Health Care Reform And Biologics


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Presentation to the Louisville Life Sciences Community - July 2010

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Health Care Reform And Biologics

  1. 1. Health Care Reform and Biologics Pathway for the approval of “generic” versions of genetically engineered medicines
  2. 2. Biologics Price Competition and Innovation Act nThe Patient Protection and Affordable Care Act signed into law on March 23, 2010 – includes a subchapter called the Biologics Price Competition and Innovation Act (“Biologics Act”). nCreated a regulatory path for expedited approval of “biosimilar” versions of pioneer biologics. nRegulates the interaction between patent holders and manufacturers of biosimilars.
  3. 3. Biologics Price Competition and Innovation Act nBiologics – therapeutic drugs that are derived from biological processes, i.e. a virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product or analogous product (PHSA, 42 USC § 262) nBiosimilars – refers to new versions of existing biologics – often called “follow-on-biologics”
  4. 4. Biologics Price Competition and Innovation Act nFunction – to expedite approval of new biologics sufficiently similar to FDA approved biologics by allowing biosimilars to use submitted data obtained from predecessor biologics for the FDA approval process. nGoal – to increase competition and reduce the cost of biologics as well as reformation of patent litigation procedures as they relate to biologics.
  5. 5. Biologics Price Competition and Innovation Act nAct provisions – standards for application and approval similar to those for generic pharmaceuticals – provides data and market exclusivity for the pioneer biologic – provides biosimilar exclusivity for the first approved follow-on product – establishes a scheme for handling patent disputes
  6. 6. Biologics Price Competition and Innovation Act n New requirements to deal with patented reference products – notice to pioneer within 20 days of application – strict timelines on disclosures similar to those used in patent litigation rocket docket districts – requires good faith negotiations – goal is to force patent litigation soon after the application is filed to avoid removing biosimilars from the market – non-compliance by pioneer can limit damages to a reasonable royalty or even loss of rights to enforce the patent – non-compliance by follow-on gives pioneer right to file an action outside of the 30 day window for filing an action after disclosures
  7. 7. Biologics Price Competition and Innovation Act n Concerns of the biotech industry – difficult to recoup investment back in the time allotted by the Act – could lead to compression of recoupment period and increase in the cost of biologics – anticipated shift of investment income to more lucrative investments – potential antitrust issues related to anticipated creative patent infringement action settlement agreements as well as the appearance of collusion with biosimilar manufacturers
  8. 8. Biologics Price Competition and Innovation Act n Safety issues – biosimilar products more likely to result in adverse health effects due to impurities – biosimilars may perform differently from pioneer biologics due to high molecular complexity and the negative impact of nearly undetectable levels of impurities – the follow-on manufacturer does not have access to the originator's molecular clone and original cell bank, nor to the exact production processes
  9. 9. Biologics Price Competition and Innovation Act n Ultimate effect of the law? – accelerates the availability of biosimilars – will likely will increase the cost of biologic therapeutics – may drive needed investment capital away from startups and decelerate the discovery of pioneer biologics – forces patent holders to initiate patent litigation during the approval process – increased need for competent patent and antitrust counseling for both parties
  10. 10. James M. Francis, Esq. Greenebaum Doll & McDonald, PLLC Co-Chair, Life Sciences Team Registered US Patent Attorney 101 S 5th St., Suite 3500 Louisville, KY 40202 502-587-3661 (Office) 502-540-2261 (Fax)