Commercialization and Patent Infringement

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Commercialization and Patent Infringement

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On Saturday, May 4, 2013, the Sino-American Biomedical & Pharmaceutical Professionals Association (SABPA) held its 8th Annual Biomedical Forum. The forum focused on career development,......

On Saturday, May 4, 2013, the Sino-American Biomedical & Pharmaceutical Professionals Association (SABPA) held its 8th Annual Biomedical Forum. The forum focused on career development, entrepreneurship and the latest innovations in pharma/biotech and medical devices industries. The biomedical forum strives to provide an attractive platform for entrepreneurs, scientists, engineers, investors, executives, and policy makers to promote life sciences, biotech, medical device and alliances across the biomedical industry in Southern California and Asian countries. Knobbe Martens Partner Terry Tullis presented on “Commercialization and Patent Infringement.”

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  • 1. Commercialization and Patent InfringementTerry K.Tullis,JD, MBAMay 4, 2013SABPA 8th Annual Biomedical ForumThe recipient may only view this work. No other right or license is granted.
  • 2. ©2012 Knobbe Martens, Olson & Bear, LLP all rights reserved.© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 21. What is a patent?2. Why do you need patents tocommercialize your product?3. FDA related patent issues
  • 3. 3© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.1. What is a patent?• Public invention disclosure in exchange for an exclusivity period• An issued patent gives the owner the right to stop others from:– making– using– selling– offering to sell– importingthe patented invention in that country.• But - an issued Patent does not necessarily give the patent ownerthe right to make, use or sell the invention
  • 4. 4© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.Example patent claim• Claim 1: A drug composition, comprising:– Agent A;– Agent B;– Agent C; and– Agent D (your improvement).• Competitor can sue you if they own any of A, B, or C.• You can sue if Competitor makes, uses, sells, offers to sell, orimports all of A+B+C, and D.
  • 5. 5© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.Requirements to get a Patent• No requirement to develop any product or prototype• Full disclosure of invention– Enable ordinary person in the field to make theinvention– Describe the “best mode” of making the invention• The invention - as claimed - must be– Novel– Not Obvious over “Prior Art”
  • 6. 6© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.What is Prior Art? (simplified)• Prior publication, knowledge or use of theinvention by others• Any patent or article published more than oneyear before the filing date of the application• Any public use or offer to sell the invention in theU.S. more than one year before the filing date ofthe application
  • 7. 7© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.Steps To Get a Patent• Prior Art Search• Prepare patent application – carefully craft claims• File Patent Application with Patent Office• Patent Application Publishes (18 mos. after filing)• Examination• Argue with Examiner• Appeal (if necessary)• Gain Allowance, Pay Issue Fee• Patent Granted• Pay Maintenance FeesREPEAT
  • 8. 8© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.International Patent Protection• No “world-wide” patent• File within one year of U.S. Priority date• Expensive to file and prosecute• Priority must be before any public disclosure
  • 9. 9© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.PCT (International) Patent Application• Prepare and file single application, with claims• Secures option to pursue patent protection in all PCTmember countries (over 100), including U.S. and China(but not Taiwan)• Can hold national phase prosecution for up to 30 months• Obtain non-binding preliminary examination• Can be filed instead of a U.S. Patent Application or within1 year of U.S. filing date.• Cost: about $5000 – 8000 in filing fees
  • 10. 10© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.Patent Protection in China (and elsewhere)• Use foreign patents as a tool to enter foreign markets• Seek patent protection where products are made, usedor sold• Patents must be filed before public disclosure• Costs can be high• Medical methods are not patentable outside of the U.S.and Australia• Consider enforcement challenges
  • 11. ©2012 Knobbe Martens, Olson & Bear, LLP all rights reserved.© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 111. What is a patent?2. Why do you need patents tocommercialize your product?3. FDA related patent issues
  • 12. 12© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.2. Why do you need patents to commercialize your product?• Patents protect your investment– Protect your market and secure financing• 94% of venture-backed start-ups own patent or application(average 25 patents & applications)• Branded drugs: Millions in revenue for each day ofexclusivity– Defensive purposes– Leverage in deals
  • 13. 13© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.13Seek Patents That Block Competitive AlternativesCommercial ProductPatent RelevantScope Market
  • 14. 14© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.Survey competitive patent landscape• Look for freedom to operate or patent clearance obstacles earlyon to avoid pitfalls– Assess patentability– Assess risk (“freedom to operate”)– Identify competitors and their patent claims, and potentialdesign around– Work with your patent counsel to understand the patentroadblocks to commercialization• Delay can be a costly mistake!It’s not just about what you have, it’s about what they have
  • 15. ©2012 Knobbe Martens, Olson & Bear, LLP all rights reserved.© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 151. What is a patent?2. Why do you need patents tocommercialize your product?3. FDA related patent issues
  • 16. 16© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.4. Coordinating Patents with Regulatory Issues• ANDA Generic Drug litigation• Safe Harbor 271(e) exceptions to infringement forclinical trials• Biologics Price Competition and Innovation Act• Patent Term Extension to Coordinate with FDAApproval• Consistency with 510k submissions
  • 17. 17© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.Generic Drug Litigation and Exclusivity• Clinical Trials: Investigational New Drug application (IND)• Market “branded” drugs: New Drug Application (NDA)approvals, patents listed in the Orange Book• Generics: Abbreviated New Drug Application (ANDA)– Hatch-Waxman Act and patents: the first drug manufacturer to• successfully challenge FDA-listed patent and market anapproved generic, or• prevail in litigation establishing the patent is invalid or notinfringedis rewarded with 180 days of generic marketing exclusivity
  • 18. 18© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.Allergan, Inc. v. Sandoz Inc. (Fed. Cir. May 2, 2013)• Appeal court finds 3 of 4 patents for COMBIGAN ophthalmicglaucoma drug treatment are “nonobvious”• Generic drug waits until last patent expires in 2022
  • 19. 19© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.Safe Harbor 271(e): generic drug experiments• Exceptions to infringement for uses reasonably related to thedevelopment and submission of information under a Federal lawwhich regulates the manufacture, use, or sale of drugs.– Experimenting for generic FDA approval– Dissemination of data developed for FDA approval– Use of patented compounds in preclinical studies that werenot included in FDA submission• Once generic ANDA is filed, action is considered “infringement”
  • 20. 20© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.Biosimilars – approval short cut for biologicsAbbreviated approval for ‘biological products’ that are highlysimilar (i.e., biosimilar) to or interchangeable with an FDA-licensedreference biological product.– Biological products therapies used to treat health conditions e.g.,vaccines, blood and blood components, gene therapies, tissues, andproteins (except any chemically synthesized polypeptide).• Generally are made from human and/or animal materials rather thanchemical process.• Cell lines not identical: only similar.– A biosimilar• Highly similar to an approved biological product• No clinically meaningful differences in terms of the safety, purity, andpotency.
  • 21. 21© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.Biologics – examplesFigure shared under Creative Commons license from Pharmaceuticals 2012, 5(12), 1393-1408; doi:10.3390/ph5121393http://www.mdpi.com/1424-8247/5/12/1393
  • 22. 22© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.• Biosimilar approval application may not be submitted until fouryears after the date the reference product was first FDA licensed• The filing of a biosimilar application constitutes an artificial act ofpatent infringement that confers jurisdiction on the federal courts.Biosimilar BasicsHatch-Waxman BiosimilarsExclusivity First-filer has thepotential to have 180 daysexclusivityUp to 42 months exclusivity butonly if biosimilar is determinedto be interchangeableDeterminingPatent Coveragefor ReferenceProductOrange Book No Orange Book equivalentStatutorily required pre-litigation exchange of patentinformationStay of FDAApprovalAutomatic 30-month staybefore generic can entermarket absent a courtdecisionNo automatic stay,however,thebiosimilar application cannotbe approved until 12 years afterfirst licensure of the referenceproduct
  • 23. 23© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.Patent Term Extension• Hatch Waxman Act (1984): PTE to compensate forpotential delays in FDA approval, available only for:– new drug, antibiotic drug, or human biologicalproduct– new animal drug, veterinary biological product– new medical device Class 3 pre-market approval(PMA) (not Class 1 or 2 abbreviated 510k)• Get up to 5 more years patent term based on FDAapproval timing (must file within 60 days)
  • 24. 24© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.Patent Term Extension examples• http://www.uspto.gov/patents/resources/terms/index.jsp
  • 25. 25© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.Statements about Predicate Devices• Consider implications of declaring similarity topredicate devices• Patentability• Infringement
  • 26. 26© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved.26Conclusion: Patent Pitfalls1. Failing to appreciate the value of IP to your business2. Misunderstanding the rights conferred by a patent3. Ignoring your competition4. Protecting a product instead of a market space5. Ignoring overlap and interactions with regulatoryagencies
  • 27. Thank you. Terry.Tullis@knobbe.com(949) 760-0404