Roche's new breast cancer drug that could cut treatment time denied patent

Roche has filed for a patent for its new drug formulation meant for subcutaneous administration

The Indian Patent Office has refused a patent for an invention by Swiss pharma major F Hoffmann-La Roche AG related to a drug formulation meant to be injected below the skin to treat breast cancer, following a pre-grant opposition by the Indian Pharmaceutical Alliance (IPA). The company has claimed that the method, which has several advantages compared to intravenous injections, is useful in cancer drugs such as Trastuzumab (Herceptin) and Pertuzumab (Perjeta).

The decision was taken in response to a national phase application Roche had filed in January 2012 for its invention titled Subcutaneous anti-HER2 Antibody Formulation. The IPA filed its opposition against the grant of a patent in January 2015, following which, a hearing was held in January 2017.

In an order issued by the Assistant Controller of Patents and Designs, Chennai, the Patent Office said that the claims for patent application did not involve any inventive step and are not patentable under the provisions of the Patents Act, 1970. Hence, the authority refused to proceed with the patent application for grant of a patent under section 15 of the Patents Act, 1970.

According to the filings by Roche with the Patent Office, the application was on an invention related to highly concentrated stable pharmaceutical formulations of the anti-HER2 antibody, which is used in treating breast cancer, or a mixture of such molecules for subcutaneous injection. Subcutaneous injection is a method of injecting medicine with a short needle into the tissue layer between the skin and the muscle.

While in many instances, antibodies are injected through the intravenous route, the amount of medicine administered through this route has various limitations. Subcutaneous injections allow the medical practitioner to perform treatment in a short intervention with the patient and the patient can be trained to perform the injection herself, which means no hospital care is needed to administer the dose. It could also help the doctor to administer multiple doses at multiple sites of the body surface.

The company claimed it has invented a formulation that is suitable for subcutaneous administration to achieve these benefits.

IPA, the organisation comprising the top domestic pharmaceutical companies in the country, opposed the patent application on various grounds, including that the invention is anticipated given the information in the previously published patents, the invention is obvious and lacks inventive step, and it is not patentable under Section 3(d) and 3(e) of the Patent Act. Roche refuted all these allegations and argued for patent protection.

While rejecting the IPA's arguments that the invention was anticipated and was a mere discovery within the meaning of Section 3(d) of the Act, the Patent Office, however, observed that Roche's claims did not involve any inventive step and the subject of the patent sought by the company was a substance obtained by mere admixture resulting only in an aggregation of properties, which is not patentable under the provisions of Section 3(e) of the Act.

Roche has been working on this formulation for several years now and has claimed earlier that Herceptin SC (subcutaneous) may provide greater convenience to patients versus the traditional intravenous method due to its less invasive administration route and quicker administration time of around 5 minutes versus 30–90 minutes.