1. Orlando, Florida | www.lowndes-law.com Mayo v. Prometheus by:Jon M. Gibbs Lowndes, Drosdick, Doster, Kantor and Reed PA

2. Orlando, Florida | www.lowndes-law.com Autoimmune Disease Inappropriate immune response to substances or tissues normally present in a body

3. Orlando, Florida | www.lowndes-law.com Thiopurine Drugs Commonly used to treat certain autoimmune diseases

4. Orlando, Florida | www.lowndes-law.com Claim 1 of the ‘623 Patent 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 pmol per 8x10 8 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 more than about 400 pmol per 8x10 8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

5. Orlando, Florida | www.lowndes-law.com In Essence... A method of determining whether a drug is effective or toxic comprising: - giving a drug - testing for the drug; and - using the results to determine whether more or less of the drug should be given at a later time.

6. Orlando, Florida | www.lowndes-law.com Background Facts Prometheus sole and exclusive licensee of the subject patents. Sold tests to Mayo. Mayo announced it would begin using and selling its own test using a different threshold for toxicity. Prometheus sued.

7. Orlando, Florida | www.lowndes-law.com District Court Mayo’s test was an infringement. ºToxicity risk level numbers that Mayo used were too similar to those in the patent. However, Court granted summary Judgment in favor of Mayo. ºfinding that a correlation between certain levels of a drug and its toxicity and therapeutic values is a natural phenomenon and therefore ineligible for patent protection

8. Orlando, Florida | www.lowndes-law.com Federal Circuit REVERSED ºthe “administration and determination” steps of the method involve transformation of the human body and therefore the patents satisfied the Fed. Circuit’s “machine or transformation test” thereby satisfying 35 USC §101.

9. Orlando, Florida | www.lowndes-law.com Supreme Court VACATED ºOrdered that the matter be reconsidered in light of Bilski which held that the “machine or transformation test” was not the definitive test for patent eligibility, but an important test nonetheless.

10. Orlando, Florida | www.lowndes-law.com Federal Circuit II PATENTABLE ºApplied the “machine or transformation” ºThe test led to a clear and compelling conclusion that the claims of the subject patents do not encompass laws of nature and therefore contained patentable subject matter

11. Orlando, Florida | www.lowndes-law.com Supreme Court II Question: ºwhether the subject 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.

12. Orlando, Florida | www.lowndes-law.com Supreme Court II, continued NO, they do not. º“if a law of nature is not patentable, then neither is a process of 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.”

13. Orlando, Florida | www.lowndes-law.com Supreme Court II, Continued Doctors used thiopurine drugs to treat patients suffering from autoimmune disorders long before the subject patent claims were asserted. Researchers routinely measured thiopurine metabolites as part of the investigation into whether drug levels are effective or toxic

14. Orlando, Florida | www.lowndes-law.com Analysis of Prior Cases Diamond v. Diehr – Patent eligible method of molding rubber Parker v. Flook – Unpatentable formula for adjusting alarm limits.

15. Orlando, Florida | www.lowndes-law.com Finding Claims at issue in Mayo were: ºWeaker than Diehr; and ºNo stronger than Flook. Claims, therefore, invalid under 35 USC §101.

16. Orlando, Florida | www.lowndes-law.com Consider A method of driving on I-4 comprising: ºadministering pressure to the throttle of a vehicle travelling on I-4; and ºdetermining the speed of the vehicle by viewing a speedometer attached to the vehicle, wherein a speed of less than 45 mph indicates a need to increase the speed of the vehicle and wherein a speed of greater than 70 mph indicates the need to decrease the speed of the vehicle.

17. Orlando, Florida | www.lowndes-law.com Post Mayo? Fed Circuit has issued no real opinions Next big case will be Myriad ºIsolated DNA ºMethod of screening potential cancer therapeutics

18. Orlando, Florida | www.lowndes-law.com Myriad July 29, 2011, Federal Circuit ºDetermined that isolated DNA and method of screening cancer therapeutics were patentable.

19. Orlando, Florida | www.lowndes-law.com Myriad, continued March 26, 2012, Supreme Court ºVacated July 29 Order and remanded in light of Bilski.

20. Orlando, Florida | www.lowndes-law.com Myriad, continued April 30, 2012, Federal Circuit entered Order: ºRecalling the July 29, 2012 Opinion and reinstating the Appeal; ºRequiring parties to file supplemental briefs addressing applicability of Mayo on subject claims; and ºScheduling oral argument for July 20, 2012