The recent judgment of the Intellectual Property Appellate Board, IPAB has yet again asserted the fact that even though the patent protection has been granted it can be revoked when the patent lacks an invention under the definition of the Indian Patent Act, 1970.
The Kibow Biotech Inc., a foreign company based at United States, filed a patent application titled "A Process for Making a Pharmaceutical Composition" in 2003 comprising of 16 claims out of which 1-10 claims were directed towards pharmaceutical composition and 11-16 pertained to method claims for producing the same. The patent dealt with prebiotic and probiotic compositions and methods for their use in gut-based therapies comprising a prebiotic agent, a probiotic agent, an amminophillic urea degrading micro organism, water sorbent, a sorbent for inorganic phosphate and an adsorbent for specific uremic solutes other than urea. The composition was claimed to treat renal, hepatic and gastrointestinal diseases by eliminating toxins and other metabolic wastes and reducing undesirable bacterial growth. However, the main area of interest for the application was the renal diseases. A patent (Indian patent no. 205478) was granted to the application having only six claims pertaining to method while all the claims pertaining to pharmaceutical composition were withdrawn by the patentee.
The essential elements for producing the pharmaceutical composition, as derived from the granted claims, were one prebiotic, one probiotic and an amminophillic urea degrading microorganism. Every other ingredient was optional. The probiotic used for the patent were selected from Lactobacillus and Bifidium species. The pharmaceutical composition was either enteric coated or microencapsulated.
La Renon Health Care Pvt. Ltd., a competitor company of Kibow, started producing a generic version of the patented composition by the name CUDO. Kibow issued a notice for discontinuation of the production of CUDO, after non-compliance of which they filed an infringement suit against La Renon. In response of which La Renon filed a revocation application against the patent granted to Kibow Biotech Inc. before IPAB. The grounds for revocation taken up by Le Renon were invention not new, false representation, insufficient disclosure, claims not based on the description, lack of inventive step under section 64 (1) (d)(e)(f)(h)(i)(j) and not an invention under the section 3 (e).
La Renon pleaded that the application claimed a pharmaceutical composition and a method to produce the same, while, the protection was granted for the process for producing the said pharmaceutical composition only, which has not been disclosed in the patent specification in detail properly and hence is a false representation. They also listed out many relevant prior art which destroyed the novelty of the invention and made it obvious for a skilled person to conceive. Also all the ingredients except the essential elements were optional and the essential elements were all disclosed in the prior art having known functions while the patent application does not provide any information showing the synergism of the ingredients making the patent not an invention within the meaning of section 3(e). Further La Renon argued that neither claims nor the examples provide the ratio or the amount in which the ingredients are mixed; also the methods of enteric coating or micro encapsulation were disclosed in prior arts for the similar compositions.
The arguments of Kibow were that the pleadings of La Renon were groundless and false. The prior arts were incorporated in the application as reference for many aspects like the method of preparation of said pharmaceutical composition, the species of probiotic bacteria, process for micro encapsulation and enteric coating, etc. Further they also argued that the ingredients and their amounts to be used are specified in Example 3 of the specification along with the synergistic effect of mixture of three known ingredients. The patent for the invention was granted in several countries including United States of America, Australia and Republic of Korea.
The bench members of IPAB found that
the information in the examples are insufficient and does not clearly show the synergism due to the essential ingredients;
the examples are regarding the food composition while the invention talks about pharmaceutical composition;
the claims are not supported by description as it discloses a pharmaceutical composition and not a process to produce the same;
entire species are claimed to have probiotic effect and no examples available as proof of the same;
upon close inspection the prior art produced by La Renon, they are found to be highly relevant to the invention and hence, the invention lacks inventive step and novelty;
no inter-working of the ingredients of the invention and hence it is a mere admixture.
The IPAB bench held that the revocation of patent is sustainable in the eyes of law if there has been no invention in view of the provisions of the Patent Act. The patent granted was revoked with costs.
La Renon Health Care Pvt. Ltd. v. Kibow Biotech Inc. and The Controller Of Patents
ORA/28/2011/PT/MUM and M.P. Nos. 70 of 2012 & 34 of 2013 in ORA/28/2011/PT/MUM