1. Developing an International IP Strategy that Includes Biotherapeutic Technologies Jerry L. Hefner SABPA 7th Annual Pacific Forum November 12, 2011

2. © 2011 Knobbe Martens Olson & Bear LLP2 2 What is a Biotherapeutic  A therapeutic molecule that is a biological product as set forth under 42 USC § 262(i)(1) – “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide) or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings” Hormones such as insulin, glucagon, and human growth hormone are currently treated as drugs and regulated under the FDCA

3. © 2011 Knobbe Martens Olson & Bear LLP3 3 Protecting a Biotherapeutic with IP  Areas of special consideration Nature of the subject matter – what type of biological material will be subject of regulatory approval International filing strategy and potential subject matter exclusions When should I file my application What kind of claim scope can I obtain What types of claims are most useful

4. © 2011 Knobbe Martens Olson & Bear LLP4 4 Protecting a Biotherapeutic with IP  Areas of special consideration How to deal with follow on biologics (FOBs) How to maximize patent term Contemplate 2 nd and 3 rd generation products

5. © 2011 Knobbe Martens Olson & Bear LLP5 Nature of the Subject Matter  What is it that you intend to protect?  Peptide  Antibody  Cell  Tissue/Organ  Virus/VLP  Complex biological mixture  It matters!

6. © 2011 Knobbe Martens Olson & Bear LLP6 Is it Off Limits  Subject Matter Exclusions in Major Jurisdictions  Cells of plants and animals – India  Human ES derived inventions – EU, China  Higher life forms – Canada  Methods involving surgery, treatment or diagnostics – EU, Canada, China, JP

7. © 2011 Knobbe Martens Olson & Bear LLP7 When Should I File  As soon as you have enabled the technology  First to file is the standard worldwide  Reality in United States on March 16, 2013  File a United States provisional patent application  Provides for priority but does not count against your term  Continue to supplement provisional application with additional working embodiments for up to one year

8. © 2011 Knobbe Martens Olson & Bear LLP8 What Can I Protect/How Much Can I Get  One important object is to cover biosimilars and interchangeables  Should I start narrow or should I start broad  Depends on jurisdiction and how much data you have  Because most jurisdictions allow continuing applications it can be useful to start narrow  You may be able to capture biosimilars and interchangeables under the doctrine of equivalents - but not if you start broad and make narrowing amendments

9. © 2011 Knobbe Martens Olson & Bear LLP9 What Can I Protect/How Much Can I Get  Other reasons to start narrow  Most jurisdictions give very little scope beyond what has been demonstrated by working examples  Several working examples may support a genus claim – especially if you identify a common structural motif that links variants together  Reasons to start broad  Broad claims attract investors  Broad claims can be scary for competitors  Double patenting issues – e.g. Canada

10. © 2011 Knobbe Martens Olson & Bear LLP10 What are the Most Useful Claim Types  Composition of matter  Cover approved product  Cover approved product and related variants  Prohibits making, selling, using, offering to sell and importing in most jurisdictions  Methods of Use  Good but usually third party infringement action  Watch out for two party infringement issues

11. © 2011 Knobbe Martens Olson & Bear LLP11 What are the Most Useful Claim Types  Methods of Making  Can be difficult to prove infringement unless jurisdiction offers discovery or seizure procedure

12. Dealing with FOBs  Claims related to systems/devices  Can protect ultimate dosage form or delivery device  For example – Amgen v. F. Hoffman-La Roche  Amgen claims – “[a] pharmaceutical composition comprising a therapeutically effective amount of human erythropoeitin and a pharmaceutically acceptable diluent, adjuvant or carrier, wherein said erythropoietin is purified from mammalian cells grown in culture.” © 2011 Knobbe Martens Olson & Bear LLP12

13. Dealing with FOBs  Roche’s MICERA molecule is the same sequence but has different post-translational modifications  MICERA found to literally infringe Amgen’s claim – 580 F.3d 1340 Fed. Cir. 2009  Consider related methods  Consider obtaining IP to methods of characterizing the product  Even better – consider IP to monitoring the effect of the biotherapeutic agent © 2011 Knobbe Martens Olson & Bear LLP13

14. Dealing with FOBs  Consider label claims  Exemplary claim to “a method of making a biotherapeutic drug product” –  providing the biotherapeutic molecule; and  instructing a patient to fast for at least 12 hours before administering the molecule to the patient  Regulatory requirements may cause the biosimilar or interchangeable to literally infringe the claim © 2011 Knobbe Martens Olson & Bear LLP14

15. Dealing with FOBs  Consider keeping certain manufacturing and/or process- related details trade secret  America Invents Act – still maintains the best mode requirement but no real consequences for violating it © 2011 Knobbe Martens Olson & Bear LLP15

16. Maximize Patent Term in United States  Take advantage of Patent Term Adjustment (PTA)  Maximize PTA for each patent application that is filed  Be cautious of terminal disclaimers  Carefully select single best patent for Patent Term Extension (PTE)  File within 60 of first approval of biotherapeutic  The MDCO case and AIA © 2011 Knobbe Martens Olson & Bear LLP16

17. Consider Second Generation Products  Make FOB obsolete  Modified dosage form  Delayed release  Longer circulation time  Targeted biologic  Increase specificity for target area  Combine with device  Can provide for a second PTE © 2011 Knobbe Martens Olson & Bear LLP17

18. Build Value  Without a sound IP portfolio, the exits are limited  Develop a sound IP strategy from the beginning and increase the likelihood that you will see return on your investment © 2011 Knobbe Martens Olson & Bear LLP18

19. kmob.com Orange County, CA San Diego, CA Riverside, CA Los Angeles, CA San Francisco, CA Washington, D.C. Seattle, WA Jerry L. Hefner jhefner@kmob.com