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Patent office rejects IP Alliance’s pre grant opposition; grants patent to Alcon Research’s ophthalmic drug

Gireesh Babu, New Delhi
Thursday, June 23, 2022, 08:00 Hrs  [IST]

Indian patent office has approved the patent application of Alcon Research Ltd, the eye care devices business spun off from Swiss pharma major Novartis in 2019, for high concentration of olopatadine, used for treatment of ocular allergic disorders by rejecting the pre-grant opposition by Indian Pharmaceutical Alliance (IP Alliance).

The application was filed in August 2013, for high concentration olopatadine ophthalmic composition, and IP Alliance filed its opposition to grant of patent in April 2016, seeking the patent office not to grant the patent.

IP Alliance, in its opposition, argued that the composition lack novelty, lack inventive step, and the claims are obvious given the prior documents available on the subject and it is not patentable under Section 3(e) of the Indian Patent Act, which states that “a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance,” is not patentable.

Alcon in its patent specification claimed that the composition contains an ophthalmic aqueous solution containing a relatively high concentration of solubilised olopatadine wherein the solution is capable of providing enhanced relief from symptoms of ocular allergic disorders such as conjunctivitis, in early and late phases.

While its solutions sold under the trade name Patanol and Pataday, containing olopatadine, from Alcon are used to reduce the symptoms such as ocular irritation, itching, redness and the like in those who are suffering from allergic conjunctivitis, the company claimed that it has discovered that high concentrations of olopatadine is surprisingly helpful in significantly improving reduction of redness in early phase and reduction of late phase ocular allergic conjunctivitis symptoms in addition.

It claimed that solubilising higher concentrations of olopatadine has proven difficult and further innovation was needed to create a desirable olopatadine formulation that not only solubilised sufficient amounts of olopatadine, but also allowed the formulation to achieve other desirable pharmaceutical characteristics.

The company later amended the claims, in order to overcome some of the objections raised during the process.

Considering arguments from both sides, the Deputy Controller of Patents agreed with Alcon’s argument that all the particular features of the claimed composition are not disclosed as in the prior art.

The official also declared that the first six amended claims are inventive and the amended claims overcome the objection Section 3(e) of non patent ability. The amended claims clearly and sufficiently recite the subject matter for which protection has been sought, added the official.

“After having considered all the circumstances of this case, representation for oppositions, reply of the applicants, written submissions and arguments in the hearing made by all the parties and also my discussion and findings as mentioned above the following amended claims 1-6 are granted u/r 55(5) by rejecting the representation for opposition,” said the order issued on June 20, 2022.

Novartis announced completion of spin off of the Alcon eye care devices business through a dividend-in-kind distribution to holders of Novartis shares and American Depositary Receipts, in April, 2019.

The spin off was to allow Novartis to fully focus its capital allocation and management attention on medicines and keep its financial profile closer to its pharmaceutical industry peers, including higher group margins.

 

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