Lunvatinib: Chia Tai Tianqing uses his spear to attack his shield and is expected to win market exclusivity for one year

Lenvatinib (Lenvatinib) trade name Leweima (Lenvima) is vascular endothelial growth factor receptor (VEGFR) 1-3, fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptor (PDGFR) α , RET and KIT multi-target inhibitors.

Lenvatinib was developed by Eisai and was first approved for marketing by the FDA in 2015.

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On May 25, 2021, Eisai announced its fiscal year 2020 financial report.

Although lenvatinib entered the 2020 version of the medical insurance catalog, the price drop was as high as 80.

On May 25, the State Intellectual Property Office declared a patent for lenvatinib to be invalid.

Picture source: State Intellectual Property Office

This is another fatal blow to the patent protection of lenvatinib after the State Intellectual Property Office announced on April 30 that the patent of lenvatinib crystal form C was invalid.

Picture source: State Intellectual Property Office

The requester for the invalidation of the two patents was Nanjing Chia Tai Tianqing Pharmaceutical Co.

Image source: Insight database (https://db.

Zhengda Tianqing’s two requests for invalidation of patents can be described as a snake hitting seven inches, and the efficiency is quite high.

Note: The yellow bottom is divided into two invalid patents

The Chinese patent of lenvatinib includes compound patents, preparation methods, compositions, crystal forms, indications and other patents.

Why is Zhengda Tianqing attacking the shield with the spear this time? Eisai applied for two lenvatinib preparations (compositions) patents CN101001629 and CN102470133 in 2005 and 2010 respectively.

Picture source: State Intellectual Property Office

It can be seen that the patent claims do not include calcium carbonate, the key component in lenvatinib capsules, while the 2010 formulation patent (CN102470133) claims include calcium carbonate.

Picture source: State Intellectual Property Office

This time, CP Tianqing requested the 2010 lenvatinib preparation patent that the core evidence is CN101001629.

Why did Eisai operate so unreliable in the first place?

Compared with other industries, the road to market for new drugs is extremely difficult, and it takes far more time than other industrial products.

Of course, if Eisai adds a dose to CN101001629 (such as 4 mg lenvatinib, etc.

After all, drug research and development is an exploratory process.
Any possible situation is also analyzed after the fact.
But as the saying goes, the past is not forgotten.
The importance of patent protection and development strategy research in the development of innovative drugs are important for product launch.
The duration of the subsequent exclusivity plays a decisive role, and how much investment it pays is the cost that pharmaceutical companies need to pay to develop innovative drugs.

The patent of Eisai lenvatinib compound will expire on October 19, 2021.
If two invalid requests for Eisai to abandon the appeal or the final appeal fails, the listing of Chia Tai Tianqing's generic drug will no longer be barrier-free.

On May 18, CDE issued a notice on the public testing of the patent information registration platform related to the early settlement mechanism of drug patent disputes, and officially launched the online test of the "China Listed Drug Patent Information Registration Platform", which also marks the link to China's drug patents.
The system has taken a substantial step towards landing.

In September 2020, the State Food and Drug Administration and the State Intellectual Property Office jointly issued the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial) (Draft for Comment)", in which Article 11 is an encouraging policy:

"For the first chemical generic drug that successfully challenged the patent and was approved for marketing, the market exclusivity period will be granted.
The drug regulatory department of the State Council will no longer approve the marketing of the same type of generic drug within 12 months from the date of approval of the drug.
The exclusivity period does not exceed the patent right period of the challenged drug.
During the market exclusivity period, the national drug review agency will not stop technical review.
For the registration application of chemical generic drugs that have passed the technical review, it will be 20 working days before the expiration of the market exclusivity Transfer the application of related chemical generic drugs to the administrative examination and approval process.
"

It is clearly proposed that a maximum of 12 months of market exclusivity for first prescription drugs that have succeeded in the patent challenge can be regarded as a remedy for the lack of three types of new drugs in the old drug law.

This means that if the "Implementation Measures for the Early Resolution Mechanism for Pharmaceutical Patent Disputes" are further implemented, CP Tianqing is expected to be a patent challenger for lenvatinib and is expected to obtain a one-year market exclusivity.
This means that CP Tianqing is in Lun The vartinib market will have a major opportunity, and future sales can be expected.