被上訴人：BAYER AG and Bayer Corporation
專利權人/上訴人：HOUSEY PHARMACEUTICALS, INC.
系爭專利：US4,980,281, 5,266,464, 5,688,655, and 5,877,007
本案緣起一個侵權訴訟，專利權人Housey在District of Delaware提出侵權訴訟，被告Bayer提出專利無效、無法主張與不侵權的簡易判決請求，原告Housey隨即提出回應，強調Bayer直接侵權、共同侵權與誘使他人侵權，主張法條即35 U.S.C. § 271(g)。
被告Bayer的回應是，35 U.S.C. § 271(g)僅適用製程方法，卻不適用如系爭專利的方法中。Housey指控有兩部分侵權物：通過專利方法得到的重要資訊，以及通過專利方法製作的藥（成份）。
通過在美國境內或境外使用專利方法製造的藥品，當被告在美國販售此包括可以判斷目標蛋白質的抑制劑或催化劑的成份的藥品時，應擔負侵權責任；當被告進口使用專利方法得到的研究數據或資訊，被告擔負侵權責任。
而地方法院判決撤銷原告的侵權主張，理由是，35 U.S.C. § 271(g)的規定是針對製程方法製作的物品，與取得資訊的方法不同。
原告上訴CAFC。
系爭專利為同一家族專利，如US5,877,007，關於篩選蛋白質抑制劑與催化劑的方法。
列舉US5,877,007請求項1，此項標的雖為測試細胞（test cell），但是專利範圍係以方法步驟界定使用測試物質抑製或激活靶蛋白的生物化學功能的測試流程。
1. A test cell in which there is present in the cell a target protein, wherein the presence of the target protein induces a change in a selected phenotypic characteristic of the test cell, other than the level of the target protein in the test cell, per se, wherein the change in the selected phenotypic characteristic is comparatively greater in the test cell than in a control cell, and wherein the change in the selected phenotypic characteristic has been found to be responsive to treatment with a test substance that is capable of inhibiting or activating a biochemical function of the target protein, by a method comprising the steps of:
a) providing a test cell in which a target protein is present at a higher level relative to a control cell which produces the protein at a lower level or essentially does not produce the protein;
b) treating the test cell of step (a) containing the target protein of step (a) with a test substance; and
c) examining the treated test cell of step (b) to determine whether an selected phenotypic characteristic that is responsive to inhibition or activation of the target protein of step (a) has been altered by treatment with the test substance of step (b).
上訴議題涉及35 U.S.C. § 271(g)的侵權條件，法院調用字典來解釋271(g)內的用語，如"make"，解釋為製造；也可以解釋為形成計算結果。這樣來看，沒有結果。
再用法條直接解釋，看來法規解釋是在「製造」。
在35 U.S.C. § 271(g)中，有兩個例外條款，這兩個例外條款讓法官能夠前後一致地解釋所述"make"就是製造。
[法條]
35 U.S.C. § 271(g) Whoever without authority imports into the United States or offers to sell, sells, or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer, if the importation, offer to sell, sale, or use of the product occurs during the term of such process patent. In an action for infringement of a process patent, no remedy may be granted for infringement on account of the noncommercial use or retail sale of a product unless there is no adequate remedy under this title for infringement on account of the importation or other use, offer to sell, or sale of that product. A product which is made by a patented process will, for purposes of this title, not be considered to be so made after—
更嚴謹地，法院參考了國會立法的歷史，確認了"make"就是指"product manufactured by a patented process"。
"A subsequent bill in the following year again proposed a precursor of section 271(g): "[i]f the patent invention is a process, whoever without authority uses or sells within, or imports into, the United States during the term of the patent therefor a product produced by such process infringes the patent." S.REP. No. 98-663 at 30 (1984) (discussing S. 1535, 98th Cong. § 2 (1984)). According to the Senate Report, a principal aim of S. 1535 was "[t]o declare it to be patent infringement to import into, or to use or sell in the United States, a product manufactured by a patented process." Id. at 1 (emphasis added)."
綜觀各方面的法律，沒有任何指示是指製作非具體物品以外的意思。
"Id. at 40 (emphasis added). The "manufacturer" was referred to as the "preferred defendant because of its direct knowledge of the process." Id. at 39. The proposed statute also permitted suit against "the persons receiving the goods in this country in the belief that they may be in the best position, apart from the manufacturer, to determine how the goods were made." Id. (emphasis added). Here again, there is no indication of any intent to reach products other than tangible products produced by manufacturing processes."
立法的目的是提供流程專利權人有意義的保護，專利權人可以從美國境內使用未授權的流程中取得賠償，如此，境內的製造才會侵害製程專利的權利，境外的製程不侵權。
"The purpose of this bill is to provide meaningful protection to owners of patented processes. Under current patent law, owners of such patents have remedies for unauthorized use of the process only if the process was used in the United States. As a consequence, while a domestic manufacturer using the patented process would infringe the process patent, a foreign manufacturer who imports the product would not."
這個提醒很重要。新的製程技術的價值反映在產生的新的產品，新的流程可以提昇產品品質，或是新的流程可以允許產品更經濟地被製造。如生物科技，唯有新的流程產生新的物品。因此，流程的專利權人的優勢是提告、販售產品、授權等，如果無法約束製程產生的物品的進口、銷售或使用，將減損製程專利的價值。
"The value of new manufacturing techniques is reflected in the resulting new products. A new process may enhance the quality of the product produced, or the new process may permit the product to be made much more economically. In some cases, for example biotechnology, the new process may be the only method of producing a new product. In all of these instances, the advantage to the process patent owner is realized by suing or selling the product, or licensing others to do so. As a consequence, the unfettered ability of others to import, sell or use a product made by the patented process, severely diminishes the value of a U.S. process patent."
資訊（如知識）的進口是抽象議題，不容易掌控。在此案例中，Bayer指出，擁有被宣稱侵權的資訊的人，可能因為入關美國而被控侵權。
"Finally, reading the statute to cover processes other than manufacturing processes could lead to anomalous results. The importation of information in the abstract (here, the knowledge that a substance possesses a particular quality) cannot be easily controlled. As Bayer points out, a person possessing the allegedly infringing information could, under Housey's interpretation, possibly infringe by merely entering the country."
CAFC在本次判決中，解釋271(g)僅限定在製程專利所製作的具體物品上，而不包括專利流程產生的資訊（"does not include information generated by a patented process"），而在此侵權爭議中，主張的「具體物品」並非由專利流程所製作，因此判斷侵權不成立，確認地院撤銷Housey反訴的決定。
（這個片段來源：https://www.eff.org/files/2015/11/10/clearcorrect_v_itc_-_opinion.pdf）
一些重點摘錄：
- 35 U.S.C. § 271(g)規範下的侵權行為及於專利製程製造的具體物品，而不是產生的資訊。（"we conclude that infringement under 35 U.S.C. § 271(g) is limited to physical goods that were manufactured and does not include information generated by a patented process"）
- 35 U.S.C. § 271(g)所述僅在物品的製造方法，而不是收集資訊的方法或是定出直得發展的物質。（"Section 271(g) addresses only products derived from patented manufacturing processes, i.e., methods of actually making or creating a product as opposed to methods of gathering information about, or identifying, a substance worthy of further development.""）
- 當Housey主張：專利法101條規定可專利的"manufacture"建議是271(g)的「製造"made by"」，不應被限定在「製造方法」（"Housey urges that the use of the term "manufacture" in 35 U.S.C. § 101 suggests that "made by" as used in section 271(g) should not be limited to methods of "manufacture." "），但法院回應是：101中的「made」與271(g)無關，不會過廣解釋271(g)（"We see nothing in section 101 that suggests that "made" in section 271(g) should be construed to be broader than "manufacture."）。如此可知，271(g)規範的侵權範圍就是限定在方法專利所製造的「實體物品」上。
判決文：
https://openjurist.org/340/f3d/1367/bayer-ag-v-housey-pharmaceuticals-inc
my two cents:
從案例可知，35 U.S.C. § 271(g)被限定在方法專利所製作的「物品」的侵權行為，而根據一些資訊可知，「35 U.S.C. § 271(g)常用來做Section 337防禦」，也就是，ITC管的是進口美國的侵權議題，卻也僅及於實體物品，不能管道數位內容。
可參考前篇報導：筆記美國專利法第271條（http://enpan.blogspot.tw/2017/11/271.html），若要以271(g)抵禦Section 337，即考量其中侵權排除的項目：(1)it is materially changed by subsequent processes; or (2)it becomes a trivial and nonessential component of another product，相關專利流程已經被重大改變，或是相關製程產品已經變成其他產品中不重要的部分。
資料參考（需登入）：
https://www.law360.com/ip/articles/780027/the-role-of-section-271-g-in-the-wake-of-clearcorrect
其他參考：
ITC管不到數位內容 - In ClearCorrect v. ITC and Align Tech (CAFC 2015)（http://enpan.blogspot.tw/2015/11/itc-in-clearcorrect-v-itc-and-align.html）
Ron
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