Vifor (International) Ag (Sr No 48/2015/PT/KOL) Vs Controller of Patents

The Court: The appellant assails an order dated 3 September, 2015 passed by the Assistant Controller of Patents and Designs rejecting application no.1755/KOLNP/2010 on the ground of lack of novelty in view of prior art D1, lack of inventive steps under section 2(1)(ja) and nonpatentability under sections 3(d) and 3(e) of the Patents Act 1970.

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Briefly, the appellant is part of the GalenicaGroup of Companies, a company established in 1927and incorporated in Bern, Switzerland. The appellant is one of the world’s leading companies in the treatment of iron deficiency and iron deficiency anemia. The appellant is also involved in the development of innovative pharmaceutical products, particularly for use in treatment of iron deficiency with or without anemia; treatments for infectious diseases and consumer health products. The appellant has through its comprehensive clinical and scientific development programs, put in place an “ Iron Replacement Product Portfolio ” consisting of its products

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Ferinject, Venofer, Maltofer as well as Velphoro. Velphoro is the marketed product of the appellant which is covered and claimed by the Indian Patent Application no.1755/KOLNP/2010.

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The subject invention is for a pharmaceutical composition comprising iron oxy hydroxide in a high loading form suitable for oral composition. The pharmaceutical composition according to the revised set of claims is as follows:

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Iron oxy-hydroxide in high loading of 10-80% wt/wt expressed in relation to the total weight of the composition;

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The use of saccharaose and starch as specific stabilizers for an oral administration form which is not complexed;

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Composition that is capable of disintegration in the oral cavity or in a small amount of liquid prior to ingestion; and

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The amount of iron oxy hydrozide per dosage form of 700-1700mg.

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The technical advantages of the invention are as follows:

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(a) Low pill burden of 3-4 administration per day;

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(b) That the administered form is stable and retains its phosphate adsorbent properties on storage

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(c) That the administration form that is essentially devoid of side effects, in particular an inacceptable high iron-release rate.

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(d) Can be manufactured into an appropriate mechanically stable table;

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(e) is an oral composition that retains its high phosphate binding capacity;

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(f) has low iron release of below 2.5%w/w, which is essential for phosphate adsorbents to avoid iron overload as the aim is not to deliver iron to the patient but to adsorb the phosphate in the patient gastro intestinal tract.

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(g) Has desired disintegration characteristic so as to achieve desired bio-availability for the incorporating drug i.e. dissolution must precede absorption.

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The application for patent was filed on 14 May 2010. The First Examination Report was issued on 28 September 2013. Pursuant thereto, the appellant filed its response alongwith the requisite documents on 9 January 2014. Thereafter, a hearing notice was issued on 25 June 2014 when the appellants appeared before the Assistant Controller of Patents and Designs on 24 July 2015 and the hearing was ultimately concluded on 31 August 2015.Subsequently, the impugned order was passed on 3 September 2015.

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It is alleged by the appellant that the impugned order has been passed without application of mind. The prior art D1 cited by the respondent relates to anentirely different substance and is not comparable. The said document is aimed to overcome the problems of the use of iron (III) chloride as the starting material in the preparation of the phosphate adsorbent which leads to corrosion problems in production owing to the presence of chloride ions. The solution provided by D1 is a process which was developed to prepare a phosphate adsorbent based on iron sulfate or iron nitrate compound. This document was not concerned with the problem of providing a suitable oral administration form of an iron based phosphate adsorbent. The appellant also contends that the respondent authorities entirely ignored the data in the specification provided at the time of filing of the application. The impugned order also fails to consider the replies and responses filed by the appellant with regard to the First Examination Report where the appellanthighlighted the unexpected property, the surprising effect of the compounds claimed combined with the commercial success of the marketed productVelphoro, covered by the present invention and the requirement to

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have a product for treatment of Hyperphosphatemia. In fact, several grants have been received in respect of identical claims in countries such as Australia, Japan, Korea, Russia, Singapore and Europe. The respondent authority also erred in holdingthat the subject application fell within the ambit of section 3(d) or 3(e) of the Act.

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On a perusal of the impugned order it appears that the impugned order is a verbatim reproduction of the Hearing Notice and the FER. There has been no application of mind by the Controller in passing the impugned order. The scope and ambit of technical advancement of the subject invention has not even been considered. The data including the comparative materials provided by the appellant have been disregarded. The benefit of the invention in phosphate adsorption has not even been examined. The data relied on by the appellant which suggested the unexpected properties and the synergistic effect in using saccharose and starch as the excipients in the manufacture of a high loading, oral administration formulation capable of disintegration in the oral cavity or in a small amount of liquid prior to ingestion of iron-oxy hydroxide of 10-80% wt I wt of composition has not even been adverted to in the impugned order.

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In passing the impugned order, though the respondent has reproduced Tables 8 and 9 which had been disclosed in the patent specification yet the same has not even been discussed. Tables 8 & 9 suggest that in example 8(b)there is a noticeable higher iron release rate of 3.4% which is to be avoided in order to avoid an iron overload in patients. Example 8(c)suggests that if a composition has only dextran, it has a comparatively low iron release rate of 5 wt%. It is evident from examples 8(1)

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and 8(g) that the best results are achieved using a combination of saccharose (sucrose) and starch. This has not even been considered in the impugned order.

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The reliance on the cited document D1 is also misconceived. D1related to a different substance and could not have been considered as a prior art. The document D1 relates to an altogether different technical problem and this is irrelevant for the present invention. In Titan Umreifungstechnik GMBH and Co. KG vs. Assistant Controller of Patents and Designs (C.A.(COMM.IPD-PAT) 114/2022: 2023:DHC:3832) it has been held that “…if two prior art documents address different problems, it would not be plausible for a person skilled in the art to realistically combine the teachings of the referenced prior art”.

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Theinvention has not been discussed in the impugned order. There is no mention of the scientific and technical evidence relied on by the appellant. In particular, the affidavits ofDr.Gesser and Dr. Phillips have not even been considered in the impugned order.There has been no reference to the technical advancement of the subject invention. There has also been no discussion of the inventive stepsof the subject invention. In Bristol-Myers Squibb Holdings Ireland Unlimited Company &Ors.vs. BDR Pharmaceuticals International Pvt. Ltd. &Anr. [Unreported decision dated 30 January 2020 passed by the High Court at New Delhi in CS(COMM) 27/2020] it has been held as follows:

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36.(1) A hindsight reconstruction by using the patent in question as a guide through the maze of prior art references in the right way so as to achieve the result of the claim in the suit, is required to be avoided.

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(ii) The patent challenger must demonstrate the selection of a lead compound based on its promising useful properties and not a hindsight driven search for structurally similar compounds.

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(iii) There should be no teachings away from the patent in question in the prior art.

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(iv) Mere structural similarity cannot form the basis of selection of lead compound in a prior art and the structural similarity in the prior art document must give reason or motivation to make the claim composition.

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(v) Though mosaic of prior art documents may be done in order to claim obviousness, however, in doing so, the party claiming obviousness must be able to demonstrate not only the prior art exists but how the person of ordinary skill in the art would have been led to combine the relevant components from the mosaic of prior art.

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(vi) It has to be borne in mind, small changes in structures can have unpredictable pharmacological effects and thus, structural similarity alone is not sufficient to motivate to selection of the lead compound.

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(vii) Though it would be tempting to put together a combination of prior arts but this requires a significant degree of hindsight, both in selection of relevant disclosures from these documents and also in disregarding the irrelevant or unhelpful teachings in them.

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The finding that the subject invention fell within the scope of sections 3(d) and 3(e) of the Act is also without any basis and unsubstantiated. There are no reasons at all in the impugned order as to why either section 3(d) or 3(e) of the Act have any application whatsoever.

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The finding that the outstanding objections raised by the Controller have not been addressed by the appellant is also incorrect. On the contrary, by a communication dated 31August, 2015,the appellant had duly responded to all the objections raised by the Controller and this compliance has been ignored in the impugned order. As a consequence, there were no outstanding objections which remained to be answered by the appellant.

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In view of the above, the impugned order is unsustainable and is set aside. The matter is remanded back to a different Hearing Officer for re-

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hearing in accordance with law after giving a right of hearing to all the parties. It is made clear that the above exercise is to be completed within four months from the date of communication of this order. It is also made clear that all issues are left open to be decided in accordance with law.

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(Ravi Krishan Kapur, J.)

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SK.

Vifor (International) Ag (Sr No 48/2015/PT/KOL) v. Controller of Patents

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Vifor (International) Ag (Sr No 48/2015/PT/KOL) v. Controller of Patents

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