Covington lawyers have been extensively involved in every aspect of the Hatch-Waxman legislation since its passage in 1984, before FDA, in the courts, and before Congress. We give advice on strategies relating to patent listing, generic approval standards, non-patent (regulatory) exclusivity, pediatric exclusivity, settlement of patent litigation, authorized generics, and 180-day generic exclusivity. We have extensive experience with citizen petitions, pursuing formal and informal advocacy at FDA, and engaging in targeted litigation to maximize product lifecycles. We have also represented PhRMA on all issues relating to the Hatch Waxman legislation, including in rulemakings, on amicus briefs, and with respect to legislative proposals. We were deeply involved in the rulemaking and legislative changes in 2003, and we are routinely involved — on behalf of PhRMA and individual biopharmaceutical companies — in legislative proposals in this space.
Covington lawyers were also deeply engaged in the policy discussions and legislative negotiations that culminated in enactment of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), on behalf of a large coalition of biotechnology innovators, many individual biopharmaceutical companies, and PhRMA. Since enactment of this law in March 2010, we have been heavily involved in implementation on behalf of the research-based industry, coordinating advocacy in the United States with advocacy on biosimilar issues worldwide, and assisting numerous companies with development and execution of lifecycle defense strategies for key products. Our work for individual companies in this space includes advocacy at FDA on scientific, regulatory, and legal issues specific to their products (for example, on exclusivity eligibility, the scientific standards governing biosimilar applications, and policy issues connected to naming and labeling). Covington can put together integrated teams of regulatory, patent advisory, and patent litigation lawyers — all steeped in the issues presented by biosimilars — in order to craft coordinated (and, if needed, global) patent and regulatory defense strategies.
Over the years, Covington has represented virtually every major research based pharmaceutical company on product exclusivity and lifecycle issues.
Representative Matters
- We assisted sanofi-aventis with a multi-year multi-jurisdiction strategy with respect to ensuring that follow-on versions of Lovenox (enoxaparin sodium), a complex and not fully characterized molecule, contains all pharmacologically active and clinically significant components of Lovenox. This strategy has had legislative, regulatory, and litigation aspects and included, for example, a citizen petition arguing that FDA should refrain from approving any generic drugs citing Lovenox as the reference listed drug absent certain scientific findings by the agency, and litigation against the agency following its approval of an ANDA.
- We argued successfully that the DC Circuit should affirm a district court grant of summary judgment in favor of FDA and Shire in a challenge by a generic manufacturer to the agency’s grant of five years of exclusivity to Shire’s drug, Vyvanse (lisdexamfetamine dimesylate). The firm’s regulatory specialists were engaged at FDA on behalf of clients aligned with Shire and worked closely with the firm’s patent and litigation specialists.
- In the district court, we challenged FDA’s authority to approve applications for generic versions of Eloxatin (oxaliplatin) before expiration of sanofi-aventis’s 30-month stay, where the Federal Circuit had stayed the District Court’s judgment of non-infringement pending review.
- We drafted a citizen petition for Astellas arguing that FDA should refrain from approving any generic version of Prograf (tacrolimus) absent additional bioequivalence studies in transplant patients. We also represented Astellas in challenging FDA’s denial of the citizen petition and the agency’s approval of an ANDA.
- We drafted a citizen petition on behalf of Ista Pharmaceuticals arguing that FDA should refrain from approving a generic version of bromfenac ophthalmic solution 0.09% that utilizes discontinued labeling or omits any portion of the new labeling. We then represented Ista in litigation challenging FDA’s denial of the petition.
Accolades
- Law360, Life Sciences Group of the Year (2012)
- Chambers Global (2013)
- Life Sciences, Global-wide
- Life Sciences, Europe-wide
- Chambers USA (2013)
- Life Sciences, Nationwide
- Life Sciences, CA
- Chambers UK (2013)
- Life Sciences, UK-wide
- Life Sciences, Regulatory, UK-wide
- Chambers Asia (2013)
- Life Sciences (International Firms), China
- PLC Cross-border Super League
- Ranked 1st in the Life Sciences Regulatory Super League (2004-2011)
- Ranked 1st in the Life Sciences Industry Super League (2005-2010)
- PLC - Life Sciences, Which Law Firm? (2012)
- Leading: Life Sciences, England, EU, and USA
- Leading: Regulatory, Belgium, England, EU, and USA
- Leading: Government Enforcement and Investigations, USA
- Highly Recommended: Life Sciences, Belgium
- LMG Life Sciences (2012)
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