API and IP Newsletter
Content
API development activities by Piramal
General information.
Chronic Wounds Pipeline Drugs and Companies Insight Report: Analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments.
Pfizer, Sanofi’s Pharmaceutical Rebate Suits Get on FTC’s Radar.
Intellectual Property.
Tavaborole Attorney fee reimbursement litigation.
API development activities by Piramal
Piramal Pharma Solutions, as per their website, their R&D team develops novel/non-infringing process for APIs and is supported by a state-of-the-art, ‘best in class’, analytical research capabilities.
We tried to dig into their development portfolio using Import/Export database. Piramal has several development centers at different location across the globe.
We attempted to map development activities as per their locations. Below are the glimpses of our analysis, some probable development activities of the center/(s) located near Mumbai port.
General information
Chronic Wounds Pipeline Drugs and Companies Insight Report: Analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments
Galnobax, by Novalead Pharma, has completed a global Phase I/II clinical trial in DFU successfully meeting both primary and secondary endpoints for both safety and efficacy. The company is investigating it in the Phase III clinical trial. (Read more)
Pfizer, Sanofi’s Pharmaceutical Rebate Suits Get on FTC’s Radar
Pfizer Inc., Sanofi S.A., other care providers have sued competitors for allegedly giving rebates to insurers and pharmaceutical benefit managers in return for their products getting on preferred formulary lists.
Pfizer claimed in 2017 that Johnson & Johnson violated antitrust laws by threatening UnitedHealthcare that it would withhold significant rebates unless the health insurance giant denied coverage of Pfizer’s drug Inflectra an immunosuppressive drug used to treat severe arthritis and Crohn’s disease in favour of its own drug, Remicade. (Read more)
Intellectual Property
Tavaborole Attorney fee reimbursement litigation
Anacore Pharmaceuticals is Pfizer’s unit and originator of Tavaborole. Anacore was issued patents US 9,549,938, 9,566,289, 9,566,290, and 9,572,823 claiming formulations for treating fungal infections.
FlatWing challenged these patents in PTAB (The Patent Trial and Appeal Board)
The broad representative claims are as below.
1. A method of delivering a compound, in a human, from a dorsal layer of a nail plate to a nail bed to treat onychomycosis caused by Trichophyton rubrum or Trichophyton mentagrophytes, the method comprising: contacting the dorsal layer of the nail plate with a pharmaceutical composition comprising a compound that penetrates the nail plate, tavaborole or a pharmaceutically acceptable salt thereof, thereby treating onychomycosis due to Trichophyton rubrum or Trichophyton mentagrophytes.
2. The method of claim 1, wherein the pharmaceutical composition is in the form of a topical solution comprising 5% w/w of tavaborole, and wherein the pharmaceutical composition further comprises ethanol and propylene glycol.
The Board (PTAB) decided that the prior art taught the use of antifungal compounds (though prior art does not disclose tavaborole per se) and combination of prior art documents taught all the elements of the claimed invention. The Board held that routine experimentation by any skilled person would have yielded the claimed formulations with reasonable expectation of success (to be effective against onychomycosis).
Thus, Anacore lost the case in PTAB. Anacore appealed. In meantime Lupin, Encube, Glasshouse filed ANDA along with FlatWing.
Later CAFC (Appeal court) affirmed the PTAB decision.
FlatWing filed the pending motion for Attorney’s fees, meaning, asking Anacore to reimburse expenses during IPR action, which was about USD 1.3 mio.
In an exceptional case, in US, Court orders to reimburse reasonable attorney fee. The Court has reviewed Anacor’s non-obviousness argument and, concluded though Anacore was unsuccessful, the Court did not think that it was objectively unreasonable to file such claims. The Court said, losing is not an unusual occurrence, someone loses in every case, and it certainly does not by itself entitle the winner to fees.
Disclaimer
Sidvim LifeSciences Private Ltd has taken due care and caution in developing this document. Since the data used for analysis in this document is based on the information available in the public domain, its adequacy or accuracy or completeness cannot be guaranteed. This document is for information only and Sidvim is not responsible for losses that may or may not arise due to any decisions made based on the same. No part of the document shall constitute or be represented as a legal opinion of any kind or nature. No warranties or guarantees, expressed or implied, are included in or intended by the document, except that it has been prepared in accordance with the current generally accepted practices and standards consistent with the level of care and skill exercised under similar circumstances by professional consultants or firms that perform the same or similar services.
