A win-win situation for domestic Pharmecutical Concerns and Patents

The Apex Court vides its recent judgment rejected Swiss drugmaker Novartis AG’s plea for patent protection of its cancer drug Glivec.

The Apex Court vides its recent judgment rejected Swiss drugmaker Novartis AG’s plea for patent protection of its cancer drug Glivec.

The Apex Court dismissed the claim of Novartis primarily on the grounds, as under:

• That the drug it was seeking to patent was nothing but a sheer modification of an older medicine called imatinib rather than offering any improved or new therapeutic efficacy.
• In order to succeed for grant of patent in case of such medicines under the Indian Patents Act, it is necessary that there is an improved efficacy of newer forms of known drugs which, as held, was not so in the present claim of Novartis.

Background:

Novartis has been contesting for a patent on Glivec since 1998. It had filed an application before the Assistant Controller for grant of patent for Imatinib Mesylate in beta crystalline form at the Chennai Patent Office in July, 1998.

Holding:

• The Apex Court made a distinction between Section 3(d) as it stood prior to 2005 amendment in Patents Act and as it stands now.
• It observed the importance of the amendment made in section 3(d), the addition of the opening words in the substantive provision and the insertion of explanation to the substantive provision, cannot be under-estimated and held that:

o The amendment/addition made in section 3(d) is meant especially to deal with chemical substances, and more particularly pharmaceutical products.
o The amended portion of section 3(d) clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for true and genuine inventions.
o And at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds.
o In view of the genesis of section 3(d), “therapeutic efficacy” of a medicine was felt necessary to be adjudged strictly and narrowly. It was held as necessary to be kept in mind that each of the different forms mentioned therein have some properties inherent to that form, and thus the explanation in other words meant to indicate what is not to be considered as therapeutic efficacy.
o The subject product, i.e., the beta crystalline form of Imatinib Mesylate, was held to be as failing the test of section 3(d) of the Patents Act, though it was clarified that it would be a grave mistake to read the present judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Parent Act.
o The Apex Court eventually concluded that the beta crystalline form of Imatinib Mesylate, since failed in both the tests of invention and patentability as provided under clauses (j), (ja) of section 2(1) and section 3(d) respectively, and so the appeals filed by Novartis AG were dismissed with cost.
o In case of chemicals and especially pharmaceuticals if the product for which patent protection is claimed is a new form of a known substance with known efficacy, then the subject product must pass, in addition to clauses (j) and (ja) of section 2(1), the test of enhanced efficacy as provided in section 3(d) read with its explanation.

CONCLUSION

In conclusion the present judgment would certainly mean that, Patients, who cannot afford to buy expensive quality medicines, can now have an access to them. It’s a win-win situation for local or domestic pharmaceutical concerns and also for the investors considering investments with domestic players. The economical or call it right the affordable versions can continue to exist.