[CDI Medical Eye] Two Trials (Part 1)

In Tokyo, the request for shortening business hours to restaurants has been lifted.

This is the fifth wave, which was the largest ever, but overall, it can be said that the number of deaths relative to the number of infected people has dropped significantly, and I think that the effect of advanced vaccination was still significant. On the other hand, the tight medical system has become a problem, such as the increase in patients who cannot be hospitalized and the number of deaths during home medical treatment. In the UK, the number of infected people per day is in the 40,000 range, so it seems that this is not the end, so it seems important to take a sharp response while observing the situation. Even so, it's been a month since the state of emergency was lifted, but experts haven't sent out any convincing information about factor analysis ... Analysis based on non-speculative data is awaited. ..

This time is the story of the trial

By the way, the topic has changed, and this time we will talk about the hottest trials in the medical and healthcare fields. Two trials have been held since September. The first is the "Opdivo Proceedings" in which Professor Tasuku Honjo, a Japanese Nobel laureate, is arguing with Ono Pharmaceutical for the price of the invention. The other is a trial in which Elizabeth Holmes, an entrepreneur who founded the blood test startup Theranos in the United States and was called "the next generation Steve Jobs", has been accused of fraud.

Opdivo proceedings

This is about the patent royalty of "Opdivo", which is an immune checkpoint inhibitor for cancer developed based on the research results of Dr. Honjo. It is a trial that sues Ono Pharmaceutical Co., Ltd., the manufacturer and distributor. There is a dispute with Dr. Honjo about how to distribute the patent royalties (Merck → Ono Pharmaceutical) obtained in the lawsuit with Merck, which sells the same type of cancer immunotherapy "Keytruda". It amounts to 26.2 billion yen. The trial began on September 2 at the Osaka District Court, and a settlement proposal is currently under discussion. The Sankei Shimbun's detailed report reports the exchanges at the trial in great detail.

ReferenceDetailed report on Opdivo proceedings 2021.9.2 (Sankei Shimbun)

Point (1): How much is a reasonable price?

The thought of Professor Honjo who filed the trial seems to be that the so-called "invention consideration = royalty (Ono Pharmaceutical → Professor Honjo)" is too small in the first place. By the way, each claim in the trial is roughly as follows

[Both claims in trial]

Mr. Honjo: Request a reasonable price for dealing with the proceedings with Merck & Co. There must have been a proposal from Ono Pharmaceutical to allocate 40%. (Pay a fair price!)

Ono Pharmaceutical: I did make a proposal, but I couldn't agree with Professor Honjo. So I paid 1% as the consideration according to the original contract conditions. (Janken afterwards is sloppy!)

There is a so-called "market price" for patent royalty rates. "Standards for each industry" are organized based on surveys of past cases. Specifically, the "License Rate 5th Edition (Invention Association Research Center 2003)" and "Royalty Rate Data Handbook (Ministry of Economy, Trade and Industry Intellectual Property Policy Office 2010)" are typical references. In the fields of medicine and biotechnology, the range is 3-5%, or 6% on average. * Please note that the case of the trial is a dispute over the "allocation" of the license fee paid by Merck & Co., but it is not a direct comparison of these with 1% or 40%.

However, this story also raises the question, "Isn't the loyalty so far wrong?", So it may be that the judgment based on past cases is not good in the first place. , It will be a discussion that throws a stone at the question "What is the distribution of consideration for the legitimate invention of the inventor and the company?" In addition, Professor Honjo says that he will use the money he earns to create a fund for young researchers. This can be said to be an effort to form an ecosystem in the medical and healthcare fields, so I would like you to do your best.

Point (2): But ... I wonder if I had a contract?

On the other hand, what is worrisome is that Ono is paying the price based on the contract signed in 2006. Having a contract means that both parties have agreed. The contract says, "If you get a patent royalties from a third party, you will pay 1% of the price." In other words, there was a proper agreement with Merck. Regarding this point, Professor Honjo claims that he made a contract at an unreasonably low rate without providing accurate explanations and information, but I would like to determine the conditions in advance by company regulations like employee inventions. This is not the case, so I think the fact that there was already a contract cannot be ignored.

確かに、本庶先生は研究者であり契約の専門家ではありませんが、2006年ということは・・・たぶん京都大学には知的財産企画室とか「医学領域」産学連携推進機構とか、あったはず、ということを、その頃にちょうどその周辺をウロウロとしていた身としては思う次第であったりします。もし機会があれば当時の状況などちょっとどなたかに教えて貰えないかな、とも思っています。

The discussion of intellectual property is very important in the field of medical and healthcare, so I would like to continue to pay attention to it. Next time are two trials (second part). I would like to write about the trial of entrepreneur Elizabeth Holmes, who has been accused of fraud in the United States.

Responsibility: Ai Ito

Ai Ito (Executive Officer, CDI Medical Co., Ltd.)

Completed a master's course at the Graduate School of Pharmaceutical Sciences, Osaka University (pharmacist). Completed a master's degree at Kyoto University Graduate School of Medicine.

After working as a trading company, an independent venture capital firm, a healthcare / bio venture company, a management consulting firm, etc. Conducts consulting including strategy support and execution support, including mid-term business strategy, new business strategy, overseas development, open innovation strategy, etc., mainly in the life sciences and healthcare field.