1. 1 1 AIPLA Firm Logo American Intellectual Property Law Association Myriad Guidance for Biotechnology and Chemical Practice Joerg-Uwe Szipl Griffin and Szipl, P.C. _____ AIPLA IP Practice in Japan Committee Premeeting AIPLA Annual Meeting Washington, DC, October 21, 2014

2. 2 2 AIPLA Firm Logo American Intellectual Property Law Association Myriad and Mayo Guidance USPTO issued Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena & Natural Products (Guidance) on March 4, 2014. A forum was held on May 9, 2014 at which members of the public were invited to give comments on the guidance. Comments on the Guidance were almost universally critical. This talk attempts to summarize the major criticisms of the Guidance, and indicate where the Guidance departs from existing law in significant ways.

3. 3 3 AIPLA Firm Logo American Intellectual Property Law Association Guidance treatment of Mayo and Myriad decisions Much criticism focused on the fact that Mayo and Myriad should be applied narrowly according the the language of the cases themselves. Mayo: –The question before Mayo was “whether the claims do significantly more than simply describe [the] natural relations” or “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 the natural laws.”

4. 4 4 AIPLA Firm Logo American Intellectual Property Law Association Guidance treatment of Mayo and Myriad decisions Mayo: – In Prometheus the claims at issue state that the claimed methods are for “optimizing therapeutic efficacy for treatment” however, the claims contain no step that requires one to apply to the natural correlation to achieve a practical result.

5. 5 5 AIPLA Firm Logo American Intellectual Property Law Association Guidance treatment of Mayo and Myriad decisions Mayo: –The Guidance implies that claims must contain at least one step that is not “well understood, routine or conventional activity.” That is not what Mayo requires. –Mayo requires a practical application of the law of nature, not merely a referral to the law of nature with instructions to “apply it.” –Mayo should only require at least one process step that results in a practical application of the law of nature.

6. 6 6 AIPLA Firm Logo American Intellectual Property Law Association Guidance treatment of Mayo and Myriad Myriad: –The Supreme Court in Myriad went through great lengths to state what is was not deciding and to limit its holding to the case before it. –The holding in Myriad relied on two factual findings The patentee had not created or altered the genetic information in the BRCA1 and BRCA 2 mutations, nor did the patentee create or alter the structure of the claimed DNA; and The claims were written in such a way that they relied solely on the genetic information in the isolated polynucleotide.

7. 7 7 AIPLA Firm Logo American Intellectual Property Law Association Guidance treatment of Mayo and Myriad Myriad (cont.) –“Myriad’s claims are simply not expressed in terms of chemical composition, nor did they rely in any way on the chemical changes that result from the isolation of a particular section of DNA.” –The Court noted that Myriad’s claims are “concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition.” –Myriad simply does not support the USPTO’s interpretation that all compounds and compositions isolated or purified from nature are patent ineligible unless markedly different in structure

8. 8 8 AIPLA Firm Logo American Intellectual Property Law Association Guidance treatment of Mayo and Myriad Myriad simply does not support the USPTO’s conclusion that all compounds and compositions isolated or purified from nature are patent ineligible unless markedly different in structure.

9. 9 9 AIPLA Firm Logo American Intellectual Property Law Association Chakrabarty –Congress plainly contemplated that the patent laws be given wide scope –Chakrabarty recites with approval Louis Pasteur’s patent on “yeast, free from organic germs of disease, as an article of manufacture.” –Is the invention “a nonnaturally occurring manufacture or composition of matter” having “markedly different characteristics from any found in nature and one having the potential for significant utility.” –The USPTO test of “markedly different structure” is not found in Chakrabarty. USPTO Guidance departs from Chakrabarty

10. 10 AIPLA Firm Logo American Intellectual Property Law Association USPTO Guidance departs from Chakrabarty In re Bergy –CCPA in a companion case not considered by the Supreme Court found pure culture of Streptomyces Vellosus to be patentable subject matter. –The CCPA decision in Bergy is binding precedent on USPTO.

11. 11 AIPLA Firm Logo American Intellectual Property Law Association USPTO Guidance departs from Chakrabarty USPTO Guidance departs from many decades of USPTO practice in granting patents on purified and isolated microorganisms, and chemical compounds found in nature. –USPTO has issued patents on numerous isolated and purified microorganisms, and isolated chemical compounds of which aspirin and adrenalin are some of the most famous examples. The USPTO justification for the guidelines appears to be: “we were wrong and now we’re correcting our error” in spite of the fact that no such error was identified by the Supreme Court.

12. 12 AIPLA Firm Logo American Intellectual Property Law Association Guidance Examples Example A –A stable energy-generating plasmid, which provides hydrocarbon degradative pathway. –USPTO concludes this is not patentable if the plasmid has the same structure as found in the natural bacterium –If the plasmid is isolated and purified, claimed in terms of chemical structure,and has a characteristic markedly (such as a new utility) different from what is found in nature (i.e., the bacterium), and it should be patentable.

13. 13 AIPLA Firm Logo American Intellectual Property Law Association Guidance Examples Example B –Purified Amazonic Acid –USPTO concludes that this is not patentable because the structure is identical to what is found in the leaves of an amazonian plant. This means that patents for numerous discovered drugs would be invalid. –If the isolated and purified compound is new, and has markedly different characteristics from what is found in nature (i.e., the tree leaves), then it should be patentable.

14. 14 AIPLA Firm Logo American Intellectual Property Law Association Guidance Examples Example C –Assumes that gunpowder is a naturally occurring substance. –Gunpowder is a mixture of saltpeter, sulfur, and charcoal. –Rewrites chemistry, physics and history, did the ancient Chinese mine gunpowder?

15. 15 AIPLA Firm Logo American Intellectual Property Law Association Guidance Examples Example D –Follows the facts of Funk Bros., 333 U.S. 127 (1948) –A combination of bacteria not patentable subject matter where each of the bacteria “serves the ends nature originally provided and act independently of any effort of the patentee.” –This is distinguishable from the isolated and purified bacteria cases where the isolate has a unique utility compared with what is found in nature. –Distinguished by Chakrabarty

16. 16 AIPLA Firm Logo American Intellectual Property Law Association Guidance Examples Example E (Primers) –Primer examples have structure of Seq. ID NO. 1 and Seq. ID NO. 2. –USPTO concludes are not patentable if the portions of the two sequences are found in a natural chromosome. –This conclusion exceeds the scope of the Myriad decision where the claims did not recite any chemical structure. –If the primers have a markedly different characteristics and the exact sequences are not found in nature, they should be patentable.

17. 17 AIPLA Firm Logo American Intellectual Property Law Association Guidance Examples Example F –Diagnostic claim utilizing a new antibody and a specific assay technique concluded to be patentable subject matter. –Not controversial Example G –Claim to exposing a patient to sunlight to effect mood just an appropriation of a natural principle

18. 18 AIPLA Firm Logo American Intellectual Property Law Association Conclusion The USPTO’s guidance goes far beyond the holdings of Myriad and Mayo Without support in the case law the USPTO has concluded that all substances derived from nature (even if not found in isolated and purified form) would not be patentable subject matter unless they have have a significantly different structure (even if the isolated compound has significant utility not present in what is found in nature). USPTO is largely inconsistent with decades of practice in the pharmaceutical field.

19. Thank you Joerg-Uwe Szipl Griffin and Szipl, P.C. Arlington, VA, USA Szipl@Szipl.com 19