We were recently looking at the European patent landscape of a product for Relapsing-remitting multiple sclerosis (RRMS). There are several divisional patents & patent applications which are part of the core composition patent family and are at various stages of prosecution or opposition (some are revoked & under appeal).
While the parent patent was revoked, a divisional with a broader scope of protection was granted. This divisional was also revoked in 2018 by the European patent office’s (EPO) opposition division and is under appeal now. The Board of Appeal’s preliminary opinion suggests that the decision to revoke the patent likely will be affirmed.
Further some of these divisional patent applications when received an intention to grant were abandoned, however the proceedings were continued when further processing was requested.
Though all this similar scope divisional patents/applications hopefully will meet the same fate at EPO /opposition division, as the parent patent, this tactic of the innovator may protect the product from generic competition beyond data exclusivity or the SPC expiry.
The intent for the provision of divisional application is, if an applicant whose application is rejected due to lack of unity of invention requirement wishes to obtain a patent for all the inventions, may file divisionals. However, this is only applicable for subject-matter which does not extend beyond the content of the parent application as filed. Further the divisional is deemed to have the same date of filing as the parent application. A valid divisional application also enjoys the priority right(s) of the parent application.
However, the innovators are using this provision to delay the generic competition by filing “cascades” of divisional patents, most often just before the previous member of the family approaches grant.
The grant of a divisional application triggers a new opposition deadline and an opposition proceeding can take anywhere between 3 – 6 years from start to the final resolution, which creates legal uncertainty for a party seeking to launch generic product.
Most of the time divisionals are filed for the secondary patents with overlapping or broader scope. The actual scope of a patent can be determined only once it is granted. Waiting for a series of divisional patent application to get granted or the opposition proceeding to conclude may delay the launch indefinitely. However, on the other hand if generic decides to go ahead with the launch, it may run into patent infringement issues. The only option in those circumstances is to commence proceedings in national courts, which can be expensive. Moreover, there is also the risk of launch getting blocked due to interim injunction or else, potential damages being awarded by a national court.
A divisional can be filed any time while early parent patent application is pending. Sometimes innovators file it after the launch of generic product to encompass the generic within the scope of the claims, given there was support in the parent application.
Even if the parent patent has been invalidated, one can never be sure about the divisional, as it may still get issued and survive the opposition. Innovator may choose to keep this divisional game going for a long time by filing a divisional every time one patent approaches grant.