Comments on Draft Guidelines. for Examination of. Patent Applications in the Field of Pharmaceuticals. before the Indian Patent Office (IPO)

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1 Where Technology, Law and Business Intersect TECH CORP LEGAL LLP PATENT ADVOCATES & INTERNATIONAL LEGAL CONSULTANTS Comments on Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals before the Indian Patent Office (IPO)

2 To: Controller General of Patents, Designs and Trademarks, Office of the Controller General of Patents, Designs & Trade Marks, Bhoudhik Sampada Bhavan, Antop Hill, S. M. Road, Mumbai Dear Sir, RE: Comments on Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals dated 20 March, Response to be submitted to a.chakaraborti@nic.in On 28 February, the Indian Patent Office (IPO) published Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals. We highly appreciate the steps undertaken by your office for issuance of above- mentioned guidelines. However, we have certain apprehensions and the same have been explained herein-below for your kind perusal.

3 Comments: 4. Claims of Pharmaceutical Inventions Markush Claims: With regards to various terms / definitions included in the referenced section, we respectfully submit that the use of Markush claim structures can leave the multinational pharmaceutical companies or the Indian drug companies unprotected when structurally diverse compounds with the same activity for e.g. bioisosteres are identified. Further, it should be noted that the currently available field-based processes allow the routine detection of such bioisosteres and can be used to evaluate patent positions, strengthen the process of new patent filings and select innovative chemistry methods to get over existing chemical patents. A simple example of a Markush formula is as follows: R1 R2 wherein R1 is phenyl or 1-naphthalene, and R2 is chlorine or bromine. This patent claim would include chlorobenzene, bromobenzene, 1- chloronaphthalene and 1-bromonaphthalene. However, for determining novelty of

4 the invention, a prior art disclosure of even just one of these compounds in the prior art document would render the claim lacking in novelty. Further, a typical Markush claim might be constructed using language such as an alcohol of the formula R-OH, wherein R is selected from the group consisting of CH3-, CH3CH2- and (CH3)2CH-. In practice, for the purposes of the patent claims, each of the potential combinations of substituents is considered to be equivalent and have unity of invention. For example, in the case of a pharmaceutical drug, all of the potential structures are assumed to have the same efficacy, side effects and other biological properties which are difficult to determine. For a patent examiner to conduct prior art search for a markush claim claiming a number of compounds is virtually impossible, the search of the patent office and the corresponding patent claims granted should be limited to what has been actually assessed and supported by the examples provided in the detailed description of the patent specification. Moreover, the patent examiner should make a note that patent claims covering a large range of compounds should not be allowed. If the patent specification provide

5 sufficient disclosure, such as fusion point, Infrared Absorption Spectrum (IR) or Nuclear Magnetic Resonance (NMR), and the like obtained through true testing and experimentation results to enable the reproduction by the disclosed method of every embodiment of the invention for which protection is sought by the patent claims, the said patent claims covering a large range of compounds can be allowed. However, patent claims of limited scope could be granted if evidence is provided at least that, with the substitution of any member within the same family class, the same disclosed result would be obtained. The scope of the patent claims should be limited to what is actually enabled by the patent disclosure and the examples cited in the patent specification. If the members of the Markush group are sufficiently less in number or so closely related in patent claims that a search and examination of the entire claim can be made, the patent examiner must examine all the members of the Markush group in the patent claim on the merits, even though they are directed to independent and distinct inventions.

6 5. Prior Art Search With regards to conducting a prior art search by the patent examiner included in the referenced section, we respectfully submit that the patent examiner should also take into account patent family status of corresponding foreign applications and review the prior art patent applications and non-patent literature cited by foreign patent examiners. Moreover, the examiner should design and frame a comprehensive patent search strategy and analyse backward patent citations and forward patent citations of the highly relevant prior art that impacts on the patentability of the patent specification during the patent examination stage. The first examination report (FER) issued by the patent examiner should not be limited to the prior art cited in International Search Report (ISR) issued with the PCT document and extensive additional search should be conducted.

7 7. Assessment of Novelty: 7.4 Implicit disclosure: With regards to the point of implicit disclosure, we respectfully submit that the prior art is read through the understanding of the person skilled in the art, and as a result the implicit features of a specification may also be taken into account for determining novelty of the invention. Subsequently, if the person skilled in the art would read a specification as including a particular feature without it being specifically mentioned it would be considered an implicit feature of that disclosure. In particular, the operating conditions used in a process will need to be very similar in order to sustain an argument that a reaction or process will inevitably give the same product. For example, a claim defines an industrial process for preparing a product comprising a particular ratio of compounds A and B wherein a set of steps are carried out using specific reaction parameters for e.g. ph, temperature, and the like. However, a prior art citation discloses a similar process for preparing a mixture of A and B, but does not disclose the specific ratio of these components claimed in the present application. In this particular case, it may be necessary to

8 consider the examples described in the prior art specification in order to determine whether the one or more parameters are sufficiently similar that it could be concluded that the prior art disclosure would inevitably provide the presently claimed ratio. 7.9 Product-by-process claims: With a view to understand product-by-process claim in detail the patent examiner should take into consideration that product-by-process claim is one in which the product is defined in whole or in part in terms of the process used to manufacture the product, instead of solely by structure, composition, properties or characteristics. We respectfully submit that product-by-process claims fall into either the statutory category of article of manufacture or composition of matter claims. Moreover, when the structure of a product is unknown, and the product cannot adequately be defined in terms of composition, structure, properties or characteristics, a product-byprocess claim may be allowable. These patent claims are in particular relevant for biological products or polymers that cannot be defined in terms of their structure or composition.

9 8. ASSESSMENT OF INVENTIVE STEP: 8.7 Hindsight Analysis: We respectfully submit that the patent examiner should attempt to place themselves in the shoes of the person skilled in the art faced with the problem. This is difficult in practice since the examiner approaches the consideration having both the problem and the solution in hand. To assess the inventive step of the invention, the patent examiner should identify the claimed inventive concept, by assuming the onus of the normally skilled but unimaginative addressee in the art at the priority date and to ascribe to him what was, at that date, common general knowledge of the art in question. Subsequently, identify what, if any, differences exist between the matter cited as being "known or used" and the alleged invention. The patent examiner should determine the inventive step without any knowledge of the alleged invention, whether these differences constitute steps which would have been obvious to the person skilled in the art or whether they require any degree of invention.

10 9. Industrial applicability We respectfully submit that the word "Industry" should be understood in its broadest sense and includes any functional and practical activity as distinct from intellectual or aesthetic activity. In general there must be something in which a new and useful effect, be it creation or alteration, may be observed. It need not be an article or substance nor necessarily involve a manufacturing process, but it must be useful in practical affairs. 10. Inventions not patentable: Section 3(e): Mere Admixture Resulting Only In Aggregation Of The Properties Or A Method Of Making Such Mere Admixture 10.17: Illustrative examples for section 3(e): With respect to examples cited in the guidelines, we respectfully submit that the following Intellectual Property Appellate Board(IPAB) order is of particular importance as it is a classic case where IPAB revoked Indian Patent granted to Kibow Biotech INC, titled A process of making pharmaceutical composition bearing patent grant number IN and at the same time Intellectual Property

11 Appellate Board (IPAB) upheld Patent Revocation Petition filed by Gujarat based La Renon Health Care for the product patent titled Compositions for Augmenting Kidney Function for patent No granted to Kibow Biotech Inc. On 13 th November, 2013 Intellectual Property Appellate Board (IPAB) upheld Patent Revocation Petition filed by Gujarat based La Renon Health Care Pvt. Ltd for patent No granted to Kibow Biotech Inc., for the patent invention Compositions for Augmenting Kidney Function under the provisions of the Indian Patents Act, However, on the same day, Intellectual Property Appellate Board (IPAB) revoked Indian Patent granted to Kibow Biotech INC, titled A process of making pharmaceutical composition bearing patent grant number IN under the provisions of the Indian Patents Act, The IPAB found that the granted patent No is not obvious in view of the prior art documents cited by La Renon HealthCare. The inventive composition of the patent comprises at least one probiotics bacteria of a certain kind, in a certain composition and it is not a mere admixture and is patentable under the Indian Patent Act, As stated by IPAB the invention covers a new and inventive

12 composition comprising at least one probiotic bacteria of a certain kind, in a certain composition and along with other additives (such as vitamins etc) that confer synergistic impact, enabling the augmentation of kidney function. By no stretch of imagination can this unique composition be labelled as mere admixture. However, from time to time, India has been held responsible by foreign pharmaceutical and biotech companies that India s patent ecosystem is weak and doesn t encourage innovation nor provides adequate patent protection to research and development activities. However, recent judgement of Intellectual Property Appellate Board (IPAB) has been ruled in favour of US-based biotechnology company Kibow, headed by Natarajan Ranganathan upholding its initial patent and affirming that the company s break through probiotic dietary supplement sold under the brand name Renadyl capsules is patentable in India. Therefore, Kibow Biotech s win in patent battle for its probiotic dietary supplement, Renadyl in Indian court, has busted the myth that we completely lack ecosystem for patent protection.

13 Accordingly, we submit that such orders and / or judgements should be used as reference. Thank you for your time and consideration. We at Tech Corp Legal are grateful to have the opportunity to comment on the guidelines and would be happy to answers any questions related to above mentioned points, if any. Best Regards, Prity Khastgir PARTNER, Tech Corp Legal LLP