Tuesday, December 11, 2012

Schering Corp’s Patent Revoked in Cipla’s Post Grant Opposition by Chennai Patent Office

In a 20-page decision delivered on December 10, 2012 in a post-grant opposition filed by Cipla, the Chennai branch of the Indian patent Office revoked Schering Corp’s patent 246328 on “An aerosol suspension formulation for inhalation”. The patent was revoked for lack of inventive step.

The patented invention addressed issues related to use of non-CFC (Chlorofluorocarbons) propellants in pressurized aerosol formulations, such as the ones used in inhalers by Asthma patients. In particular, the patent addressed problems associated with use of HFA 227 (1,1,1,2,3,3,3-heptafluoropropane) and HFA 134a (1,1,1,2-tetrafluoroethane) as propellants in inhalers.

Following are certain extracts from the decision:

“From the above disclosure it can be concluded that both HFA 227 and HFA 134a are the propellants that can be used according to invention. Though HFA 134a has the disadvantage of settling the active drug it can be overcome by shaking the canister, hence the argument made by the agent for the Patentee that the Patentee has restricted to HFA 227 in the claims is not convincing.

Had the Patentee thought the HFA 134a cannot be used in the inventive formulations then the description and claims are not in inconsistent with each other? Use of both HFA 227 and HFA 134a not compatible with valve assemblies is concluded to be a known problem and the solution as discussed in the granted specification is also concluded as known solution and does not have any impact on the alleged invention.

Surprisingly in the entire granted specification no comparison has been provided by using a carrier and not using a carrier. As understood the problem to be solved by this patent is the elimination of CFCs from the process of preparing the aerosol suspension formulations. How this problem is related either to the presence or absence of a carrier? The granted specification has no answer for this question.

The entire granted specification addresses to the problems associated with using non-CFCs in the making of aerosol suspension formulations. These problems and the solutions were amply discussed in the cited documents filed by the Opponent. None of the documents i.e D1 to D6 and other documents had discussed on the effects of carrier or the problems that may arose in the absence of carrier.

Then what is the functional difference between a carrier and a propellant? A carrier in general parlance is defined as are substances that serve as mechanisms to improve the delivery and the effectiveness of drugs. Drug carriers are used in sundry drug delivery systems such as: controlled-release technology to prolong in vivo drug actions; decrease drug metabolism, and reduce drug toxicity.

The propellant in general parlance is understood as technically, is the general name for chemicals used to create thrust. A propellant, in other words, is a chemical which is used in the production of energy and pressurized gas that is used to create movement of a fluid or to generate propulsion.

By looking at a plain reading on the definitions, both the carrier and propellant are doing the same job. Though there is a difference in applications, it is needless to say that when drug has to be delivered in aerosol suspended form the propellant is the only option for intended use. Therefore in the present formulations the propellant is used for effective delivery. 

Hence the concept of the Patentee on claiming “substantially free of a carrier” is not understandable in the context of the proposed solution for solving the proposed problem. With respect to the combination therapy and the dosages fixed there is no inventive concept in the impugned patent.

Also there is no inventive step in the selection of non-CFCs for the preparation of the aerosol suspension formulation of the patent. There is no inventive concept on selecting HFA 227 and/or HFA 134a from known non-CFCs. There is no inventive concept on the preferential use of HFA227 over HFA 134a.  The claims are inconsistent with that of description as there is no comparative data with respect to the absence or presence of a carrier in the said formulations.

The claim 1 either on individual parameters or in its entirety lacks inventive step. Consequently the claims dependent on the claim 1 are not inventive. The sole process claim also in its entirety is not inventive as the said claim does not describe any inventive feature.

The descriptive portion of the specification does not throw any light on the carrier itself and hence based on the arguments during the hearing which were made around the presence or absence of a carrier is considered to be insufficiently disclosed.”

Friday, December 7, 2012

Supreme Court Order in Sutent: Opposition Board’s Recommendations Must be Shared with Parties

I had earlier blogged on the Supreme Court setting aside the revocation of the Sutent patent of Sugen Inc. The Supreme Court set aside the revocation on the ground that principles of natural justice were not adhered to by the Controller, since the Opposition Board’s recommendation was not shared with the parties, in particular the patentee. 

A friend and well-wisher of the blog has been kind enough to share a copy of the SC's order in the matter!

Following are the relevant observations of the Supreme Court in its order dated November 27, 2012:

Sub-rule (1) of Rule 62 confers power on the Controller to require members of the Opposition Board to be present in the hearing after receiving recommendation of the Opposition Board. The Controller, after hearing the parties if they so desire and after taking into consideration the recommendation of the Opposition Board, has to decide the opposition giving reasons.

Provisions of the Act and the Rules, therefore clearly indicate that the Opposition Board has to make its recommendations after considering the written statement of the Opposition, reply statement, evidence adduced by the parties with reasons on each ground taken by the parties. Rule 62 also empowers the Controller to take into consideration the reasons stated by the Opposition Board in its Report. In other words, the Report of the Opposition Board has considerable relevance while taking a decision by the Controller under Section 25(4) of the Act read with Rule 62(5) of the Rules.

The Opposition Board in a given case may make a recommendation that the patent suffers from serious defects like lack of novelty, lack of inventive steps etc., so also it can recommend that the patent shall be granted since the invention has novelty, inventive steps etc. Such recommendations are made after examining the evidence adduced by the parties before it. Unless the parties are informed of the reasons, for making such recommendations they would not be able to effectively advance their respective contentions before the Controller. 

Section 25(3)(b) read with Rule 56(4) cast(s) no obligation on the Opposition Board to give a copy of the Report to either of the parties. So also no obligation is cast under Section 25(4) or under Rule 62 on the Controller to make available the report of the recommendation of the Board. But considering the fact that the Report of the Opposition Board can be crucial in the decision making process, while passing order by the Controller under Section 25(4), principles of natural justice must be read into those provisions. Copy of the Report/recommendation of the Board, therefore, should be made available to the parties before the Controller passes orders under Section 25(4) of the Act.

We have gone through the order passed by the Controller and we notice that Controller has placed reliance on recommendation of the Opposition Board, but without giving copy of the report to either of the parties. Hence, order is vitiated for violation of natural justice. Order passed by the Controller on 24.09.2012 is, therefore set aside.

The Apex Court also set aside the orders of the Single Judge and the Division Bench of the High Court in Sugen Inc’s writ and Cipla’s Letters Patent appeal respectively.

The matter has now been remanded to the Controller for disposal of the post-grant opposition within one month from the date of communication of the Supreme Court’s order. 

Thursday, December 6, 2012

Bajaj v. TVS: Chennai Patent Office Rejects Bajaj’s Pre-grant Opposition to TVS Patent Application

In a 13-page order dated November 21, 2012, the Chennai Patent Office rejected Bajaj Auto Limited’s pre-grant opposition against TVS’s application numbered 78/CHE/2004 on “Automatic Device for Providing Optimum Ignition Timing Characteristics for SI Engines”. Under Rule 55(6), a patent was granted to TVS.

The copy of the order which has been uploaded on the website of the Patent Office is not reader-friendly since portions of the order are missing. Also, the order does not make itself amenable to analysis since the prior art references (cited by Bajaj) alluded to in the order have not been identified.

I would be grateful to readers if someone could share with me the references cited by Bajaj against TVS’s application.

In all likelihood, Bajaj is bound to appeal against the grant of the patent or file a post-grant opposition. This promises to be yet another battle between the two-wheeler giants.