A recent case decided by the Controller in a pre-grant opposition highlights the practice of opposing applications from big pharma for the sake of opposition. In this case, the Applicant (Abbot Labs.) had to resort to investigating the background of one opposing party, and submit voice recordings to the Controller to help him decide whether the opposition filed was frivolous. The post highlights summarizes the opposition proceedings in the case and provides certain practice pointers at the end. Hat tip to one of our regular readers: Sandeep Rathod. Long post follows.
Abbot Biotechnology Ltd. (“Abbot”) filed an application 6618/DELNP/2006 related to treating tumour necrosis factor alpha (TNF-a) related disorders, having a priority date of April 9, 2004. Abbot initially had 39 claims when it entered national phase (NP) but during the course of prosecution reduced the total number of claims to 31 with four independent claims (1, 11, 24 and 31), and others dependent upon independent claims 1, 11 and 24.
Glenmark Pharmaecuticals Ltd. (“Glenmark”) filed a first opposition petition under section 25(1) in late 2008 (Nov.18, 2008). One Mr. Sanjay Gupta, a resident of Sector 13 Dwarka, filed a second opposition on 16.9.2009. [NOTE: For our readers who are not familiar Delhi, Sector 13 (address of Mr. Gupta) is adjacent to Sector 14 (address of our patent office. See Delhi metro map.]
The first opposition raised the following grounds against the patentability of the claims:
1. Lack of novelty; 2. Lack of inventive step; 3. Not an invention; 4. Insufficient description; 5. Disclosure.
Lack of Novelty: Glenamrk submitted that claims 1 and its dependent claims were anticipated by the disclosures in WO1997/29131 (“131”) and another application 1096/MUMNP/2003 (“096”). In response, Abbot submitted that Glenmark had cherry picked the from the above two references and even the sections cited by Glenmark pertained to definition and background sections.
The Controller decided that because the cited document did not anticipate the application, therefore the ground of lack of novelty was moot with regard to the ‘131 and the ‘096 references. Additionally neither the 131 or the 096 reference cited the complete elements of the independent claim, and hence the references did not anticipate the claims of the application.
Lack of Inventive Step: Glenmark submitted additional references and reports of trials from 1999, and that TNF-a antibody (subject matter of claims) was available in the public domain. Glenmark also referred to a text, Medical Pharmacology by Tripathi to further bolster their claims that the invention as claimed was obvious.
In response, Abbot distinguished the application from the references cited. Abbot provided additional references that helped the Controller to further distinguish the claimed invention in view of the cited references by the Opponent. The Controller agreed with Abbot and held that the invention involved an inventive step and was non-obvious.
Not an invention (under section 3(e) and (i) of the Act): Glenmark asserted that the claimed invention fell within the purview of sections 3(e) [mere admixture] and 3(i)[method for treating a human being] of the act and hence was not an invention. Abbot rebutted the contention by stating that because the invention was directed towards a composition that results in unexpected results or synergistic properties and hence it was not a mere admixture. Additionally, the claims did not fail under section 3(i) because they were directed towards a composition and pre-loaded syringes of the antigen/antigen binder.
Additionally, because the International Search Authority (“ISA”) also does not conduct a search on methods for human treatment and that the ISA had NOT done such a search for this case, the claimed invention did not fall within the purview of section 3(i). Similarly the European Patent Convention (EPC) also keeps composition claims out of the purview of unpatentable subject matter.
The Controller partly agreed with Abott and allowed claims 1-8 but rejected claims 9-31 because they fell within the purview of section 3(i). Claims 9-31 were directed towards a total body dose or treatment amount of the human TNFa antibody, or antigen-binding fragment.
Second Opposition: The Controller considered the opposition by Mr. Gupta on the grounds of public interest even though Mr. Gupta did not appear for the hearing. It is extremely interesting to note that the references cited by Mr. Gupta (on the same five grounds of the first opposition) were the same as the ones cited by the first opponent, Glenmark! Although the decision does not disclose the references cited, the Controller in the decision specifically stated that the Annexes (or references) cited by the Second Opponent to support the grounds of opposition were analyzed by the Controller. See Page 33 of the decision, last paragraph.
Quotable Quote: “[T]he agent for Applicant have conducted an investigation. And submitted said investigation report before me along with an audio CD ….But the authenticity of the CD has not been proved by the Agent therefore it can not taken into consideration.”
1. Novelty: To anticipate the applicants claim, the prior art publication must contain clear and unmistakable directions to do what the claims to have invented;
For anticipation it must be shown that all elements of the claimed invention are found in the prior art.
2. Obviousness: When dealing with obviousness, unlike novelty, it is permissible to make a ‘mosaic’ out
of the relevant documents, but it must be a mosaic which can be put together by an unimaginative man with no inventive capacity.
3. ISA search reports and EPC reports in cases involving section 3(i): Are a most direct response. Use them.
🙂 Perhaps the patent applicant should regularly avail the services of a seasoned detective who can provide authenticated voice recordings of individual opponents. In this case it is surprising (or not depending on your perspective) that the second opponent cited the same references as the first one even though the second opposition was filed months after the first.