Cipla’s Patent Application For HIV Drug rejected

The Indian Patent Office rejected Cipla’s patent application for its HIV drug composition comprising combination of “ritonavir” and “darunavir”. The application, in particular, was directed to a pharmaceutical composition comprising a solid unit dosage form comprising: (i) ritonavir; (ii) darunavir; (iii) a water insoluble polymer and/or water soluble polymer, wherein the ratio of the weight of the ritonavir or darunavir to the weight of the polymer is from 1:1 to 1:6. Further, the claimed composition was a tablet composition comprising ritonavir and polymer in first layer and darunavir in second layer. The first layer is obtainable by hot melt extruding, and the second layer is obtainable by direct compression or by wet granulation.

The application was rejected on the grounds of lack of inventive step in view of the prior published documents. The controller cited 6 prior art documents and heavily relied on one particular D6: US 2005/0048112 in his inventive step analysis which describes that solid pharmaceutical dosage forms comprising ritonavir and, a second species of HIV protease inhibitor, including TMC-114 (darunavir). Therefore, according to the Controller, D6 provides strong motivation to formulate a solid pharmaceutical dosage form that comprises both ritonavir and darunavir. D6 additionally discloses that dosage may be provided as dosage forms consisting of several layers and such “multilayer forms have the advantage of processing  two active ingredients which are incompatible with one another  or controlling the release characteristics of the active ingredient(s). The claims were therefore considered obvious by the Controller. in addition to this, the Controller held that the claimed subject matter does not clearly show advantage/surprising effect over prior art composition to show non-obviousness (no comparative data being provided by the Applicant).

The Controller also rejected the application under section 3(d) as he considered the  new layered form of a known combination of prior art, as being statutorily barred from the patentability u/s 3 (d).

 

IPAB ADMITS APPEALS ON ORDERS ISSUED UNDER NON-APPEALABLE PROVISIONS

In two landmark cases,the Intellectual Property Appellate Board treated orders issued under non-appealable provisions of section 11(B) (4) and 77(f) as appealable.

The first such order was issued under section 11(B) (4) treating an application for patent as ‘deemed withdrawn’ for failure to file the request for examination within the prescribed time period of 48 months from the date of priority of the application. The case of the petitioner was that the Indian Patent Office (IPO) made an incorrect entry in the cash receipt stating that the fee for examination was filed after the expiry of the prescribed period in spite of the timely filing of the same. The Petitioner brought the incorrect entry to the notice of the Patent Office. In what can be seen as a gross violation of the principles of natural justice, the Controller of Patents issued an order treating the application as withdrawn without issuing a hearing notice to the Applicant.

Statutorily, orders passed under section 11(B) (4) are not appealable but the attorneys of the Appellant argued that since the Applicant had timely filed the request for examination, said order should be taken as an order under section 15 of the Indian Patents Act which bestows upon the Applicant a right to appeal. The Appellate Board agreed with the submissions of the Appellant and allowed the appeal.

In the second case, an order issued in a pre-grant opposition, which was treated as a review petition under orders of the Delhi High Court to correct a procedural irregularity that had ensued due to a patent being granted without processing of a pre-grant opposition, was treated as patentable by the IPAB. The IPAB held that the order issued in the review petition under section 77(f), was in effect an order in a pre-grant opposition that was being treated as a review petition under directions of the High Court and since orders in pre-grant oppositions are appealable, the order in this case was also held appealable.

These orders have brought in their wake a stand to draw curative measures to address administrative errors.