美國聯邦巡迴上訴法院（CAFC）August 31, 2011做出一個判決（Classen Immunotherapies v. Biogen Idec），確立了生物科技方面的專利權，Nature News Blog是描述為生物科技專利的cornerstone（基石）
此類專利可能會遇到美國專利法101是否為法定可專利標的，與是否為抽象概念（abstract idea）的問題，特別是Bilski v. Kappos判例（http://enpan.blogspot.com/2009/03/in-re-bernard-l-bilski-and-rand-warsaw.html）之後
Classen Immunotherapies擁有幾個判斷疫苗是否會在一段時間內產生逆向的邊界效應的方法的專利，專利內容有關嬰兒對傳染性疾病的免疫與之後發生慢性免疫失調的關聯性，其中引用動物控制組（control group）與實驗組（experimental group）的比對，根據比對討論此疫苗免疫的狀態。
三件專利：
No. 5,723,283、No. 6,638,739與No. 6,420,139名稱相同，為「Method and composition for an early vaccine to protect against both common infectious diseases and chronic immune mediated disorders or their sequelae」，揭露一種早期對抗一般傳染並與慢性免疫失調的防疫方法、組成與相關後遺症
其中較早專利No. 5,723,283的獨立範圍是：
1. A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.
而其中具代表性的範圍在No. 6,638,739
1. A method of immunizing a mammalian subject which comprises:
- (I) screening a plurality of immunization schedules, by
- (a) identifying a first group of mammals and at least a second group of mammals, said mammals being of the same species, the first group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a first screened immunization schedule, and the second group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a second screened immunization schedule, each group of mammals having been immunized according to a different immunization schedule, and
- (b) comparing the effectiveness of said first and second screened immunization schedules in protecting against or inducing a chronic immune-mediated disorder in said first and second groups, as a result of which one of said screened immunization schedules may be identified as a lower risk screened immunization schedule and the other of said screened schedules as a higher risk screened immunization schedule with regard to the risk of developing said chronic immune mediated disorder(s),
- (II) immunizing said subject according to a subject immunization schedule, according to which at least one of said infectious disease-causing organism-associated immunogens of said lower risk schedule is administered in accordance with said lower risk screened immunization schedule, which administration is associated with a lower risk of development of said chronic immune-mediated disorder(s) than when said immunogen was administered according to said higher risk screened immunization schedule.
在地方法院的判斷上，認為這三件專利都有不符101規定的事實
但是CAFC法官則以較寬廣的角度來解釋101的規定，認定Classen Immunotherapies擁有的方法專利符合101的規定，但另外的問題是要面對可能無法順利克服102, 103, 112的專利性檢驗！其中有專利無效，是因為其權利範圍不符足夠揭露的規定，而非是因為抽象概念的問題。最後總結是上述No. 6,638,739與No. 6,420,139符合101的規定，而No. 5,723,283則不符101規定，相對侵權議題隨之消失
SUMMARY
The district court’s holding of ineligibility for patent-ing under §101 is reversed as to the claims of the ’139 and ’739 patents, and affirmed as to the ’283 patent. The judgment of non-infringement is affirmed as to Merck, and is vacated as to Biogen and GlaxoSmithKline insofar as based on §271(e)(1). Other claims, counterclaims, and defenses raised by complaint and answer were not decided by summary judgment, and are not before us on this appeal. We remand for appropriate further proceedings.
§271(e)(1)： (1) It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products. 若僅為合理用來開發的藥品，為侵權免責
此判決結論是：即便這些專利可能不符102, 103, 112等規定，但是仍符合101之法定標的，可接續判斷其專利性
摘錄：
We conclude that the claimed subject matter of two of the three Classen patents is eligible under §101 to be considered for patenting, although we recognize that the claims may not meet the substantive criteria of patentability as set forth in §102, §103, and §112 of Title 35.
因此，引用其結論，相關方法專利仍然是法定可專利的標的！
Ron
資料參考：
http://blogs.nature.com/news/2011/09/us_court_upholds_biotech_metho.html
http://www.patentlyo.com
http://enpan.blogspot.com/2010/07/bilski.html
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