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"A Look at Personalized Medicine" from the U.S. Patent Office Patent Applicants Beware

February 26, 2009

David S. Resnick, Esq Leader, Biotechnology/Chem team Nixon Peabody LLP Boston, MA [email protected]

USPTO Presentation

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Dis c laimer

S lides with th e U S P T O logo were c opied direc tly from th e U S P T O typos an d all!

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A L ook at P ers onalized Medic ine

Kathleen B ragdon Quality As s uranc e S pec ialis t T ec hnology C enter 1600

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Introduction

· · · · · · Biotechnology, chemical, and pharmaceuticals (BCP) technology groups quarterly customer partnership meeting Opportunity for PTO to provide insight on a developing technology Growth of personalized medicine Rapidly evolving case law regarding 35 USC 101 Analysis of PTO presentation Practice Suggestions

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USPTO Presentation

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Overview

Wh at is pers on alized m edic in e? Gen etic m appin g an d S NP s T h e diagn os tic in du s try P u blic polic y P h arm ac ogen etic s C as e s tu dy ­ warfarin S am ple c laim s relatin g to pers on alized m edic in e

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A Definition of P ers onalized Medic ine

P ers onalized medic ine is th e u s e of in form ation from a patien t's gen otype to: · in itiate a preven tative m eas u re again s t th e developm en t of a dis eas e or c on dition , or · s elec t th e m os t appropriate th erapy for a dis eas e or c on dition th at is partic u larly s u ited to th at patien t.

Definition paraphrased from www.wikipedia.org Other sources: Jones, D. Nature Reviews Drug Discovery 2007; 6:770-771; Katsanis et al. Science 2008; 320(5872):53-54; Feero et al. JAMA 2008; 299(11):1351-1352

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· The Debate on Direct-to-Consumer Tests

­ Pros ­ Cons

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P ublic P olic y and P ers onalized Medic ine

Gen etic In form ation Non dis c rim in ation Ac t of 2008 (H .R . 493, S .358) S en ator (n ow P res iden t-elec t) B arac k Obam a's G e n om ic s an d P e rs on alize d Me dic in e Ac t of 2007 (S .976) D H H S S ec retary's Advis ory C om m ittee on Gen etic s H ealth an d S oc iety (S AC GH S )

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Sources: www.govtrack.us and Qureshi et al. Future Medicine 2008; 5(4):311-316

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Examples of SNPs Linked to Drug Response

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Source: Human Molecular Genetics, 14(2): R207-R214 (2005)

C as e S tudy: W arfarin

· Mos t

widely pres c ribed oral an tic oagu lan t for preven tin g th rom bolytic even ts , des pite its n arrow th erapeu tic ran ge m edic ation s dos in g du e to patien t's diet, age, an d oth er

· P roblem atic · S ec on d

m os t c om m on dru g im plic ated in advers e dru g reac tion -lin ked em ergen c y room vis its

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Sources: US FDA (www.fda.gov), Warfarin Information; Rettie et al. Molecular Interventions 2006; 6(4):223-227; Flockhart et al. Genetics in Medicine 2008; 10(2):139-150

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Intellec tual P roperty R ights and P ers onalized Medic ine

C laim s drawn to m eth ods of treatm en t bas ed on gen etic in form ation (S NP s ) of an in dividu al u s in g s u itable dos ages of m edic ation s (warfarin ) C laim s drawn to is olated S NP s in D NA C laim s drawn to m eth ods of treatm en t of dis eas es bas ed on gen etic in form ation (S NP s ) of an in dividu al u s in g c orrelation s of partic u lar S NP s (E GF R )

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E xample 3: Methods C orrelating Correlation Claims S NP s and Dis eas es

3. A m eth od for determ inin g wheth er a h u m an s ubjec t having breas t c anc er will be effec tively treated with "breas t c anc er drug X", s aid m ethod c om pris ing: a) c on s idering data in a databas e c om pris ing genetic patien t in form ation about the E R B B 2 gen e at pos ition 101 of S E Q ID NO:1; and b) c orrelatin g the pres enc e of a c ytos ine at pos ition 101 of S E Q ID NO:1 with effec tive treatm en t of the h u m an s u bjec t with "breas t c an c er drug X".

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Neith er t ied to a m ac hin e/app aratus nor p erfor min g a tr an s for m atio n, ther efor e, does n ot meet t he req uir em ent s for 35 US C 101

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PTO Position

· claim is invalid for failing to qualify as statutory subject matter under the recent Federal Circuit decision in In re Bilski · "[n]either tied to a machine or apparatus nor performing a transformation, therefore, does not meet the requirements for 35 USC 101." · "Considering" "correlating"

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E xample 4: Methods of T reating Treating claimwith S NP s Dis eas es that C orrelate

4. A m eth od for treatin g a h u m an s u bjec t h avin g breas t c an c er, s aid m eth od c om pris in g: a) obtain in g a n u c leic ac id s am ple from s aid h u m an s u bjec t; b) s u bjec tin g th e s am ple to P C R an d iden tifyin g th e n u c leotide pres en t at pos ition 101 of S E Q ID NO:1; an d c ) treatin g th e h u m an s u bjec t with "breas t c an c er dru g X " wh en a c ytos in e is detec ted at pos ition 101 of S E Q ID NO:1.

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PTO Position

· Claim 4 is proper statutory subject matter

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Why claim 4 and not claim 3?

· Claim 3-method of determining the effectiveness of treatment · Results of the method tell if drug x will be effective · Results of the claim gives user information- no action required · Claim 4-method for treating a patient · Claim 4 requires action

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Claim 3 vs Claim 4

· · · No specific mention (in the pto presentation) that claim 4 satisfies the requirements of In re Bilski. Examiner Bragdon noted that treatment methods are clearly statutory subject matter (in the U.S.) thus avoiding LabCorp. While medical treatments methods certainly were patentable preBilski, it is not clear that such claims are necessarily either "transformative" or "machine-implemented." The patentability of certain medical treatment claims post-Bilski remains unclear.

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Claim 3 vs Claim 4

· The steps of claim 3, "considering data in a database" and "correlating the presence" of the mutation with effectiveness of treatment purely mental steps? claim 4 specifically requires the active steps, of "obtaining a nucleic acid sample" and "subjecting the sample to PCR." Active not mental steps tied to a machine or apparatus?

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Claim 3 vs Claim 4

· · · · · · Practice suggestions set forth a particular methodology (like in claim 4) used to analyze the biomarker, i.e., PCR of the nucleic acid should meet the "transformation" requirement of Bilski machine or apparatus? Include alternative methodologies/diagnostic platforms in the specification Avoid "buzzwords"

­ "comparing" "considering" "correlating"

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Caution!

· · · claiming treatment methods may solve problems related to patentability may raise other problems including enforcement. Infringement of claim 4 may involve the actions of three different parties

­ the party that obtains the nucleic acid (medical technician) ­ the party that performs that PCR analysis (a testing lab) ­ the party that treats the patient (oncologist)

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Caution!

· Under U.S. law a claim cannot be infringed by multiple parties unless there is one actor exercising direction and control over the others (Muniauction, Inc. v. Thompson Corp., 532 F.3d 1318 (Fed. Cir. 2008)). · medical personal who practice claims directed to certain medical procedures may be exempt from patent infringement under U.S. law (35 U.S.C. § 287(c)). · Still claim!

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Strategy

· The PTO examples did not address the patentability of a "diagnostic" type claim setting forth a particular methodology used in the biomarker analysis. · Example -the preamble similar to claim 3 and steps similar to claim 4

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Strategy

· A method for determining an increased likelihood of pharmacological effectiveness of treatment by "drug x" in an individual diagnosed with breast cancer comprising: ­ subjecting a nucleic acid sample from a breast cancer sample from the individual to PCR, wherein the presence of a cytosine at position 101 of SEQ ID NO:1 indicates an increased likelihood of pharmacological effectiveness of treatment by "drug x." · · we believe that such claims satisfy 35 USC 101 and should be included in any patent application where appropriate. Include in the application what can be done with the results of the method, e.g., treatment protocol.

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E xample 5: E nabling Methods of Caution T reating Dis eas es that C orrelate with S NP s

A m eth od for treatin g a h u m an s u bjec t h avin g breas t c an cer, s aid m eth od com pris in g: a) obtain in g a n u c leic ac id s am ple from s aid h u m an s u bject; b) s u bjectin g th e s am ple to P C R an d iden tifyin g th e n u c leotide pres en t at pos ition 101 of S E Q ID NO:1; an d c ) treatin g th e h u m an s u bjec t with "breas t can cer dru g X " wh en a c ytos in e is detected at pos ition 101 of S E Q ID The specification teaches that SEQ ID NO:1 is a variant of the ERBB2 gene having an A NO:1. 5.

(adenine) to C (cytosine) mutation at position 101 (A101>C). *this mutation (A101>C) is typically found in breast cancer patients. *this mutation (A101>C) correlates with a significantly better response to "breast cancer drug X" versus placebo. *without mutation (A101>C), "breast cancer drug X" is an ineffective treatment. Further, the specification did not distinguish among patient populations tested.

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E xample 5 (c on't): E nabling Methods of Caution T reating Dis eas es that C orrelate with S NP s

Prior art teaches that variability in treatment responses among patient populations may be an unpredictable factor in SNP correlation studies. Post-filing date art teaches: *Patient population A and patient population B subjects follow the correlation disclosed in the specification *But no correlation found in patient population C subjects having the ERBB2 gene A101>C mutation (i.e., Patient population C subjects responded similarly to "breast cancer drug X" and placebo demonstrating that "breast cancer drug X" is ineffective for this population). The post-filing date art shows evidence that the instant method is not effective for treating patient population C with breast cancer. The appropriateness of making any enablement rejection should be considered based on the foregoing facts.

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More Caution!

· · enablement under section 112 with regard to personalized medicine claims. The enablement issue arises under the hypothetical set forth in Example 5 of the presentation because a post-filing date publication shows evidence that there is a patient population that does not show the claimed correlation between the mutation in the ERBB2 gene and responsiveness to breast cancer drug X. While the presentation does not pronounce that under these circumstances the claim would be invalid for lack of enablement, it states that "[t]he appropriateness of making any enablement rejection should be considered based on the foregoing facts." While post-filing evidence can be used to show that a claim is not enabled, the suggestion that claim 4 may be per se unpatentable in the face of after-filing evidence that not all patients fall within the scope of the claim, goes well beyond the requirements for enablement under 35 U.S.C. § 112, first paragraph. Method for determining an increased likelihood of pharmacological effectiveness...

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Strategy

· · · · · · · Claim subject matter besides diagnostic methods Kits Devices Reagents Methods of treatment "Bilski type" claims FIGHT BACK!

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Information

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