Kolkata Patent office Clarifies ITS Decision on Divisional Applications of Herceptin

This has a reference to the above-mentioned matter published today. The response of the Kolkata Patent Office vis-à-vis the news item is given herein below:

A.    India has partly revoked patents granted to Roche Holding AG for its breast cancer drug Herceptin, a spokesman for the drugmaker confirmed on Sunday. Swiss newspaper Schweiz am Sonntag reported that the Kolkata Patent Office had lifted divisional patents for Herceptin on July 17 on the grounds they had not been properly submitted. “I can confirm that the Assistant Controller of Patents at the Kolkata Patent Office has revoked divisional patents of Herceptin and that we are now considering the further course of action,” a spokesman for Roche said.

Response of the Office: The news item does not fully reflect and appreciate the situation under which the Patent Office has disposed of the said divisional applications. A synopsis of the patent/ applications for patent related to Herceptin is given herein below:

1. An application for patent IN/PCT/2000/391/KOL was filed on 11102000 and was later granted a patent with a title A composition comprising a mixture of anti-HER2 antibody. The grant of the patent was published on 06.04.2007. It may be noted that after the grant of a patent, the said grant may be opposed by an interested member of the public. In the instant case, the grant of the said patent has been challenged through this post-grant opposition procedure.
2. As per the Indian Patents Act, a patent is granted for one invention only [Section 46 of the Patents Act]. If the claims of an application relate to more than one application, such application can be divided and further applications (called divisional applications, please see Section 16 of the Act) can be filed. A divisional application has to be filed before the date of grant of the first application (usually referred as  mother application). Let it be noted that after the filing of the application, the application is duly published in the Official journal. An applicant has to file a request for examination for an application within forty eight months from the date of priority of the application (other than divisional applications) and within forty eight months from the date of priority or within six months from the date of filing in the case of divisional applications. If the requests are not filed within time they are treated as withdrawn under section IIB(4) of the Act
3. Three divisional applications were filed out of this application, namely :
4. 1638/KOLNP/2005, divisional application out of IN/PCT/2000/391/KOL date of filing: 16-08-2005. Date of filing of request: 17032006
5. 3272/KOLNP/2008 divisional application out of 1638/KOLNP/2005 Date of filing of request: 12022009
6. 3273/KOLNP/2008 divisional application out of 1638/KOLNP/2005 Date of filing of request: 12022009
7. In all these cases, the Controllers of the Patent Office offered the applicant, opportunity of being heard before the final disposal of these cases.
8. In  1638/KOLNP/2005, the Controller found that the Request for Examination had been filed on 17.03.2006, i.e., beyond the prescribed period (which was due on 16.02.2006) according to Rule 24(B)(iv) of the Patents Rules. An opportunity of hearing was offered on 18.06.2013 before exercising any discretion vested in the controller by or under this Act adversely to the applicant. At the request of the applicant™s newly appointed agent the hearing was rescheduled on 23.07.2013. The agent of the applicant did not appear in the hearing and even did not submit any notes of argument. Under these circumstances, the Controller ordered that the application should be treated as withdrawn by the applicant under section 11B(4) of the Act.
9. In the matter of 3272/KOLNP/2008, the Controller found that the instant application was divisional to a divisional application, which in his opinion was not permissible. As the present application was to be construed as the divisional application of the first filed application (IN/PCT/2000/391/KOL), the said divisional application was filed after the grant of the first filed application and was not permissible under the ˜Act. The Controller gave due opportunity of hearing to the agent on 31/05/2013. After the first hearing, the Controller fixed another date of hearing in the subject matter on 15/07/2013, which was not attended by the applicant. In the operative part of the decision the Controller said the application no. 3273/KOLNP/2008 is not considered to be a divisional application at all within the meaning of section 16 of the ˜Act. The application has not been properly filed complying with the requirements of the ˜Act and therefore, treated as abandoned.
10. In the matter of 3273/KOLNP/2008 also, similar decision was arrived at by the Controller and in the instant case also, the applicant™s agent did not turn up on the date of the hearing.
11. It is submitted that the said divisional applications have not been revoked but were treated as withdrawn due to non-filing of Request for Examination within prescribed time or abandoned due to incorrect filing. Before the Controllers issued their decisions, the applicants were given due opportunity of being heard but the applicants have chosen not to attend.
12. Still thereafter, the applicant may explore further legal possibilities, as they so desire.

B.   The decision is the latest in a series of rulings on intellectual property and pricing in India that have frustrated attempts by Western drug makers to sell their medicines in India`s fast-growing drugs market.

Response of the Office: Regarding this paragraph, it is submitted that in the instant cases, the Patent Office has followed the due course of principle of natural justice, gave the applicant the opportunity of being heard and then only finally disposed of the matter. In the instant cases, it is found that proper steps for filing request or filing divisional applications were not followed by the applicants.

C. On Friday, India revoked a patent granted to GlaxoSmithKline`s for breast cancer drug Tykerb, following on from a landmark court ruling in April disallowing patents for incremental innovations.

Response of the Office: Perhaps the news item refers to a decision of the Intellectual Property Appellate Board. The IPAB, is an independent judicial authority.

D.   Roche has already adapted its business model in India to increase affordable access to drugs and try to stave off trouble from India`s patent authorities. In August 2012, it introduced cut-price versions of Herceptin and another cancer drug MabThera, under an alliance with Indian generics firm Emcure Pharmaceutics.

Response of the Office: The present abandonment or rejection of the divisional applications related to Herceptin has no nexus with the pricing of the drug. The news item failed to appreciate this fact. Once again, it is submitted that the instant divisional applications were not filed in proper manner.

 E.    Last year, India revoked patents granted to Roche`s hepatitis C drug Pegasys, Pfizer Inc`s cancer drug Sutent, and Merck & Co`s asthma treatment aerosol suspension formulation. All were revoked on grounds that included lack of innovation.

Response of the Office: Except for Pfizer Inc™s drug Sutent, the rejections or revocations of were made by independent judicial authorities. The revocation of Sutent was done after following due process of law under post-grant opposition. However, the revocation has been set aside by the Intellectual Property Appellate Board on a procedural issue and the matter has been remanded back.