ITC管不到數位內容 - In ClearCorrect v. ITC and Align Tech (CAFC 2015)

ITC案經上訴到CAFC，縱有法官持不同意見，但是多數CAFC法官認為ITC（美國國際貿易委員會）對進入美國的數位內容沒有管轄權，ITC僅能管實質有形的物體。

涉及法條：
Section 337, Tariff Act of 1930, Investigations of Unfair Practices in Import Trade
...
Finding: If the accused imports are determined to infringe a valid and enforceable U.S. patent, copyright, registered trademark, or mask work, the USITC may issue orders excluding the products from entry into the United States and/or directing the violating parties to cease and desist from certain actions. Where such infringement is shown, injury need not be shown to establish a violation of section 337. In cases involving other unfair methods of competition or unfair acts, if the USITC finds that the importation of the accused articles substantially injures or threatens to substantially injure an industry, prevents the establishment of such an industry, or restrains or monopolizes trade and commerce in the United States, it may also issue exclusion and/or cease and desist orders. USITC orders are effective when issued and become final 60 days after issuance unless disapproved for policy reasons by the U.S. Trade Representative within that 60-day period. Appeals of USITC determinations may be taken to the U.S. Court of Appeals for the Federal Circuit. Violators of USITC section 337 orders are liable for civil penalties of up to $100,000 a day or twice the value of the imported articles. (For further information, see section 337 of the Tariff Act of 1930, 19 U.S.C. 1337.)

爭議涉及ITC法源Section 337的條文，規定ITC可以管轄是否准予侵犯美國專利、著作權、商標、光罩等物品（the "article"）進口美國，ITC判決可以禁止物品進口，或停止某些工作。主旨以侵權與否發出禁令，並不涉及損害，但仍可因避免傷害產業、壟斷等不公平競爭的情況而對進口物發出禁令。

案件資訊（In ClearCorrect v. ITC and Align Tech (CAFC)）：

原告"Align Technology, Inc."於ITC對"ClearCorrect Operating, LLC"等被告提起侵權禁令告訴。
系爭專利：
U.S. 6,217,325、U.S. 6,705,863、U.S. 6,626,666、U.S. 8,070,487、U.S. 6,471,511、U.S. 6,722,880、U.S. 7,134,874

相關爭議是一種用在牙科矯正牙齒用的建模技術，被告ClearCorrect的技術在於掃描病患牙齒，並建立數位重建的資訊，這是一種數位3D影像，用於建立實體「熱塑成型」模型。然而，被告物品（the "article"）為數位模型、數位數據與醫療計畫，這些是「虛擬」物件，並非具體物品。

ITC行政法官判決ClearCorrect侵權成立，因此發出被告禁止電子輸入數位模型到美國的禁令（從Pakistan輸入）。

簡單列舉其中880案的Claim 1如下，明顯是個軟體發明，用以建立牙齒位移的資訊。
Claim 1:
A method for making a predetermined series of dental incremental position adjustment appliances,
said method comprising:
a) obtaining a digital data set representing an initial tooth arrangement;
b) obtaining a repositioned tooth arrangement based on the initial tooth arrangement;
c) obtaining a series of successive digital data sets representing a series of successive
tooth arrangements; and
d) fabricating a predetermined series of dental incremental position adjustment appliances based on the series of successive digital data sets, wherein said appliances comprise polymeric shells having
cavities shaped to receive and resiliently reposition teeth, and said appliances correspond to the series of successive tooth arrangements progressing from the initial to the repositioned tooth arrangement.

325案的Claim 21為建立齒模的方法。

Claim 21:

A method for fabricating a dental appliance, said method comprising:

providing a digital data set representing a modified tooth arrangement for a patient;

controlling a fabrication machine based on the digital data set to produce a positive model of the modified tooth arrangement; and

producing the dental appliance as a negative of the positive model.

CAFC階段：
經被告上訴CAFC，爭議在於Section 337是否賦予ITC管轄數位內容？不論各方提出的大字典如何解釋，最後CAFC採用ITC自己在1924年發表的字典的解釋，表示「article」為一般用品。

...

數位內容傳輸不能解釋為一般海關的輸入。

並且，CAFC認為「article」有被製造、被生產、被處理與被挖掘的意思，即便用較廣的方式解釋，但仍不能涵蓋數位資訊。
"We recognize that section 1337 covers both articles that were “made” and articles that were “produced, processed, or mined.” While this language in section 1337 perhaps suggests a broader scope for section 1337 than for section 271(g), nothing in section 1337 suggests coverage of information, in addition to articles under section 271(g)."

最後更針對ITC的立法歷史的異議，就是避免輸入商務交易傷害美國本土企業，如果涵蓋過廣的範圍，會有不公平競爭的疑慮。
"The provision relating to unfair methods of competition in the importation of goods is broad
enough to prevent every type and form of unfair practice and is, therefore, a more adequate protection to American industry than any antidumping statute the country ever had."

結論：
在Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc. (1984).判決中，似乎毫無疑義地認為ITC的判決效果可及於電子傳送的數位資料，但ITC管轄範圍因為337條文"article"是否僅指為"material things"而有疑義，CAFC認為電子傳送的內容或許有具體的特徵，比如「電子」本身為有量的物質，不過，一般常識都可曉得這與字面上"material things"有明顯差異，因此CAFC認為ITC對數位內容進口沒有管轄權。

一些爭議應該交與國會用更高的立場來解決。

my two cents:
雖我沒有能力評斷，不過曉得美國案例之所以有些參考價值，或說有趣，就是因為從頭到尾都表示出一些價值觀，司法判決的邏輯，或是依循的前例都很有智慧（我認為）。

侵權成立不代表ITC有管轄權，這有點在玩文字遊戲，各方列舉很多種字典來證明"article"的意思，連引用了字典意思還有爭議，因為很多語言意思會隨著時間演變，因此不少法官有不同意見，但是就「海關」來看，是否管得到網路上傳送的數位資訊，真是有待商榷。

CAFC判決文：
http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/14-1527.Opinion.11-6-2015.1.PDF
（備份：https://app.box.com/s/66ff9dubunkv4o0tt1e7939unr7usyr2）

資料參考：http://patentlyo.com/patent/2015/11/expansion-electronic-importation.html

其他參考：
ITC介紹：http://enpan.blogspot.tw/2011/10/itc.html
有關Chevron Two-Step：http://enpan.blogspot.tw/2015/08/cafcitc.html

Ron

TPP的智慧財產權議題補充

延續先前摘要由WikiLeaks流出TPP的報導（http://enpan.blogspot.tw/2015/10/tpp.html），本篇則是針對公開的TPP草案補充相關內容。

可參考搜尋到比較完整也容易查閱的紐西蘭外交事務部提供的TPP（跨太平洋戰略經濟夥伴關係協議，Trans-Pacific Partnership）全文（草案）：http://tpp.mfat.govt.nz/text。

有關智慧財產權的檔案：http://www.mfat.govt.nz/downloads/trade-agreement/transpacific/TPP-text/18.%20Intellectual%20Property%20Chapter.pdf。

紐西蘭針對有關該國的內容整理出概要：http://www.tpp.mfat.govt.nz/assets/docs/TPP_factsheet_Intellectual-Property.PDF。

有關智慧財產權的議題在第18章（Intellectual Property），資料參考：
https://zh.wikipedia.org/wiki/跨太平洋戰略經濟夥伴關係協議。

(updated on Nov. 26, 2015)
我國專利局提出的「跨太平洋夥伴協定(TPP)智慧財產章簡要說明與翻譯」
http://www.tipo.gov.tw/ct.asp?xItem=571002&ctNode=7127&mp=1

摘錄wikipedia的一段話，就大約知道這個約定簽下去，會影響我們的工作實務，至少會修法。

智慧財產權相關條款
從美國提案處外洩出來的TPP條文當中，含有一些關於著作權與專利權的條款，引發許多爭議。並且藥材專利可能傷害大眾用藥權利。
日本漫畫家赤松健擔憂，同人誌之類的衍生作品可能遭非法化。
TPP含有極具爭議性的ISDS（Investor-state dispute settlement）機制，該機制確保外國投資者與地主國產生爭端時交由第三方國際仲裁機構（而非地主國司法體系）進行仲裁；然而仲裁機構通常採黑箱機制，並向投資者與財團利益靠攏，而否決地主國的法律乃至立法，透過控告來阻撓地主國健康、環保法規的立法與施行。

第18章全文74頁，簡單來看，參考紐西蘭外交事務部的5頁整理，以及我認為的重點如下：

1. 簽署TPP，對各國都有衝擊。
2. TPP承繼TRIPS的目的與原則，TRIPS為WTO下的智慧財產權協議（Trade-related Aspects of Intellectual Property Rights）。
   
   著作權
3. 著作權（copyright）期限（延長）為70年（中華民國103年著作權法第三十條：著作財產權，除本法另有規定外，存續於著作人之生存期間及其死亡後"五十年"。），但不適用目前法規已經過期的著作。
4. 著作權期限保護不能低於著作人過世後70年；如果作者非自然人（如法人），不得少於發表後70年；如果未於創作後25年內授權出版，期限仍是自創作日後70年。也就是，如果是創作日後25年內出版，就於該日起70年期限。
   Article 18.63: Term of Protection for Copyright and Related Rights
   Each Party shall provide that in cases in which the term of protection of a work, performance or phonogram is to be calculated:
   (a) on the basis of the life of a natural person, the term shall be not less than the life of the author and 70 years after the author’s death; and
   (b) on a basis other than the life of a natural person, the term shall be:
   (i) not less than 70 years from the end of the calendar year of the first authorised publication of the work, performance or phonogram; or
   (ii) failing such authorised publication within 25 years from the creation of the work, performance or phonogram, not less than 70 years from the end of the calendar year of the creation of the work, performance or phonogram.
5. TPP沒有影響平行輸入的產品，各國可以自行設定國際耗盡原則。
   Article 18.11: Exhaustion of Intellectual Property Rights
   Nothing in this Agreement prevents a Party from determining whether or under what conditions the exhaustion of intellectual property rights applies under its legal system. (updated on Nov. 14, 2015)
   
   商標
6. 商標註冊起保護不得低於10年，每次延展不得低於10年。
7. 地理名稱標誌（Geographical Indications）可依各國國內法，但輸出時保留異議與無效的權力；另有貿易協議獲准的地理標誌的辦法，兩者具有彈性。
8. 建立地理標誌保護與識別的程序：
   各國提供仲裁、請願程序，並能撤銷有關地理標誌保護的措施。
   Article 18.31: Administrative Procedures for the Protection or Recognition of Geographical Indications
   If a Party provides administrative procedures for the protection or recognition of geographical indications, whether through a trademark or a sui generis system, that Party shall with respect to applications for that protection or petitions for that recognition:
   (a) accept those applications or petitions without requiring intercession by a Party on behalf of its nationals;
   (b) process those applications or petitions without imposition of overly burdensome formalities;
   (c) ensure that its laws and regulations governing the filing of those applications or petitions are readily available to the public and clearly set out the procedures for these actions;
   (d) make available information sufficient to allow the general public to obtain guidance concerning the procedures for filing applications or petitions and the processing of those applications or petitions in general; and allow an applicant, a petitioner, or their representative to ascertain the status of specific applications and petitions;
   (e) ensure that those applications or petitions are published for opposition and provide procedures for opposing geographical indications that are the subject of applications or petitions; and
   (f) provide for cancellation of the protection or recognition afforded to a geographical indication.
   
   專利
9. 任何物的發明、方法發明，只要具有新穎性、進步性與產業利用性，可賦予專利權。
10. 可專利標的：已知物品的新用途、使用已知物品的新方法、使用已知物品的新流程，而非已知物品自身的使用而已。
11. 法定不可專利標的：違反公眾秩序與道德的發明、人類動物或植物生命或健康或自然現象等，包括：外科手術診斷、治療、非生物與微生物的生物方法。
    Article 18.37: Patentable Subject Matter
    1. Subject to paragraphs 3 and 4, each Party shall make patents available for any invention, whether a product or process, in all fields of technology, provided that the invention is new, involves an inventive step and is capable of industrial application.
    2. Subject to paragraphs 3 and 4 and consistent with paragraph 1, each Party confirms that patents are available for inventions claimed as at least one of the following: new uses of a known product, new methods of using a known product, or new processes of using a known product. A Party may limit those new processes to those that do not claim the use of the product as such.
    3. A Party may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to nature or the environment, provided that such exclusion is not made merely because the exploitation is prohibited by its law. A Party may also exclude from patentability:
    (a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;
    (b) animals other than microorganisms, and essentially biological processes for the production of plants or animals, other than non-biological and microbiological processes.
    4. A Party may also exclude from patentability plants other than microorganisms. However, consistent with paragraph 1 and subject to paragraph 3, each Party confirms that patents are available at least for inventions that are derived from plants.
12. 醫藥議題很重要，TPP讓會員國可以快速取得新藥，涉及醫藥檢驗時間、專利期限延長等議題。
13. TPP要求各國提供5年內的藥品成份，10年農用化學品資料保護。
14. TPP提出專利期限補償措施，也就是專利局造成的延遲要補償專利權人，如美國PTA。
15. 專利期限補償的延遲要件（對於核准專利）如：(1)未於申請日後五年內獲准；(2)未於提出實際審查請求後3年內獲准；(3)因為申請人造成的延遲不得要求延長專利期限。Article 18.46: Patent Term Adjustment for Patent Office Delays
    1. Each Party shall make best efforts to process patent applications in an efficient and timely manner, with a view to avoiding unreasonable or unnecessary delays.
    2. A Party may provide procedures for a patent applicant to request to expedite the examination of its patent application.
    3. If there are unreasonable delays in a Party’s issuance of patents, that Party shall provide the means to, and at the request of the patent owner shall, adjust the term of the patent to compensate for such delays.
    4. For the purposes of this Article, an unreasonable delay at least shall include a delay in the issuance of a patent of more than five years from the date of filing of the application in the territory of the Party, or three years after a request for examination of the application has been made, whichever is later. A Party may exclude, from the determination of such delays, periods of time that do not occur during the processing of, or the examination of, the patent application by the granting authority; periods of time that are not directly attributable to the granting authority; as well as periods of time that are attributable to the patent applicant.
16. TPP要求各國政府在藥品上市前通知藥品專利擁有者知道藥品安全檢驗批准，可以讓專利權人主張權利，包括禁令。
17. TPP要求各國政府提供專利藥過期資訊，讓製藥廠可以使用過期專利藥（學名藥）。
18. TPP沒有禁止學名藥品出口。
19. TPP要求專利優惠期有12個月，這不同我國現行專利法。
20. 各國海關有權延遲侵權產品進口。
21. 針對醫藥專利不合理的期限減縮：
    要求提供最好而有效率的檢驗時間，避免不當延遲；提供不合理延遲的專利期限補償。
    Article 18.48: Patent Term Adjustment for Unreasonable Curtailment
    1. Each Party shall make best efforts to process applications for marketing approval of pharmaceutical products in an efficient and timely manner, with a view to avoiding unreasonable or unnecessary delays.
    2. With respect to a pharmaceutical product that is subject to a patent, each Party shall make available an adjustment of the patent term to compensate the patent owner for unreasonable curtailment of the effective patent term as a result of the marketing approval process.
    3. For greater certainty, in implementing the obligations of this Article, each Party may provide for conditions and limitations, provided that the Party continues to give effect to this Article.
    4. With the objective of avoiding unreasonable curtailment of the effective patent term, a Party may adopt or maintain procedures that expedite the processing of marketing approval applications.

my two cents:
看似對大家好的或公平的協議，但是對於美國這種專利、著作權、軟硬體技術輸出大國來說，各會員國只能接受，並在相關產業增加許多使用成本，至少很多音樂、著作、電影都被保護得好好的。這會是一個文化衝擊，聲稱「文創」很厲害的台灣，如果真的很厲害，應該是好事。

醫藥方面，美國也是生物藥物科技的大國，這個協議充滿保護色彩，會讓不少醫藥成本上升，因為專利藥成本墊高，學名藥又被延遲，不過會得到最新卻很貴的藥品。

一般專利期限補償，這是好事，衝擊的是專利審查單位。

Ron

用途發明的挑戰 - Merck v. Ono Pharmaceutical 歐洲專利法院案例討論

此案例討論「用途發明」中所採用的元素為已知物質，而先前文獻是否有任何使用此物質解決特定問題（該用途）的動機。特別在醫療領域中，藥物上市前有很多實驗，實驗是否證明有特定療效的成功機會，即便藥品最後可能在不同的用途上，但是這些實驗（或相關領域的實驗）都有可能是阻礙藥品在其他用途的後續專利的證據。

用途發明就看專利說明書是否提出有力的實驗證明該用途。

案件資訊：
專利權人/侵權原告：ONO PHARMACEUTICAL CO., LTD.（日本公司）
侵權被告：Merck Sharp & Dohme Limited

系爭專利：EP1537878 

系爭專利揭露「Immunpotenzierende zusammensetzungen」，這是一種治療癌症的抗體與PD-1受體的技術。

這個曾經被異議而仍存留的專利權，請求項範圍如下，請求項1界定一種「使用發明（use invention）」，使用已經存在的物質的用途發明，專利關於一種使用「反PD-1抗體（anti-PD-1 antibody）」的技術，其抑制用於治療癌症藥的PD-1免疫抑制信號，（不懂沒關係），而其附屬項描述此反PD-1抗體就是人類的反PD-1抗體。其他兩項範圍則是界定此抗體。

1. Use of an anti-PD-1 antibody which inhibits the immunosuppressive signal of PD-1 for the manufacture of a medicament for cancer treatment.
2. The use according to claim 1, wherein the anti-PD-1 antibody is a human anti-PD-1 antibody.
3. Anti-PD-1 antibody which inhibits the immunosuppressive signal of PD-1 for the use in cancer treatment.
4. Anti-PD-1 antibody for the use according to claim 3, wherein the anti-PD-1 antibody is a human anti-PD-1 antibody.

不懂系爭專利沒關係，但是可以明顯知道這是一種已知物質的用途發明，且專利範圍簡單地描述用途。這就是爭議的來源 - 範圍過廣（涵蓋所有癌症治療？）。

被告Merck Sharp製造了「anti-PD-1 antibody pembrolizumab (Keytruda)」，也是一種如系爭專利所述的反PD-1抗體，推出市場後宣稱可以治療不能用手術切除或已經轉移的腫瘤。

有錢也頗為阿沙力（任性），Merck承認，如果專利有效，他的產品確實落於專利範圍中。但也不是直接認栽，而興起一連串專利無效主張，理由包括新增事務（added matter）、揭露不充分（insufficiency）、優先權有誤、缺乏新穎性與進步性等。

不曉得是不是外電撰寫的風格，這回原告Ono Pharmaceutical也頗為乾脆，認為如果專利的優先權錯誤的話，其專利無效，因為其優先權文獻記載了證明抑制PD-1抗體而降低腫瘤生長的記錄。甚至聲明，如果專利侵權成立，也不會對手提起禁制令。

專利有效性的爭議中，「用途發明」危險的地方是，是否相關先前技術（PD-1抗體）有隱含這個用途，是否有此案所稱可以治療癌症的效果？如果先前技術的文獻已經足夠揭示出系爭專利的治療效果，系爭專利應該不予專利，對此案來看，先前技術並未有支持有腫瘤治療效果的實驗產生，無法證明專利缺乏新穎性。這種爭議應該常見於醫療領域的專利。

「優先權」的爭議在於，Merck聲明系爭專利優先權日前的技術顯示不是每種腫瘤都可用免疫系統治療，這樣證明系爭專利可以治療癌症的使用範圍過廣。不過法官認為，癌症與免疫系統的關聯將來可能會有變化，如此不能認定專利無效。

系爭專利在進步性的討論中，就頗為複雜，重點在於是否有先前技術已經揭示出抑制特定免疫信號是否可以降低腫瘤成長？先前小鼠腫瘤實驗證明「PD-1抗體」可以排除自身免疫性疾病，關鍵就在，這個系爭專利是有關「反PD-1抗體」，而此是否阻礙了PD-1抗體的治療效果？這有關相關領域技術人員是否有相關治療效果的期待。

即便有不少先前實驗的證據，法院"正確的"「動機」判斷影響系爭專利是否顯而易見。

(updated on Nov. 20, 2015)『問題在於顯而易見性應可考量事實，法院應考量相關環境中的特別因子，這些可能包括系爭專利是否有動機得出解決問題的方案、可能的研究經費、得到解決方案與期待成功的努力等。』

"The question of obviousness must be considered on the facts of each case. The court must consider the weight to be attached to any particular factor in the light of all the relevant circumstances. These may include such matters as the motive to find a solution to the problem the patent addresses, the number and extent of the possible avenues of research, the effort involved in pursuing them and the expectation of success."

(updated on Nov. 20, 2015)『根據以上證據，認為相關技術領域中具有一般知識的技術者根據優先權日當時文獻可知，如果無法被免疫系統識別的話，反PD-1抗體不會有治療癌症的效果。因此相關技術人員並不會考慮是否此反PD-1抗體會有效，也非已知免疫原性。就此而論，在小鼠中可成功，反PD-1抗體的療性。』

"Taking this evidence together I find that the thinking of a skilled person with their common general knowledge reading the document at the priority date would be as follows.  Obviously an anti-PD-1 antibody cannot have an effect on a cancer if it is not recognised by the immune system but the skilled person would not think that the fact that a cancer had been regarded as unresponsive to existing immunotherapies was determinative of whether anti-PD-1 treatment would work and would not regard “known immunogenicity” as a useful category in this context.  Given the successful results in the mouse models, it is plausible that anti-PD-1 therapy, which is focussed on the immune system, will have the capacity to treat any type of tumour because all tumours express antigens not found in normal cells."

(updated on Nov. 20, 2015)『法院認為，相關領域技術人員從優先權文件可以得到反PD-1抗體對於癌症的療效。即便迄今都認為反PD-1抗體非癌症系統可識別的免疫原性，但系爭專利的思想讓此反PD-1抗體對癌症可能具有療效。』

"I find that a skilled person reading the first priority document would be able to make a sound prediction that anti-PD-1 antibodies would work in cancer generally, irrespective of whether the tumour cells expressed PD-L1 or PD-L2.  The idea that the anti-PD-1 therapy could treat cancers even if they were not hitherto regarded as immunogenic is a plausible one."

結論：
專利有效。

理由是(updated on Nov. 20, 2015)：
1. 優先權日文獻支持系爭專利技術中採用特定抗體的療效，相關領域技術人員也因此可以得出有療效的結論。
2. 相關技術領域的人員從來沒有考慮反PD-1抗體對於癌症的療效。
3. 雖系爭專利專利範圍很廣，但是不能排除其技術貢獻，證據也支持anti-PD-1抗體的療效。
4. 系爭專利為非顯而易知，因為先前技術對anti-PD-1抗體的療效沒有太高期待。
5. 先前技術無法證明系爭專利無效。

1. At the priority date the common general knowledge of the person skilled in the art included the idea that the PD-1 pathway was an important aspect of the immune system with a role in self-tolerance.  It could be a target for therapeutic manipulation.  This knowledge included the concept that PD-1 was an inhibitory receptor.  However it also included knowledge of a debate about the PD-1 pathway.  It was known that ligands to PD-1 also had a co-stimulatory effect and it was known that a proven explanation had not emerged.
2. The in vivo mouse data contained in the first priority document, in which two different kinds of tumour are transferred to PD-1 knockout mice, represent an important advance.  The data make plausible the idea that an agent which blocks the PD-1 receptor can manipulate the immune system in such a way as to treat cancers in general, not only those tumours which express PD-1 ligands.  Nevertheless, while the reasonable prediction which the priority document supports is a wide one, it does not purport to promise that every cancer patient in all circumstances can be treated.  Claims 1 and 3 are plausible and are entitled to priority. 
3. The patent enables the skilled person to make and use anti-PD-1 antibodies as anti-cancer medicines.  Moreover, and crucially, the evidence today shows that anti-PD-1 antibodies have been approved to treat a number of different cancers and are worth investigating in a very wide range of cancers.  The evidence today also shows that anti-PD-1 monotherapy probably does not treat prostate cancer and most colorectal cancers, but this does not demonstrate a lack of technical contribution or undue burden.  The law does not require perfection.
4. The prior art document Dana Farber 557 discloses the idea of manipulating the PD-1 pathway and includes the idea of an anti-PD-1 agent as a therapeutic agent to be used to treat a number of diseases including cancer.  That agent could be an anti-PD-1 antibody.  However the document includes evidence of both the inhibitory effect of the PD-1 receptor and the co-stimulatory effect of PD ligands.  While its disclosure may be enough to support the general idea of using an agent which acts somehow on the PD-1 pathway in medicine, it does not make plausible the specific idea of an anti-PD-1 agent to treat cancer.  The same is true for the prior art Wyeth 499.  Therefore claims 1 and 3 are novel.
5. The claims involve an inventive step over the Latchman paper and Dana Farber 557 because the common general knowledge includes knowledge of the existence of the debate about the cause of the co-stimulatory role of PD-1 ligands.  Although it was known that the PD-1 receptor was inhibitory, the existence of the debate meant that a skilled person who conducted a test of PD-1 blockade against a tumour in a mouse, would not have a fair expectation of success.  The mouse tumour results in the patent were exciting and were not predictable from the prior art.  Claims 1 and 3 are not obvious.
6. The Tchekmedyian and Davis abstracts do not render the claims obvious either.  They are not concerned with the PD-1 pathway at all.  

my two cents:
使用已知物品的用途發明（swiss type）應會面對很多的挑戰，實務上比較少見，但是顯然常見於醫療領域。

(updated on Nov. 20, 2015)

此案例重要結論是，當先前技術無法證明系爭專利是否有可實施性，也就是法官/專利審查官無法證明專利無法達成時，而被告侵權者反而證明專利技術可以成功，使得系爭專利優先權日的技術成為重要議題，這些證據都讓本系爭專利判為有效。

因此，本案例因為優先權文獻證明專利描述的真實性，讓相關領域技術人員可以得出系爭專利是有可能成功的，以及證明在此優先權之前的技術都呈現系爭專利技術「不會成功、沒有成功的期待」，這些證據都證明本案例「用途發明」的非顯而易知性。

另，看不懂內容也要學到知識。

部落格文章：
http://enpan.blogspot.tw/2011/11/swiss-type-claiming-about-claims-xlii.html
（其中也提到Merck！）

參考資料：
http://www.eplawpatentblog.com/eplaw/2015/11/uk-merck-v-ono-pharmaceutical-bristol-myers-squibb-.html（其中有判決原文檔案）

Ron

解決已知問題的技術為顯而易知 - NL-ZTE v. Vringo 歐洲案例討論

標題雖這樣講，但是其中細節如下。

本次討論的議題涉及一種「問題發明（problem invention）」，也就是解決特定技術問題的發明。應該所有發明/專利都是解決至少一個技術問題，然而，如果相關問題的解決方式為已知，或說對相關技術人員而言為「顯而易知（obvious）」，在此案例看來解決問題的手段也不多（證據顯示僅有兩種），將使得解決問題的手段也為顯而易知，對應的專利/發明也變得顯而易知，不具進步性。

涉及相關進步性考量的議題的歐洲訴願案：T 971/92（1994年），其中Technical Board of Appeal認定「為相關技術人員的普通動作而不具進步性」的技術如：缺點改進、參數優化、能源或時間節省等，為不具進步性的技術（重要，可供專利申請人參考）。

Vringo Infrastructure Inc.看來是一個專利授權公司（NPE），握有不少買來的專利，包括本次對中興通訊荷蘭分公司主張侵權的專利是從Nokia買來的。

海牙地院編號： C/09/481474 / HA ZA 15-100 
侵權原告：Vringo Infrastructure Inc.
侵權被告：ZTE Netherlands B.V.

緣起：
根據系爭專利119案的資訊得到，Vringo於2012年自Nokia取得專利，當時交易的數量達500件，花了大筆前取得專利，自然是要從其中獲取利益，當年在另一個海關程序中更已經成功地阻擋了ZTE產品進口荷蘭，接著Vringo即於2014年對部分已經禁止進口的ZTE產品提出扣押（attach）以及侵權告訴。

不過，這個似乎「順水推舟」的告訴仍遭遇了阻礙，雖然系爭專利曾經遭遇異議、無效，甚至是訴訟都存留下來，但是這回ZTE提出的無效理由讓法官猶豫了。

系爭專利：EP 1186119
這是一種利用兩個天線以分散多樣方式傳送序列中符碼（symbol）的傳送技術，能根據資料幀（frame）的開始碼得到的資訊定義傳輸型態（pattern），以及定義出天線傳送模式。

Claims 1. A method (300,400,500) for transmitting a certain sequence of symbols, where -a frame is constructed of a certain number of consecutive symbols, -the symbols belonging to the sequence are transmitted (404,502,606) using at least two antennas and -the transmission of the sequence of symbols is characterized (401,601) with a certain transmission pattern, characterized in that -the transmission of the sequence of symbols is started (402) from a predefined antenna and -the transmission pattern is started (403,405) from the beginning in the beginning of each frame.

法院審理系爭專利有效性時，針對進步性議題，無效理由包括用於3G通訊中的UMTS標準公佈時間比系爭專利優先權日更早，結合差不多時間的其他文件，如此，法院認為相關技術人員可以透過結合這些先前文獻而提出如系爭專利解決通訊問題的技術手段，系爭專利不具進步性。

雖Vringo爭辯其系爭專利解決了本質上的技術問題，不過因為缺乏有力的說法，甚至有證據揭露了曾有專家間的電子郵件已經在討論系爭專利欲解決的技術問題，法院認為因為相關問題已經存在，因此使得解決相關問題的系爭專利技術顯得「顯而易見」，不具進步性。參考案例為T 971/92。

法院最終判決：ZTE正確地主張先前技術中已經有兩個解決相關問題的選項，因為證據顯示解決相關問題的方式不多，並非系爭專利曾經面對的異議程序中TBA（技術訴願委員會）所提到的多種解決選項，使得解決相關問題的技術對相關技術人員而言為顯而易知，也就是系爭專利前這類技術問題已經被討論，系爭專利被判不具進步性。

以上提到系爭專利曾經面對的阻礙可見於本判決文中，前後TBA態度差異是因為過去並未提出其他解決相關問題的先前技術，或是已知的解決方案；而ZTE在此案例中明確提到僅有兩種解決相關問題的選項，這樣使得系爭專利並未通過本次無效理由的考驗。

ZTE提出兩種解決問題的技術手段：

結論顯示，119專利無效，且Vringo要繳付15萬歐元的訴訟費用等：

my two cents:
對於被告或是主張專利無效的人來說，本次ZTE的策略與舉證方式可為參考，至少可以嘗試證明系爭專利為解決已知問題的有限選項之一而已。

對於專利申請人或專利權人而言：
雖然這是歐洲案例，不過內容與結論都頗有參考價值，特別是針對「解決已知問題」的技術手段對於相關領域技術人員而言是否是「顯而易知」？這也常常是答辯上的議題之一，問題或許是已知，但是如果是長久以來已知的問題，卻沒有任何解決方案，如果某專利已經提出解決方案，這點可證為具有進步性的技術，甚至如果僅是簡單的技術手段，在Secondary Consideration中也可證明為解決長久問題而具有進步性的技術。

但是，如果解決相關問題的手段為已知，如果選項也不多，相關專利或發明則在相關技術領域中為顯而易知；此時，發明人仍不需氣餒，只要提出明確而細節的技術方案（不能只有概念），在以上提到的歐洲訴願案的意見也有相關支持，相關實務上更是如此，這樣的專利仍具有專利性的可能。

海牙地方法院判決文：
http://www.eplawpatentblog.com/2015/November/ZTE%20v.%20Vringo%20%28EN%20%20translation%29.pdf

參考案例T 971/92：
http://www.epo.org/law-practice/case-law-appeals/recent/t920971eu1.html#q=
（案例備份：https://app.box.com/s/1bbusm18dtnatdgdlc9nftc4n0lcj1tz）

資料參考：
http://www.eplawpatentblog.com/eplaw/2015/11/nl-zte-v-vringo.html

Ron

重複專利討論(double patenting) iv

過去有關重複專利（double patenting）的討論有：

重複專利(double patenting) i（http://enpan.blogspot.tw/2011/02/double-patenting-i.html）
重複專利(double patenting) ii（http://enpan.blogspot.tw/2011/02/double-patenting-ii.html）
暫時性重複專利核駁-(double patenting) iii（http://enpan.blogspot.tw/2013/03/double-patenting-iii.html）

本次討論源自同事的問題：

1. 如果專利申請案遭遇Non-Statutory Double Patenting（非法定重複專利）/obviousness-type double patenting時，如果是「相同申請人」，應該就是提出終權聲明（Terminal Disclaimer）為解決方式，除非有答辯空間。但如果答辯期間，另一涉及重複專利的申請案已經被轉讓給別人，如何解決？
2. Double Patenting無效理由關於「新穎性」，不過，在同一申請人下，可不可以利用Non-Statutory Double Patenting作為再審程序（re-examination）中的無效理由？

[問題1]的回應：
這個問題的回答見於MPEP 804的某處Examiner Note。
...
If the provisions of 35 U.S.C. 102(b)(2)(C) or pre-AIA 35 U.S.C. 103(c)(1) apply to the commonly owned conflicting inventions of different inventive entities or if the provisions of 35 U.S.C. 102(c) or pre-AIA 35 U.S.C. 103(c)(2) apply to non-commonly owned inventions subject to a joint research agreement and thereby obviate the rejection(s), double patenting rejection(s) should be made (or maintained) as appropriate. If, however, it is determined that the provisions of 35 U.S.C. 102(b)(2)(C) or pre-AIA 35 U.S.C. 103(c) do NOT apply because the inventions were not commonly owned or subject to an obligation of assignment to the same person at the time the later invention was filed or made, or because the claimed invention did NOT result from activities undertaken within the scope of a joint research agreement as required by 35 U.S.C. 102(c) or pre-AIA 35 U.S.C. 103(c)(2) and (3), and there is evidence of record to indicate that a patent or application is prior art against the application being examined, the examiner should make (A) any appropriate double patenting rejection(s), and (B) the appropriate prior art rejection(s) under 35 U.S.C. 102 and/or 35 U.S.C. 103 in the application being examined. See the charts in MPEP § 804. Rejections under 35 U.S.C. 102 or 35 U.S.C. 103 cannot be obviated solely by filing a terminal disclaimer.

此段描述，不論是否共同擁有，或受到共同研發合同限制的不共同擁有的專利，都可能遭遇重複專利核駁。若非共同擁有，或是讓與到同一人，或是非規範於共同研發合同中，不能適用103(c)排除同人的先前發明的阻礙。此類專利都因此無法以Terminal Disclaimer克服非法定重複專利，而會遭遇102/103核駁理由。

[問題2]的回應：
Double Patenting在不同申請人的情況下，自然是「後申請案」無法專利才是。但前後案為同一申請人時，前案也不見得可以成為後案的無效證據，但卻可能讓前後案都面對「非法定重複專利」的問題，不過這是否可以成為「無效理由」？

根據MPEP 2258的規定，重複專利確實可以成為無效理由，當然這是因為35 U.S.C. 102(b)(e)(g)等規定，如果前後專利因為「不察」而都獲准專利，後案（或說後發明案）理應不具有新穎性。

如果前後專利為「相同發明」，顯然後申請案無法准予專利，若有一些差異，後申請案則面對是否為顯而易見的問題。

但是，若前後「非法定」重複專利案為同一申請人，兩案並非相同發明的情況下，兩者之間又沒有「Terminal Disclaimer」，顯然後申請案有不當延長專利權的疑慮，這仍可以成為提起美國專利再審程序的理由之一。

根據MPEP 2258的規定，再審程序應依據先前技術提出無效理由，但依據1997年聯邦巡迴法院案例，「非法定重複專利」可為無效理由。

MPEP 2258 SCOPE OF EX PARTE REEXAMINATION
...
Typically, substantial new questions of patentability and rejections in a reexamination proceeding are based on “prior art” patents and publications. There are exceptions, however. For example, in In re Lonardo, 119 F.3d 960, 43 USPQ2d 1262 (Fed. Cir. 1997), the Federal Circuit upheld a nonstatutory double patenting rejection in which the patent upon which the rejection was based and the patent under reexamination shared the same effective filing date. See also the discussion as to double patenting in subsection I.D. below. Analogously, a 35 U.S.C. 102(g)(2) rejection may be asserted in a reexamination proceeding based on the examples illustrated in the chart below: 

重複專利有四種樣態：(A)由同一實體提出申請；(B)由不同實體提出申請，但具有共同發明人；(C)由共同授讓人（擁有人）提出申請；(D)35U.S.C.103(c)(3)定義的共同研發合同範疇下的結果。

以上流程描述一個範例，兩個專利申請案分別申請於1/4/07與2/4/07，前後申請日差一個月，並為相同發明的專利。

情況一是沒有共同受讓人或發明人，這兩件專利「誰為先發明」將成為爭點之一，可以衝突程序（interference）協調。此例顯示後申請案贏得衝突程序，使得先前申請案反而遭遇102(g)/103(a)核駁。

情況二是具有共同授讓人，但是卻為不同的發明實體/發明人（在發明當下並沒有共同擁有權，沒有共同研發合同），授讓人將取得在前的發明。此例顯示後申請案為先前發明者，因此前申請案因為102(g)/103(a)而無效（此有系爭案申請與獲准時間點的適用）。

但此無效理由可透過Terminal Disclaimer克服。

在共同研發合同的狀況下，2004年12月10日公告領證的案子適用，當申請人並未提出Terminal Disclaimer時，不論是否共同擁有、為相同發明實體等，重複專利的無效理由都適用於再審程序中。但仍可以Terminal Disclaimer克服。

[法條參考]
102(g)：http://enpan.blogspot.tw/2008/09/102g.html

35 U.S.C. 103(c)(3):
For purposes of paragraph (2), the term “joint research agreement” means a written contract, grant, or cooperative agreement entered into by two or more persons or entities for the performance of experimental, developmental, or research work in the field of the claimed invention.

MPEP 2258
...

Double patenting may exist where the patent being reexamined and a patent or application contain conflicting claims and:

• (A) are filed by the same inventive entity;
• (B) are filed by different inventive entities having a common inventor; and/or
• (C) are filed by a common assignee (common ownership); and/or
• (D) result from activities undertaken within the scope of a joint research agreement as defined in 35 U.S.C. 103(c)(3).

A double patenting rejection based on common ownership may be applied if the earlier invention would qualify as prior art for purposes of obviousness under 35 U.S.C.103(a) only under 35 U.S.C. 102(g), or under 35 U.S.C. 102(e) in a reexamination proceeding in which the patent under reexamination was granted on or after December 10, 2004; or in a reexamination proceeding in which the application which issued as a patent undergoing reexamination was filed on or after November 29, 1999.

As is the case for an application, a judicially created double patenting rejection (made in a reexamination) can be overcome by the filing of a terminal disclaimer in accordance with 37 CFR 1.321(c). Where a terminal disclaimer is submitted in a reexamination proceeding, form paragraph 14.23.01 should be used if the terminal disclaimer is proper. If the terminal disclaimer is not proper, form paragraph 14.25 should be used, and one or more of the appropriate form paragraphs 14.26 to 14.32 must follow form paragraph 14.25 to indicate why the terminal disclaimer is not accepted. See also MPEP § 1490.

3.   JOINT RESEARCH AGREEMENT

Where the patent under reexamination issued on or after December 10, 2004, a double patenting rejection may be applied (assuming that the patent owner has not already filed the appropriate terminal disclaimer) if:

• (A) the patent under reexamination claims an invention that is not patentably distinct from an invention claimed in a non-commonly owned pending application or issued patent (i.e., not patentably distinct from an invention claimed in a “reference application or patent”);
• (B) the patent being reexamined and the non-commonly owned reference application or patent are by, or on behalf of, parties to a joint research agreement; and
• (C) a statement has been filed under 37 CFR 1.104(c)(4)(iii) to disqualify the non-commonly owned reference application or patent from being prior art under 35 U.S.C.103(c)(2).

Thus, the patent being reexamined and the subject matter disqualified under 35 U.S.C. 103(c), as amended by the CREATE Act, will be treated as commonly owned for purposes of double patenting analysis. Such a double patenting rejection will be made regardless of whether the patent being reexamined and the non-commonly owned reference patent or application have the same or a different inventive entity. This double patenting rejection may be obviated by filing a terminal disclaimer in accordance with 37 CFR 1.321(d). A double patenting rejection may NOT be made on this basis if the patent under reexamination issued before December 10, 2004. 

Ron

蝙蝠車有著作權保護

即便是電影上的「想像」物品，都有著作權，這回是有位老兄Mark Towle仿製了電影中的蝙蝠車（Batmobile），結果被DC Comics與Warner兄弟公司提出侵權告訴。

被告Mark Towle有在「 www.gothamgarage.net」販售車輛與相關工具：

在地方法院階段，客觀上，認為即便幾代的蝙蝠車有所變化，但是有些特徵仍屬一致，特別是高科技的工具、武器、蝙蝠形式的基本設計、顏色等，法院根據一些如以上的調查，判定蝙蝠車可以主張著作權保護。

並且，DC Comics也是透過商品維護了其著作權，判定Mark Towle的仿製品侵害了DC Comics漫畫書中蝙蝠車的著作權。

地方法院甚至認為Mark Towle有蓄意侵權的意圖。

上訴法院階段：
法院重申著作權的保護並非只在其原創的內容，也應具有足夠特別的元素（表示方式），如漫畫書。
“Courts have recognized that copyright protection extends not only to an original work as a whole, but also to “sufficiently distinctive” elements, like comic book characters, contained within the work.“

雖然著作權法並未針對「漫畫書中的角色」，但從華德迪士尼的卡通人物開始，就已知一個卡通（內容本身有著作權）內的個別角色也都具有可被著作權保護的資格。因此，如本案，漫畫書、電視、電影中的個別角色應該都具有可被著作權保護的資格。

有關「車輛角色」可被著作權保護也不乏先前案例，因此上訴法院根據蝙蝠車不僅是個虛擬角色，而且有實體物品，以及具有可識別的特徵（容易判斷侵權行為）等探索與資訊，判定蝙蝠車是有著作權保護，侵權成立。

還有個議題是衍生著作的問題，未經授權的衍生著作（如一部車）導致其侵害基礎工作（如蝙蝠圖案），這裡引用Apple v. Microsoft當年作業系統操作介面的著作權爭議，十分有趣。

結論：
不論是地方法院，或是上訴法院，都因為電視（1966）、電影（1989）（始自1941年漫畫）中的蝙蝠車具有足夠的可辨識的特徵（可辨識侵權物），認為Warner/DC Comics擁有蝙蝠車的著作權，判定Mark Towle侵權，而且是蓄意侵權。

美國第9上訴法院判決書：
http://cdn.ca9.uscourts.gov/datastore/opinions/2015/09/23/13-55484.pdf

參考資料：
http://mcclimanlawfirm.blogspot.tw/2015/09/update-regarding-lawsuit-involving.html

http://www.iptrademarkattorney.com/2011/05/copyright-trademark-dc-comics-mark-towle-vehicle-kits-batman-cars-batmobile-comic.html

Ron

生日快樂歌著作權屬於公眾

一個新聞的標題，簡單的歌與複雜的歷史，生日快樂歌在80年後終於為「免費」。知道這首芭樂歌有版權，我們卻也唱了一輩子。

「Happy Birthday To You」：

（影像來自wikipedia）

1998年金氏世界紀錄認定"Happy Birthday To You"為最熟知的英文歌曲，而此全世界的人都可朗朗上口的生日快樂歌的旋律原本來自於1893年Patty Hill與Mildred J. Hill寫的"Good Morning To ALL"，之後在1912年才被人結合到日後傳唱的“Happy Birthday To You”的歌詞上。Warner宣稱，雖歌曲部分已經是公眾財，但是根據1935年著作權法（合法取得版權），他們仍擁有歌詞的著作權。

（source: http://www.warnerchappell.com/）

過去版權（歌詞）所有人為Warner Music確實用此歌曲得到不少授權費用，每年約200萬美元，來源如舞台劇、電視節目、電影或生日卡片，這樣看來，開個生日宴會，或是餐館播放生日快樂歌（含歌詞）都是可以主張版權的狀況。

原本的Good Morning To All：

（影像來自wikipedia）

不過，這個一有人生日就在唱的生日快樂歌的版權在2015年法院判決中判定生日快樂歌屬於公眾領域（public domain），因此這是沒有版權的歌曲。（updated on Nov. 3, 2015）

案件資訊：
原告：Rupa Marya, et al.
被告：Warner/Chappell Music, Inc., et al.

(updated)使用生日快樂歌相關故事：1994年，製片Steve James付給Warner Music使用生日快樂歌的權利金$5000，要在其講述非裔美人追夢成為職業籃球員的紀錄片「Hoop Dreams」中使用，但這對於一個小製片來說，是一筆很大的金額，而且在片中僅用了9秒鐘。

(updated)緣起：抱怨不如提告，Rupa Marya, Robert Siegel, Good Morning to You Productions Crop., Majar Productions, LLC提出版權爭議的集體訴訟（class action），主張被告並未有此歌詞版權，理由是與多年前已經拋棄版權的「Good Morning To All」的歌詞太像，且其中版權轉移的資訊都不是很明確（這也算一種小蝦米對大鯨魚的訴訟）。

Sep. 22, 2015 地方法院判決：

旋律原始的歌詞與後來的生日快樂歌詞，以及一些版權的轉移資訊都揭示在判決文中，還包括過去一些有關這首歌的爭議，用於判決參考，有興趣者可以看原文，這裡僅摘錄一點點：

雙方版權爭議如下摘錄，地方法院認為，根據多年前聯邦政府登錄的版權資料並不能證明被告擁有其版權：

誰寫了生日快樂歌歌詞？
雖然原告可能不用證明誰是生日快樂歌原作者，但是卻也提到在上個世紀初有許多出版品都提到這首歌，到底是誰是作者，很難說是原來寫出「Good Morning To All」的人的改編歌詞，可以溯及1911年，雖仍比原作者時間晚，但是卻比被告宣稱有版權的1935年早許多年。

地方法院簡易判決（Summary Judgement）中提到，在許多爭議中，原告提出有力的證據表示生日快樂歌的版權在1922年的一本書「The Everyday Song Book」已經有拋棄版權的資訊，其中表示當年作者（Hill姊妹）授權給Summy Co.，Summy Co.也允許出版與公開，應該已經是一般公開，表示Hill姊妹已經在當時拋棄版權。即便如此，這個證據也不強。

當然，證據仍有爭議，判決文從許多冒出來的證據，更提到許多對我來說頗難理解的權利變化的判斷，因為還涉及歌詞的作者可能不只有已經拋棄的人，還有共同作者、合約、權利移轉等議題，這都造成判斷的困難度。

權利移轉資訊對被告不利：

最後，法院在此簡易判決中認為，被告沒有提出證據（口頭或書面證據）表示「歌詞」權利移轉，因為許多證據都是有關歌曲，沒有直接證據顯示「生日快樂歌詞」在一個世紀前由作者移轉給後來的人，被告也沒有證據顯示已經取得歌詞授權。

法院認為，很多證據都顯示歌曲權利的移轉，後來也被拋棄，卻沒有明確歌詞上的授權與註冊，原作者也沒有以法律行為拒絕他人使用生日快樂歌詞，後來取得權利的Summy Co.也僅取得歌曲版權，不是歌詞，這樣也使得生日快樂歌變的廣泛使用。

這樣，目前主張權利的Warner Music就沒有生日快樂歌的權利，這是一個公共財（public domain）。

後語：
有興趣者可以直接參考判決書。
版權爭議確實有趣，特別是這種需要考古的芭樂歌。
審查過程就是等於探索這首歌的版權擁有權，包括揭露出這首歌過去獲利的歷史，取得權利金的歷史可以回溯到1935年。本案仍有上訴機會。

判決書：
http://documents.latimes.com/happy-birthday-ruling/

參考資料：
https://en.wikipedia.org/wiki/Happy_Birthday_to_You

http://www.latimes.com/local/lanow/la-me-ln-happy-birthday-song-lawsuit-decision-20150922-story.html

http://dailysignal.com/2015/10/01/why-the-happy-birthday-songs-copyright-has-finally-been-ruled-invalid/

Ron