近期美國聯邦巡迴上訴法院專利判決整理

這次的判決整理有生物相似製劑相關訴訟，有多方複審上訴的美國憲法第三條的當事人適格性議題 (這個重要)，有書面描述要件未滿足導致專利無效的案件，以及小公司被大公司合作結果技術被拿去申請專利的故事。

AMGEN INC. v. SANDOZ INC. [OPINION - PRECEDENTIAL] (May 8, 2019)

Amgen依生物製劑價格競爭與創新法 (Biologics Price Competition and Innovation Act) 第262條，在北加州地院提起的確認訴訟，主張Sandoz欲申請上市的filgrastim生物相似製劑侵害其相關專利。(關於filgrastim的相關資訊，可參考Technews 2017年的這篇文章。) 北加州地院認為Sandoz的產品未侵害 US 8,940,878的請求項第7項。上訴法院確認了這個不侵權判決。

這個案子值得注意的，是兩個關於請求項用語解釋的爭點：

(1) CAFC引用Mformation案 (Mformation Technologies, Inc. v. Research in Motion Ltd., 764 F.3d 1392, 1398–1400 (Fed. Cir. 2014)) (這是個軟體侵權訴訟案)，認為方法請求項中標示了 (a)、(b) 的各步驟，其用語邏輯上要求各步驟須依序執行：

First, as in Mformation, the claim language logically requires that the process steps, lettered (a) through (g), be performed in sequence.

(判決文第9頁)

(2) CAFC認為依說明書一致的描述，請求項第7項的 "清洗" 跟 "沖洗" 是兩個分開的步驟，且必須用不同溶液 (請求項本身沒有這個限制)：

Second, washing and eluting are consistently described in the specification as separate steps performed by different solutions.

(判決文第9頁)

Sandoz的產品製程中，只採用了一種緩衝溶液清洗一次。因此如果請求項照上面這樣解釋，Sandoz的產品沒有侵權。


BRADIUM TECHNOLOGIES LLC v. IANCU [OPINION - PRECEDENTIAL] (May 13, 2019)

PTAB在多方複審 (inter partes review) 程序後，認為Bradium的US 7,908,343與US 8,924,506 (後者是前者的部分延續案) 因顯而易見而無效。聯邦巡迴上訴法院維持了PTAB的決定。

本案兩個觀察點。首先，本案中PTAB把請求項用語 "Limited Bandwidth Communications Channel" 解釋為 "a communications channel whose bandwidth is limited"。Bradium認為PTAB解釋得太廣，嘗試做限縮解釋，但CAFC不支持其主張。關於CAFC的相關論述，請見判決文第16-21頁，基本上只是把請求項解釋的基本原則仔細操作一遍而已。

其次，Bradium的請求項其實有個特別的prioritization特徵，但CAFC認為在PTAB審理過程中，Bradium自己放棄了與prioritization相關的論述，所以無法上訴，造成343專利的請求項第15項無效。關於這個程序問題，請見判決文第25-27頁。


AVX CORPORATION v. PRESIDIO COMPONENTS, INC. [OPINION - PRECEDENTIAL] (May 13, 2019)

本案重要。AVX對Presidio的專利聲請多方複審，PTAB認為Presidio的專利部分請求項無效，部分請求項有效。AVX針對部分請求項有效的部分不服上訴。CAFC認為AVX當事人不適格，無法上訴。

這其實是老問題：針對PTAB多方複審的結果，部分當事人會因為不適格而無法上訴到CAFC尋求救濟。中間主要的爭點，在於當事人是否欠缺美國憲法第三條所要求的，尋求司法救濟必須具備的 "Cases or Controversies"，使其具備美國憲法第三條的當事人適格性。要主張這點，當事人必須證明其具備以下要件：

1. an “injury in fact,” (“a legally protected interest which is (a) concrete and particularized” and “(b) actual or imminent, not conjectural or hypothetical.”)
2. “a causal connection between the injury and the conduct complained of,” and
3. a likelihood that “the injury will be redressed by a favorable decision.” 

(判決文第5-6頁。主要引用Lujan v. Defenders of Wildlife, 504 U.S. 555, 559–60 (1992))

之前CAFC曾經認為，若PTAB在經過多方複審後認為專利有效，多方複審的聲請人不具備 "injury in fact" ，因而不具備美國憲法第三條的當事人適格性 。本案重要之處在於，針對AVX所提出的兩個新的當事人適格性依據，CAFC針對第一個做出了很具體的回應。

AVX認為，如果AVX現在不能針對PTAB維持專利有效的決定上訴到法院，那麼日後如果Presidio對AVX主張專利權，AVX也會因為35 USC 315(e)而無法基於相同的理由在法院訴請專利無效。這造成AVX完全無法在法院尋求救濟。關於這點，CAFC說 "我從來沒說過以後你如果被專利權人告，會因為315(e)而不能在法院主張專利無效啊"：

Second, this court has not decided whether the estoppel provision would have the effect that AVX posits—specifically, whether § 315(e) would have estoppel effect even where the IPR petitioner lacked Article III standing to appeal the Board’s decision to this court.

CAFC還詳細列出了當該狀況發生時，法院會考量甚麼，然後又補一句 "我們從沒基於這些考量說過315(e)應該如何正確地適用：

For this court to so hold, we would have to consider whether that reading of § 315(e) is tied to § 319’s right of appeal for any “party dissatisfied with the final written decision” of the Board. Relatedly, we would also have to consider whether § 315(e) should be read to incorporate a traditional preclusion principle—that neither claim nor issue preclusion applies when appellate review of the decision with a potentially preclusive effect is unavailable. We have not addressed those and other considerations bearing on the proper application of § 315(e).

然後CAFC說，我們這次不處理，是因為你們還沒有好好陳述這個爭點。下次如果Presidio跟AVX真的進行專利訴訟了，AVX你在那個案子再好好上訴試看看 (CAFC真的是用test這個字)，到時我一定會認真好好處理：

We decline to do so here. The parties have not briefed the issue; indeed, we have no adversarial presentations on the issue, because AVX assumes estoppel as a predicate for its standing argument and Presidio has evidently decided not to give up a possible future estoppel argument. If, in the future, a live controversy over the upheld claims arises between Presidio and AVX, and if either an infringement action or declaratory judgment action involving those claims is filed in district court, AVX can, in such an action, test whether § 315(e) bars it from raising the obviousness challenges that the Board reviewed and rejected. At that point, the parties presumably would be adverse on the issue.

各位大律師們，CAFC下指導棋了喔！以後碰到這狀況，記得試看看！很明顯這又是一個值得上訴到聯邦最高法院的問題了。


NOVARTIS PHARMACEUTICALS CORP v. WEST-WARD PHARMACEUTICALS [OPINION - PRECEDENTIAL] (May 13, 2019)

德拉瓦州地院認為Novartis的專利US 8,410,131的請求項第1-3項並非顯而易見。West-Ward上訴，CAFC維持地院見解。


BTG INTERNATIONAL LIMITED v. AMNEAL PHARMACEUTICALS LLC [OPINION - PRECEDENTIAL] (May 14, 2019)

PTAB認為BTG的專利US 8,822,438因顯而易見而無效。CAFC維持了PTAB的決定。


NUVO PHARMACEUTICALS v. DR. REDDY'S LABORATORIES INC. [OPINION - PRECEDENTIAL] (May 15, 2019)

CAFC認為Nuvo的US 6,926,907與US 8,557,285因未滿足美國專利法112條第1段的書面描述要件 (written description requirement) 而無效。本案重點在於，關於未包覆氫離子幫浦阻斷劑 (uncoated proton pump inhibitors，簡稱uncoated PPI，請求項中提到的 esomeprazole即為一例) 的有效性，說明書缺乏相關內容，讓熟悉該項技藝者認為發明人掌握了發明，包括各個要件與限制條件：

Nevertheless, as the Generics point out and Nuvo cannot reasonably dispute, the record evidence demonstrates that a person of ordinary skill in the art would not have known or understood that uncoated PPI is effective. And there is nothing in the specification of the patents-in-suit showing “that the inventor actually invented the invention claimed.” Centocor, 636 F.3d at 1348 (emphasis added); accord Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). There must be some description, such as a constructive reduction to practice, establishing that the inventor “was in possession of the . . . claimed invention, including all of the elements and limitations.” Univ. of Rochester, 358 F.3d at 926 (quoting Hyatt v. Boone, 146 F.3d 1348, 1353 (Fed. Cir. 1998)). Patents are not rewarded for mere searches, but are intended to compensate their successful completion. Ariad, 598 F.3d at 1353. That is why the written description requirement incentivizes “actual invention,” id., and thus “[a] ‘mere wish or plan’ for obtaining the claimed invention is not adequate written description,” Centocor, 636 F.3d at 1348 (quoting Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566 (Fed. Cir. 1997)).

(判決文第18-19頁)

本案CAFC在判決文順便整理了一整套關於書面描述要件的基本觀念與判決先例，有興趣者可自行參考原文。其中Ariad這個2010年CAFC的全院庭審判決，我們有收錄在Casebook: Fundamental Concepts裡當作關鍵案例喔！


SCENTSATIONAL TECHNOLOGIES v. PEPSICO, INC. [OPINION - NONPRECEDENTIAL] (May 16, 2019)

原告Scentsational Tech (簡稱 "ST") 分別跟可口可樂與百事可樂秘密合作，開發有香味的瓶子，後來百事可樂將合作內容拿去申請專利，可口可樂發現了百事可樂的專利申請案，就終止了跟ST的合作。ST因此在南紐約地院訴百事可樂侵害營業秘密，請求損害賠償，以及變更專利的發明人為ST的Steven Landau。

關於損害賠償，由於ST的專家證人報告未達到Daubert標準被地方法院排除，在缺乏證據的情況下，整個失敗。關於發明人變更，ST僅提供了其營業秘密的內容 (拿出的證據還是百事可樂專利申請之後才整理的) 跟百事可樂專利請求項內容的比對表，沒有提供發明過程的證據，因此也失敗。

Daubert標準源自Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993)。美國訴訟程序中，專家證人報告要達到Daubert標準是基本觀念。這也是專家證人很貴，有時甚至比美國律師費還貴的原因。若要認真打美國專利訴訟，只能說這錢不能省，否則敗訴風險很高。

至於真實發明人的認定，只能說留存完整的研發紀錄很重要，尤其是共同研發案，為避免合作對象自行申請專利，必須留存研發過程中，雙方就何技術有何貢獻留存紀錄，以避免日後爭議。類似本案這樣，自己保護的營業祕密被合作對象申請專利因而公開，其實並不少見，值得業界注意，並納入企業內部智財權管理的一環。