group is not a derivative of a methyl but of benzene. Indeed, what may appear to be even minor changes in substituents between structurally similar compounds may result in significant differences in their suitability as a drug for use in humans, as is overwhelmingly demonstrated in the clinical outcomes reported for Compound I. This is similar to the case of F. Hoffman Roche v. Cipla 30 where the court refused the contention of regarding the replacement of methyl with ethynyl (which is not a derivative of methyl) as a non-inventive step. 29 Supra note (2008) 2 M.I.P.R

27 Efficacy and economic significance Also, according to the controller of Patents, Compound of formula I is more efficacious and has more beneficial properties than other known antagonists. Apart from relief in pain, mood elevation, lack of side effects and withdrawal symptoms are also observed as demonstrated in the patent specification and based on independent expert evidence submitted by Mate. In view of the multiple advantages (interfering with pain transmission and mood elevation) which the employment of a receptor and an antagonist to block the receptor has, it solves an existing problem which the person skilled in the art did not earlier know. Absence of withdrawal symptoms and possibility of paediatric and geriatric prescription of the same compound substantially increases the ease of administration and could revolutionize, in future, the treatment to pain. 31 This marks the economic significance of the same. That makes the invention non obvious to the persons skilled in art. The Indian Patents act does not define the term skilled addressee or person skilled in the art, a person skilled in the art is an average worker in the field of technology who has common knowledge in the art. He is presumed to have access to everything in the state of the art. He is not a person of exceptional skill and knowledge and he is not expected to exercise any invention or prolonged research, enquiry, or experiment, although he must be prepared to display a reasonable degree of skill and common knowledge of the art in making trials and correcting obvious errors in the specification if a means of correcting them is readily found. 32 Compound T as taught by Hensky was known for years. Had the inventive step in this case been obvious, the researchers would have come up with the claimed product years ago. A 31 Exhibit D. 32 Valensi v. British radio corporation, [1973] R.P.C. 337; Helitune Ltd v. Hughes Ltd, [1991] F.S.R. 171, 202; Motor Corporation v. Hollister Inc, [1993] R.P.C. 7, 13 (C.A.) as cited in Pharmaceutical, Biotechnology and chemical Inventions: World protection and exploitation (Duncan Bucknell ed., Oxford University Press). 27

28 person skilled in the art knows that the smallest change in a molecule can have dramatic effects and can totally change the efficacy of a molecule. Many examples in the pharmaceutical industry show that a small change in an active molecule can lead to an inactive or toxic molecule. Thus, changing the smallest Chemical group or a molecule cannot be seen as obvious. The person skilled in the art a priori never considers that it would have been obvious to change a Chemical group for another. 33 The obviousness of an invention should be tested on the standards of a "person skilled in the art" who should be presumed to be a skilled practitioner in the relevant field of technology, who is possessed of average knowledge and ability and is aware of what was common general knowledge in the art at the relevant date. It is similar to the reasonable man's standard in civil law. The personal level of skill of the inventors should not affect the standards of examination. Here, the Controller of Patents, who is an Organic Chemist and has substantial experience in examining pharmaceutical compositions can be said to qualify the standards of a person skilled in art. And according to him the patent for the claimed invention cannot be rejected on the grounds of obviousness. Patent has been granted after elaborate technical verification. Indeed, all these arguments have already been taken into account in the pre grant and post grant opposition proceedings and the patent was granted nonetheless. The defendant has not brought any new prior art document or argument in this respect. In F Hoffman Roche vs. Cipla 34, the court held that the Defendant's position about availability of post grant opposition pointing to dilution of prior stages including scrutiny and 33 F. Hoffmann-La Roche Ltd. and anr. v. Cipla Limited, (2008) 148 D.L.T Supra note

29 pre-grant or their being irrelevant is erroneous. It is submitted that post grant opposition does not efface the validity of scrutiny. 35 Hence on fulfilling the two conditions laid down by the test for obviousness, and in absence of any satisfactory evidence by the appellant to show that the invention is obvious and based on prior art, the contention of the appellant should be rejected. 3. WHETHER PRIOR PUBLICATION BY THE INVENTORS CAN DEFEAT NOVELTY? According to the decision of Intellectual Property appellate board, Chennai in K. Manivannan, Proprietor, Trading as Kumar Industries Vs. Shri M. Mani, Proprietor Valasumani Lathe Works 36, generally the following "Criteria for prior claiming" may be taken into consideration while examining a patent application: The comparison must be made between (and limited to) the claims in the relevant specifications that is to say, it does not suffice to support an objection to show that what is claimed in the respondent's application as a subject matter for protection is to be found somewhere comprehended or described in the earlier specification. For the purpose of justifying a finding of prior claim one must find a distinct claim in the earlier specification, which, as a matter of substance, is equivalent to the claim in the applicants' specification. In the problem at hand, the appellant has not shown that how the defendant s claim is equivalent to what has been disclosed in the prior publications by the same inventors. As per the law laid down by the court, it is not sufficient if the claim is merely comprehended in the subject matter of the publications being referred to. It is to be satisfactorily concluded that the 35 F. Hoffmann-La Roche Ltd. and anr. v. Cipla Limited, (2008) 148 D.L.T (2009) 41 P.T.C. 561 (I.P.A.B.). 29

30 defendant s claim in the patent application is distinctly same as disclosed in the prior publication. If not, then anticipation by prior publication does not exist. It shall be seen whether the prior publication by the inventors anticipates the respondent's invention claimed in his claim. Firstly when such anticipation can arise is to be seen. When any prior publication in the form of a document shall fully and completely anticipate the invention claimed in the later specification, the invention claimed later on becomes anticipated by way of prior publication. 37 In words of the Sachs LJ in General Tire 38 : To determine whether a patentee's claim has been anticipated by an earlier publication it is necessary to compare the earlier publication with the patentee's claim... If the earlier publication, so construed, discloses the same device as the device which the patentee by his claim, so construed, asserts that he has invented, the patentee's claim has been anticipated, but not otherwise. And Lord Westbury in Hills v. Evans, 39 : The information given by the prior publication must, for the purposes of practical utility, be equal to that given by the subsequent patent. In words of Lord Justice Aldous, To anticipate the patentee's claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented. 40 In this case, the publications of the inventors dated June 5, 2008 merely concluded the possibility of a pain killer employing ABC Receptor antagonists. However the application for patent was filed for a line of such pharmaceutical products for the treatment of chronic pain. 37 (2009) 41 P.T.C. 561(I.P.A.B.). 38 (1972) R.P.C. 457, (1862) 4 De.G.F. & J. 288, Beloit Technologies Inc., Beloit Walmsley Limited v. Valmet Paper Machinery Inc. and Valmet pazper Machinery (UK) Limited (1997) E.W.C.A. Civ

31 With regard to the sufficiency of knowledge, the earlier publication must give the requisite knowledge clearly, and it was not enough that it merely gave the means of attaining such knowledge. It must give sufficient information to a workman skilled in the particular art or craft in order to enable him to carry out the invention. 41 Where the question is solely one of prior publication, it is not enough to prove that an apparatus described in an early specification could have been used to produce this or that result. It must also be shown that the specifications contain clear and unmistakable directions as to use it. 42 While in the present case the inventors had only comprehended the possibility of such a product. Hence on the above mentioned grounds it can be concluded that prior publication by the inventors cannot defeat novelty. 4. IF A POST GRANT OPPOSITION HAS BEEN FILED, CAN THE SAME PARTY FILE FOR A REVOCATION AND ALSO CHALLENGE THE PATENT IN A COUNTER CLAIM FOR INFRINGEMENT. If a post grant opposition is filed, can the same party file for revocation and also challenge the patent in a counter claim for infringement. The counsel humbly submits that if a party has filed a post grant opposition under section 25(2) of the Patents Act, 1970, the same party cannot simultaneously file for revocation under section and also challenge the patent in a counter claim for infringement under section 64(1) of the Patents Act, A. If the post grant opposition is filed and pending Section 25(2) eclipses remedies available under Section 64(1) 41 V.K. Ahuja, Intellectual Property Rights in India 934 (LexisNexis 2009). 42 Canadian General Electric Company v. Fada radio, A.I.R P.C