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© 2015 Waller Lansden Dortch & Davis, LLP. All Rights Reserved. Ready to Patent? Value and Risk Considerations Nicolo Davidson
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* Forbes, 2014
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| 4 Baby Patting Machine U.S. Patent No. 3,552,388
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| 5 Portable Automobile Partition U.S. Patent No. 6,260,903
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| 6 Valuation Market Freedom to Operate (Risks) Scope
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| 7 Scope Claims define protected invention Claims are amended during prosecution to overcome prior disclosures (prior art) Continuation applications can seek broader claims
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| 8 Scope Claims must be described in application TClaims CLAIMS SPECIFICATION
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| 9 Market What is the market? How big is the market? – Is market growing? How long will it take to enter the market? – Scale up – Regulatory
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| 10 Market How much of the market do you expect to control? – Limited to certain segments? – Geographical limitations? – Do you have freedom to operate? Who are your competitors? – Barriers to entry? – IP or other exclusive rights?
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| 11 Freedom to Operate Invention AInvention BComponent A Component B Patent filed for Invention A before Invention B patentable Is Invention B patentable over Invention A? practice Can one practice Invention B?
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| 12 Freedom to Operate – Patentability Claim Comparison Invention A. A composition for treating a fever, comprising: 70% - 90% of Component A; and 10% - 30% of Component B. Invention B. A composition for treating a fever, comprising: 50% - 80% of Component A; and 20% - 50% of Component B.
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| 13 Freedom to Operate – Patentability Different limitations Invention A. A composition for treating a fever, comprising: 70% - 90% of Component A; and 10% - 30% of Component B. Invention B. A composition for treating a fever, comprising: 50% - 80% 65% of Component A; and 20% 35% - 50% of Component B.
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| 14 Freedom to Operate Patentability – New Use Discovery of unappreciated (inherent) property – NOT PATENTABLE – Inherent property must necessarily flow from prior art – Property need not be appreciated in prior art “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada (Fed. Cir. 1990). New use for old compound may be patentable
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| 15 Freedom to Operate Patentability – New Use Prior patent - Method of treating anxiety by use of fluoxetine hydrochloride New use patent - Method of blocking serotonin uptake by use of fluoxetine hydrochloride New use held to be inherent in first patented use – New “use” = result of same structure/compound Eli Lilly & Co. v. Barr Laboratories, Inc. (Fed. Cir. 2001)
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| 16 Freedom to Operate Patentability – New Use Jansen patent – Method of treating or preventing macrocytic-megaloblastic anemia [MMA] by administering folic acid and vitamin B 12 to a human in need thereof (i.e., recognized need) Rexall – Folic acid and vitamin B 12 for maintenance of proper blood homocysteine levels New use held not to infringe Jansen Method performed for different intended purpose New “use” = unexpected new property Jansen v. Rexall Sundown (Fed. Cir. 2003)
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| 17 Freedom to Operate Infringement 35 USC 271(a) -... whoever without authority makes, uses, offers to sell, or sells any patented invention, within the [US] or imports into the [US] any patented invention during the term of the patent therefor, infringes the patent. 35 USC 271(e)(1) - It shall not be an act of infringement to make, use, offer to sell, or sell … a patented invention... solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.
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| 18 Freedom to Operate New use, formulation, or delivery of patented for composition of matter New use of composition not under patent New delivery / formulation of composition not under patent No patent = lack of exclusivity – Orphan Drug (<200K patients) – 7 – New Chemical Entity – 5 years – “Other” – 3 years (e.g., new studies for new use)
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| 19 Freedom to Operate New use, formulation, or delivery of patented for composition of matter INFRINGE Anyone who “makes, uses, offers to sell, or sells” composition of matter is liable for infringement Requires permission (i.e., license) from patent owner – Costly – Little incentive
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| 20 Freedom to Operate New use of composition not under patent – NO INFRINGEMENT – May be patentable Are you protected from off-label use? Weak pricing power Who is infringing? Who will you enforce against? Is new use patentable or is it inherent?
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| 21 Freedom to Operate New delivery / formulation of composition not under patent NO INFRINGEMENT; may be patentable High bar to patentability Drug repurposing is crowded field KSR v. Teleflex (2007) – “obvious to try” New combinations? Look for superior and unexpected results
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| 22 Freedom to Operate New uses or formulations often are done by the same company
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| 23 Bringing it Together scope Patent scope can define your exclusive rights market Must consider market to see how you can monetize your exclusive rights freedom to operate Without freedom to operate, there is no market
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| 24 Nicolo Davidson Waller Lansden Dortch & Davis, LLP Nashville, TN nicolo.davidson@wallerlaw.com 615.850.8464
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