Conducting a post-mortem on Astella’s Indian Patent No: 234753

(i) Proof of inventor-ship: As per Section 7(3) of the Patents Act, 1970 all patent applications will have to be accompanied by proof of the right to make the application. Further Section 10(6) of the same Act also requires a declaration as to the inventor-ship of the invention. The Patent Rules prescribe the forms etc. in which this information is to be given. For e.g. please click on Form 1 and Form 5 to view the manner in which this information is requested for by the patent office. Now please click here and here to see the initial patent application filed by Astellas along with a copy of all the letters written by their Patent Agents to the Patent Office in the course of the patent prosecution. Each letter mentions the enclosures and none of these enclosures mention anything about a proof of the right to apply or even a declaration as to inventor-ship. Which begs the question, how did Astellas establish the right to file the patent application that resulted in Indian patent no: 234753. Of course, it is also possible that the patent office has not placed this correspondence on the IPAIRs system.

(ii) Power of Attorney: Very, very surprisingly the original patent application was not accompanied by a ‘power of attorney’. Page 2 of the correspondence file available over here, is the covering letter for the patent application. In the list of enclosures, the patent agent states that the ‘power of attorney’ will ‘follow’. This letter is dated the 25th of May, 1997. On the 10th of March, 2008 the Examiner of Patents issued the ‘First-Examination Report’ (available here) and one of the objections mentioned is the absence of a ‘power of attorney’. This means that this patent application continued for 11 years without a power of attorney. The remaining correspondence too is silent on the filing of a ‘power of attorney’. Why in God’s name did the patent office even examine this file when there was no POA filed in the name of the patent agent? A POA is the most fundamental of instruments establishing that the patent agent is indeed authorized by the patent applicant to prosecute the application in question. If there is no valid POA, the patent office should just reject the entire application.

(iii) Substitution of the applicants under Section 20 of the Patents Act, 1970: The original patent application for Indian patent no: 234753 was filed in the year 1997 by Yamanouchi Europe B.V. On 1st April, 2005 Yamanouchi Pharmaceuticals merged with Fujisawa Pharmaceuticals to create Astellas Pharma Inc. It appears that all subsidiaries were also merged. Section 20 of the Patent Act, 1970 prescribes the procedure to substitute the names of the applicants of an existing patent application which has not yet been granted. On the 31st of July, 2006 the patent agents for the original patent applicants filed a Form 6 (available over here), under Section 20, for the substitution of the patent applicants i.e. the original applicant was going to be replaced by Astellas Pharma Europe B.V. The official reason cited in this Form is the merger and as supporting proof the patent agents enclosed an extract from the trade register along with an English translation. This extract from the trade register in Netherlands has not been put up by the Patent Office on IPAIRS. The following issues arise in this context:

(a) Was Yamanouchi Europe B.V. merely re-named Astellas Pharma Europe B.V. or is the latter a new legal vehicle resulting from the merger of Yamanouchi and Fujisawa?

(b)If it’s a mere name-change then the proof submitted by the patent agent, i.e. an extract of a trade-register, should be enough, although if we want to get technical we need to examine whether it has been authenticated as per Indian law.

(c)However if Astellas Pharma Europe B.V. is a new legal entity then in that case Section 20(3) of the Patents Act, 1970 requires the filing of a specific assignment deed between two parties, with reference to the patent application number etc. which has not been submitted in this case. This would require Yamanouchi to transfer the patent application via an assignment deed to Astellas Pharma Europe B.V.

(iv)The objections raised in the FER: On the 10th of March, 2008 the examiner of patents issued a detailed First Examination Report (FER) (available over here). The following issues arise from this FER:

(a) Objections on the lack of inventive step: The examiner of patents had raised a fundamental objection on the lack of an inventive step in the patent specification. He supported his argument by citing four other patents in the same field. Surprisingly the patentee has been granted this patent without providing any clarification on this point. After all if an objection has been raised in writing, it has to be taken care of in writing. The response to objections has to be in writing so that there is a record of it.

(b)The Section 8 arguments: The examiner of patent has asked the applicant to file the examination/search reports generated by the EPO, JPO and the USPTO for the corresponding patents filed in those countries. The patentee however has gone ahead and filed only Form 4, which contains only cursory details as to the stage of the patent in foreign countries. The patentee seems to have disregarded this very specific request of the patentee.

Conclusion: There are clearly several issues that need to be clarified by the patentee in this case unless of course the patent office has not put up the complete information on the IPAIRS system.