Attributes of Pharma Biotech Patenting a European Perspective a - PowerPoint PPT Presentation

Gedeon Richter Pharma GmbH, BioIP Department Attributes of Pharma Biotech Patenting ‐ a European Perspective a European Perspective Szeged May 11, 2012 Walter Hinderer 1

Attributes of Pharma Biotech Patenting > Agenda Agenda [Slide No.]:  Defintion of Biotechnology [3]  Attraction of Biotechnology for the Pharmaceutical  Attraction of Biotechnology for the Pharmaceutical Industry [4 – 6]  Legal Background (EPC) [7  Legal Background (EPC) [7 – 8] 8]  Patent Filing Strategies of Pharma Biotech [9 – 11]  Practical Difficulties with Biotech Patents [12 – 14]  Multiple SPCs for Biotech Products [15 – 16] p [ ]  Case Studies: G2/08 and Medical Use Claims [17 – 22]  Raising the Bar: Intermediate Experience [23]  Raising the Bar: Intermediate Experience [23] Szeged May 11, 2012 Walter Hinderer 2

Pharma Biotech Patenting > Introduction  Defintion of Biotechnology “ Biotechnology is the integrated application of biochemistry microbiology and process of biochemistry, microbiology and process engineering with the aim of making technical use of the properties of micro ‐ organisms, cell f th ti f i i ll and tissue cultures and parts thereof.“ Source: European Federation of Biotechnology Szeged May 11, 2012 Walter Hinderer 3

Attraction of Biotech > Top 10 Drug Blockbusters Attraction of Biotechnology for the Pharmaceutical Industry  Big Ten Branded Blockbusters 2010 Big Ten Branded Blockbusters 2010 11.4 Biotech Products 9.6 8.4 7.8 7 8 7 4 7.4 6.9 6.5 6.1 5.8 5.4 Source: pharma.about.com Szeged May 11, 2012 Walter Hinderer 4

Attraction of Biotech > Top 10 Biotech Blockbusters Attraction of Biotechnology for the Pharmaceutical Industry  Top Ten Biologics Drugs July 2010 to June 2011 p g g y 6.6 6 6 6.5 6.4 antibodies 5.5 5.4 4.5 5.1 4.1 3.7 3.6 Total World ‐ wide Biologic Market: $ 148.2 billion Source: IMS Health Szeged May 11, 2012 Walter Hinderer 5

Attraction of Biotech > Lower Failure Rates Attraction of Biotechnology for the Pharmaceutical Industry  Drug Development Success (2006 ‐ 2010) Drug Development Success (2006 2010) Small Molecules % Success 82 40,000 Candidates 78 Successfully passed development stages ↓ 1 Approved drug 58 44 Bi t Biotech h 27 17 400 Candidates 12 ↓ ↓ 9 9 4 1 Approved drug 2 Source: Genetic Engeneering & Biotechnology News 2012 Szeged May 11, 2012 Walter Hinderer 6

Biotech Patenting > Legal Background (EPC)  Biotech ‐ specific Regulation in the EPC:  Rule 26: Definitions  Rule 27: Patentability of Biotechnological Inventions  Art. 53: Exceptions from Patentability  Rule 28: (Ethical) Exeptions from Patentability  Rule 29: Human body Notes (very basic): Notes (very basic):  A technical solution is allways required (Rule 27)  Drug + medical use is patentable (Art 53)  Drug + medical use is patentable (Art. 53)  Transgenic animals: Medical benefit required (Rule 28)  Just a gene sequence is not patentable (Rule 29)  Just a gene sequence is not patentable (Rule 29) Szeged May 11, 2012 Walter Hinderer 7

Biotech Patenting > Legal Background (EPC)  Important Definitions (Rule 26, EPC): " i "Biotechnological inventions" are inventions which concern a h l i l i i " h h product consisting of or containing biological material or a process by means of which biological material is produced, process by means of which biological material is produced, processed or used. "Biological material" means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system. reproduced in a biological system. "Microbiological process" means any process involving or performed upon or resulting in microbiological material Szeged May 11, 2012 Walter Hinderer 8

Biotech Patenting > Filing Strategies (Originators) Patent filing along the development chain Pharma ‐ Cloning Process Analytical Clinical Non ‐ GMP Dossier ceutical methods studies Expression Expression USP USP clinical clinical develop ‐ d l Approval Validation studies Validation (I ‐ III) Cell bank DSP ment Multiple patent protection: Life cycle strategies Szeged May 11, 2012 Walter Hinderer 9

Filing Strategies > Patent Categories  Two patent categories exist: 1. Basic patents p  Define market entries for biosimilars  To be considered, may be opposed, circumvention not possible  Claims: Substance, DNA ‐ sequence, AA ‐ sequence, recombinant expression, biological function, key indication, dosing…  B  Basis for filing SPCs i f fili SPC 2. Secondary patents y p  Circumvention possible, often opposed  May emerge late (during biosimilar development)  Claims: Process, improved quality, formulation, device, dosing regimen, follow on indication(s), combination therapy, …  M  Moving targets for FTO assessments i t t f FTO t Szeged May 11, 2012 Walter Hinderer 10

Filing Strategies > Maximizing Protection Period  Sequence of Patent Filings for Biopharmaceuticals: Sequence, cell clone, expression, func � on: basic patents → SPCs Fermentation conditions, purification methods: secondary patents Pharmaceutical composition, drug delivery: secondary patents Pharmaceutical composition, drug delivery: secondary patents D Dosing, application, indication(s): basic/secondary patents i li i i di i ( ) b i / d To maximize the patent protection period h d Szeged May 11, 2012 Walter Hinderer 11

Practical Difficulties with Biotech Patents  Total number of patents: Very high for a given biotech product.  Scope of claims: Often difficult to interpret. Claims may refer to p p y sequences or even to deposited materials (cell clones).  Difficult search: Due to inconsistent nomenclature of the molecules and often meaningless titles and abstracts. Class ‐ specific search or structural search is insufficient.  Indirect substance protection: In most cases recombinant proteins receive no direct substance protection, since the corresponding natural occurring proteins are prior art Hence the patent protection natural occurring proteins are prior art. Hence, the patent protection is often related to specific production methods or biological targets (e.g. antibodies).  Multiple originators: Regularly there are no monopolies for biotech products, several companies developed in parallel comparable (me ‐ too) products. ) d Szeged May 11, 2012 Walter Hinderer 12

Practical Difficulties with Biotech Patents > Search  Systematic Keyword Search in 2002 No. of Hits 10000 First Wave of Biosimilar Candidates 9000 Databases: Databases: WPIX 8000 HCAPlus 7000 BiotechABS BiotechABS 6000 Approved Biosimilars (2006 – 2010) 5000 4000 3000 2000 2000 1000 0 0 Insulin IFN α EPO G ‐ CSF hGH IFNß FVIII 13 Szeged May 11, 2012 Walter Hinderer

Practical Difficulties with Biotech Patents > Multiple Originators 3 5 3 3 2 2 2 2 4 2 2 BioIP / Confidential 14

Biotech Patenting > Multiple SPCs  Examples of Biotech Products with Multiple SPC Applicants Enbrel Humira Leucomax Herceptin Xolair (Amgen) (Abott) (Schering ‐ Plough) (Roche) (Novartis) Schering Immunex Abbott Genentech Genentech Biotech Corp Genentech Yeda Novartis Chiron Tanox Research Abbott Research PDL PDL Peptech Corporation Biopharma Biopharma AHP Manufacturing M f t i Sanofi ‐ Aventis & General Hospital l l Proprietor of Product i f d Licensor , Licensee or Codeveloper i i d l Szeged May 11, 2012 Walter Hinderer 15

Multiple SPCs > EC Regulation  REGULATION (EC) No 469/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 May 2009 y Article 3 / Conditions for obtaining a certificate A certificate shall be granted if in the Member State in which the A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application: a)… b)…. c) the product has not already been the subject of a certificate; ) th d t h t l d b th bj t f tifi t d)…. Multiple SPCs (per country) are in conflict with Art. 3(c) of the EC Regulation 469/2009. Later granted SPCs should be invalid. [“ 1 Product → 1 SPC“ ] Szeged May 11, 2012 Walter Hinderer 16

Pharma Biotech Patenting > Case Study Case Study: Multiple Indications: Humira  Approved indications in the EU of Humira (adalimumab)  Approved indications in the EU of Humira (adalimumab) Ps RA AS CD JIA J UC PsA PsA EMA 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012  Sequential approval of 1) RA = Rheumatoid Arthritis seven distinct indications seven distinct indications 2) PsA = Psoriatric Arthritis 2) PsA = Psoriatric Arthritis  Different dosing regimens 3) AS = Ankylosing Spondilitis  Specific medical use patent 4) CD = Crohn‘s Disease applications filed 5) Ps = Psoriasis  Claims mirror regulatory 6) JIA = Juvenile Idiopathic Arthritis variations (labeling) i ti (l b li ) 7) UC 7) UC = Ulcerative Colitis Ul ti C liti Szeged May 11, 2012 Walter Hinderer 17