API and IP Newsletter
Contents
US FDA to boost inspections of drug manufacturing units in India
Minerva Neurosciences falls as US FDA declines to approve drug for schizophrenia symptoms
FDA Statistics
We follow USFDA website. There’s lot of interesting information being published at the site.
FDA publishes statics about ANDA approvals, timelines for approvals and other aspects. FDA published such data in December 2023.
About ANDA submissions:
General timelines as per FDA website are as below:
Other details are as below:
More details could be found here
General information
US FDA to boost inspections of drug manufacturing units in India
The U.S. drug regulator is set to increase the number of inspections at Indian drug manufacturing units in 2024 amid growing concerns over the quality of drugs, a top executive for the Food and Drug Administration (FDA) told Reuters.
The FDA conducted more than 200 inspections in 2023 in India, picking up after a lull in unannounced inspections during the pandemic.
News here.
Minerva Neurosciences falls as US FDA declines to approve drug for schizophrenia symptoms
Minerva Neurosciences said on Tuesday the U.S. Food and Drug Administration (FDA) has declined to approve its drug to regulate behavioral changes in patients with schizophrenia that can cause social withdrawal and lack of motivation.
News here
Intellectual Property
Newron Pharmaceuticals SpA (appellant) v The Comptroller-General of Patents (respondent)
This is an interesting case of SPC (Supplementary Protection Certificate)
Supplementary protection certificates (SPCs) are an intellectual property right that serve as an extension to a patent right. They apply to specific pharmaceutical and plant protection products that have been authorised by regulatory authorities. The EU wishes to provide sufficient protection for these products in the interest of public health and to encourage innovation in these areas to generate smart growth and jobs.
Supplementary protection certificates aim to offset the loss of patent protection for pharmaceutical and plant protection products that occurs due to the compulsory lengthy testing and clinical trials these products require prior to obtaining regulatory marketing approval.
An SPC can extend a patent right for a maximum of five years.
This is the case regarding patent EP 1613296 B, issued to Newron Pharmaceuticals SpA.
The patent claims “Methods for the Treatment of Parkinson’s Disease”. It was granted on 1 July 2009 and expires on 7 April 2024. It was only necessary to consider claim 1, which is as follows:
“1. The use of a first agent selected from safinamide from 0.5 to 1, 2, 3, 4 or 5 mg/kg/day in combination with levodopa/PDI, for the preparation of a medicament as a combined product for simultaneous, separated or sequential use for the treatment of Parkinson’s Disease.”
Newron applied for supplementary protection certificates (SPC) as an extension of patent rights after April 2024, till April 2029. Interestingly although all countries in the EU are required to provide SPCs, no unified cross-recognition exist. Applications must be filed and approved on a country-by-country basis.
So, when Newron applied for SPC in UK, the officer, Lawrence Cullen, held that the marketing authorisation for Xadago covers one ingredient, ie safinamide rather than a combination thereof, meaning it differs from the patent’s scope. Claim 1 of EP 296 references safinamide as being in combination with levodopa and/or a peripheral decarboxylase inhibitor (PDI). The role of the PDI is to inhibit the breakdown of levodopa while travelling through the bloodstream of the body to the brain. Once the levodopa crosses the blood-brain barrier, which the PDI cannot, the levodopa exerts its therapeutic effect.
Safinamide is authorised for the disease’s treatment as an add-on therapy to another drug, levodopa. Healthcare professionals can administer Xadago alone or in combination with other Parkinson’s disease medicines.
It was accepted by Newron that the use of levodopa with a PDI was already a known treatment for Parkinson’s disease.
One must note that SPC could be applied to specific pharmaceutical products that have been authorised by the regulatory authorities. The officer, Lawrence Cullen concluded claim scope is different than the authorised product and rejected SPC protection in UK.
Newron appealed.
The UK Court of Appeal has dismissed an appeal brought by Newron Pharmaceuticals regarding the meaning of 'product' in pharmaceutical marketing authorisations.
In doing so, the second-instance court is applying existing case law criteria around the granting of SPCs for combination drugs, dismissed the appeal and upheld the decision that the application for supplementary protection certificate number SPC/GB15/046 shall not be granted.
Newron accepted that the use of safinamide in combination with levodopa is a known treatment for the disease, it put forward several arguments. Most importantly, it argued the phrase “the product” has a broader meaning under Article 3(b) compared to Article 3(a) of the SPC regulation.
However, the Court of Appeal opined that the marketing authorisation (MA) only authorises Newron to market Xadago as safinamide. It does not cover the marketing of any other active ingredient, including levodopa, meaning the UKIPO was right to refuse an SPC.
Newron may petition the Supreme Court for a third appeal.
Case details here
Those who are interested in following court proceedings could invest time in watching below videos in courtrooms.
https://www.youtube.com/watch?v=UI6k-0nsEgs
https://www.youtube.com/watch?v=N87awc5ATWk
