Breaking News:Novartis’s Patent Application Rejected by Chennai Patent Office

In a 5-page order dated October 9, 2012, the Chennai Patent Office rejected Novartis AG’s patent application on “An Ethanol-free Pharmaceutical Composition” which was filed in 2006.

The application was rejected after hearing the applicant under Section 14 of the Patents Act since, according to the Patent Office, the applicant’s response to the second examination report did not overcome the objections raised by the Patent Office.

The primary objections were under Section 3(e) and Section 10(5) of the Act. Despite claims being amended by the applicant, the Patent Office was of the view that the amended claims attracted Section 3(e) and did not comply with Section 10(5). The amended claims were as follows:

1. A pharmaceutical foam composition substantially free of ethanol and comprising pimecrolimus in a carrier vehicle comprising a mixture of oily solvents amounting to atleast 40% of the total weight of the composition and consisting of:

i. Hexylene glycol in the range of 1% to 10%

ii. Optionally Oleyl alcohol  in the range of 1% to 20%and

iii. Dimethyllisosorbide  in the range of 35% to 90% and medium  chain triglycerides in the range of 5% to 20% and additionally:

iv. Hydroxypropyl  cellulose  and /or stearyl alcohol in the range of 0.1% to 5%

v.  p_hydroxybenzoic  acid ester with ethyleneglycol  phenylether in the range of 0.1% to 0.5% and

vi.  glyceryl monostearate in the range of 1 to 3% and non-ionic  sugar esters and butane/propane  80/20 as propellant  gas for foaming.

2. A Pharmaceutical foam composition substantially free of ethanol and comprising a mixture of and Pimecrolimus in a carrier vehicle comprising a mixture of oily solvents amounting to  atleast 40% of the total weight of the composition and consisting of:

i.  Hexylene glycol in the range of 2% to20%

ii.  medium chain triglycerides in the range of 50% to 80% and optionally Dimethyl lisosorbide in the range of 0% to20%  and additionally:

iii.  Water in an amount less than 25%

iv.  polyvinylpyrrolidine and stearyl alcohol in the range of 1% to 10%

v.  p_hydro xyberuoic acid ester with ethylenegrycor phenyrether in the rangeof 0.1% to 0.5% and

vi.  glyceryl monostearate in the range of I% to 3% and lecithin; andbutane/propane  80/20  as propellant  gas for foaming.

The Patent Office seems to have had issues with the fact that the components claimed in Claims 1 and 2 are not identical, and even where the components are identical, their range differs. This, according to the Office, ran afoul of the requirement of unity of invention (single inventive concept). Also, the Office took the view that the claims weren’t clear and succinct.

Therefore, according to the Office, the claims did not comply with Section 10(5) of the Act which states that “claims shall relate to a single inventive concept, and shall be clear and succinct and shall be fairly based on the matter disclosed in the specification.”

Also, the Patent Office observed that no experimental data had been provided by the applicant to establish that the claimed compositions exhibited synergistic effect over and above the prior art.

There is also a cursory observation that the patent application claims subject-matter which is barred under Section 3(e) i.e. “a substance obtained by mere admixture resulting only in the aggregation of the properties of the components therof or a process for producing such substance”.

The problem with the order is that it is tersely-worded and does not give a reader a clear picture as to what according to the Patent Office is the specific relationship between the components claimed in Claim 1/their range, and the inventive step sought to be protected by the applicant.

Had this been clarified, one would have been in a better position to understand how different is the inventive step in Claim 2 due to different ranges and components being claimed.

In other words, how do the components and their ranges in Claims 1 and 2 affect the preamble of the claim, namely “A pharmaceutical foam composition substantially free of ethanol and comprising pimecrolimus in a carrier vehicle comprising a mixture of oily solvents amounting to atleast 40% of the total weight of the composition..”

Also, there is no elaboration on the finding on Section 3(e). This in itself could render the decision reasonably appealable before the IPAB under Section 117A.

It would really help if decisions of the Patent Office reflect application of mind by the Office. At least this way, the ground of “absence of reasoning” could be done away with in an appeal.