How Tenelia latecomers lost chances in preferential sales

IMD succeeded in patent challenge and applied for approval, but fails to meet first patent trial requirement

Decisions on patent invalidation and evasion made on the same day

Although Kyungdong Pharmaceutical first received approval on antidiabetic Tenelia’s incrementally modified drug (IMD), the drug is apparently not eligible for the preferential sales right given to the generic market.

 

Regardless of the preferential right, any Tanelia IMDs that successfully evaded the original’s salt base patent can be launched at the same time.

 

And as the stepped drug pricing system stipulates, the first 20 items approved would also receive premium pricing benefit.

 

According to the industry sources on Sept.

 

7, the first IMD to have applied for the government approval after evading Tenelia's salt patent and the expiration of the original’s post-marketing surveillance (PMS) period, was not eligible for the preferential sales right to begin with .

 

In order to win the preferential sales right, a drug first has to either request for the first patent trial (or requested within 14 days from the first trial date), or to conclude the patent trial before the first company to request the trial.

 

The second prerequisite condition is to win the patent challenge, and the third is to be a first to apply for the item license.

 

Kyungdong Pharmaceutical’s IMD ‘Teneritine 20 mg tablet,’ approved as of Sept.

 

4, has met the second and third conditions.

 

But it turns out that the drug has failed to meet the first condition.

 

The original Tenelia has a substance patent, expiring on Oct.

 

25, 2022, and a salt-base patent, expiring on Feb.

 

17, 2026.

 

Besides the substance patents the Korean pharmaceutical companies lost at a trial, the follow-on drug companies attempted to challenge the salt-base patent.

 

The first patent challenges were made by Hana Pharm and Intro Biopharma.

 

Hana Pharm first filed a patent trial on Apr.

 

10, 2015 to nullify Tenelia’s salt-base patent.

 

The two Korean companies are currently developing drugs identical to Tenelia with same active pharmaceutical ingredients and salt base.

 

Meanwhile, pharmaceutical companies with IMDs filed their first patent challenge on Oct.

 

19, 2018, three years after Hana Pharm’s trial.

 

Kyungdong Pharmaceutical requested for a negative confirmation of patent right scope to evade the original’s patent.

 

In order to acquire the preferential sales right, the IMD companies have to fulfill the prerequisite conditions.

 

The first condition was to complete the legal proceedings before Hana Pharm.

 

The possibility was still open as the Intellectual Property Trial and Appeal Board prioritizes the negative confirmation of patent scope.

 

Unfortunately, however, the final decision on the IMD’s patent evasion was made on the same day as the patent invalidation trial with Hana Pharm and Intro Biopharma.

 

Both trials on patent evasion and invalidation were concluded on Dec.

 

31 last year.

 

Immediately after trial, the IMD companies applied for both item approval and preferential sales rights, but the Ministry of Food and Drug Safety (MFDS) reportedly denied the application due to the incomplete fulfillment of the prerequisite conditions.

 

If the IMD trial decision was made even a day earlier, Kyungdong Pharmaceutical and other IMD companies would have acquired the preferential sales rights effective from Oct.

 

26, 2022.

 

Although Hana Pharm and Intro Biopharma have requested the first patent challenge and met the requirements for a successful patent challenge, they failed to apply for the government approval on the day after when Tenelia's PMS ended on Apr.

 

29.

 

As a result, none of Tenelia's latecomers would have the preferential sales rights.

 

Nevertheless, the first 20 items to be licensed would receive premium pricing, according to the stepped drug price system.

 

The said Korean companies may have failed to win the preferential sales rights through patent challenge, but at least the follow-on drugs would obtain the premium pricing benefit as long as their development speed is fast enough.

 

Meanwhile, Tenelia is a seventh dipeptidyl peptidase 4 (DPP-4) inhibitor released in the South Korean market.

 

Developed by the Japanese-based Mitsubishi Tanabe Pharma, Handok has licensed the sales rights in the Korean market.

 

UBIST reported the drug has made 9.5 billion won from the outpatient prescriptions in the first half of this year.