Regulatory Advice and Consultation, Oral and Written Opinions, and Expert Witness Testimony
Pharmaceutical Law Group’s founder, Gregory Glover, MD JD, is nationally known for providing in-depth regulatory knowledge and expert opinion on the complex interactions between intellectual property, FDA regulation, and market dynamics.
Dr. Glover, a registered patent attorney and non-practicing physician, is among the nation’s most experienced experts on FDA-related legal matters involving the Hatch-Waxman Act, patent and non-patent market exclusivity provisions, and intellectual property and market exclusivity issues for biologics and biosimilars under the provisions of the Biologics Price Competition and Innovation Act (BPCIA). Learn More About Gregory Glover.
Providing Advice, Consultation, and Expert Testimony at the Intersection of Intellectual Property Law and FDA Regulation.
Dr. Glover provides consultation and expertise for attorneys, life science companies, and investors on matters involving innovator and generic drugs, biologic and biosimilar products, regulatory exclusivities, and the interaction of FDA regulation and intellectual property.
Typical consultations and strategic engagements relating to intellectual property issues and FDA regulation include:
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FDA-Related Litigation
Dr. Glover provides valuable consultation, opinion, and expert testimony on the effects of regulatory exclusivities and other statutory provisions on the contractual relationships and commercial positions of the parties.
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Evaluating Eligibility for Regulatory Exclusivities
Dr. Glover specializes in helping life sciences companies, investors, attorneys, and others evaluate the availability of regulatory exclusivities, including 5-year data exclusivity, 3-year new product exclusivity, 12-year reference product exclusivity, orphan drug exclusivity, pediatric exclusivity, GAIN exclusivity, and other forms of regulatory exclusivity for pharma and biotech products.
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Strategic Regulatory Exclusivity Advising
Dr. Glover applies his expertise regarding regulatory exclusivities to provide advice and expert opinion in consultations and engagements, such as:
- Reviewing product development strategies and competitive contexts to identify additional available regulatory exclusivities or other marketing advantages
- Conducting due diligence to confirm expectations regarding regulatory exclusivities and intellectual property protections
- Evaluating the impact of available patents and regulatory exclusivities on the development of competing products
- Reviewing regulatory and intellectual property strategies for products in development
- Managing the differences in scope and applicability of various forms of regulatory exclusivities applied to small molecules, biologics, non-biological complex drugs (NBCDs), and combination products
- Evaluating the impact of regulatory exclusivities or patents in the context of the approval pathways for follow-on products
- Identifying additional available regulatory and patent protections for products with limited existing patent life
- Developing strategies to use available regulatory pathways to obtain patent and regulatory exclusivity protection for product improvements
- Drafting proposed labeling to optimize available regulatory exclusivities, to anticipate the requirements for follow-on product approval, and to coordinate existing and potential patent protection
- Evaluating the availability of labeling carve-outs
- Assessing the significance of regulatory exclusivities or patents for products for which manufacturing determines product identity, such as biologics and non-biological complex drugs
- Evaluating the availability of regulatory exclusivities and other regulatory protections for drug-biologic combination products, drug-device combination products, fixed-dose combination drug products, and other complex products
- Assessing potential regulatory pathways for competing products in consideration of available regulatory exclusivities, patents, and the characteristics of the product
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Orange Book Listings
Dr. Glover provides expert advice on compliance with relevant regulations and statutes associated with Orange Book patent listings, including matters related to initial patent listings, modifications following the approval of supplements for new indications, dosage forms, or conditions of use, and the development of Use Codes for method-of-use patents.
Dr. Glover has experience providing written Orange Book listing opinions. Patent listings that can raise complex or novel issues under the relevant statutes and regulations include:
- Patents for non-biological complex molecules (NBCMs)
- Patents covering forms of the approved drug substance that are the same as (but not identical to) the drug substance that was the subject of the approval
- Patents related to adverse events
- Patents related to metabolism considerations
- Patents for combination products* and fixed-combination prescription drugs**, including patents for products sold in combination with devices
* A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Combination products are defined in FDA’s regulations at 21 CFR 3.2 (e).
**Fixed-combination prescription drugs include two or more drugs combined in a single dosage form when each component makes a contribution to the claimed effects and the dosage of each component (amount, frequency, duration) is such that the combination is safe and effective for a significant patient population. Fixed-combination prescription drugs are defined in FDA’s regulations at 21 CFR 300.50.
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Advice on Expedited Review Programs and Specialized Incentives
Dr. Glover offers expert advice on eligibility, commercial benefits, and strategic uses of expedited review programs and specialized incentives, including fast track designation, breakthrough therapy designation, accelerated approval pathways, priority review designation, qualified infectious disease product (QIDP) designation, the limited population pathway for antibacterial and antifungal drugs, regenerative medicine advanced therapies, FDA designation as a competitive generic therapy, tropical disease priority review vouchers (PRVs), rare pediatric disease PRVs, and material threat countermeasure PRVs.
Consultation, Opinion, or Expert Witness Testimony on Pharma IP Law or FDA Regulations
Dr. Glover’s expert insights on FDA regulation, intellectual property, and market dynamics assist clients nationwide in achieving success in the pharmaceutical and biotechnology industries.
Contact Gregory Glover, MD, JD, and Pharmaceutical Law Group
202.589.1780 or Connect Online