Boryung’s early release of its Lenvima generic unclear

Boryung discovers an unregistered use patent for Lenvima…company files a claim to invalidate and evade the unregistered patent at the same time

Boryung invalidated the composition patent but the original company filed an appeal… judgment on the use patent is yet to be ruled upon

Boryung’s plan to launch a generic version of the liver cancer drug Lenvima (lenvatinib) early to coincide with the expiration of Lenvima’s product patent is facing setbacks.

 

Despite the amount of time spent overcoming the patents, the number of remaining patents seems to be increasing rather than decreasing.

 

With less than a year left before the expiration of the product patent, Boryung has been unable to overcome all the remaining patents.

 

Rather, the original company filed appeals for some of the first-instance decisions that Boryung won, signaling a prolonged dispute.

 

In addition, Boryung recently discovered an unlisted use patent and filed claims to both invalidate and evade the patent.

 

According to industry sources on the 25th, Boryung recently filed for invalidation and passive trial on the scope of rights against Lenvima’s unregistered use patent.

 

The unregistered patent expires in December 2035.

 

The patent relates to the combination therapy of Keytruda and Lenvima.

 

Lenvima is approved for 4 indications ▲locally advanced or metastatic thyroid cancer; ▲first-line treatment of hepatocellular carcinoma; ▲combination therapy with Keytruda in advanced endometrial cancer; and ▲combination therapy with Keytruda as first-line treatment of advanced renal cell carcinoma.

 

The unlisted patents for Lenvima reportedly relate to the third and fourth indications.

 

Lenvima is primarily used to treat liver cancer, but its use has recently been expanded in combination with Keytruda.

 

Given the reimbursement extension potential of the Lenvima+Keytruda combination, it is in Boryung’s long-term interest to overcome the patents before launching its generic version.

 

This explains why Boryung has filed both an invalidation and a passive trial on the scope of rights for Lenvima’s new patent.

 

Boryung’s simultaneous filing of both trials indicates the company’s commitment to overcoming patents related to its use as combination therapy with Keytruda by any possible means.

 

Boryung is challenging Lenvima’s patents across the board, including unregistered use patents.

 

Lenvima was previously protected by 5 patents: a product patent, a use patent, a salt and crystalline form patent, a formulation patent, and a composition patent.

 

Of these, Boryung’s plan was to evade and invalidate 4 patents, all but the product patent that expires in April 2025, and then launch its generic version early.

 

However, the patent dispute over the use of patents is being prolonged, without even a first instance judgment.

 

In November 2022, Boryung filed a request to invalidate Lenvima’s use patent, but nearly a year and a half passed without a ruling made by the Patent Trial and Appeal Board.

 

As for the challenge to the composition patent, Boryung won the first trial, but the original’s company appealed.

 

Boryung filed for the invalidation of the composition patent in August last year and won the first trial in March this year.

 

However, Eisai filed a lawsuit to cancel the ruling to the Intellectual Property High Court last month, claiming that the decision was unjust.

 

For Boryung, there are 3 patents left to overcome with less than a year to go before Lenvima’s material patent expires.

 

Amid Lenvima’s recent sales decline, Boryung's plan to launch a generic upon the expiration of the substance patent is likely to be disrupted.

 

According to the market research institution IQVIA, Lenvima’s sales last year were KRW 10.3 billion, down 24% from KRW 13.6 billion in 2022.

 

Lenvima’s sales steadily increased from KRW 7.5 billion in 2019 to KRW 12.2 billion in 2020, then to KRW 15.8 billion in 2021, but have been declining ever since.