API and IP Newsletter
Contents
Sun Pharma: Patent Portfolio analysis Part III
General information.
Brexit: Key Considerations for Swiss Pharmaceutical Companies.
Canopy Growth Files Patent Infringement Lawsuit Against GW Pharmaceuticals.
Intellectual Property.
Pemetrexed disodium case in US.
Sun Pharma: Patent Portfolio analysis Part III
Below table contains information about Sun Pharma research and development activity in during 2015, broadly say by July 2015 to October/November 2015.
In 2015, Sun was very much active in general compositions which would be applicable to class of compounds, say alkaloids. Many applications are still being prosecuted (about 40%) and must be part of dossiers of Sun Pharmaceuticals. Please find relevant comments in SIDVIM comments section in the below table.
General information
Brexit: Key Considerations for Swiss Pharmaceutical Companies
From January 1, 2021, Qualified Person (QP) certified medicines from the European Economic Area (EEA) will be accepted in Great Britain if certain checks are made. These medicines will not require retesting or recertification by a UK QP if imported and checked by a wholesale dealer in Great Britain. Existing wholesale dealer’s licences will remain in force. (here)
Canopy Growth Files Patent Infringement Lawsuit Against GW Pharmaceuticals
The lawsuit, filed in the U.S. District Court for the Western District of Texas, alleges that GW Pharma's anti-seizure drug, Epidiolex is produced using Canopy's patented extraction process. U.S. Patent No. 10,870,632. Details (here.)
Intellectual Property
Pemetrexed disodium case in US
Pemetrexed is a chemotherapy drug that is manufactured and marketed by Eli Lilly and Company under the brand name Alimta.
According to Coherent Market Insights, the Pemetrexed market was valued at US$ 2,062.5 million in 2017, and is projected to exhibit a CAGR of 1.3% over the forecast period (2018–2026)
Please note, this market size information must be for all Premetrexed formulations and this case is related to Alimta, which is pemetrexed disodium. We could not find sales data for disodium salt in public domain.
OB listed patent information is as follows.
Claim of US 7772209 is as follows
A method for administering pemetrexed disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium, wherein
the methylmalonic acid lowering agent is selected from the group consisting of vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanocobalamin, or chlorocobalamin.
Apotex filed NDA with USFDA to market different salt i.e., pemetrexed dipotassium. Eli Lilly sued Apotex for infringement.
District Court issued summary judgment of infringement in favor of Lilly. On 21 December 2020 Federal Circuit affirmed district court’s summary judgment, found infringement under Doctrine of Equivalents (DoE). More details here.
Generic launch would be possible only in May 2022.
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.
