U.S. Biosimilars - Red Flags for Patent Attorneys
 

U.S. Biosimilars - Red Flags for Patent Attorneys

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On March 14, 2013, Knobbe Martens Partner Carol Pitzel Cruz presented at the 24th C5 Forum on Biotech Patenting 2013. The presentation was titled "The Red Flags Every Patent Attorney Needs to Know to ...

On March 14, 2013, Knobbe Martens Partner Carol Pitzel Cruz presented at the 24th C5 Forum on Biotech Patenting 2013. The presentation was titled "The Red Flags Every Patent Attorney Needs to Know to Successfully Navigate the Regulatory Landscape for Biosimilars" and Pitzel Cruz covered the U.S. law.

Her presentation analyzed the key features of the new Food and Drug Administration guidelines for American biosimilar approval under the Biologics Price Competition and Innovation Act.

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U.S. Biosimilars - Red Flags for Patent Attorneys U.S. Biosimilars - Red Flags for Patent Attorneys Presentation Transcript

  • U.S. Biosimilars Carol Pitzel Cruz 14 March 2013 Red Flags for Patent AttorneysThe recipient may only view this work. No other right or license is granted. knobbe.com 1
  • Biologics Price Competition and Innovation Act (“the Biosimilars Act”) • Signed into law March 23, 2010, as part of the Patient Protection and Affordable Care Act of 2009; amends §351 of the Public Health Services Act. • Codified at 42 U.S.C.§262. • Creates an abbreviated approval pathway for generic ‘biological products’ that are demonstrated to be highly similar (i.e., biosimilar) to or interchangeable with an FDA-licensed reference biological product.© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 2
  • What are Biological Products? – Biological products are therapies used to treat diseases and health conditions. They include a wide variety of products including vaccines, blood and blood components, gene therapies, tissues, and proteins (except any chemically synthesized polypeptide). Unlike most prescription drugs made through chemical processes, biological products generally are made from human and/or animal materials. See, e.g., 42 USC §262(i)(1) (emphasis added). – “Protein” – any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size. See FDA Draft Guidance, “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product” at 22. – “Chemically synthesized polypeptide” – any alpha amino acid polymer that (1) is made entirely by chemical synthesis; and (2) is less than 100 amino acids in size. See id.© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 3 View slide
  • How do you demonstrate biosimilarity? Interchangeability?© 2013 Knobbe, Martens, Olson & Bear, reserved.©2012 Knobbe Martens, Olson & Bear, LLP all rightsLLP all rights reserved. 4 View slide
  • Biosimilarity - The Statute A biosimilar is a biological product that is highly similar to an already approved biological product, notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biosimilar and the approved biological product in terms of the safety, purity, and potency. See 42 USC §262(i)(2) and (3) (emphasis added).© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 5
  • The FDA • Current Draft Guidance Documents – Scientific Considerations in Demonstrating Biosimilarity to a Reference Product – Quality Considerations in Demonstrating Biosimilarity to a Reference Product – Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 • Additional FDA Guidance expected in 2013 – Submission of Clinical Pharmacology Data as Evidence of Biosimilarity for Biologics and Protein Products • The FDA has not yet provided a guidance document regarding the standard for demonstrating interchangeability© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 6
  • Biosimilarity - What has the FDA told us? The FDA will consider the “totality of evidence provided by a sponsor to support a demonstration of biosimilarity, and recommends that sponsors use a stepwise approach in their development of biosimilar products.” See FDA Draft Guidance, “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product” (emphasis added)© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 7
  • Biosimilarity - What has the FDA told us? • The FDA expects that a showing of biosimilarity will be based on: – Analytical studies – Animal studies; and – A clinical study or studies. See FDA Draft Guidance, “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product” • The type and amount of testing will be “determined on a product- specific basis.” Id. • As a whole, the guidance documents focus on extensive characterization of both the proposed biosimilar product and the reference product.© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 8
  • Biosimilarity • What does this mean for patent attorneys? • What types of tests, instruments, studies will be used to demonstrate biosimilarity? • What kind of patent protection is in place? – 271(e) Safe Harbor – Need for testing post-approval • When can the biosimilar application be filed with the FDA? • What happens once the biosimilar application is filed with the FDA?© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 9
  • The Biosimilar Application • An application submitted for biosimilar approval may not be submitted until four years after “the date on which the reference product was first licensed….” 42 USC §262(k)(7)(B). • An application submitted for biosimilar approval may not be approved until twelve years after “the date on which the reference product was first licensed….” 42 USC §262(k)(7)(A). • The filing of a biosimilar application triggers a complex exchange of information between the applicant and the reference product sponsor (RPS) prior to the filing of a lawsuit. 42 USC §262(l). • The filing of a biosimilar application constitutes an artificial act of patent infringement that confers jurisdiction on the federal courts. 35 U.S.C. § 271(e)(2)(C).© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 10
  • Exclusivity Timeline Interchangeable Exclusivity Ends Market Exclusivity Ends ~1 yr Data Exclusivity Ends Reference Product 8 yrs – No biosimilars can Licensed enter the market 4 yrs – No biosimilar applications can be Patent dispute resolution process filed 11 0 2 4 6 8 10 12 Years© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 11
  • Patent Litigation under the Biosimilars Act Which patents will be litigated? – The listing and sharing of patent information is conducted by the Reference Product Sponsor (RPS) and the Applicant through a series of prescribed confidential exchanges prior to the filing of a lawsuit. 42 USC §262(l).© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 12
  • Patent Exchange Timeline Applicant Notify FDA (Agree on patents) RPS must bring suit (Agree on patents) Negotiation Deadline 30 days 30 days Infringement contentions & invalidity responses (RPS) Invalidity/non-infringement contentions (Applicant) 15 days Assertable patents & potential licenses (RPS) 60 days RPS Notified (Applicant) 60 daysApplication Submitted 60 days 20 days 0 20 40 60 80 100 120 140 160 180 200 220 240 260 280 300 30 days 30 days Applicant Notify FDA Days 5 days (No agreement) RPS must bring suit (No agreement) List Exchange (No agreement)© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 13
  • Preparing in Advance for the Patent Exchange© 2013 Knobbe, Martens, Olson & Bear, reserved.©2012 Knobbe Martens, Olson & Bear, LLP all rightsLLP all rights reserved. 14
  • Pre-Litigation Strategies for Reference Product Sponsor • Organize patent portfolio to identify patents applicable to specific biosimilar application • Obtain claims that cover design-arounds and alternative manufacturing processes • Consider licensing additional third-party patents that could be asserted against applicant • Review existing licenses and determine standing and ability to enforce • Evaluate risk associated with identifying patents (i.e., research tools or platform technology) • Identify patents that may be appropriate to license to applicant • Monitor applicant’s compliance with disclosure rules to assess whether an injunction may be available© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 15
  • Pre-Litigation Strategies for Applicant • Proactively identify RPS’ patents – Monitor any publicly announced licensing deals • Develop non-infringement positions early – May require testing or expert analysis depending on claims • Develop invalidity positions early – Search for prior art – Consult with experts on invalidity issues • Monitor RPS’ patent portfolio for pending applications that could issue • Comply with exchange deadlines in order to avoid DJ action© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 16
  • Portfolio Review by Reference Product Sponsor – Do you have claims to design-arounds? Methods of manufacture? – Make sure you have coverage not just for your product/process but also for modifications/improvements/alternate processes/etc. – Consider dividing claims into one or more cases to allow the ability to assert only one of the patents in a given litigation – Assess whether to assert any “platform technology” patents – Consider licensing/acquiring additional patents – Consider standing issues • Especially true for licensed and acquired patents – Consider the potential use of AIA procedures to strengthen portfolio (e.g., supplemental examination)© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 17
  • Portfolio Review by Biosimilar Applicant • Review of Applicant’s patent portfolio – While not involved in the patent exchange, are there patents that can be used offensively against the RPS? Against other future biosimilars? – Are there claims that can be obtained to use offensively? – Are there patents that can be licensed? Acquired? Obtained? • Patents on platform technologies or research tools – How are these patents being used by the Applicant? – Can the Applicant rely upon the “safe harbor” exemption of 271(e)(1)?© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 18
  • Evaluation of Litigation Risk by Reference Product Sponsor • Consider strength of all patents in portfolio – Perhaps some would be better served in the second phase of litigation • Consider use of platform technology or research tool patents for future litigation against other biosimilar applicants for different products© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 19
  • Licensing and Enforcement Considerations© 2013 Knobbe, Martens, Olson & Bear, reserved.©2012 Knobbe Martens, Olson & Bear, LLP all rightsLLP all rights reserved. 20
  • Licensing Issues for Reference Product Sponsor • Third party ownership issues – RPS’ patent portfolio often involves patents licensed from third parties • Review existing license agreements – Evaluate standing issues – Review provisions relating to enforcement and joinder of licensor • Consider whether any provisions should be updated – Shortened notice period for infringement – Consent to joinder – Confidentiality issues – Rights to sublicense – Acceptable terms for sublicense© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 21
  • Issues to be Addressed in License Agreements • Standing • Timing – consider provisions requiring prompt action once a biosimilar application is filed – e.g., if a University is involved, can they move quickly to provide information? Approve involvement in lawsuits? etc. • Confidentiality and access to the biosimilar application – Prosecution bar issues • Consider provisions to require Licensor to maintain/update a list of all relevant licensed patents • Notification – consider provisions requiring RPS/Licensee to provide prompt notice to Licensor of the filing of a biosimilar application – Include additional notice procedures tied to deadlines in the patent exchange procedure© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 22
  • Issues to be Addressed in License Agreements • Control of litigation and patent exchange – Timing is key – pre-litigation timing deadlines are short, consider provisions requiring action within a specified timeframe – Strategy Choices • Who has control? Input? • Decision as to which patents to include during the patent exchange process • Choice of counsel • Willingness to be a party to the litigation© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 23
  • Enforcement Considerations • Prepare EARLY – given the short time frames for the pre-litigation exchange, you must be prepared ahead of time • Strategies for timing of litigation – Which patents should be included in the first wave of litigation v. the potential second wave of litigation? • Compliance with the pre-litigation procedures – Compliance impacts available remedies© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 24
  • Thank You