Lessons from the past: What are the implications of the giants' patent disputes?

September 5, 2022/eMedClub News/--According to the "14th Five-Year Plan" for the development of the pharmaceutical industry, it is mentioned that domestic pharmaceutical companies should be promoted to enter the international market at a higher level.

Modena vs Pfizer: You can't live better than me after a breakup

Moderna and BioNTech had been collaborating on mRNA technology and vaccines for over a decade before COVID-19 emerged

On Aug.

The lawsuit will revolve around two components of the mRNA vaccine and its three related patents

The lawsuit filed also suggests that Moderna is viewing the COVID-19 pandemic as having entered various stages

The FDA granted emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine in December 2020, and Moderna received the same authorization a week later

Months after Bristol Myers Squibb (BMS) brought its patent battle against Gilead's Kite unit to the Supreme Court, Gilead is now arguing that the petition should be dismissed because it challenges more than 50 years of precedent

Back in 2017, Juno, which was acquired by Celgene and BMS, sued Gilead's Kite unit, alleging that the company's CAR-T therapy Yescarta infringed a patent granted to Juno by Memorial Sloan Kettering Cancer Center

The jury sided with Juno in 2019, with Judge Philip Gutierrez ruling that Kite should pay more than $778 million

The entire dispute actually revolves around the "190 patent".

Kite is second only to Novartis in the approval of its CAR-T product, Yescarta

Daiichi Sankyo VS Seagen: Property division after "divorce"

In 2000, the world's first ADC drug Mylotarg was launched, but in subsequent confirmatory clinical trials, Mylotarg was terminated early due to its failure to prolong survival and its safety was questionable

The agreement was terminated in 2015, and the two parties have developed a new generation of protease cleavable linkers during these 7 years, and the patent is shared by both parties

In April, Seagen also asked for additional royalties on future sales of Enhertu in the U.

In July, the U.
S.
District Court for the Eastern District of Texas found that Enhertu infringed Seagen's U.
S.
patent (US10808039)
.
The court found that the infringement was intentional and ordered Daiichi Sankyo to pay Seagen $41.
8 million in patent damages
.

But Seagen wants more than that, they want Daiichi Sankyo to pay running royalties on future sales of Enhertu before the 039 patent expires in 2024
.
Some analysts believe that Enhertu's annual revenue will reach $6 billion by 2026, and if Seagen wins the case, it may receive 5% to 10% of Enhertu's global sales
.

In August this year, the patent infringement case between Daiichi Sankyo and Seagen finally came to an end.
Daiichi Sankyo lost both the first and second instance, but obtained a favorable judgment in the final instance
.
Daiichi Sankyo issued an announcement on August 13 announcing the arbitration result.
The announcement introduced the ins and outs of the lawsuit and explained the arbitration result.
Daiichi Sankyo retained the relevant patent rights of its ADC drugs and will continue to develop and develop as planned.
commercialize these products
.
This result more or less affected Merck's acquisition negotiations for Seagen
.

summary

Combining the disputes between pharmaceutical giants in the above fields, it can be seen that there is still no suitable mechanism or boundary for foreign innovative drug cooperation to limit the scope of cooperation and the right to use the results, and the rights and interests of subsequent products are not yet divided.
It is clear that some litigation disputes have some meanings of "future money" in the editor's opinion
.
How to determine the respective contributions and rights of the cooperation results is an important issue before the research.
After all, if the company is involved in a patent dispute in the future, it is likely to affect the company's stock price
.
Based on the above lessons learned, whether domestic pharmaceutical companies should organize a "prenuptial agreement" that anticipates various consequences before cooperating may be the primary consideration
.

References:

1.
https://endpts.
com/gilead-fights-back-against-bms-supreme-court-petition-in-patent-fight/

2.
https://endpts.
com/bristol-myers-petitions-the-supreme-court-in-a-final-bid-to-prove-gileads-kite-infringed-on-car-t-patents/

3.
https://endpts.
com/with-kites-pdufa-date-looming-federal-court-tosses-junos-car-t-patent-challenge-for-now/

4.