Unlisted Trajenta patents hinder early release of generics

Generic companies torn over the discovery of another unlisted Trajenta patent

Generic companies file requests to invalidate or evade 8 unlisted patents in 9 months

“Even unlisted patents must be overcome for the early release of generics”

Last listed patent expires in June of next year, but unlisted patents remain an obstacle

The patent challenges made for the early release of antidiabetic ‘Trajenta (linagliptin)’ is going through a rough patch.

 

The patents that the original company registered with KIPO but not with the MFDS are acting as obstacles.

 

For the generics companies that filed patent challenges, a prolonged dispute is now inevitable as they would have to overcome all of Trajenta's unlisted patents, which may be up to 10 or more, in order to release their generics.

 

Number of claims have been filed against Trajenta’s unlisted patents...

 

8 in total in 9 months

Pic of Trajenta

According to industry sources on the 28th, Genuone Sciences filed a trial against Boehringer Ingelheim to invalidate Trajenta’s use patent (10-2427380).

 

The use patent was not listed on the Ministry of Food and Drug Safety’s Green List.

 

Genuone Sciences had previously filed claims to has also requested a trial on 5 other unlisted patents of Trajenta.

 

In September last year, the company filed a claim to confirm the passive scope of rights on Trajenta’s substance patent 10-2051281, and invalidation trials on 3 use patents (1558938/10-1655754/10-1806786) and 1 manufacturing method patent (10-1541791) in October last year.

 

In addition, two other challenges are being made to Trajenta’s unlisted patents.

 

In addition to Genuone Sciences, Sinil Pharmaceutical, Korea United Pharm, Hutecs Korea Pharmaceutical, Korea Biochem, and Hallim Pharmaceutical are also challenging Trajenta’s patent.

 

In April this year, the companies requested a passive trial to confirm the scope of rights on two Trajenta formulation patents (10-1710881/10-1855323).

 

This means that 8 of Trajenta’s unlisted patents have been targeted by generic companies in about 9 months from last September.

 

Generic companies have no problem obtaining authorization as latecomer drugs even without overcoming unlisted patents.

 

However, the situation is different when the companies actually release their generic products.

 

Without overcoming all of the patents, the companies become embroiled in patent infringement lawsuits with the original company.

 

If the original drug’s company files a petition for a preliminary injunction to block the release of the product when it files the patent infringement lawsuit, the release date of the generic company’s product may be delayed.

 

In addition, if the company loses the patent infringement lawsuit, it may lead to additional lawsuits for damages.

 

Trajenta’s last listed patent expires in June next year...

 

Unlisted patents remain barriers The generic companies have succeeded in avoiding or invalidating most of Trajenta’s unexpired and listed patents on MFDS’s Green List.

 

Boehringer Ingelheim, the original company, listed 6 patents for Trajenta in the Green List.

 

Among them, one substance patent 1 (10-1150449) expired in September last year.

 

Use patents 1 (10-1111101) and 2 (10-0926247) also expired in August and September last year, respectively.

 

In 2016, the generic companies succeeded in evading or invalidating Trajenta’s substance patent (10-1478983) and crystalline patent (10-1452915) which were set to expire in April 2027.

 

Therefore, the only listed patent that has a term remaining is Trajenta’s substance patent 2 (10-0883277), which is set to expire in June next year.

 

Therefore, on the surface, the early release of generics seems possible after June next year.

 

In fact, generic companies have originally planned to release their generic versions early, in line with the expiration of the second substance patent in June next year.

 

However, the patents that were not listed on the Green List are acting as obstacles to the early release of their generics.

 

Since releasing generic drugs without overcoming the unlisted patents will lead to patent infringement, the generic companies must overcome all of the patents before launching their generic drugs.

 

"There may be up to or over 10 unlisted Trajenta patents”...

 

increases the burden of dispute on generic companies↑ The problem is that Trajenta has too many unlisted patents.

 

The industry expects that there may be a total of more than 10 unlisted patents, including those for which claims are yet to be filed.

 

This means that there are more than 10 trials that generic companies would need to win additionally for the early release of their Trajenta generics.

 

From the perspective of generic companies, the burden of concurrently ongoing patent disputes is not small.

 

In particular, since they are not listed on the Green List, generic companies have to search for the patent information and individually request trials, which is also a hassle.

 

Given this situation, the industry predicts there is a high possibility that the patent dispute related to Trajenta will continue in the long-term.

 

An industry official said, “Because they are not listed on the Green List, generic companies have to find hidden patents one by one and request a trial.

 

Moreover, when the original drug’s company applies to register a patent to the KIPO, the company does not enter the product or brand name in its inventions, therefore, finding the patents is in itself very cumbersome, and there is always the possibility that they may miss some patents.”