Microsoft powerpoint - acct - biotech seminar - fenwick.pptx

1. Utility and Promise of the Patent2. Disclosure requirements – post-Viagra®3. Methods of Medical Treatment - Dosage Demonstrated Utility
• No actual data needed in application as filed • If no data, application as filed must include reference to a study supporting claimed utility • Utility must be proven upon challenge • Support for utility must be present at Canadian (Pfizer v. Novopharm, 2010 FCA 242) Sound Prediction
• Three requirements when supporting utility 2. Articulable and “sound” line of reasoning (Apotex v. Wellcome, 2002 SCC 77) • Facts and reasoning must be in the application (Novopharm v Eli Lilly, 2010 FC 195) • Canadian filing date is date for determining (Aventis Pharma v. Apotex, 2006 FCA 64) • Post “Apotex v. Wellcome” • Significant increase in number of patents • Be careful what uses are “promised” as this is the standard against which the utility of the invention is measured “Where the specification does not promise a specific result, no particular level of utility is required; a ‘mere scintilla’ of utility will suffice. However, where the specification sets out an explicit ‘promise’, utility will be measured against that promise…[T]he question is whether the invention does what the patent promises it will do.” (Eli Lilly v. Novopharm, 2010 FCA 197 – “Olanzapine”) “When this Court said at paragraph 80 of Olanzapine, cited above, that the promise of the patent must be ascertained, it should not be taken to have assumed that every patent contains an explicit promise of a specific result since…there is no obligation on the part of the inventor to disclose the utility of his invention in the patent…[I]f there is no explicit promise of a specific result, then a mere scintilla of utility will do.” (Sanofi-Aventis v. Apotex, 2013 FCA 186 – “Plavix”) 1. Have human data
Pharmascience v. Pfizer, 2010 FCA 102 Latanoprost for glaucoma – patent had monkey/human data “causes insignificant ocular side effects” 2. Promise construed favourably
– Apotex v ADIR, 2009 FCA 222– Perindopril for hypertension – patent had ACE inhibition data– Promise construed that claimed compounds will have some level of ACE inhibition, and that some will be able to treat hypertension – “useful as antihypertensive agents” may have been fatal Rely on known link between data and human therapeutic
treatment
Pfizer v. Mylan, 2011 FC 547 Donepezil – promise construed as being effective for treating Alzheimer’s disease Supported by mice/rat data – sound prediction supported by theory AChE inhibitors useful for such Rely on comparison to known/marketed compounds with
promised therapeutic effect
– Pfizer v. Apotex, 2005 FC 1205– Quinapril – promise construed as being useful for treatment of – Supported by rat data – sound prediction supported by similar Promise construed higher than data supports/chronic disease
– Apotex v. Pfizer, 2011 FCA 236– Latanoprost for treatment of glaucoma– Single dose study on monkeys/humans not sufficient to meet promise of Promise too much
– Ratiopharm v. Pfizer, 2009 FC 711– Amlodipine besylate – promise that this salt was “unique” and “outstandingly – Other salts were just as good – therefore promise not fulfilled Data not sufficient
– Pfizer v. Pharmascience, 2013 FC 120– Pregabalin – for the treatment of pain– Data did not support all types of “pain” • Determination is fact specific; no general rule• Human clinical data generally not required• If similar known compounds have been shown to have therapeutic activity based on same data, or if good link between data in application and therapeutic treatment, then likely utility • Very difficult to get life science claim without data• Novel compound claims generally easier than use • If selection, necessary to have support for • Be cautious with language which describes invention – “effective”, “advantageous”, “improved”, “outstanding”, “human use”, “chronic” • If invention is based on improved efficacy, have • If advantage is reduced side effects, may require • Include disclosure and claims to mechanism of action; do not include superfluous terms and specific uses: – Compounds of the invention are inhibitors of angiotensin converting enzyme (ACE), and in some embodiments, are useful for hypertension.
– Compounds of the invention are improved inhibitors, have less side effects, and are specifically useful for treating chronic hypertension in humans.
• Don’t use general terms to describe 1. Compound X for the treatment of pain.
2. Compound X for the treatment of persistent post-operative pain.
Disclosure Requirements
• Sufficiency of disclosure – Patent Act, s. Correctly and fully describe the invention and its operation or use; II. Enable a person skilled in the art to make and III. For a machine, describe the best mode; IV. For a process, explain necessary sequence.
“The disclosure in the specification would not have enabled the public “to make the same successful use of the invention as the inventor could at the time of his application”, because even if a skilled reader could have narrowed the effective compound down to the ones in Claim 6 and Claim 7, further testing would have been required to determine which of those two compounds was actually effective in treating ED.” (Teva v. Pfizer, 2012 SCC 60) • Disclose as much information as possible• Identify compounds and their specific activity • Compound 1 is methyl benzene and has IC of 5 nM; or • Compound 1 (methyl benzene) is one of the preferred compounds and induces penile erection.
• Claim one specific compound in claims • Methods of medical treatment not patentable in Canada – usually just convert “method” claim to “use” claim – Method of treating X comprising administering • Many dosage regimen limitations have been – a dose of 13 to 15 mg/kg/day (Axcan v – a dose of 50 to 300 units (PAB Decision no. 2009)– 5 mg wherein the period between administrations is about one year (Novartis v. Cobalt, 2013 FC 985) • Any variability in claim will likely be rejected – 1.0 mg tablet as a daily dose (Merck v – 70 mg on a once-weekly basis (Merck v Apotex, • Limitations which claim “vendible product” • Include list of single dosages – even if it requires adding hundreds of claims to eventually cover commercial embodiment (no claims fees in Canada) – 1.0 mg, 2.0 mg, 3.0 mg, 4.0 mg….

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