myriad and mayo what went wrong? warren d. woessner, j.d., ph.d. robin a. chadwick, j.d., ph.d....

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Slide 2 Myriad and Mayo What Went Wrong? Warren D. Woessner, J.D., Ph.D. Robin A. Chadwick, J.D., Ph.D. Schwegman Lundberg & Woessner, P.A. Minneapolis, MN 55402 Slide 3 Pretty Much Everything In Myriad, S. Ct. held that claims to isolated genomic DNA and to segments thereof were patent-ineligible as attempts to claim natural products. claims to cDNA were found patent eligible[PE] 569 U.S.___(2013). Fed. Cir. twice held that claims to comparing a BRCA1 tumor cell sequence with a non-tumor cell BRCA1 sequence, wherein a difference in the tumor sample indicates a BRCA1 gene alteration in the tumor sample were found to be patent ineligible as abstract ideas 689 F.3d 1303 (Fed. Cir. 2012) Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 4 Pretty Much Everything (cont.) In Mayo Collab. Services v. Prometheus, 132 S. Ct. 1239 (2012), Court held that claims to acquiring an indication of proper drug dosage based on determining if levels of metabolites fell within a predetermined range were patent ineligible as attempt to monopolize a law of nature. (Correlation between metabolite levels and efficacy too much drug, bad!) Court said diagnostics were not before it. Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 5 Court wanted some undefined more The question before us is whether the claims do significantly more than simply describe these natural relations. To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent eligible processes that apply natural laws? If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself. Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 6 The USPTO s. 101 Guidelines Training materials were released in March 2014. A public forum was held on May 9 th to receive feedback Weve had enough talk, now get a rope! PTO feels it must interpret Myriad, Mayo Chakrabarty and Funk Bros. for Examiners. How to eviscerate patent law 101. Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 7 Claims that recite judicial exceptions to s. 101 are suspect. Abstract ideas Threaten diagnostic methods, business method patents, computer systems. Laws of Nature Threaten diagnostics (Claims that recite relationships between in vivo markers and disease taken broadly), method of treatment cls. Natural Products Threaten all purified natural products: biologicals (DNA and polypeptides), primers, biomarkers, drugs from natural sources, diagnostics and methods of treatment using natural products. Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 8 Hierarchy of Abstract Ideas Thoughts that cannot be reproduced or verified. (The Golden Rule) Mathematical formulae and algorithms (A truth about the natl world that always existed).(Mutations in DNA(?)) Methods of organizing human activity (Economics and finance) Need solution to a technological problem to avoid Mayo Step Two. Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 9 Laws of Nature/Natural Phenomena include naturally occurring relations or correlations, etc. [such as] The relationship between blood glucose levels and diabetes. (If A, then B). This is capitulation to Judge Breyers dissent in LabCorp. v. Metabolite Labs., in which 3 Justices wrote that a diagnostic assay based on elevated Hcys in the blood was a natural phenomenon coupled to a mental step. Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 10 More Suspect Claims that Involve a Law of Nature Diagnosing a condition based on a naturally occurring correlation of levels of a substance produced in the body when a condition is present. Identifying a disease using a naturally occurring relationship between the presence of a substance in the body and incidence of the disease. [Substance will usually be a natural product and so doubly suspect.] Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 11 Claims In the Clear? Claims that do not recite or involve Laws of Nature (MPEP 2106.01(III)(C)(para. 3) Treating a patient by performing a medical procedure. ( Give drug A to treat condition B) MPEP 2106.01(III)(D)(para.4) A new way of using an existing drug. A new drug (But all may recite natl products) (The last two are taken from Prometheus.) Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 12 Natural Products Purification is not sufficient (Good-by adrenalin!) To be patent-eligible, a claimed compound [or composition containing it] must be both non- naturally occurring and markedly different [in structure, not just in utility] from naturally occurring products. PTO: Supreme Court has never allowed a patent on a composition that was not changed in structure from its structure in its natural state. CCPA allowed claim to purified PGE 2 In re Bergstrom. Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 13 Markedly Different PTO: A Marked Difference is a Significant Difference Between what is claimed and what is a natural product. Do the identified differences rise to the level of a marked difference in structure? But before this test can be applied, we must settle on a definition of natural product and non-naturally occurring product. Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 14 What is a Natural Product? Legally, it is a subgenus of phenomena of nature which in turn is a subgenus of laws of nature. Chakrabarty says non-naturally occurring composition of matter and gives examples. Myriad is one of the only recent cases to apply the judicial exception of natural product. Although Chakrabarty defined composition of matter very broadly, in Myriad, the Court said the DNA claims were not expressed in terms of chemical composition nor did they rely on chemical changes. (So how can they claim natural products?) Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 15 The Real Holding: No Composition of Matter Claims--Literally. Even though the location of the genomic sequences encoding BRACA 1 and 2 had been identified, claiming them (A that encodes B) focusses only on the genetic information encoded thereby. Myriad simply discovered where the genes were located. Myriad did not create any new compositions of matter. Once discovery was invoked, Court cited Funk Bros, which treated claims to an inoculate mixture of bacteria as barred by the phenomenon of nature exception. In fact, the composition of matter claims were not rejected as directed to natural products, but as not the product of invention. (No more than an advance in packaging.) Dissent would have found failure to meet todays WDR. Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 16 So What is a Non-Naturally Occurring Product? If Myriad did not involve claims to new compositions of matter even if isolation was involved, where can we look for guidance? In the Fed. Cir.s Myriad I or II opinions below, Judge Lourie stated: While purified natural products thus may or may not qualify for patent[s] under s. 101, the isolated DNAs of the present patents [fall under Chakrabarty]. He noted that Parke-Davis involved an unchanged molecule that was for every practical purpose a new thing. (But did not rely on purification.) Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 17 In re Bergy (II) 596 F.2d 952 (CCPA 1979)(Pure culture of bacterium producing antibiotic is not a natural product.) In the Fed. Cir. Myriad opinions, Judge Lourie did not rely on the purified natural products case law including Bergy, but he could have. Bergy was vacated by the S. Ct. when it took up Chakrabarty as moot, but the same questions were presented was the claimed bacterium a patenteligible manufacture or composition of matter, or was it excluded because it was living, naturally occurring, or a hitherto unknown natural phenomenon? (444 U.S. 1028). Bergy has been extensively cited as precedent ever since. Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 18 Markedly Different Is a term used in Chakrabarty, in a para. contrasting the inoculants in Funk Bros.: Here, by contrast, the patentee has produced a new bacterium with markedly different characteristics from any found in nature, and one having the potential for significant utility. These characteristics were due to extra plasmids in Chakrabartys bacterium, but there was no language disparaging Bergy, or requiring structural alterations. The Bergy cultures would meet this language. Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 19 But the questions remain Is the invention naturally-occurring, e.g., a natural product or not? This is a yes/no question. (Purified drugs are back in yes) If it is not, it still must be markedly different in structure from naturally occurring products. While Chakrabartys oil-eating bacterium was markedly different, what does that test mean for other inventions? Does markedly different mean structurally unobvious? Are unexpected results relevant in the inquiry? Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 20 In re Bergstrom 427 F.2d 1394 (CCPA 1970)(Pure prostaglandins patentable in view of impure extracts). In Myriad I and II, Judge Lourie dismissed Bergstrom as decided under s. 102., but the court reversed both s. 102 and s. 101 rejections: The Board and the solicitor seem to have taken an affirmative view [that a reference disclosing an impure form of a compound can support a rejection both under s. 101 and s. 102]The sole issue it accurately posed [is] whether the claimed pure materials are novel as compared with the less pure materials of the reference It seems to us thatby definition, pure materials necessarily differ from less pure or impure materials and, if the latter are the only ones existing and available as a standard of referenceperforce the pure materials are new with respect to them. Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 21 If the claim involves a natural product or a law of nature It must undergo further testing: Does the claim as a whole recite something significantly different that the judicial exception(s)? Claim must recite some number of elements that are in addition to the judicial exception(s) and that add significantly more to the exception(s). (Language is from Prometheus) Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 22 Wands-Like Factors From Hell Other claim elements must impose meaningful limits on claim scope. Elements must not be insignificant, routine or conventional extra-solution activities or features. (Mixtures of natural products and carriers.) What about Drawing a Diagnostic Conclusion?? (Intema is non-precedential.) Pass the Machine or Transformation Test. Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 23 In summary: Myriad and Mayo (much less dicta in Chakrabarty discussing Funk Bros.) do not provide sufficient rationale to depart from about a century of practice and analysis that culminated in Bergy. Natural product, markedly different and significantly different have not been adequately defined by case law or Congress. This Guidance Memorandum is disruptive, regressive and should be withdrawn. Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 24 In re Roslin Institute Dolly the sheep is led to the slaughter by Fed. Cir. on May 8, 2014. Living, existing organism is not patentable. (Note implied reversal of Bergy II. ) Dollys donor sheep is a natural product Dolly is not markedly different from donor. Therefore Dolly cannot be PE under s. 101. Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 25 Alternative Dolly Analysis No living, existing organism is patentable! Dolly was made by the hand of man and so is not naturally occurring. Dollys sameness made her markedly different than any other sheep. Dolly is not a natural product and is PE. Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 26 Thank you for your consideration Warren Woessner is a founding shareholder of Schwegman Lundberg & Woessner in Minneapolis, MN. He received his Ph.D. and J.D. degrees from the University of Wisconsin Madison. His practice focusses on client counseling in pharmaceuticals and biotechnology, with an emphasis on due diligence opinions and solutions for complex prosecution problems. He has spoken and published widely on issues in life sciences IP and chaired both the Chemical Practice and Biotechnology Committees of the AIPLA. Warren served two terms on the Amicus Committee and is a Fellow of the association. Copyright 2014 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Slide 27 Thank you for your participation. For more information please visit : www.SLWip.com Note: Please use this slide at the vary end. Feel free to change the Thank You message as desired.