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Lumacaftor Drug Patent Structure Research * Section 3d Indian Patent Law

Understanding Lumacaftor Drug Patent Structure Search by Pharmaceutical Patent Lawyer

Lumacaftor drug patent is a Cystic Fibrosis Transmembrane Conductance Regulator Potentiator.

Lumacaftor Drug Patent, Structure Research , Lumacaftor Drug Patent Structure Research , Biotech Drug Patent Expirations, Drug Patent Expirations, Biotech Drug Patent Expirations fto patent attorney

What is Lumacaftor?

Lumacaftor is a Cystic Fibrosis Transmembrane Conductance Regulator Potentiator. Lumacaftor is 3-(6-(1-(2,2- DIFLUOROBENZO[D][1,3] DIOXOL-5-YL) CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN- 2-YL) BENZOIC ACID. Cystic fibrosis is a disease that is caused by dysfunction of the cystic fibrosis transmembrane conductance regulator protein (CFTR). When a patient is suffering from cystic fibrosis it affects the body. Eventually,  cystic fibrosis disease leads to progressive lung disease. Lumacaftor is an effective treatment for cystic fibrosis because it helps correct CFTR as well as the associated functions.

Key Parameters to be Considered while Performing Lumacaftor Drug Patent Structure Research

InChI: InChI=1S/C24H18F2N2O5/c1-13-5-8-19(27-20(13)14-3-2-4-15(11-14)21(29)30)28-22(31)23(9-10-23)16-6-7-17-18(12-16)33-24(25,26)32-17/h2-8,11-12H,9-10H2,1H3,(H,29,30)(H,27,28,31)
Molecular Formula: C24H18F2N2O5
Molecular Weight: 452.4132 g/mol

SMILES CC1=C(N=C(C=C1)NC(=O)C2(CC2)C3=CC4=C(C=C3)OC(O4)(F)F)C5=CC(=CC=C5)C(=O)O. To learn more about pharmaceutical patent searching click here. Contact us to perform patent searches and identify whether patents relating to a pharmaceutical product already exist in the country of interest. All our patent attorneys are trained in patent searching. Our in-house prior art searching capabilities allow us to deliver high quality legal opinions at a fixed cost to patent attorneys and in-house counsel worldwide.

Action mechanism of Lumacaftor Drug Patent

The mechanism of action of lumacaftor is as a Chloride Channel Activation Potentiator, Cytochrome P450 3A Inducer, Cytochrome P450 2B6 Inducer, Cytochrome P450 2C8 Inducer, Cytochrome P450 2C9 Inducer, Cytochrome P450 2C19 Inducer, Cytochrome P450 2C8 Inhibitor, and Cytochrome P450 2C9 Inhibitor.

Lumacaftor Drug Patent

International Application No. PCT/US2008/085456 entered India under national phase on 04/06/2010. The Indian patent application number is 2056/KOLNP/2010. The title of invention filed was “SOLID FORMS OF 3-(6-(1-(2,2- DIFLUOROBENZO[D][1,3] DIOXOL-5-YL) CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN- 2-YL) BENZOIC ACID”. The patent application was published on 03/09/2010 and Request for examination was filed on 25/11/2010. The patent application was examined and First Examination Report was issued on 20/08/2014.

In the hearing letter there were nine objections. The major technical objections was on the grounds of novelty, inventive step and non-patentability of the claimed subject matter u/s 3(d) of the Indian patent law.

Section 3 (d) of the Indian patent law relates to:

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

The patent claimed matter relates to polymorphic form of the already known compound 3-(6-(1-(2,2- DIFLUOROBENZO[D][1,3] DIOXOL-5-YL) CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL) BENZOIC ACID. It was argued, that the crystalline and free solid polymorphic form which was characterized by XRD data is novel and inventive in the light of supportive technical data filed as affidavit along with reply statement in respect of pre-grant opposition of the same case under section 25(1). According to the patent counsel, the technical data provided explained better pharmacokinetic properties and superior bioavailability of the formulation of claimed polymorphic Form I compared to the hydrochloride salt of the compound.

Analysis of Lumacaftor Drug Patent from Indian Patent Examiner’s Viewpoint

The actual compound 3-(6-(1-(2,2-DIFLUOROBENZO[D][1,3] DIOXOL-5-YL) CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL) BENZOIC ACID was already known in the prior art. The present polymorphic Form I was selected out of the cited prior art document WO2007/056341 dated 18/05/2007.

However, to establish the novelty aspect of the invention in favour of the claimed solid crystalline Form I there was no supportive technical data for better technical effect or result in the complete patent specification at the time of filing the patent application.

Disclose technical data in detail to get drug, pharmaceutical patent in India. Anything beyond the patent disclosure of complete specification is not acceptable. Provide efficacy data to provide the novelty aspect of the invention.

The patent examiner was of the opinion that there is no direct evidence for betterment of therapeutic efficacy in respect of claimed Form I free solid crystalline form. Better bioavailability does not necessarily lead to better efficacy. Further, the patent applicant had failed to provide any superior therapeutic efficacy data in respect of claimed Form I, as characterized by the XRD data.

According to the patent examiner, the claimed polymorphic forms and process of preparation in the absence of better efficacy result was considered as mere new form and process and therefore, not patentable under section 3(d). The patent application was refused for grant of patent under section 15. Earlier, the pre-grant opposition was filed under section 25(1) by Indian Pharmaceuticals Alliance, Mumbai.  The petition u/s 25(1) was accepted while refusing the grant of the patent application no. 2056/KOLNP/2010.

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