這幾天有個紅透半邊天的武漢病毒專利侵權議題熱烈發行中，愛姆斯並不是專利法的專家，但前曾經接手一些藥廠專利的案子，對這個議題有點興趣。所以想要提出一些想法。然後有幸的能邀請到正在美國Medler Ferro Woodhouse & Mills PLLC當Patent Agent的Minxi Rao(美國專利師)一起來討論這個議題。
首先這個問題在於生技大廠吉列德科學(Gilead)所擁有的主要專利應該是US9724360B2，此專利時間到2035年左右才會過期(要看專利期調整或延長情形)。代表這個NCE(新化學物質)還有足足約15年的保護。然後最有意思的在US10251904B2這個專利(Methods for treating arenaviridae and coronaviridae virus infections)。可以看到這個專利2015年就送出申請，然後在2019年被美國核准(US10251904B2主要是Claim在治療沙狀病毒arenaviridae的部分且已被核准，而治療冠狀病毒科的部份目前也已得到准許通知書，專利大約3～4個月以內會發布)。然而在中國都還是在審查中(pending application)。就字面上看Coronaviridae為冠狀病毒科等於武漢病毒在其範疇之中。但治療Coronaviridae這個部分Gilead將其分成另一篇專利申請書，申請案只差三到四個月就會被發佈。
所以武漢研究所申請了新的用途? 可以的!而且很常見。但會不會成功呢? 不一定且可能機會不大…
【Who owns the coronavirus cure patent in China?】
The trending news lately has been about the Wuhan Institute of Virology intellectual property issue, and I found it intriguing and wanted to share some thoughts. Even though I am not an expert in patent law, I have come across a few cases involving pharmaceutical patent before and am fortunate to have a U.S. patent agent, Minxi Rao of Medler Ferro Woodhouse & Mills PLLC, join me in the discussion.
When I first saw the news, I thought it was somewhat unbelievable. But as a regulatory affairs enthusiast, these types of issues are highly interesting, so I took a deep dive into the situation at hand.
The first part of the issue is that pharmaceutical giant, Gilead, owns U.S. Patent No. 9,724,360, which won’t expire until at least 2035 (the exact date depends on maintenance fee payment and patent term extensions). This means that the new chemical entity (NCE) has at least 15 more years of protection.
Another interesting patent held by Gilead is U.S. Patent No. 10,251,904 (title: Methods for Treating Arenaviridae and Coronaviridae Virus Infections). Public records show that this patent was filed in 2015 and issued in 2019. (The ‘904 patent claims are directed to a method for treating an Arenaviridae infection in a human. A continuation of the ‘904 patent, U.S. Patent Application No. 16/265,016, was recently allowed and has claims directed to a method of treating a Coronaviridae infection in a human.) The ‘904 patent has a corresponding application pending in China. At a glance, the Coronaviridae class of viruses disclosed in the patent would include the 2019-nCoV from Wuhan, and Gilead’s patent application directed to a method treating a Coronaviridae infection has been allowed will likely issue into a patent in 3 to 4 months.
Wuhan Institute of Virology’s Patent
The Wuhan Institute of Virology issued the following press release: “As part of our collaborative efforts to control the epidemic, the parties have agreed to the following regarding the two compounds being tested for efficacy in treating the 2019-nCoV: no patent applications will be filed for chloroquine, which has already been on the market and of which China is fully capable of producing, in order to stem collaboration; regarding Remdesivir, which is not marketed in China and is subjected to patent protection, we have applied for a patent in China on January 21, 2020, in accordance with Chinese practice and in the interest of protecting national interest, for its use in treating the 2019-nCoV and plan to file patents worldwide through the PCT.
From their statement, the Wuhan Institute of Virology appears to focus on the 2019-nCoV, which is a particular species out of the large class of Coronaviridae viruses. This becomes a very interesting patent issue for the Patent Office examiners. However, based on the available information, Professor Sheng Ding, Dean of the School of Pharmaceutical Sciences at Tsinghua University, thinks that Wuhan Institute of Virology’s chances for a broad patent may be low because methods of treating Coronaviridae infections using Remdesivir are already disclosed in the Gilead ‘904 patent, which would include the 2019-nCoV even though it is not specifically mentioned (it would certainly be a burdensome and endless task to include every single Coronaviridae virus). Professor Ding also noted that according to Chinese patent law, a patent for an invention can be granted if it is novel, inventive, and has industrial applicability. Thus, if the Wuhan Institute of Virology attempts to patent a method that is already disclosed or very similar to the disclosure of Gilead’s patent, it is not likely to be successful.
Just as in the U.S., it is common to see one company owning patent rights to a drug compound, and another company applying for a patent on use of the drug for different diseases. However, whether the “method of use” patent will ultimately be granted depends on the situation.
Is it common to apply for a patent on using a known compound for a new purpose?
So the Wuhan Institute of Virology can apply for a patent on the “new purpose.” This is a common practice, but we do not yet know how successful they will be.
Then why did they do it?
I believe that aside from IP rights, the Chinese may be considering potential drug pricing. We all know that typically a new drug hits the market with a high price.
The Wuhan Institute of Virology is a government facility and can be considered a representative of the Chinese government. Perhaps they are hoping that obtaining patent protection will force Gilead to reconsider putting a high price tag on remdesivir if it ultimately comes to the market. I personally think that this is a potential strategy by the Chinese government. Even though the chances of obtaining broad patent protection may be low, obtaining a patent can still provide some negotiating power. This seems like a pretty smart move by the Chinese to anticipate potentially high drug pricing by Gilead. Of course, this is all discussed outside of the context of business ethics; from the point of view of providing cheaper drugs to patients, this appears beneficial, but it is also unfair to the pharmaceutical company.
So will Gilead take any action? Let’s consider where this epidemic is concentrated: China.
If this epidemic were occurring in a Western country like the U.S. or Europe, Gilead would be favored to prevail in a dispute.
How a Chinese authority will view a dispute will likely not be a surprise to anyone. The question is whether Gilead will take the risk here and challenge China, or take the clinical trial study fees and be satisfied with a lower-priced drug?
This question has both political and business considerations. Perhaps Gilead never planned to become involved in a dispute all along.
1. The epidemic is occurring mainly in China, China also has the highest number of patients, and so the clinical trial will take place in China. This is China’s main stage, not the U.S., and the pharma company needs to tread lightly when dealing with Chinese authorities.
2. A new use for a known drug is common in the patent world and in some ways can be thought of as analogous to a 505(b)(2) for a new indication of use for a known chemical entity. In principle, anyone can apply for a patent to a new use of a known compound, which is what Wuhan Institute of Virology did here, but whether the patent will be granted remains to be seen.
3. U.S. Patent No. 10,251,904, owned by Gilead, already discloses method of treating Coronaviridae infections using remdesivir. The Wuhan Institute of Virology states that their patent application is specifically directed towards the 2019-nCoV, but chances of a broad scope patent are low.
Article by Ames, in collaboration with Minxi Rao
1. Press release by Wuhan Institute of Virology
2. Gilead’s Patents
3. Related Chinese news report