EPO gears up to hear EpiPen patent opposition
The European Patent Office (EPO) will hear an opposition against a patent covering Mylan’s EpiPen (epinephrine) at the end of March.
ALK-Abello, a Denmark-based pharmaceutical company that makes the Jext injector, opposed European patent number EP1,786,491 B, along with Merck, in November 2016.
Tim Powell, partner at Potter Clarkson, explained that 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.
Injection devices sell in very high numbers worldwide both for personal and hospital use, Powell added.
He noted that one reason for the significant expansion of the personal-use market is that self-medication has increased in relation to numerous long-term medical conditions, and also in connection with field-use situations, such as on a military battlefield.
Auto-injection devices are often commercially important aspects of the marketing of pharmaceutical and other injectable products, said Powell.
He added: “As a result patents concerning the injection devices can be vitally important barriers to entry to particular prescribing and dispensing markets.”
The patent is owned by Meridian Medical Technologies, a subsidiary of Pfizer and the manufacturer of EpiPens for Mylan.
The battleground
The opponents have 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.
If ALK-Abello and Merck succeed in this argument, the patent would be revoked or maintained in a narrowed form.
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.
According to Powell, Meridian’s primary advantage in the opposition is that the patent is extensive, and therefore provides “seemingly extensive scope for filing amendments”. The Pfizer subsidiary has submitted multiple amendment options in advance of the hearing.
“The battle lines therefore are drawn in a classic EPO opposition confrontation,” concluded Powell.
A decision on whether the ‘491 patent can be maintained, and if so in what form, will be made at the hearing, on March 28. According to Powell, the hearing is expected to last one day.
But that’s not the end. Whichever party is adversely affected by the decision can appeal.
Powell explained that in light of the commercial importance of many injection device patents, it’s likely that an appeal will be filed by at least one side in the disagreement.
Another patent covering the EpiPen, EP2,311,510, was revoked by the EPO in December 2016, after opposition by ALK-Abello. This patent is also owned by Meridian.
The Opposition Division revoked the patent because it did not fulfil the requirements of article 76(1) of the European Patent Convention since claims 1 and 2 of the patent comprise subject matter extending beyond the content of the originally filed grandparent application.
Meridian has appealed against the Opposition Division’s decision to revoke the ‘510 patent.
An examination is also in progress for EP2,204,201, called “Automatic injector”, applied for by Meridian.
In August last year, LSIPR reported that Mylan had finalised a $465 million payment to the US government to settle a lawsuit about the classification of EpiPen under the Medicaid Drug Rebate Program.
Potter Clarkson does not represent either of the parties.
ALK-Abello and Pfixer both declined to comment.
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