Pre-grant opposition is a newly emerging hot topic of discussion on the international scenario too. The Indian Patent Office, unlike certain other patent offices does not host the opposition decisions rendered by it. These documents have their own importance as they are instrumental in setting precedents for our patent litigation system and could provide guidelines for others in filing or defending oppositions. Even these could be of assistance for the prosecution of applications and for internal use by the examiners who may use these to examine applications taking guidelines from these decisions.
There are at least around hundreds of decisions regarding various oppositions, initially post grant and now both pre and post grant from the different patent offices in India. There is a patent office manual which reports several cases but these are not easily accessible and should be put on the net. If the Patent community in India and abroad would have access to theses judgments then one can use them in future oppositions and also get a better understanding on how each section is interpreted by the IPO. This could also be of helpful to the patent community in the neighboring countries like Bangladesh and Pakistan whose laws are based on the old Indian Law.
Present scenario
One often finds articles stating information like, After hearings on a pre-grant opposition filed by the domestic drug maker USV Ltd that lasted a year, the Kolkata patent office has rejected US drug giant Eli Lilly & Co.'s patent application IN/PCT/2000/00119 for Forteo, its osteoporosis drug. Forteo is a biotechnology-based drug that generates $600 million in annual sales for Lilly. The company had already launched this product in India anticipating a patent protection.
The decision delivered noted that the application has been rejected on grounds of prior knowledge.... and failure to establish enhancement of known efficacy.
Or Glaxo filed a patent application [872/CAL/98] for Abacavir Hemisulfate Salt [corresponding to Orange Book listed US6294540] with the Kolkata Office. This application was opposed by the Indian Network for People living with HIV/ AIDS. Post the filing of Opposition, Glaxo has withdrawn the mentioned application. The Kolkata Patent Office vide a letter dated 01/Oct/2007 has confirmed that the application has been withdrawn by Glaxo.
Or sometimes even little better, Indian companies, Natco Pharma and G.M. Pharmaceuticals filed a pre-grant opposition against Astra's application, Iressa which is a branded formulation of the drug, known in generic terms as Gifitinib since the drug was not a new drug, under Indian law. "The scientific data regarding the efficacy and therapeutic functions of the chemical entity, Gefitinib, had been in the public domain before AstraZeneca filed its patent application 841/DEL/96 dated April 19, 1996 in India and also because of "lack of inventive steps."
After hearing pre-grant oppositions filed by Indian drug companies for more than a year, the patent office in New Delhi has rejected pharmaceutical giant AstraZeneca's patent application for its lung cancer drug Iressa.
The patent office rejected the application citing "known prior use" of the drug, which prevents grant of a patent in India under the country's 2005 amended patent laws.
Amended patent law
Pre-grant opposition is not a common provision in many countries although there may be other options available like filing third party representation or having interference proceeding. India amended its intellectual property law pertaining to pharmaceuticals and agrochemicals in 2004 to comply with its commitment to World Trade Organization to commence product patent regime in these two areas in the country by 1st January 2005. The amended law also provides opportunity for any person to file objections to patent claims even before and also after granting the patent. It is alleged that these provisions are being largely used by local drug companies who make generic versions of the patented drugs.
Section 2(1)(j) of the Patents Act, 1970 defines an invention as a process or a product that is novel, involves an inventive step and is capable of industrial application. The determination of novelty of a claimed invention is a matter of fact that is examined by an element-by-element comparison of the technical features of the claimed invention with the disclosure of the prior art. The issue of obviousness and lack of inventive step is the major ground of contention between the parties involved in an opposition proceeding.
Problem-solution approach
It has been a continuous practice of the Indian Patent Office in assessing the inventive step underlying an invention to assess the contribution made by the claimed invention to the advancement of the state of the art. In doing so, the Patent Office is guided by the principle that the advancement to the state of the art should have its origin in at least one novel technical feature of the claimed invention.
Thus, in Eli Lilly and Company v. Wockhardt Ltd., 675/CAL/95 dated June 14, 1995 the Controller held that a correct application of the problem solution approach rules out an inadvertent application of an impermissible ex post facto analysis and this has been one of the guiding principles of the Patent Offices in the assessment of inventive step. The problem solution approach comprises:
(i) determining the closest prior art;
(ii) establishing the objective technical problem to be solved; and
(iii) considering, whether or not the claimed invention, starting from the closest prior art and the objective technical problem, would have been obvious to a person skilled in the art.
The controller held it clearly inherent within these stages for problem-solution determination to assess the inventive step involved examining the inventive step to looking forward from the prior art rather than looking backward from the claimed invention. It is this approach to the assessment of inventive step that brings out the technical contribution made by the claimed invention to the advancement of the state of the art. The Controller further held that the problem formulated in the assessment of inventive step may contain no pointers to the claimed invention, which would otherwise lead to an application of the impermissible hindsight analysis of the inventive step.
An invention is regarded obvious if it could be easily arrived at by a person skilled in the art without an inventive ingenuity. Further, the advancement to the state of the art requirement requires that the claimed invention state and demonstrate, preferably by quantitative data based evidence that the claimed technical features do indeed produce a substantive advantageous effect not found in the prior art. Under this requirement, the applicant bears the burden to credibly show that the drawbacks and deficiencies of the prior art have been successfully overcome.
Person skilled in the art
A person skilled in the art is a hypothetical construct who is presumed to be aware of the common general knowledge in the field of the claimed invention and have access to all the technologies existing before the date of the claimed invention.
The assessment of inventive step arises only if the claimed invention possesses novelty over the state of the art. Thus, in GRAF & CIE AG v. Maschinenfabrik Reiter AG v. Vivek Vardhan Prasad, in 422/CAL/2000 dated July 25, 2000, the Controller did not consider it worthwhile to assess the inventive step when the claimed invention itself was anticipated. The Controller found as hereunder:
In my opinion, the question of inventive step can only be raised if an application survives attack on novelty. "The question is - is there an inventive step?" only arises if there is novelty. In the instant case, since the subject matter already lacks in novelty, the question of inventive step is redundant. In this case the Controller even treated a drawing in an earlier document not described in the text as relevant prior art. This is an important step forward in the Indian patent scenario. The following is the part extracted from the judgment:
From these rival contentions, it appears to me that a prior art drawing may be taken into consideration as a prior art disclosure if it discloses the essential features of the impugned claim in a sufficiently and clearly understandable manner to a skilled person and also if the drawing is such that it provides an enabling disclosure either explicitly or implicitly.
The closest prior art
The closest prior art is defined as a prior art document having maximum structural features in common with the subject-matter of the claimed invention i.e. which requires a minimum of structural modifications in traversing from the prior art to the claimed invention. Thus, the "closest prior art" is determined using a "structural approach" as opposed to a "functional approach", wherein the closest prior art is determined to be the document disclosing most relevant "functional features" in common with the claimed invention. Thus, in Astra Zeneca v. Natco Pharma in 841/DEL/96 dated April 19, 1996 the Controller held that:
To be relevant, such comparative tests must meet certain criteria. These include the choice of a compound disclosed in the application and of a comparative substance taken from the state of the art; at the same time, the pair being compared should possess maximum structural similarity.
It was held that only by a comparison with such a prior art could an inference be drawn that at least substantive technical feature of the claimed invention is responsible and origin of the unexpected or surprising advantage over the prior art.
Inventive step
In Berwind Pharmaceutical Services Inc. v. Ideal Cures Pvt. Ltd., (IN/ PCT/2002/00020/DEL dated January 4, 2002, the claimed pharmaceutical coating composition claimed PolyVinyl Alcohol in an amount of from 25-55% whereas the prior art, disclosing the same ingredients, taught the use of PVA in an amount of at least greater than 65%. Importantly, the comparative test data furnished by the applicant failed to compare the properties of the composition having greater than 65% PVA but compared the properties of the compositions having PVA levels in the claimed range with other compositions having PVA levels in the same claimed range.
It was found that in the absence of any comparative test data against the closest prior art disclosing greater than 65% PVA, the evidence of record failed to substantiate that the claimed levels of PVA, being the only distinguishing feature of the claimed invention, was indeed the origin of the advantages claimed by the applicant. Accordingly, the requirements of inventive step over the "closest prior art" could not be said to have been credibly met by the technical features recited in the claimed invention.
Section 3(d)
Last but not the least, the Indian law also has an additional section 3(d) which prevents patent protection to minor modifications or innovations of known or existing drugs, unless the efficacy of the drug is enhanced significantly. Some of the known parameters which may prove the efficacy of a particular derivative of a pharmaceutical substance may be EC50, LC50 or the therapeutic index, which depends upon the EC50 and the LC50. The lower the therapeutic index, better is the efficacy of a drug for a desired activity.
Therefore, in Torrent Pharmaceuticals Limited v. Astra Aktiebolag (1354/DEL/98 dated May 21, 1998 ), at issue was the claimed formulation which was similar to the formulation taught by the prior art except that the claimed invention recited a selective quality of HPMC as the preferred binding agent and/or separating layer whereas the prior art taught HPMC generally. Therefore, the question before the controller was whether the use of specific quality of HPMC used in the claimed formulation made it patentable over the prior art. The controller found that there was apparently no difference between the claimed formulation and the formulation taught by the prior art apart from the alleged selection of HPMC quality, which led to an improvement in the consistency of production of coated tablets having more than 75% release rate. Hence, the claimed invention was deemed novel and not obvious in view of the asserted advantages.
However, the controller took cognizance of the fact that the claimed invention did not show any improvement in therapeutic efficacy compared with the prior art. Accordingly, it was found that the benefit claimed by the invention in dispute was not accruable to the user in terms of the therapeutic quality of the product but only to the manufacturer in terms of the consistency in production. Accordingly, the claimed invention was found to fail the requirements of Section 3(d) of the Patents Act.
(Ashwini Sandu is associated with United Phosphorus Limited and Faculty, Academy of Intellectual Property Studies while Raju Kumar belongs to S.Majumdar & Co.)