加拿大最高法院「否決用承諾原則」來判定專利實用性！

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來源：IPRdaily中文網(wǎng)（IPRdaily.cn）

作者：陳鈞毅博士 加拿大迪緯律師事務(wù)所

原標題：加拿大最高法院否決用“承諾原則”來判定專利實用性 Supreme Court of Canada Rejects “Promise Doctrine” When Determining Patent Utility

2017年6月30日，加拿大最高法院（最高院）公布對阿斯利康加拿大公司訴 Apotex公司一案的判決(阿斯利康案，2017 SCC 36)，否決可以用“承諾原則”來判定專利實用性。該判決對如何判定專利是否有實用性，特別是在藥學(xué)領(lǐng)域，提供了急需的指導(dǎo)。

背景

1、聯(lián)邦法院建立的專利承諾原則

專利實用性這一要求來自于加拿大《專利法》的第2條 。該法條將發(fā)明定義為一種“新的且有用的工藝、流程、機器、制造或構(gòu)成物”或“新的且有用的”改進。因此，評估實用性時要問的問題是“對什么有用?” 聯(lián)邦法院的案例以承諾原則來回答這個問題。聯(lián)邦法院認為如果一個專利承諾了一個特定的用途 (即“專利的承諾”)，只有在加拿大申請日時證明了或者合理預(yù)測了這個承諾，這個發(fā)明才有實用性，但是如果該專利沒有承諾任何特定的用途，只要有一點點實用性就可以了。承諾原則要求法院通過考慮權(quán)利要求和說明書來確定專利所承諾的實用性。此外，聯(lián)邦法院認為如果說明書中指定了多項“承諾”，該發(fā)明必須滿足所有的承諾，否則整個專利將被無效。

自從在2005年左右承諾原則被采納以來，一批暢銷藥物的專利被加拿大聯(lián)邦法院裁定“沒有用”。這些藥物包括禮來的雷洛昔芬(EVISTA?),阿托莫西汀（STRATTERA?）和奧氮平(ZYPREXA?),賽諾菲-安萬特的雷米普利(ALTACE?)和阿斯利康的埃索美拉唑(NEXIUM?)。聯(lián)邦法院甚至采用了承諾原則裁定歐洲直升機的一項關(guān)于直升機起落架的機械專利無效。

2、聯(lián)邦法院對阿斯利康案的判決

Esomeprazole (埃索美拉唑)

阿斯利康起訴Apotex，稱其產(chǎn)品侵權(quán)加拿大專利號2139653(653專利),Apotex反訴專利無效。653專利保護奧美拉唑(-)對映體（即埃索美拉唑，見下圖）的純鹽和用這些純鹽抑制胃酸分泌。

653專利的說明書有以下闡明：

“人們希望制得具有改善的藥代動力學(xué)和代謝特性的化合物，這種化合物應(yīng)能產(chǎn)生改善的治療特性，例如更低的個體間差異程度。本發(fā)明提供了這樣的化合物，它們是新的奧美拉唑單一對映體的鹽。”［下劃線為作者添加］

聯(lián)邦法院采用了“承諾原則”，并確定了兩項承諾的實用性: (1)作為質(zhì)子抑制劑(PPI)，以及 (2)因改進的藥代動力學(xué)和代謝特性提供了改善的的治療特性，例如更低的個體間差異程度(2014 FC 638)。聯(lián)邦法院認為第一項承諾的實用性，即埃索美拉唑作為PPI來降低胃酸量，得到了合理地預(yù)測，但是它認為第二項承諾的實用性在加拿大專利申請時既沒有被證明也沒有被合理預(yù)測并因此判定653專利無效。

阿斯利康上訴到聯(lián)邦上訴法院，但沒有成功(2015 FCA 158)。阿斯利康隨后請求最高院接受上訴。最高院同意其上訴請求。

最高院阿斯利康案判決

最高院法官一致否決了承諾原則，認為該原則是沒有依據(jù)的，是與《專利法》的文字和整體規(guī)劃都不一致的對實用性的解釋。最高院認為該原則在以下兩個方面過于繁重: (1)“該原則通過專利書中表明的承諾來決定評判實用性的標準”; (2)“如果專利書中表明了多項實用性承諾,該原則要求只有達到所有承諾，專利才能有效”。

特別是最高院認為承諾原則將《專利法》第2條(實用性要求)和第27(3)條(充分描述要求)合并，要求為滿足實用性要求，在第27(3)條規(guī)定下說明書披露的任何用途都需要在專利申請時被證明或被合理預(yù)測。

最高院提出了以下判定專利實用性的方法：

(1)確定專利權(quán)利要求所要求的發(fā)明的主題;

(2)考慮該主題是否有實用性 － 是否有實際用途(即實際結(jié)果)。

最高院指出，這種實用性必須與權(quán)利要求所要的發(fā)明主題的本質(zhì)相關(guān)，并且只要有一點點實用性就可以了。 因此，只要有一項與發(fā)明主題本質(zhì)相關(guān)的實用性就可以了，但是該實用性必須在專利申請日時被證明或被合理地預(yù)測。

然而最高院認為過度承諾仍是問題（“mischief”），而且《專利法》對這種行為有多種方式解決：

(1)權(quán)利要求范圍過寬;

(2)不正確、不完整的披露，或者闡明沒有事實根據(jù)的用途或者對發(fā)明的使用，可能不符合第27(3)條；

(3)過分承諾可能會使專利無效，如果按第53條的規(guī)定，過度承諾構(gòu)成“以誤導(dǎo)為目的而故意作出的”疏忽或添加。

在本案中，最高院認為653專利不缺乏實用性，因為聯(lián)邦法院認為發(fā)明的主題 －埃索美拉唑純鹽 － 作為PPI減少胃酸的產(chǎn)生。

簡短評論

總而言之，最高院廢除承諾原則是對重新統(tǒng)一加拿大與其他主要工業(yè)化國家的專利實用性判定的可喜發(fā)展。這一案例重申了專利權(quán)利要求至上的原則。對于專利申請人和所有者來說，這一判決似乎大大降低了確定專利實用性的門檻。然而，這一判決也表明在加拿大，如果申請人沒有在加拿大專利申請時證明或合理預(yù)測發(fā)明主題的實用性，專利權(quán)利要求仍可能受到缺乏實用性的攻擊。此外，最高院認為專利權(quán)利要求可能因過度承諾而無效，無效理由包括權(quán)利要求范圍過寬,說明不充分和故意誤導(dǎo)的陳述。

附：英文版

Supreme Court of Canada Rejects “Promise Doctrine” When Determining Patent Utility

On June 30, 2017, in AstraZeneca Canada Inc v Apotex Inc (AstraZeneca, 2017 SCC 36), the Supreme Court of Canada (SCC) rejected the “Promise Doctrine” as the correct approach to determine patent utility.  This decision provides the much-needed guidance on how to determine patent utility, particularly in the pharmaceutical arts.

Background

1、Development of the Promise Doctrine by the Federal Courts

Section 2 of the Patent Act (Act), the source of the utility requirement, defines an invention as a “new and useful art, process, machine, manufacture or composition of matter” or a “new and useful” improvement thereof.  Therefore, the question for assessing utility is “useful for what?”.  The Federal Courts’ jurisprudence answered this question with the Promise Doctrine, holding that if a patent promised a specific utility (the “promise of the patent”), only if that promise was fulfilled by either demonstration or sound prediction as of the Canadian filing date of the application, could the invention have the requisite utility.  However, where no specific utility was promised, a mere scintilla of utility would suffice.  The Promise Doctrine required the courts to identify the promise(s) by considering the claims and the disclosure.  Further, if there were multiple “promises” found in the disclosure, the Federal Courts held that the invention must satisfy all of them, or the entire patent would be held invalid.

Since the adoption of the Promise Doctrine in about 2005, a host of blockbuster drug patents were found not to be “useful” by the Canadian Federal Courts. This list included Eli Lilly’s raloxifene (EVISTA?), atomoxetine (STRATTERA?) and olanzapine (ZYPREXA?), Sanofi-Aventis’ ramipril (ALTACE?) and AstraZeneca’s esomeprzole (NEXIUM?).  The Federal Courts also applied the Promise Doctrine to invalidate Eurocopter’s mechanical patent for a helicopter landing gear.

2、The Federal Courts’ Decisions in AstraZeneca

AstraZeneca sued Apotex for infringement of its Canadian Patent No. 2,139,653 (653 Patent) and Apotex counterclaimed for a declaration of invalidity.  The 653 Patent claims optically pure salts of the (-)enantiomer of omeprazole, esomeprazole (shown below) and use of these salts for inhibiting gastric acid secretion.

Esomeprazole

The disclosure of the 653 Patents states the following：

“It is desirable to obtain compounds with improved pharmacokinetic and metabolic properties which will give an improved therapeutic profile such as a lower degree of interindividual variation. The present invention provides such compounds, which are novel salts of single enantiomers of omeprazole.” [Underlining added]

The Federal Court (FC) applied the Promise Doctrine and identified two promises of utility: (1) use as a Proton Pump Inhibitor (PPI), and (2) improved pharmacokinetic and metabolic properties which would give an improved therapeutic profile such as a lower degree of interindividual variation (2014 FC 638).   The FC found that it was soundly predicted that esomeprazole acted as a PPI to reduce acid in the stomach.   However, it found that the second promise was neither demonstrated nor soundly predicted at the Canadian filing date and consequently held that the 653 Patent was invalid.

AstraZeneca appealed to the Federal Court of Appeal (FCA) but was not successful (2015 FCA 158).  AstraZeneca then sought leave to appeal to the SCC.  The SCC granted the leave.

SCC Decision in AstraZeneca

In an unanimous decision, the SCC rejected the Promise Doctrine, holding that this doctrine is unsound and is an interpretation of the utility requirement that is incongruent with both the words and the scheme of the Act.  It held that the doctrine is excessively onerous in two ways: (1) “it determines the standard of utility that is required by reference to the promises expressed in the patent”; and (2) “where there are multiple expressed promises of utility, it requires that all be fulfilled for a patent to be valid”.

In particular, the SCC found that the Promise Doctrine conflates section 2 (utility requirement) and section 27(3) (sufficient description requirement) of the Act by requiring that to satisfy the utility requirement, any disclosed use under section 27(3) be demonstrated or soundly predicted at the time of filing.

The SCC provided the following approach to utility:

(1)identify the subject-matter of the invention as claimed in the patent;

(2)ask whether that subject-matter is useful – is it capable of a practical purpose (an actual result).  

The SCC noted that this usefulness must be related to the nature of the claimed subject-matter. It also noted that a scintilla of utility will do.  Thus, a single use related to the nature of the subject-matter is sufficient; however, that utility must be either demonstrated or soundly predicted by the filing date.

The SCC nevertheless viewed that overpromising is a “mischief” and that the Act treats this mischief in multiple ways:

(1)claim overbreadth;

(2)a disclosure which is not correct and full, or states an unsubstantiated use or operation of the invention, may fail section 27(3); and

(3)overpromising may void a patent where such statements amount to an omission or addition that is “willfully made for the purpose of misleading,” under section 53.

In this case, the SCC found that the 653 Patent is not invalid for lacking utility, because the FC found the claimed subject-matter – optically pure salts of esomeprazole – to be useful as a PPI to reduce production of gastric acid.  

Brief Comments

Overall, the rejection of the Promise Doctrine by the SCC is a favourable development in realigning Canada’s law on patent utility with those of other major industrialized nations.  This case reaffirms the primacy of claims in a patent.  For patent applicants and owners, this case appears to have significantly lowered the bar to establish patent utility.   Nevertheless, this decision also suggests that in Canada, patent claims may still be subject to attacks based on lack of utility if the applicant had not demonstrated or soundly predicted some practical usefulness of the claimed subject-matter by the Canadian filing date.   Further, the SCC suggests that patent claims may be held invalid for overpromising on several grounds including overbreadth， insufficiency and wilful misleading statements.

來源：IPRdaily中文網(wǎng)（IPRdaily.cn）

作者：陳鈞毅博士，加拿大迪緯律師事務(wù)所

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