Patent Office refuses divisional application of Merck's antibiotic

The application lacked distinct invention from parent application, the Patent Officer said

The Indian Patent Office has refused a divisional patent application of Merck Sharp & Dohme for an antibiotic to treat infections that are resistant to various known antibiotics, citing that the claims lack distinct invention from parent application. 

The invention was related to a novel natural product that possesses antibacterial activity against various diseases where there is drug resistance to some other antibiotics.

The particular application, for invention titled, “Antibiotic Compound”, was filed as a division of another patent application filed under the same title, in January, 2006. The parent application was granted and a certificate was issued on July, 2009, according to the documents.

The counsel appeared for the company during a hearing held on December 30, 2015, argued that in parent application claim are related to antibiotic compound and method of making the claimed antibiotic which was in single inventive concept while divisional application was filed for distinct invention directed to Streptomyces sp.

While Monika Yadav, assistant controller of Patents & Designs, raised an objection that the microorganism claimed in divisional application is identical to microorganism defined in claim two of parent application, the counsel argued that the parent application does not recite claims for the microorganism.

The Patent Officer added that according to her view, a divisional application must be filed only when the claims of the complete specification in parent application relate to more than one invention and divisional application should not include a claim for any matter claimed in parent application.

"This technical advantage of isolated Streptomyces sp. having ATCC accession number ATCC# PTA-5316 (MA7327) or ATCC accession number ATCC#PTA-5317 (MA7331 ) in cultivation and fermentation for recovering antibiotic compound has already been claimed in parent application and no distinct Microorganism has been claimed in divisional application," she said adding that the application is not a fit case for divisional patent.

According to the company's specification to the patent application, the claimed invention is related to a novel natural product that possesses antibacterial activity. Infections caused by bacteria are a growing medical concern as many of these pathogens are resistant to various common antibiotics and the invention comprises an important contribution to therapy for treating infections that are resistant to various known antibiotics.

It may be noted that the divisional applications filed by the originator companies has been a bone of contention in various forums of intellectual property. Earlier a patient group has approached the Delhi High court seeking direction to the Patent Authorities to look into various divisional patent applications so that it should not be used for evergreening of patent. Besides, another order from the Intellectual Property Appellate Board (IPAB) related to the divisional applications has been challenged in the High Court of Calcutta.

According to Section 16(1) of the Patents Act, 1970, a patent applicant, before the time of grant of patent can file a further application (divisional patent) if he so desires or in order to address the objection of the Controller of Patent that the claim in the first patent application relate to more than one invention. In such instance, the patent applicant can file a further application, but has to ensure that the main application and the divisional applications may be amended to ensure that neither of the complete specifications include a claim for any matter claimed in the other.