3834/CHENP/2007A: Human Monoclonal Antibodies

International Application No. PCT/US06/03644 by University of Massachusetts has lately entered into Indian National Phase and published as Application No. 3834/CHENP/2007A for HUMAN ANTIBODIES AGAINST RABIES AND USES THEREOF. The National Phase Application is filed on September 03, 2007 claiming priority from International Application (published as WO2006/084006) filed February 02, 2005.

PCT Application for Ritonavir Polymorph Enters Indian National Phase

Illinois-based healthcare company Abbott Laboratories has lately filed a National Phase Application # 1638/MUMNP/2007A for a new crystalline polymorph of Ritonavir, maturing from its PCT Application # PCT/1999/16334 published as WO 2000/004016 (the ‘016 publication) dated January 27, 2000. The National Phase Application claims its earliest priority from the US Application # 09/119,345 filed July 20, 1998. The ‘016 publication claims a crystalline polymorph (designated as Form II), a substantially pure amorphous form of Ritonavir and processes for the preparation. The crystalline Form II is obtained by treating amorphous Ritonavir with a C1-C3 alcohol, preferably anhydrous alcohol, or by recrystallization of Form I or mixtures of Form I and Form II from a solution in a suitable solvent, with seeding with Form II crystals, followed by addition of an anti-solvent. The substantially pure amorphous form is prepared from the Form I crystalline polymorph by melting Form I and rapidly cooling the melt, isolating the resulting solid provides amorphous Ritonavir, or by slowly adding a solution of Form I in a suitable solvent to an anti-solvent/water, followed by isolation of the resulting solid, or by lypophilization of a solution of Form I. The National Phase Application is divisional application of earlier filed National Phase Application # IN/PCT/2001/0018/MUMA. It seems to be that Abbott bifurcated crystalline polymorph of Ritonavir and Substantially pure amorphous Ritonavir into two applications.

Suven Life Sciences gets two European patents

India-based Suven Life Sciences Ltd said the European Patent Office has granted patents for two of Suven's compounds (EP1523486 B1 & EP1581538 B1) TETRACYCLIC 3-SUBSTITUTED INDOLES HAVING SEROTONIN RECEPTOR AFFINITY, aimed at treating cognitive impairments associated with neurodegenerative disorders like Alzheimer's, Parkinson's disease and schizophrenia.

The compounds are being developed as therapeutic agents and the patents are valid until June 2022, the company said in a filing to India's National Stock Exchange.

Cobalt Eyes AstraZeneca’s Blockbuster Cholesterol Drug

In a major development, the Canadian drug manufacturer Cobalt Pharmaceuticals stunned AstraZeneca by making Paragraph IV certification against Astra’s money-spinning cholesterol drug Crestor which worth US $ 2 billion in a process for submission of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking regulatory approval to market generic version of Crestor, generically known as rosuvastatin calcium, before the expiration of Astra’s Orange Book listed patents valid till 2021. AstraZeneca has 45-day statutory period under the Hatch-Waxman provision for deciding to initiate an infringement action and halting FDA from approving the generic version for at least 30 months. AstraZeneca has three patents listed with the Orange Book including composition-of-matter patent. In its notice to Astra, Cobalt intended market generic version of Crestor before the expiration of US Patent Nos. RE 37, 314 (the ‘314 patent) and 6,316,460 (the ‘460 patent) alleging that the claims of the ‘314 and ‘460 patents are not infringed, invalid or unenforceable. Also stated that its ANDA contains a certification under section 505(j)(2)(A)(viii) of the FDCA alleging that its labeling will not include medical uses claimed in the US Patent No. 6,858,618 (the ‘618 patent). The ‘314 patent expires in January 2016, the ‘460 patent expires in August 2020, and the ‘618 patent expires in December 2021.