Biotechnology law requires special expertise and attorneys having advanced scientific degrees. Our clinician attorneys provide comprehensive guidance and solutions to biotechnology companies across the country.
Biologics have exceptionally long and expensive product-development life cycles. More new drugs tend to be biologics commanding both high prices and 12 years of exclusivity.
To date, the Food and Drug Administration (FDA) has approved close to 30 biosimilar products, half of them since 2019. However, no interchangeable biosimilar has yet been approved. As a result, automatic substitution between a reference product and a biosimilar is not permitted. Despite the fact that almost every state has enacted biosimilar substitution laws, the “Purple Book” does not contain a single patent.
Estimates are that biosimilars could save the U.S. healthcare system approximately $250 billion over the next 10 years. As the U.S. tries to reduce healthcare costs, it is obvious that improved access to biosimilars is poised to play a key role in that effort. Legislative measures to increase access to biosimilars include the 2020 Increasing Access to Biosimilars Act. This proposed bill has bipartisan support. Another bill would waive all out-of-pocket expenses (i.e. allow for zero co-pay) for seniors prescribed biosimilars under Medicare Part B for the first 5 years that a biosimilar is on the market. Additionally, in the future CMS has indicated an intention to partner for shared services – i.e. offer providers a percentage of any net savings realized.
Protection of intellectual property is difficult, complex and costly for this industry. The patent intricacies of the Biologics Price Control and Innovations Act (BPCIA) as well as post grant proceedings such as inter partes reviews require seasoned lawyers who can provide strategic and legal advice to avoid costly mistakes. We secure and enforce patents, trademarks and copyrights, protect trade secrets, license technology and develop litigation strategies. Our attorneys have extensive experience with inter partes review (IPR) cases before the Patent Trial and Appeal Board, and we frequently advocate for clients before the International Trade Commission, U.S. District Court and federal appeals courts.
Use of IPR to eliminate blocking patents prior to filing an Abbreviated Biologics License Application (aBLA) or to determine the strength of patent protection covering the reference product and challenges favoring non-Orange book patents are now attractive strategies for biopharmaceutical companies. Changes to IPR now require the use of the same claim interpretation standard that is being used by the courts in patent litigation, although the lower standard of proof based on preponderance of evidence and lack of standing requirements remain. The use of the same claim interpretation standard has the potential to greatly improve predictability in the post-issuance review process and mitigate against inconsistent results that have occurred when the same patent is adjudicated in different venues. IPRs should be considered part of any biosimilar development program and are especially useful for attacking follow-on patents covering formulations, use in specific patient populations or dosing regimens. At Frier Levitt, we have our finger on the pulse of trends appearing in the over 100 IPR decisions rendered.
Until 2010 and the BPCIA, there was no mechanism for marketing biosimilars. Marketing biosimilars involves a very complex process as evidenced by the fact that the first biosimilar was not approved under this pathway until 2015. Significant differences exist between the BPCIA and Hatch Waxman approval pathways. The “patent dance” for biosimilars has proven to have difficult steps for even the best dancer to follow and often the parties proceed to litigation bypassing the need to even ask each other to dance. Our team has published and presented extensively in the biosimilar arena:
- Rumore MM, Vogenberg R. Biosimilars: Still Not Ready For Prime Time. P&T Journal. 2016;41(6):366, 368-375. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4894513/
- Rumore MM, Cobb E, Sullivan M, Wittman D. Biosimilars: Opportunities and Challenges for Nurse Practitioners. J Nurse Practitioners 2016;12(3):181-191. https://www.npjournal.org/article/S1555-4155(15)00827-2/pdf
- Wong A, Rumore MM, Chan AK. Biosimilars on the United States: Emerging Issues in Litigation. BioDrugs 2017;31(3):189-205. https://pubmed.ncbi.nlm.nih.gov/28424972/
Corporate Counseling and Transactions
We take a collaborative approach to corporate counseling. We have assisted clients in portfolio due diligence, mergers and acquisitions and licensing agreements.
FDA Regulation/Life Sciences
In July 2020, FDA withdrew approximately 20 Center for Biologics Evaluation and Research (CBER) guidance documents pertaining to biologics some dating back to the 1980s. One notable deletion is the 2001 Draft Guidance pertaining to Type V Drug Master files. Other Guidances have been updated as needed and finalized. In March 2020, FDA provided Guidance for the BPCIA provisions pertaining to labeling of BLA products. FDA also provided Guidance in the form of Q&A for applications for a biological product approved under section 505 of the Federal Food, Drug & Cosmetic Act (FD&C Act) which will be “deemed to be a license” for the biological product under section 351 of the Public Health Service Act (PHS) on March 23, 2020 (the transition date). After March 23, 2020, all sponsors seeking approval of a biological product that previously could have been submitted under section 505 of the FD&C Act will need to submit a marketing application under section 351 of the PHS Act; either:
- a 351(a) BLA (i.e., a “stand-alone” BLA); or
- a 351(k) BLA for a proposed biosimilar product or a proposed interchangeable product.
In addition to product and portfolio development, we offer a full range of FDA regulatory services including:
- Advise on a broad array of issues in connection with advertising and promotion of biologic drug products (including labeling) in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and implementing regulations, The Office of Prescription Drug Promotion (OPDP) guidance, Anti-Kickback Statute, False Claims Act, Office of Inspector General (OIG) Guidance, PhRMA Code and Sunshine Act
- Counsel promotional review committees (on periodic and ad hoc promotional material reviews) which would include legal, medical affairs, regulatory affairs and marketing teams
- Provide advice to commercial and medical teams on programs, engagements, grants, sponsorships and other initiatives to ensure compliance with relevant healthcare laws, guidance documents, advisory opinions, enforcement trends and settlements (Food & Drug Administration, Office of the Inspector General, and Department of Justice (DOJ)
- Provide advice on access and reimbursement, patient support programs, financial assistance and other market access matters, including government pricing and state price transparency reporting, if applicable
- Provide legal advice and support regarding policies and procedures to ensure compliance with federal and state healthcare laws and regulations governing drug promotion, field customer engagement and incentive compensation, financial arrangements with healthcare providers (gifts, grants and consulting), transparency reporting (Sunshine Act), disease awareness “ads” and scientific communications (symposia, CME and publications)
- Provide advice and counseling concerning various commercial agreements, including marketing activities (vendor and consultant agreements), managed care access (Managed Care Option, Pharmacy Benefit Manager (PBM) and Group Purchasing Option (GPO)), channel distribution (wholesale, specialty pharmacy) and patient support (HUB)
- Provide general legal advice and FDA counseling on commercial launch preparation activities and brand-related strategic planning
Contact us for the strategic and legal advice needed to succeed.