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Patents in the pharmaceutical industry Lars Sparre Conrad Senior Patent Counsel Corporate Patents and Trademarks The patent department • Chemical engineer, DTU (chemistry), 1990 • PhD, DTU (bio-inorganic chemistry), 1992 • European Patent Attorney, 2005 • Research chemist, Novo Nordisk, enzyme business, 1992-2000 • Patent departments • 2000-2003 Leo Pharma • 2003-2005 Novo Nordisk • 2005- H Lundbeck Slide 2 The Patent Department Lundbeck • 11 patent counsels • • • • • 5 2 2 1 1 Chemical engineers Human biolog Cand Pharm Chemists Lawyer • 5 Counsels in the US Slide 3 Role of the Patent Department Target Assay Compound Indication Salts Polymorphs Drug Discovery Formulation Process Device More indications Biomarkers Drug Development Freedom-To-Operate Slide 4 Life Cycle Management Prosecution On the Market Examples from real life • Duloxetine (SNRI) from Lilly approved 2004 in the US and 2005 in EP • First compound application 1986 • In the period 1986-2003 (at least) • • • • • 2 compound applications 11 indication applications 13 combo application 2 formulation applications 1 process application • Janssen lists 16 patents for Risperidone in Orange Book Slide 5 Why Patents • Value of company not associated with tangible assets • Value associated with an “idea” and exclusive execution of the “idea” • IPR is they way to protect ideas • Protection of investments • The average cost of developing a prescription drug is about 800 mill $ Slide 6 Patent Department involvement • Extreme cost and duration of pharmaceutical development => Focus on exclusivity – “The right to prevent others form doing something” => Focus on Freedom-to-Operate – “The right to do what you plan to do” Slide 7 Slide 8 Celexa Generic Citalopram Zoloft Generic Sertraline 22-09-06 25-08-06 28-07-06 30-06-06 02-06-06 05-05-06 07-04-06 10-03-06 10-02-06 13-01-06 16-12-05 18-11-05 21-10-05 23-09-05 26-08-05 29-07-05 01-07-05 03-06-05 06-05-05 08-04-05 11-03-05 11-02-05 14-01-05 17-12-04 19-11-04 22-10-04 24-09-04 27-08-04 30-07-04 02-07-04 Share of Total Rx Why USA Development in Share of Total Rx 25% 20% 15% 10% 5% 0% Why The number of application is ever increasing Slide 9 Slide 10 Børsen, 30 Juli 2003 Slide 11 What is a patent • A patent is an exclusive right which is granted in return for the technical contribution to the society Slide 12 Limitations of Rights Time – 20 years Geography – Country by country Scope – The claims Slide 13 What rights • Gives the right to stop others from making offering putting on the market or using the product or process using/importing a product obtained by a process which is patented Slide 14 What rights A patent does not give you the right to: Exercise your own invention Somebody may have a dominating patent Freedom-to-operate Circumvent legislation in particular fields (pharmaceuticals, agrochemicals, chemicals in general, biotechnology, weapons, broadcasting etc.) Slide 15 What can not be patented • Discoveries, scientific theories and mathematical methods • Artistic creations • Plans, rules or methods for intellectual activity, for games or for business activity or computer programs (outside US) • Presentation of information Slide 16 What can not be patented • Methods for surgery / therapy / diagnosis (Patentable in the US!!!!!) • Cloning human beings • Germ line modification • Uses of human embryos • Modifying the genetic identity of humans Slide 17 Claims in the Pharma Industry • Compounds • Salts • Enantiomers • Polymorphs R1 R2 • Use of compound in therapy • Known compound; first use in therapy • Pharmaceutical composition comprising compound • E.g. in combination with specific excipients Slide 18 Claims in the Pharma Industry • A method of treating X by the administration of compound • Compound for use in the treatment of X • Use of compound in the manufacture of a medicament for the treatment of X • Process of manufacture • Dosing regimes • Combination treatments Slide 19 Claims in the Pharma Industry • Biomarkers/patient selection/personalized medicine • Assays • Devices Slide 20 Claims in the Pharma Industry • Method of treatment claims • Allowed in the US • Not allowed in EP – Not considered industrially applicable – pre2007 – Not considered patentable for moral reasons – post-2007 • Second medical use claims the equivalent outside US Slide 21 Requirements for patentability • Three separate criteria: • Novelty • Inventive step • Industrial applicability - seldom a problem • The criteria are examined individually and all must be fulfilled! Slide 22 Novelty • Absolute novelty approach • Everything which is made public available prior to the filing date belongs to prior art • Photographic identity • Written, orally or in any other way • Not a question of whether somebody has actually read the document but whether it was available to anyone who wanted to see it Slide 23 Novelty Slide 24 Novelty Slide 25 Inventive step • The invention must not be obvious to the skilled person in view of the state of art • A leap in cognition Known to use alkali metal salts Probably obvious to use the sodium salt • Allowed to combine documents or information when evaluating inventive step Slide 26 Inventive step • Insulin solution characterised in that it comprises Zn2+ ions in an amount of above 4 Zn2+ per hexamer insulin but below the limit for precipitation of zinc-insulin complexes • Prior art disclosed insulin solutions with 4 Zn2+ per hexamer insulin Slide 27 Stability factor Inventive step Inventive step Zn++ / insulin hexamer Slide 28 Novelty Inventive step Not novel Invention Invention Prior art Prior art Inventive? Slide 29 Slide 30 From cradle to grave 20 years Enforcement Opposition Grant 7-10 years 2-7 years National/regional filings Priority filing PCT filing Publication 30 months 18 months 12 months Year 0 Slide 31 How to obtain a patent • File application, pay fees and prosecute • Priority application (T=0) One application in one country Filing date determines what is prior art Provides 12 months period to evaluate the invention • PCT – Patent Corporation Treaty (T=12 months) One application for “the whole world” Does not issue patents Issues a preliminary opinion on patentability Delays need for expensive translations Slide 32 How to obtain a patent • National/regional filings (T=30 months) EPO – European Patent Office One application for ~35 European countries Issues patents – bundle of national patents Slide 33 Stakeholders Innovative Pharma Long exclusivity for ensure revenue on investments Generic Industry Society/Payers Short exclusivity for early Market entry Stimulate innovation - Make innovation worthwhile - No resting on the laurels Affordable medicine Slide 34 Patent peculiarities in Pharma • • • • 1st medical use claim Patent term extension Limitation of exclusivity Rewards for challenging pharma patents in courts (Hatch-Waxman act) Slide 35 Supplementary Protection Certificate Counsel regulation 1768/92 • Pharmaceutical research plays a decisive role in public health • Pharmaceutical research long and costly • Effective exclusivity period ineffective to cover investment • Extension of the patent term Slide 36 SPC – conditions for grant • Product must be protected by the patent in force • MA has been issued • An SPC has not already been issued for the active compound • The MA is the first MA in EU Slide 37 SPC - Term • (Market authorisation – Patent Filing)-5 years • Max 5 years extension • Max 15 years market exclusivity Market entry 0 •A balance of interests Slide 38 20 +5 SPC – Scope of protection • Only the product covered by the patent within the limits of the patent • The patent as such is not extended • Esters and salts covered – ECJ392/97 Slide 39 Patent Term Extension IND NDA MA • Investigational New Drug • New Drug Application • Marketing Authorisation • PTE= NDA IND ( MA NDA) 2 • Maximum 5 years extension • Maximum 14 years market exclusivity Slide 40 Limitation of scope Bolar Provision • 2004/27/EC Conducting the necessary studies and trials with a view to the application of paragraphs 1, 2, 3 and 4 and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products • 35 U.S.C §271(e)(1) It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States 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. Slide 41 Reg. Environ ment Tech. Difficulties Patents Slide 42 Data Exclusivity Data Exclusivity EU • Counsel regulation 2001/83 and 2004/27 • A generic may refer to the originators registration data 8 years after originators MA • A generic drug cannot be marketed before 10 years after originators MA • Global Marketing Authorisation Slide 43 Data Exclusivity EU • Data exclusivity extended to 11 years if originator obtains MA for new indication • Within 8 years • Requiring clinical trials • Superior to existing treatment Slide 44 Data Exclusivity EU • Generic drug Same active substance Salt, ester, ether, derivative etc unless they differ significantly Same pharmaceutical form All oral IR formulation are ”same” Bio-equivalence Slide 45 Orphan drug EU • EU regulation 141/2000 • Life-threatening or debilitating disease affecting less than 5 out of 10000, or • Where the development of drug is unlikely to generate sufficient return, and • With no existing treatment • 10 years exclusivity for similar drug and same indication Slide 46 Orphan drug EU • Exclusivity period reduced or annuled if • There is a profitable return • A superior product is brought to the market Slide 47 Paediatric exclisivity EU 1901/2006 • Paediatric Investigation Plan (PIP) after Phase I • Deferral • Waiver • Data must be included in MA application and leaflet • Incentives • 6 months extension of SPC • Paediatric Use Marketing Authorisation (PUMA) – 10 years data exclusivity • Orphan drug period extended to 12 years Slide 48 Slide 49 Slide 50 Data exclusivity US • • • NDA – New Drug Application ANDA – Abbreviated New Drug Application 505(b)(2) • FDA cannot accept an ANDA for same active moiety before 5 years after originators MA 4 years if §IV certification Certification • • I. II. III. IV. Slide 51 No patent Patent expired Patent will expire before marketing Patent not infringed or invalid Data Exclusivity US • Orange Book • List all patents allegedly covering a product • If patent owner challenges ANDA => 30 months stay at FDA • §IV certification is patent infringement in and of itself • 180 days exclusivity for first §IV applicant Slide 52 Data Exclusivity US • 3 additional years • New indication for already marketed drug • Requiring clinical investigations • Exclusivity only for same drug and new indication Slide 53 Generic Drug • Same active ingredient • Same strength, dosage form and route of administration • Bio-equivalent Slide 54