侵權判斷時，Product-by-Process範圍仍考量了流程特徵 - Abbott Labs v. Sandoz (Fed. Cir. 2009)案例討論，這原則被最高法院的意見影響很深。
關於Product-by-Process權利範圍的討論很多，目前主要的結論是，撰寫此類專利範圍時，除了只能用process描述某元件特徵的條件外，不建議使用product-by-process描述專利範圍；在專利審查時，僅考量Product-by-Process中的結構特徵，其中程序特徵並不在考量之內；而侵權議題中，此案例顯示，解釋專利範圍不及於用不同程序（製程）製作的相同物品。
此案中上訴人認為解釋「Product-by-Process」不應依照「Atlantic Thermoplatics line」解釋原則，認為不應該納入Product-by-Process專利範圍中的程序（process）特徵。也就是，上訴人主張侵權判斷時應採用「Scripps Clinic & Research Foundation v. Genentech, Inc.」案例的解釋，僅及於用權利範圍描述的程序所製作的物品，不過這是已經被拋棄的1991年過時的原則。
永遠存在的議題是，是否Product-by-Process專利範圍是否及於用不同程序製作的相同物品？此案例提供了一些參考。
案例資訊：
原告/上訴人：ABBOTT LABORATORIES, ASTELLAS PHARMA, INC.
被告/被上訴人：SANDOZ, INC., SANDOZ GMBH, TEVA PHARMACEUTICALS USA, INC., etc.
系爭專利：US4,935,507
系爭專利揭露一種結晶體（Crystalline 7-(2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido)-3-vinyl-3-cephem-4-carboxylic acid (syn isomer)），原告以此系爭專利在不同地方法院提出侵權告訴，但各地方法院不約而同地作出不利於原告的判決，包括有侵權不成立、否決禁令請求等。
Eastern District of Virginia作出侵權不成立決定。
Northern District of Illinois否決原告提出的初步禁制令請求。
系爭專利涉及的結晶體（抗生素cefdinir）有個商標名稱"Omnicef"，是一個FDA驗證通過的抗生素，請求項1如下，因為FDA檢驗程序延遲也補償了1千多天的專利期限調整。
請求項1使用了化學名稱定義出具有"powder X-ray diffraction (PXRD) angle peaks"的特性，關於X光繞射角，如圖1，此為以特性界定結晶體的專利範圍。（並非認為是product-by-process）
X光繞射角：
另請求項2-5並非引用請求項1，並非如請求項1透過特性（diffraction angle）來界定結晶體。
此系爭專利'507並非是第一件相關抗生素專利，只是因為具有特定特性而准予專利權，例如US4,559,334即揭露了抗生素cefdinir的成份，也就是結構特徵已經被揭示於先前專利中。經專利答辯後，已經排除如'334的前案揭露，也就排除了"Crystal B"的實施樣態。
'334專利已經揭露這個結晶體：
'507專利（本案）揭露出這個結構，兩者基本上是一樣的：
針對請求項1，系爭專利主張前一件日本案JP62-206199的優先權，該案揭露兩種結晶體"Crystal A"與"Crystal B"，於解釋請求項1專利範圍時，採用內部證據，經法院解釋後，認為系爭專利請求項範圍提到的結晶體應該是"Crystal A"。
"product-by-process"
請求項2-5被解釋為"product-by-process"範圍，理由是其中描述是以「步驟"得到"結晶體」的描述方式：
"2. Crystalline 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer) which is obtainable by acidifying a solution containing 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer) at room temperature or under warming."
在「product-by-process」專利範圍解釋時，原告自然會希望專利範圍廣至其結構特徵而已，在MPEP（如下引用內容）中，product-by-process專利範圍的專利性（也涉及無效條件）並不考量其中方法特徵，不過在侵權判斷時，卻納入了所描述的方法特徵，這部分引用了最高法院在多件案例一致的態度。
以下是引用最高法院的對於product-by-process的意見：
"obtainable by"
其中有個議題是，請求項2使用"obtainable by"而非"obtained by"，原告企圖以此用語擴張專利範圍解釋並非在請求項中描述的方法特徵，但是，法院明察，根據系爭專利答辯歷史，原告（專利權人）曾拋棄過其他可選擇的方法，證明請求項2的描述就是唯一的限制。
"2. Crystalline 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer) which is obtainable by acidifying a solution containing 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer) at room temperature or under warming."
這個用語反倒引來了反效果，讓法院以更嚴格的角度來解釋專利範圍。
"doctrine of equivalents"
這裡提到，當以均等論解釋專利範圍時，會"逐元件（element by element）"解釋，而非針對整體請求項範圍，因此也不如原告想要以整體功能、手段與結果等方向主張專利侵權，更遑論歷史答辯禁反言（不及於"Crystal B"）。
"equivalency for purposes of patent infringement requires an element-by-element comparison of the patent claim and the accused product, requiring not only equivalent function but also equivalent way and result."
最後，CAFC同意地院不侵權與否決禁令請求的決定：'507的結晶體為"Crystal A"，也不適用均等論而涵蓋"Crystal B"，判決對請求項1-5文義不讀取，對請求項2-5均等論不適用，否決禁令請求。
my two cents:
製程、化學相關技術應該免不了使用「product-by-process」的撰寫方式，但是還是要確保其中結構特徵是有新穎性/進步性（patentability）才是；另也要有心理準備，如果寫入了程序方法，目的應該是要取得專利（這裡有矛盾，不過，這可以解釋必要程序形成的結構特徵），但在侵權判斷時，都是範圍的限制。
本案專利權人在撰寫「product-by-process」請求項時很聰明地使用了一個模糊的字眼「obtainable by」，這樣或許會產生較廣的解釋空間，甚至是不限制在該項範圍內的流程描述，不過這個手法被法院打臉，還是不要輕易嘗試這種有模糊解釋的用語。
資訊補充：
本部落格相關Product-by-Process報導如：
http://enpan.blogspot.tw/2011/12/product-by-processabout-claims-xliv.html
http://enpan.blogspot.tw/2009/09/about-claims-xxiv-product-by-process.html
MPEP 2113幾段關於product以及process解釋專利範圍與專利有效討論的段落，其實美國專利局很討厭product-by-process專利範圍：
“Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.”
"because validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes."
"The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product."
"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion."
"The lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith."
MPEP 2173.05(P)
"A product-by-process claim, which is a product claim that defines the claimed product in terms of the process by which it is made, is proper."
"A claim to a device, apparatus, manufacture, or composition of matter may contain a reference to the process in which it is intended to be used without being objectionable under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, so long as it is clear that the claim is directed to the product and not the process."
MPEP 2141.02 DIFFERENCES BETWEEN PRIOR ART AND CLAIMED INVENTION
...
The Solicitor argued the preamble was directed to a process for preparing foods and drinks sweetened mildly and thus the specific method of making the high purity maltose (the first two steps in the claimed process) should not be given weight, analogizing with product-by-process claims. The court held “due to the admitted unobviousness of the first two steps of the claimed combination of steps, the subject matter as a whole would not have been obvious to one of ordinary skill in the art at the time the invention was made.”
...
判決原文：
http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/07-1400.pdf
（備份：https://app.box.com/s/mhk8ar3v9n361a5pwuh79e2cpwf96f6r）
案件資訊來源：
http://patentlyo.com/patent/2009/05/en-banc-federal-circuit-infringement-of-product-by-process-claim-requires-practicing-the-process.html
Ron
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