According to Life Sciences IP Review, the European Patent Office (EPO) has revoked a patent covering Mylan’s EpiPen (epinephrine) injector. The EPO reportedly found that the patent amendments contravened the European Patent Convention (EPC).
In November 2016, ALK-Abello, makers of the Jext injector and Merck (the opponents) had opposed European patent number EP1,786,491, which is owned by Meridian Medical Technologies (a subsidiary of Pfizer) and the manufacturer of EpiPens for Mylan.
The EPO revoked the patent due to the fact that the invention to which it relates does not meet the requirements of the EPC. The revocation took place on March 28 but the reasons for the revocation were filed on Thursday, April 26.
While considering the multiple amendments filed by Meridian before the hearing, the EPO stated that amendments to two features of claim 1 contravene article 123(2) of the EPC, which states that a patent application can not be amended to include a 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 EPO found that the amendment of the phrase “the needle cover having an opening formed” to “the needle cover having a rear opening” does not 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.”