Title Session 8: Mr. AR.pdf ✅

In re Petering, 301 F.2d 676,681 (1962) Boehringer Ingelheim Pharma GMBH & Co. KG & Anr. v. Vee Excel Drugs and Pharmaceuticals Pvt Ltd. & Ors. [2023 SCC OnLine Del 1889] Novartis AG v. Union of India, (2013) 6 SCC 1 Contention was prior art patent did not enablingly disclose imatinib mesylate "COVERED BUT NOT DISCLOSED CONTENTION" "covered but not disclosed" argument is rejected Agrevo test The inventive step in a selection patent lies in the discovery that one or more members of a previously known class of products possess some special advantage for a particular purpose, which could not be predicted before the discovery was made (In re Farbenindustrie AG's Patents (1930) 47 RPC 283 per Maugham, J at pp 322/3). ‘In the first place, in order to leave open a field for selection by a subsequent inventor, it does not matter whether the original field is described by formula or by enumeration. A skilled chemist could, in most cases, quite easily transform the one into the other and the rights of the subsequent inventor cannot depend upon the notation used. In the present case, the ICI specification uses both a formula and, to some extent, an enumeration: it does not matter to which one directs attention. Secondly, the size of the initial group or class is not in itself decisive as to the question of prior publication of an invention related to a selected member or members. A selection patent might be claimed for one or several out of a class of 10 million (cf. IG Farbenindustrie AG.'s Patents v.s. p 321) or for one out of two (cf. the selection of one of two epimers of a synthetic penicillin combination). The size of the class may be relevant to a question of obviousness, and that question in turn may depend, in part, upon whether the later invention relates to the same field as that occupied by the prior invention, or to a different field. If an ordinary uninventive man would not be likely to look for the advantages he desires to produce in the area occupied by the prior invention a decision to do so may well amount to the beginning of an inventive step.’ Apotex Inc. v. Sanofi-Synthelabo Canada Inc., [2008] 3 SCR 265, at paras 61-71 In the Matter of a Petition for the Revocation of Kromschröder (G.) A.G.’s Patent No. 755,462[1960] RPC 75, at 79 Merck & Company (Macek’s) Patent.[1967] RPC 157 Ethyl Corporation (Cook’s) Patent, [1970] RPC 227 Daikin Kogyo Company Limited (Shingu and Another’s) Application, [1974] RPC 559 Allen & Hanburys Limited (Hayes’) Application, [1977] RPC 113 Maag Gear Wheel and Machine Co. Ltd.’s Patent, [1985] RPC 572 Same invention test. "Patentibly Distinct" test F. Hoffman-La Roche Ltd. & Anr. v. Cipla Ltd., 2015 SCC OnLine Del 13619, at para 157 T 0932/92, Triazoles/AGREVO, paras 2.5.2–2.5.3, available at EPO - T 0939/92 (Triazoles) of 12.9.1995 Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804 (Fed. Cir. 1989) In re Baird, 16 F.3d 380, at 383 (Fed. Cir. 1994) Pfizer, Inc. v. Apotex, Inc. 480 F.3d 1348, 1361-1369 (Fed. Cir. 2007) In re Peterson, 315 F.3d 1325, 1329-1330 (Fed. Cir. 2003); In re Ethicon, Inc. 844 F.3d 1344, 1351 (Fed. Cir. 2017) Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358, 1364 (Fed. Cir. 2008) Takeda Chemical Industries, Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1357 (Fed.Cir.2007) Beecham Group Ltd. v. Bristol Laboratories International SA [1978] RPC 521, para 7-11 at 579 Du Pont de Nemours & Co (Witsiepe's) Application, [1982] FSR 303 AstraZeneca AB & Anr. v. Micro Labs Ltd., 2020:DHC:3270 AstraZeneca AB & Anr. v. Intas Pharmaceuticals Ltd., 2020:DHC:3125 FMC Corp. and Anr. v. Best Crop. Science LLP and Anr., 2021:DHC:1987 Genus/Species Genus-Species Situations Prior art/anticipatory reference discloses a genus or a group of items, whereas the claimed invention is for a species of such genus. No special rules in statute NOVELTY 1. Examine the claimed invention 2. Does the genus prior art disclose (explicitly or implicitly) the species 3. Assess whether the genus prior art enables the making of such species SC suggests a different test where: (i) prior art is also a patent, and (ii) prior art patent is owned by the same person as the invention at hand Patentee's own prior granted patent in US was directed to a genus of compounds. Patentee contended that even if that Imatinib (free base) was expressly shown as an example in the prior art reference, the genus did not disclose Imatinib as a preferred compound, nor was mesalyate individually described, the disclosure being generic to all pharamceutically accepted salts. Contention rejected by SC, inter alia, holding that patentee cannot take the position that imatinib mesylate is "covered" (claimed) in prior art and yet not "disclosed" in prior art patent UK position English Court of Appeal has issued a carte blanche safeguard to all species patents where prior publication does not contain an "express/separate" description of the species. Court of Appeal held that genus did not anticipate the species patent as performing the prior art did not "necessarily" result in infringement of the later patent. US position Fact-dependent. Even if prior genus 'encompases a vast number and perhaps even an infinite number of compounds' , there may nevertheless be a 'pattern' of 'specific preferences' that constitutes a 'description of a definite and limited class of compounds' to the PSITA. The test of novelty for genus-species in US is whether a PSITA would at once envisage every member of the class of genus and whether narrowing the genus to a small recognisable class with common properties is feasible or not. If the answer to both the questions is affirmative, the species stands anticipated by the genus. EU position INVENTIVE STEP Section 10 (5) & Genus-Species Indian Position US position UK position EU position Sufficiency and Clarity requirement for the grant of patent require that a patentee may claim 100 embodiments, disclosing only 10 embodiments on the basis that 90 are obvious from the 10 disclosed. Can this preclude a patentee from claiming the 99th embodiment later Obiter of the Single Judge in Boehringer suggest that the 99th embodiment is impliedly conceded to be obvious in light of the genus. Thus the patent cannot survive except a patent of addition may be possible. However, it is possible that the species may be considered distinct if 1. The species was not made during the time of the genus (Consider was the embodiment an obvious alternative at the priority date of the genus?) 2. The species demonstrates previously undisclosed advantages/benefits. Two Stage Analysis for Inventive Step applies to genus-species cases as well. Fact-specific Common in chemistry and pharmaceutical cases but can arise in any industry Could be ranges also. E.g. Prior art says use Chemical X in process in the concentration of 10-40% and invention claimed is to use Chemical X at 15% Synthon BV v. SmithKline Beecham plc., [2005] UKHL 59; Merrell Dow Pharmaceuticals Inc. v. H.N. Norton & Co. Ltd., [1996] RPC 76 General test The invention could be a specie or a sub-genus "114. Mr Andhyarujina and Mr Gopal Subramanium, learned Senior Advocates appearing for the appellant, strenuously argued that the patent information furnished by the appellant before the US FDA, or its patent term extension application, or the legal notice given at its behest to NATCO Pharma Ltd. should not be construed to mean that Imatinib Mesylate was anticipated in the Zimmermann Patent. Mr Andhyarujina submitted that the Zimmermann Patent did not disclose Imatinib Mesylate. That the Zimmermann Patent did not describe any working method for converting lmatinib to Imatinib Mesylate. It only stated that a salt may be formed by acid without disclosing any method, but simply calling the method to be "per se". The Zimmermann Patent mentioned multiple choices of compounds including Imatinib free base but not any salt of any compound, much less Imatinib Mesylate. Mr Andhyarujina further submitted that it is well settled that the disclosure of an invention must be in a manner clear enough and complete enough for the invention to be performed by a person skilled in the art (Terrell on Law of Patents, 16th Edn. , p. 51, Para 3.2/7). The learned counsel further submitted that there was a difference between that which is covered and that which is disclosed. Imatinib Mesylate is covered by the Zimmermann Patent but not disclosed therein. He further submitted that, in any case, in patent law subsequent conduct of the patentee is irrelevant in construing the patent [Terrell on Law of Patent, 16th Edn., p. 192 citing Glaverbel S.A. v. British Coal Corpn. (No. 2)42]. Referring to the two articles in Cancer Research and Nature Medicine, Mr Andhyarujina submitted that though in the first article there was a reference to Imatinib Mesylate, there was no teaching as to how it is to be prepared. In the Nature Medicine article there was no reference to Imatinib Mesylate but only to Imatinib. 105. From the above discussion it would be clear that the drug Gleevec directly emanates from the Zimmermann Patent and comes to the market for commercial sale. Since the grant of the Zimmermann Patent, the appellant has maintained that Gleevec (that is, Imatinib Mesylate) is part of the Zimmermann Patent. It obtained drug approval for Gleevec on that basis. It claimed extension of the term of the Zimmermann Patent for the period of regulatory review for Gleevec, and it successfully stopped NATCO Pharma Ltd. from marketing its drug in UK on the basis of the Zimmermann Patent. Not only the appellant but the US Board of Patent Appeals, in its judgment granting patent for beta crystalline form of Imatinib Mesylate, proceeded on the basis that though the beta crystalline form might not have been covered by the Zimmermann Patent, the Zimmermann Patent had the teaching for the making of Imatinib Mesylate from Imatinib, and for its use in a pharmacological compositions for treating tumours or in a method of treating warm-blooded animals suffering from a tumoral disease. This finding was recorded by the US Board of Patent Appeals, in the case of the appellant itself, on the very same issue that is now under consideration. The appellant is, therefore, fully bound by the finding and cannot be heard to take any contrary plea. 119. The dichotomy that is sought to be drawn between coverage or claim on the one hand and disclosure or enablement or teaching in a patent on the other hand, seems to strike at the very root of the rationale of the law of patent. Under the scheme of patent, a monopoly is granted to a private individual in exchange of the invention being made public so that, at the end of the patent term, the invention may belong to the people at large who may be benefited by it. To say that the coverage in a patent might go much beyond the disclosure thus seem to negate the fundamental rule underlying the grant of patents. 134. However, before leaving Hogan and proceeding further, we would like to say that in this country the law of patent, after the introduction of product patent for all kinds of substances in the patent regime, is in its infancy. We certainly do not wish the law of patent in this country to develop on lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skilful lawyers, and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent." But what if the prior art is not a patent? But what if the prior art is a patent owned by a completely unrelated third party? Was SC correct? Dr. Reddy's Laboratories (UK) Ltd. v. Eli Lilly & Co. Ltd [2009] EWCA Civ 1362. Australia and SA Approves Dr Reddy's of UK Court of Appeals Opinion: perverse application of the "reverse infringement" test of novelty CA says if prior art teaches 1 million options and the later patent claims 1 option of these 1 million options, the prior art can be practiced at least in 9,99,999 ways that infringe the later patent. Implication of Section 53(4) in Indian context? Two list principles Exception to two-list principle (one list is for process parameter) Later patent is a sub-set (as opposed to a species) Narrower range from an earlier broader range Overlap in composition ranges selection is "novel" selection is not "novel" selection is not "novel" conflicting views! narrow range + far removed from the genus range narrow range + far removed from the genus range + purposive selection direct and ambiguous disclosure fact-specific, dependant on PSITA's understanding of the prior art disclosure technical advance / eco. significance obvious to PSITA 1st step Later patent must disclose an advantage 2nd step Roche v. Cipla proposes "lead compound" analysis, citing US law show motivation to select a starting point from the genus But US law is complicated Equally, UK/EU position not shown to Roche v. Cipla "2.5.3. ...If this result is only to be seen in obtaining further chemical compounds, then all known chemical compounds are equally suitable as the starting point for structural modification, and no inventive skill needs to be exercised in selecting, for instance, the compound of formula XIV of D3 for this purpose. Consequently, all structurally similar chemical compounds, irrespective of their number, that a skilled person would expect, in the light of the cited prior art, to be capable of being synthesised, are equally suitable candidates for solving such a hypothetical "technical problem", and would therefore all be equally "suggested" to the skilled person. It follows from these considerations that a mere arbitrary choice from this host of possible solutions of such a "technical problem" cannot involve an inventive step (see also e.g. T 220/84 of 18 March 1986, No. 7 of the reasons). In other words, the Board holds that, in view of the underlying general legal principle set out in point 2.4.2 above, the selection of such compounds, in order to be patentable, must not be arbitrary but must be justified by a hitherto unknown technical effect which is caused by those structural features which distinguish the claimed compounds from the numerous other compounds..." Merck & Co. (1989) rejected the "laundry list" argument In Re Baird 1994 accepted a selection because prior art taught away from selection Pfizer 2007 rejected a selection because PSITA could narrow down In re: Peterson 2003 and In re Ethicon 2017 say that selection of process parameter is obvious Ortho-McNeil 2008 suggests examine list of preferences like in novelty Takeda 2007 suggest the "lead compound" analysis Agrevo test Opinion: Inconsistency "Selection" invention as per IG test, as approved by HL in Beecham HL approves the above in Du Pont 1978 with some tweaks BUT Dr Reddy's 2009 also approves Agrevo test but as the sole and only test Situation after Agrevo? UK judgments on obviousness state two-level analysis Conventional obviousness Agrevo technical contribution test Canada Tested under "obvious to try" principles (i) Is it more or less self-evident that what is being tried ought to work? Are there a finite number of identified, predictable solutions known to the persons skilled in the art? (ii) What is the extent, nature, and amount of effort required to achieve the invention? Are routine trials carried out, or is the experimentation prolonged and arduous, such that the trials would not be considered routine? (iii) Is there a motive provided in the prior art to find the solution that the patent addresses? Prior Claiming Section 13 Section 25 Section 64 No consistent view in India AstraZeneca I Astrazeneca II remonopolization test identical claims test FMC infusion of enablement standard No consistency even in UK (old law) because new UK law has no "prior claiming" exclusion Distinct claim test Remonopolisation test Selection test Process claims- Identical Claims-Same features must be present. Two markush claims same invention test US No statutory provision: only case law Double Patenting Obviousness-type Double Patenting