SPCs and orphan drugs-- is the double layer getting messy or is it just a matter of timing? A new ruling of the District Court in the Hague to shed some light?
The ruling of the District Court in the Hague in the case C/09/595262 KG ZA 20-605 concerns the pharmaceutical Exjade (generic substance deferasirox), protected both by a patent and subsequently a Supplementary Protection Certificate as well by an Orphan Drug Designation. Novartis sued Mylan for infringement of the SPC (under the term of its Paediatric Extension) on Exjade; Mylan countersued alleging the invalidity of the Paediatric Extension. The specific ruling concerns preliminary relief proceedings...
https://ipkitten.blogspot.com/2020/10/spcs-and-orphan-drugs-is-double-layer.html
Menzis Zorgverzekeraar N.V. and AnderZorg N.V. v. AstraZeneca B.V. and AstraZeneca AB, District Court The Hague 14 October 2020, Case no. C/09/541261 / HA-ZA 17-1084
On the 14th of October 2020 the Dutch District Court of The Hague has issued a noteworthy and ground breaking interlocutory judgment in the case of health insurance company Menzis against the pharmaceutical company AstraZeneca. Menzis is set to be rewarded compensatory damages due to the unjust enrichment of AstraZeneca and their role in the lack of price competition for their medicine Seroquel XR...
http://eplaw.org/nl-menzis-et-al-v-astrazeneca-et-al/
Vaccine formulation patent invalid for obviousness and not infringed (Patents Court)
In Merck Sharp & Dohme Ltd v Wyeth LLC [2020] EWHC 2636 (Pat), the Patents Court has held that a patent for a formulation of vaccines which avoided aggregation caused by silicone in the container material was invalid for obviousness...
Central government publishes The Patents (Amendment) Rules, 2020.
In exercise of the powers conferred by section 159 of the Patents Act, 1970, the Central Government has further revised the Patents Rules, 2003 and these rules would be called the Patents (Amendment) Rules, 2020. The Rules have been amended particularly with regard to the requirements relating to working statements/ form-27. Some important changes are as follows:-
Only ‘Disclosed’ if ‘Identified’: IPAB Quashes Ceritinib Patent Revocation
An IPAB bench consisting of Chairman Manmohan Singh J. and the new technical member for Patents Dr. B.P. Singh has quashed the Controller of Patent’s decision that revoked Novartis’s patent on the anti-cancer drug Ceritinib. It held that while the compound was contained in a broader genus patent, it was not ‘disclosed’ therein, as it hadn’t been specifically identified. The 104-page order examines several issues regarding novelty and obviousness, the extent of coverage and disclosure, and timelines for filing of evidence..
China adopts revised patent law with Hatch-Waxman-like incentives for innovative drugs
On October 17, the National People’s Congress (NPC) formally adopted a revised patent law, which will take effect on June 1, 2021. The new law includes significant changes in the intellectual property legal framework with regard to pharmaceuticals in the world’s fastest growing consumer market. As we reported here, the most significant change for life science companies is adoption of Hatch-Waxman-like incentives to encourage companies to develop and seek approval in China of new, innovative drug products, and to encourage generic companies to challenge reference product patents…
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