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Who Infringes That Claim? Divided Infringement in View of Limelight v. Akamai, 2014, U.S. Supreme Court Rahul Pathak, Ph.D., J.D. August 12, 2014

Compounds and Compositions 1. The novel and inventive compound novril. 2. A pharmaceutical composition comprising the compound novril. A B C squirepattonboggs.com squirepattonboggs.com 3 3

Infringement  Direct infringer  Whoever without authority makes, uses, offers to sell, or sells any patented invention squirepattonboggs.com squirepattonboggs.com 4 4

Compounds and Compositions 1. The novel and inventive compound novril. 2. A pharmaceutical composition comprising the compound novril. A - Direct B C squirepattonboggs.com squirepattonboggs.com 5 5

Methods of Treatment 1. The novel and inventive compound novril. 2. A pharmaceutical composition comprising the compound novril. 3. A method of treating pain in a patient in need thereof, comprising the step: A administering an effective amount of a) the compound novril to treat the pain. B C squirepattonboggs.com squirepattonboggs.com 6 6

Infringement  Direct infringer  Whoever without authority makes, uses, offers to sell, or sells any patented invention  Indirect infringer  Inducement • Whoever actively induces infringement of a patent shall be liable as an infringer  Contributory infringement • Whoever knowingly offers to sell or sells…a component of a…composition…fo r use in practicing a patented process , constituting a material part of the invention…, and not a staple article or commodity of commerce suitable for substantial noninfringing use squirepattonboggs.com squirepattonboggs.com 7 7

Methods of Treatment 1. The novel and inventive compound novril. 2. A pharmaceutical composition comprising the compound novril. 3. A method of treating pain in a patient in need thereof, comprising the step: A - Inducer administering an effective amount of a) the compound novril to treat the pain. B - Direct C squirepattonboggs.com squirepattonboggs.com 8 8

Personalized Medicine – Diagnostic Methods 1. The novel and inventive compound novril. 2. A pharmaceutical composition comprising the compound novril. 3. A method of treating pain in a patient in need thereof, comprising the step: A B administering an effective amount of a) the compound novril to treat the pain. 4. A method of treating pain in a patient in need thereof, comprising the steps determining the patient’s genotype for a) drug sensitivity; and administering to the patient the b) compound novril to treat the pain in an C D amount effective to treat pain in a patient with the genotype. squirepattonboggs.com squirepattonboggs.com 9 9

Infringement  Direct infringer  Whoever without authority makes, uses, offers to sell, or sells any patented invention  There is no direct infringement unless a single party carries out (or controls or directs) each step of the claim ( Muniauction v. Thompson , 2007)  Indirect infringer  Inducement • Whoever actively induces infringement of a patent shall be liable as an infringer  Contributory infringement • Whoever knowingly offers to sell or sells…a component of a…composition…fo r use in practicing a patented process , constituting a material part of the invention…, and not a staple article or commodity of commerce suitable for substantial noninfringing use squirepattonboggs.com squirepattonboggs.com 10 10

Personalized Medicine – Diagnostic Methods 1. The novel and inventive compound novril. 2. A pharmaceutical composition comprising the compound novril. 3. A method of treating pain in a patient in need thereof, comprising the step: A B administering an effective amount of a) the compound novril to treat the pain. 4. A method of treating pain in a patient in need thereof, comprising the steps determining the patient’s genotype for a) drug sensitivity; and administering to the patient the b) compound novril to treat the pain in an C D amount effective to treat pain in a patient with the genotype. squirepattonboggs.com squirepattonboggs.com 11 11

Infringement  Direct infringer  Whoever without authority makes, uses, offers to sell, or sells any patented invention  There is no direct infringement unless a single party carries out (or controls or directs) each step of the claim ( Muniauction v. Thompson , 2007)  Indirect infringer  Inducement • Whoever actively induces infringement of a patent shall be liable as an infringer  Contributory infringement • Whoever knowingly offers to sell or sells…a component of a…composition…fo r use in practicing a patented process , constituting a material part of the invention…, and not a staple article or commodity of commerce suitable for substantial noninfringing use  There is no indirect infringement where there is no direct infringement ( Limelight v. Akamai , 2014) squirepattonboggs.com squirepattonboggs.com 12 12

Personalized Medicine – Diagnostic Methods 1. The novel and inventive compound novril. 2. A pharmaceutical composition comprising the compound novril. 3. A method of treating pain in a patient in need thereof, comprising the step: A B administering an effective amount of a) the compound novril to treat the pain. 4. A method of treating pain in a patient in need thereof, comprising the steps determining the patient’s genotype for a) drug sensitivity; and administering to the patient the b) compound novril to treat the pain in an C D amount effective to treat pain in a patient with the genotype. None of the above E squirepattonboggs.com squirepattonboggs.com 13 13

Stay tuned…  The U.S. Supreme Court invited the patent appellate court to reconsider:  Direct infringer • Whoever without authority makes, uses, offers to sell, or sells any patented invention • There is no direct infringement unless a single party carries out (or controls or directs) each step of the claim ( Muniauction v. Thompson , 2007) Questions? squirepattonboggs.com squirepattonboggs.com 14 14