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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。
一開始看到這個事件時，覺得有點扯。想說這有可能?但身為品質法規控，很喜歡探究這種問題，所以情緒立刻拋開專注在問題本身。
【吉列德目前的專利】
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。
【武漢病毒實驗室的專利】
如果看武漢研究所的公告”为服务于疫情防控，合作双方单位联合声明：在上述具有抗2019新型冠状病毒作用的药物中，我们对于国内已经上市并能够完全实现自主供应的药物磷酸氯喹，不申请相关专利，以鼓励相关企业参与疫情防控的积极性；对在我国尚未上市，且具有知识产权壁垒的药物瑞得西韦，我们依据国际惯例，从保护国家利益的角度出发，在1月21日申报了中国发明专利（抗2019新型冠状病毒的用途），并将通过PCT（专利合作协定）途径进入全球主要国家。”
可以很清楚的看到他們的專利聚焦在2019新型冠狀病毒上，算是從整體冠狀病毒科的範圍精確的縮小到其中的一種上面。這變成一個很有意思的專利問題了。這可能要等中國官方做最終裁決。但根據清華大學藥學院長丁勝認為武漢研究所應該勝算不高就是了。因為吉列德宣稱在治療冠狀病毒，其實已經包含了武漢病毒，即使沒有明確的把它寫在其中(媽呀!如果要這樣那真累死，每年增加新的冠狀毒都要重新加寫進去真的很煩又累也)。除此之外，丁勝教授也認為在中國專利法中，授予專利權的發明和實用新型，應當具備新穎性、創造性和實用性。武漢病毒所申請的抗新型冠狀病毒新用途與吉利德公司已申請的抗冠狀病毒用途具有接近性，也不可能申請成功。就像美國，一家藥廠申請了藥品專利，但其他公司申請了別的適應症用途的專利，理論上應該是可以這樣申請的，而且這其實是很常見的，但能不能成功呢?那就是另件事了。
【這種老藥新用的專利申請方式常見嗎?】
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…
【那至於為什麼要這麼做?】
愛姆斯覺得除了要挑戰這個專利外，還有一個可能的意義在於藥價。我們都知道通常新藥批准上市後，藥價都不便宜。中科院武漢病毒所是中國的官方單位，某種程度上來說可以在某種程度上代表中國政府。研究所這個做法能不能迫使吉列德科學在藥品上市後以高價出售將會是一個很趣的議題(如果你敢賣貴，我就通殺你全家的產品?)。個人覺得在這地方的操作手法很厲害而且是有可能的，但專利成功的機會嘛，應該不高，卻具有某種程度的嚇阻存在。這能不能促使吉列德退一步未來不以高價出售其產品，算是個很聰明的手段。當然這是在撇開商業道德下的情形來看，某種程度來說對社會大眾能得到便宜的藥是好事，但對藥廠的損失是不公的。另外吉列德會不會有什麼動作，回到一個問題，這個疾病主要發生在哪? 中國!主場不是在美國也不是歐盟，如果在西方國家，基本上很明確應該是吉列德會勝出。中國會做出什麼決定我們都不會意外，吉列德是否會願意冒這個風險還是寧願收回所有研發臨床經費再小賺一筆見好就收呢?這是個商業和政治同時並存的問題。搞不好他們真的壓根沒有打算要進一步冒這個風險執著在此。
最後總結一下，
1.疾病是大發生在中國，中國也是最多的病人的地方，執行臨床的點一定是在中國。這是中國的主場而不是美國。面對中國政策的不確定因素及風險，藥廠怎麼做及回應是要非常的小心及明智的。
2.針對老藥新用這種議題在專利是很常見的，像505(b)2，原則上任何人都可以申請這種專利，所武漢研究所這樣的做法其實是很常見的沒什麼問題。但會不會成功就要看怎麼裁決。
3.Gilead在US10251904B2這個專利其實已經有包含冠狀病毒的範圍了，武漢病毒研究所雖然有權提出他們的專利是在2019-nCoV上，但挑戰成功的機會應該不大。
本篇由愛姆斯撰寫以及大力感謝Minxi Rao協作及審閱
【Minxi Rao的Linkedin】https://www.linkedin.com/in/minxi-rao-a3b64333/…
參考文獻
1.中科院武漢病毒研究所專利聲明http://www.whiov.ac.cn/kyjz_105338/…/t20200204_5497136.html…
2.相關專利https://patents.google.com/patent/US9724360B2/enhttps://patents.google.com/patent/US10251904B2/en
3.相關新聞https://chinanews.sina.com/…/2020…/doc-ifztesrv9464881.shtml
English Version
【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.
Gilead’s Patents
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.
In summary:
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
Related articles:
1. Press release by Wuhan Institute of Virology
http://www.whiov.ac.cn/kyjz_105338/202002/t20200204_5497136.html?from=timeline&isappinstalled=0
2. Gilead’s Patents
https://patents.google.com/patent/US9724360B2/en
https://patents.google.com/patent/US10251904B2/en
3. Related Chinese news report
https://chinanews.sina.com/gb/chnmedia/thebeijingnews/2020-02-04/doc-ifztesrv9464881.shtml
