EpiPen patent revoked in Europe
The European Patent Office (EPO) has revoked a patent covering Mylan’s EpiPen (epinephrine) injector after finding that patent amendments contravened the European Patent Convention (EPC).
ALK-Abello, a Denmark-based pharmaceutical company that makes the Jext injector, and Merck had opposed European patent number EP1,786,491 in November 2016.
The patent is owned by Meridian Medical Technologies, a subsidiary of Pfizer and the manufacturer of EpiPens for Mylan.
LSIPR previously reported on the battleground for the patent opposition.
Claim 1 of the patent defines a number of “relatively conventional features” of an injection device, and a needle cover that is moveable between a retracted position (in which the needle is exposed for injecting) and an extended position in which the needle is shielded, according to Tim Powell, partner at Potter Clarkson.
ALK-Abello and Mylan argued that the broad wording of claim 1 on the end surface feature represents a “generalisation of the more detailed description of embodiments of the invention described in the patent”, said the Potter Clarkson lawyer.
The opponents also alleged that the claimed invention lacks novelty or an inventive step in light of the prior art, and that the description doesn’t sufficiently disclose claim 1.
On March 28, the EPO revoked the patent because the invention to which it relates does not meet the requirements of the EPC.
The reasons for the revocation were filed on Thursday, April 26, with the EPO taking into account the multiple amendment options filed by Meridian before the hearing.
According to the EPO, amendments to two features of claim 1 contravene article 123(2) of the EPC, which states that a patent application can’t be amended to include subject matter that is beyond the scope of the originally-filed application.
The original wording of one of the features in claim 1 read: “The needle cover having an opening formed therein sized to permit the passage of the needle assembly therethrough during medicament dispensing operation.”
The phrase “the needle cover having an opening formed” was amended to “the needle cover having a rear opening”, but the EPO found that this amendment doesn’t have any basis in the application as originally filed.
According to the EPO: “The needle assembly does not ever pass through the rear opening in the cover assembly during a medicament-dispensing operation and hence this is an extension of subject matter.”
Meridian can appeal against the EPO’s decision.
In December 2016, another patent covering the EpiPen, EP2,311,510, and owned by Meridian, was revoked after opposition by ALK-Abello. Meridian has appealed against the Opposition Division’s decision to revoke the patent.
An examination is also in progress for EP2,204,201, called “Automatic injector”, which Meridian has applied for.
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