enpan's Patent & Linux practice: 法院專利無效判決造成其他公司的商業契機？

2014年8月21日星期四

法院專利無效判決造成其他公司的商業契機？ - 討論Myriad案後續發展

提供一些先前報導連結，也感謝有網友指正我！
http://enpan.blogspot.tw/2013/07/usptomyriad.html（USPTO對Myriad案例的態度）
http://enpan.blogspot.tw/2013/06/1000association-for-molecular-pathology.html（「Association for Molecular Pathology v. Myriad Genetics」美國最高法院判決）
http://enpan.blogspot.tw/2014/03/blog-post_10.html（分析權利範圍中引述自然律、自然現象或是自然產物的可專利性指導方針）

這類生物科技的技術爭議在台灣比較少見，所以報導出來格外有趣。此次爭議源自2013年最高法院對Myriad案的判決：「自然基因組DNA序列方面的專利是無法專利的，而非自然經修改的基因序列仍可以被專利」。

於是相關生技業者，特別是針對高機率造成乳癌的"BRCA1/BRCA2"基因缺陷檢測技術的相關業者，因著法院認定這類基因屬於自然產物而無法成為專利標的，而大舉進入檢測市場，但是他們不曉得知不知道，一個有規模的企業對於一個重要技術不會僅壓寶在一件專利中，而應該會積極地佈局，形成相關技術領域的進入障礙（這部份也給部份研發企業參考，專利不是萬能，重要的技術也不會過於樂觀地押注在一兩件專利而已）。

於是Myriad Genetics Inc.對主要如Gene Dx Inc.等的多間公司提出侵權告訴，並一次提出16件專利，目前在Utah的聯邦法院審理中，Gene Dx公司只好對這些專利（其中11件）提出IPR，可惜IPR僅能針對102, 103等要件進行審理，而可能無法打擊這類專利的101要件，而且這些專利似乎也不同於去年Myriad最高法院判決的相關議題。對於IPR打到最後一件平均約20萬美金來看，這樣就至少要200萬美金來撤銷專利！

這些主張侵權的專利範圍如下：
claim 6 of U.S. Patent No. 5,709,999
claims 6, 16 and 17 of U.S. Patent No. 5,747,282
claims 7, 8, 12, 23, and 26 of U.S. Patent No. 5,753,441
claims 29 and 30 of U.S. Patent No. 5,837,492
claim 4 of U.S. Patent No. 6,033,857
claims 2, 3 and 4 of U.S. Patent No. 5,654,155
claims 2, 3, 4, 5, 6, and 7 of U.S. Patent No. 5,750,400
claims 32 and 33 of U.S. Patent No. 6,051,379
claim 5 of U.S. Patent No. 6,951,721
claims 3, 4, 5, 6, 7, 8, 11, 14, 17, 18, 19 of U.S. Patent No. 7,250,497
claims 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 and 18 of U.S. Patent No. 7,470,510
claims 10, 11, 15, 16, 17 and 19 of U.S. Patent No. 7,622,258
claims 2, 8 and 16 of U.S. Patent No. 7,838,237
claims 2, 3, 5, 9, 10 and 12 of U.S. Patent No. 7,670,776
claims 2 and 7 of U.S. Patent No. 7,563,571
claim 73 of U.S. Patent No. 6,083,698.

列舉一件IPR（IPR2014-01310）如下：
US5,654,155（這件是轉讓來的）
2. A method of identifying individuals having a BRCA1 gene with a BRCA1 coding sequence not associated with breast or ovarian cancer comprising:

a) amplifying a DNA fragment of an individual's BRCA1 coding sequence using an oligonucleotide primer which specifically hybridizes to sequences within the gene;

b) sequencing said amplified fragment by dideoxy sequencing;

c) repeating steps (a) and (b) until said individual's BRCA1 coding sequence is completely sequenced;

d) comparing the sequence of said amplified DNA to the sequence of SEQ. ID. NO: 1;

e) determining the presence or absence of each of the following polymorphic variations in said individual's BRCA1 coding sequence:

AGC and ACT at position 2201,

TTG and CTG at position 2430,

CCG and CTG at position 2731,

GAA and GGA at position 3232,

AAA and AGA at position 3667,

TCT and TCC at position 4427,

and ACT and GGT at position 4956;

f) determining any sequence differences between said individual's BRCA1 coding sequences and SEQ. ID. NO: 1 wherein the presence of any of the said polymorphic variations and the absence of a polymorphism outside of positions 2201, 2430, 2731, 3232, 3667, 4427, and 4956, is correlated with an absence of increased genetic susceptibility to breast or ovarian cancer resulting from a BRCA1 mutation in the BRCA1 coding sequence.

IPR主要部份有前言、聲明、專家證詞、權利範圍解釋、與無效理由等。

前言：