Generic companies partially win Trajenta patent challenges

Green light lit for the early release of Trajenta generics

Intellectual Property Trial and Appeal Board decides 'claims established' for 3 invalidation trials filed for 3 Trajenta use patents.

Only the unregistered formulation patent remains…”raises the possibility of companies releasing their generic version after substance patent expires”

Generic companies have won the dispute over unregistered use patents of Trajenta (linagliptin).

 

Although the unregistered formulation patent remains, this patent is reportedly relatively easy to avoid or invalidate.

 

As such, the industry expects there is a higher possibility that generic versions of Trajenta will be released earlier after the drug’s substance patent expires in June.

 

According to the pharmaceutical industry on the 11th, the Intellectual Property Trial and Appeal Board ruled that the validity of claims in the invalidation trials against the three Trajenta use patents by Genuone Science and others against Boehringer Ingelheim were established.

 

Genuone Sciences had filed trials against Boehringer Ingelheim to invalidate 3 Trajenta’s use patents (10-1558938, 10-1655754, 10-1806786) in October 2020.

 

Kukje Pharm, GC Biopharma, Mother’s Pharmaceutical, and Boryung had also joined in the trial with Genuone Sciences at the time.

 

After about a year and three months, the first instance court, the Intellectual Property Trial and Appeal Board ruled in favor of the generic companies.

 

All three patents expire in May 2027.

 

If the patent challengers had lost in the first instance court, the release of a generic version of Trajenta would have been pushed back to after 2027.

 

However, with the win, Trajenta generics will likely be available sooner, after the expiry of Trajenta’s substance patent in June this year.

 

The first substance patent for Trajenta expired in August last year, and the second substance patent will expire in June this year.

 

In July last year, Genuone Science and the other companies also succeeded in avoiding the unlisted formulation patent through a trial to confirm the passive scope of patent rights.

 

It is estimated that 7 unlisted formulation patents and 1 unlisted use patent remain for Trajenta.

 

However, industry insiders believe that the remaining patents are generally easy to avoid or invalidate or were registered later and do not have a significant impact on the early launch of Trajenta generics.

 

Moreover, in the case of the 3 use patents, which are key to the launch of generic versions of Trajenta, the IPTAB clearly stated the grounds for their invalidation, such as lack of description and inventiveness, the generic company has a high chance of winning later trials even if the original company appeals.

 

On the reason for invalidating Trajenta’s use patents, IPTAB pointed to “The experimental data related to linagliptin dosage is not disclosed in the patent specification, and linagliptin dosage or combination therapy with other diabetes drugs can be easily be invented from prior art." In other words, the trial court invalidated Trajenta’s patents on two grounds: lack of description and inventiveness.

 

In effect, all 3 use patents directly related to Trajenta’s indication were invalidated, increasing the likelihood of early generic launch after the expiration of Trajenta's substance patent.

 

Jong Hyuk Park, a patent attorney who participated in the patent trial, said, "This decision is significant in that it the court judge on the patentability of additional unlisted use patents that were later registered through divisional patent applications when the indications are already preannounced.

 

Since it was determined that the patents were invalid in terms of both lack of description and inventiveness, it is unlikely that the decision will be reversed on appeal."