智財法第八組期末報告V1.2
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The document discusses the Myriad case regarding whether gene sequences and diagnostic methods can be patented. It summarizes the case history from the District Court of Southern District of New York to the US Supreme Court. It also analyzes the key issues around whether isolated DNA, diagnostic methods, and transformative steps in a process are eligible for patent protection under US law. The highest court reconsidered the Prometheus case and determined that well-understood routine steps or merely comparing information would not be patentable.
智財法第八組期末報告V1.2
- 1. 基因序列與 診療方法 可以專利嗎？ 第八組 從美國案例AMP. v. USPTO. 易先勇 (Myriad case) 來看 劉思廷 吳承易 謝秉修 張旭佑 1
- 2. 案件歷程 Federal District Court of Southern District of New York (S.D.N.Y.) Mayo Collaborative Services v. Prometheus Laboratories, Inc. (C.A.F.C) Federal Court of Appeals, Federal Circuit (C.A.F.C.) Petition for Certiorari Mayo Collaborative Services v. Certiorari granted in light Prometheus of Prometheus Laboratories, Inc.(S.C) 2
- 3. 故事是這麼發生的… BRCA 1 BRCA 2 Chromosome 17 創業 Breast, Ovarian cancer Gene sequencing & diagnose Founded in 1991 3
- 4. 接著… Univ. of Utah Myriad 3,000 USD./test 競爭 vs. Others 1000 USD./test 4
- 5. 當事人 • Plaintiffs • Researchers Drs. Kazazian, Ganguly (University of Pennsylvania School of medicine, Genetic Diagnostic Lab.), Ostrer (New York University)… • Organizations AMP (Association for Molecular Pathology), ACMG (American College of Medical Genetics), ASCP (American Society for Clinical Pathology), CAP (College of American Pathologists) • Patients • Defendants • USPTO • Myriad Genetics, Inc. (Salt Lake City) former co owner and exclusive licensee • UURF (The University of Utah Research Foundation) an owner or part owner of each patent. • Amici • American Civil Liberty Union (ACLU) , Public Patent Foundation (PUBPAT)
- 6. 複習一下生物學… Central Dogma：DNA →RNA→Protein (Amino acid sequence) 6
- 7. 實驗室怎麼合成DNA？ Processing Isolated DNA 7
- 8. 合成與天然，有差嗎？ • Spliced or not (introns) • With/ without cap and poly A tail 8
- 9. 專利內容-基因序列 • Claim 1 of the „282 patent An isolated DNA coding for a BCRA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ. ID. NO: 2. 9
- 10. 專利內容－診斷方法（1） • Claim 1 of the ‟ 999 patent – A method for detecting a germline alteration in a BRCA1 gene, said alterations set forth in Table 12A, 14, 18 or 19 in a human which comprises • analyzing a sequence of a BRCA 1 gene or BRCA1 RNA from a human sample or • analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID. NO:1. 10
- 11. 專利內容－診斷方法（2） • Claim 2 of „857 patent – A method for diagnosing a predisposition for breast cancer in a human subject which comprises • comparing the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject with • the germline sequence of the wild- type BRCA2 gene or the sequence of its mRNA, wherein an alteration in the germline sequence of the BRCA2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer. 11
- 12. 專利內容－診斷方法（3） • Claim 20 of the „282 patent – A method for screening potential cancer therapeutics which comprises • growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer and the presence of a compound suspected of being a cancer therapeutic, • growing said transformed eukaryotic host cell in the absence of said compound, • determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of the said compound and comparing the growth rate of said host cells, wherein a slower rate of said host cell in the presence of said compound is indicative of a cancer therapeutic. 12
- 13. 基因序列專利 13
- 14. 什麼東西可以專利？ 「太陽底下所有為人類所製造出來之物品 （anything under the sun that is made by man），均為專利法保護之客體」 －Diamond v. Chakrabarty 447 U.S. 303 (1980) 14
- 15. 專利的例外？ Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. －35 USC § 101 - Inventions patentable Statutory Subject Matter Not products of nature Not natural phenomena Not abstract ideas 15
- 16. 過去判決－否定 In American Fruit Growers, the Supreme Court rejected patent claims covering fruit whose skin had beer treated with mold-resistant borax. In Funk Brothers, a mixture of bacteria couldn‟t be patented, since it “did not create a state of inhibition or of non- inhibition.” In General Electronic, a purified tungsten couldn‟t be patented, since it ”existed in nature and doubtless has existed for centuries.” 16
- 17. 過去判決- 肯定 In Chakrabarty, the micro-organism in question was a bacterium that had been genetically engineered to break down multiple components of crude oil. In Merck, the Fourth Circuit considered the validity of a patent claiming a Vitamin B12 composition useful for treating pernicious anemia. 17
- 18. 過去判決－結論 This requirement that an invention possess “markedly different” characteristics for purpose of section 101 reflects the oft- repeated requirement that an invention have “a new or distinctive from, quality, or property” from a product of nature… 18
- 19. 法院說法比一比 D.C. C.A.F.C. • What makes DNA unique not only • The claim covers molecules that its chemical structure, but also the hardly exist in natural status. information it conveys. • The isolated DNA is free of some • Even defined by polypeptides, the other components in the cell. functional structure remain the same. For example, BRCA2 without • The different chemical structure are introns shrink to just 80,000 just the result of purification. nucleotides in comparison with those normal with introns can have near 102,000 nucleotides. Not Patentable Patentable 19
- 20. 診斷方法專利 20
- 21. 「方法」可以專利嗎？ • In Biliski, claim 1 of „892 patent • A method for managing the consumption risk costs of a commodity sold by a commodity provider at a fixed price comprising the steps of： – (a) initiating a series of transactions between said commodity provider and consumers of said commodity wherein said consumers purchase said commodity at a fixed rate based upon historical averages, said fixed rate corresponding to a risk position of said consumer； – (b) identifying market participants for said commodity having a counter-risk position to said consumers；and – (c) initiating a series of transactions between said commodity provider and said market participants at a second fixed rate such that said series of market participant transactions balances the risk position of said series of consumer transactions. 21
- 22. Machine and Transformation Test (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.” (3) In addition, “the use of a specific machine or transformation of an article must impose meaningful limits on the claim„s scope to impart patent- eligibility,” and “ the involvement of the machine or transformation in the claimed process must not merely be insignificant extra-solution activity.” 22
- 23. 診斷方法的例子－Prometheus • In Prometheus, a method of optimizing therapeutic efficacy for treatment of an immune- mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6- thioguanine to a subject having said immune- mediated gastrointestinal disorder, and (b) determining the level of 6- thioguanine in said subject having said immune- mediated gastrointestinal disorder, • wherein the level of 6- thioguanine less than about 230 per mole per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and • wherein the level of 6- thioguanine greater than about 400 per mole per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject. 23
- 24. 診斷方法的例子－Prometheus • The “determining” step was itself construed to include the extraction and measurement of metabolite concentrations, such as high pressure liquid chromatography. • Transformation exist as human body as well as the chemical and physical changes of the drug‟s metabolites. • The “determining” step alone was transformative and central to the claimed method since determining the levels of the metabolites in a subject necessarily involves a transformation, for those levels can’t be determined by mere inspection. 24
- 25. 法院說法比一比 D.C. / C.A.F.C • The words “analyzing and comparing”, in contrast to “determining the metabolite level ”, refers to only abstract mental process. • Without specifying how about the words “analyzing and comparing” impose no meaningful limitation on the claim. Not Patentable 25
- 26. 法院說法比一比 D.C. C.A.F.C. • Viewed in entirety, the essence of the • Specific host cells transformed with claim is to compare the cell growth BCRA gene. rate. • Satisfying the transformation test, • To compare is just a basic scientific including these transformative steps: rule that slower growth rate of the • 1. host cells growing with a cell. Inserting DNA or compound into altered BCRA1 gene host cells can only be regarded as • 2. to determine growth rate with preparatory data gathering step. or without the compound, which can’t be merely speculated. • If the compound shows no • 3. these steps are central to the effect, transformation won’t happen. claimed process Not Patentable Patentable 26
- 27. 最高法院重新考慮Prometheus一案… • A well- understood, routine, conventional activity previously engaged in by researchers in the field. • Granting patent would risk disproportionately tying up the use of natural law, inhibiting their use in the making of further discoveries. 27
- 28. 思考與啟示 28
- 29. 專利對生技業的重要性？ Startup • Market Power • Market Value Mature Company • IP fences • Prevent substitutes Sales • Stream revenue 29
- 30. 專利與創新的關係？ Alternatives Backup compounds Preventing new tech. from selling, manufacturing…only Core to prolong old products’ life Substitute Invention cycle… competition 30