API and IP Newsletter

 Contents

• DMF filings in December 2022

• General information

• Huge stock of oxytocin drug seized from New Delhi station

• PIC/S revises GMP guide to reflect new EU clinical trials regulation

• Intellectual Property

• Neurim v. Mylan

DMF filings in December 2022

We analyze DMF filings of Indian companies. This month, we analyzed DMFs filed in December 2021. 

Glimpses of our analysis are as below. 

HOLDER	SUBJECT	SIDVIM comments
SUN PHARMACEUTICAL INDUSTRIES LTD	LIRAGLUTIDE	Liraglutide will become generic in early 2023 in US. Teva as per settlement with Brand, would be able to launch in December 2022. Sun perhaps would launch in the second phase, along with many others.
BIOPHORE INDIA PHARMACEUTICALS PVT LTD	INDOCYANINE GREEN	Indocyanine green is a cyanine dye used in medical diagnostics. It is used for determining cardiac output, hepatic function, liver and gastric blood flow, and for ophthalmic angiography.  Only one other DMF. Very smart molecule selection by Biophore.
BIOPHORE INDIA PHARMACEUTICALS PVT LTD	ELAGOLIX SODIUM	Elagolix Na is difficult molecule to develop. Two other Indian DMFs filed already. It will become Gx by October 2024
ALEMBIC PHARMACEUTICALS LTD	BINEMETINIB	First DMF filed for Binemetinib. In June 2018 it was approved by the FDA in combination with encorafenib for the treatment of patients with unresectable or metastatic BRAF V600E or V600K mutation-positive melanoma.
GLAND PHARMA LTD	PROTAMINE SULFATE	First Indian DMF, an old molecule, only Fresenius Kabi is in market. Others are discontinued.

General information

Huge stock of oxytocin drug seized from New Delhi station

A consignment of oxytocin injections having a market value of around Rs 22 lakh was on Wednesday seized from the New Delhi railway station by the drugs control department, official sources said.

Oxytocin is used in milch cattle to enhance milk production, and has adverse effects on the cattle, as well as humans who drink that milk.

News here.

PIC/S revises GMP guide to reflect new EU clinical trials regulation

 

Specifically, Annex 13 of the PIC/S GMP guide, which relates to the manufacture of investigational medical products, is being replaced by the new EU Annex 13, “in line with the Co-operation Agreement between PIC/S and [the European Medicines Agency] EMA.”

News here.

Intellectual Property 

Neurim v. Mylan

Generally we cover Inventive step arguments in any Case Law presentation. Simple reason behind it is, in our perception, most of the audience of this Newsletter is with science background and would not be interested in legal mumbo jumbo.

For a change let us discuss legal terminology, “issue estoppel”. So, today limit the discussion to “issue estoppel”

Neurim was successful in the UK trial in December 2020 regarding EP 1441702.  Neurim’s claims of infringement were accepted by the UK court and counterclaims on the invalidation of its patent were rejected. Here.

Later EP 1441702 was invalidated by European Patent Office (EPO). This invalidity decision of the patent was the result of Neurim withdrawing its appeal to the Technical Board of Appeal (TBA) in order to avoid an unfavourable decision from TBA. These are two different decisions by two different authorities, first was UK court and second by EPO.

Neurim was granted a divisional patent (EP 3103443) in June 2021 to expire in August 2022. Neurim then changed the claims of the divisional patent EP 3103443 to align them with ”parent” patent (EP 1441702), which had already invalidated by the EPO. (It could be separate topic for discussions for patent experts, how a divisional patent was issued when parent patent is invalidated, this is not part of this write-up) 

Mylan contends that Neurim’s application to amend the divisional granted patent is an abuse of process. 

Neurim claimed that taking into consideration the December 2020 ruling on the validity and infringement of the parent patent EP 1441702, and since the divisional patent was changed to so its claims would be identical to the claims of the parent patent, the validity and infringement of the patent could not be contested again by Mylan. In other words according to Neurim, Mylan is Mylan is “issue-estopped”.

 

The one of the preliminary issues considered by the Court was whether Mylan is “issue-estopped” from challenging the validity of the divisional patent in the light of the December 2020 decision, in which the parent patent was declared valid. 

Let is understand, what is “issue estoppel”?

In doctrine of issue estoppel, there is embargo on the party to plead or prove particular facts. The essential rule for issue-estoppel are, 

1.) parties in two proceedings must be the same and 

2.) the issue that was decided earlier must be identical with that which is sought to be re-agitated. This applies only to the Civil cases.

In this case, the Court decided there is no issue estoppel on the basis that the reasons and findings in the main December 2020 Judgment were not fundamental to the overall, eventual result.  The only and truly fundamental reason was the central revocation of the Patent following Neurim’s withdrawal of its TBA appeal.  So Court opined, Neurim’s issue estoppel arguments failed and Mylan could challenge the patent. Decision here.