Hatch-Waxman & Biosimilars

Torrey Pines Law Group's regulatory attorneys and advisors have substantial experience providing global strategic counsel regarding Hatch-Waxman and Biosimilars laws and regulations.

Under the Drug Price Competition and Patent Term Restoration Act of 1984 (also known as the "Hatch-Waxman" Amendments) a company can seek FDA approval to market a generic drug before the expiration of patents related to the brand-name drug that the generic seeks to copy.

Through the Biologics Price Competition and Innovation Act (BPCI Act) of 2009, Congress created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved biological product. This pathway was established as a way to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition.

Our team has assisted clients with developing and implementing legal and regulatory strategies with respect to New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), 505(b)(2) applications, Biologic License Applications (BLAs), and section 351(k) biosimilar applications (abbreviateted BLAs, or aBLAs). In particular, we have analyzed and provided counsel on:

Orphan Drug Exclusivity (ODE) – 7 years
New Chemical Entity Exclusivity (NCE) – 5 years
Generating Antibiotic Incentives Now (GAIN) Exclusivity– 5 years added to certain exclusivities
New Clinical Investigation Exclusivity – 3 years
Pediatric Exclusivity (PED) – 6 months added to existing Patents/Exclusivity
Patent Challenge (PC) – 180 days (this exclusivity is for ANDAs only)
Competitive Generic Therapy (CGT) - 180 days (this exclusivity is for ANDAs only)
30-Month Stays
Patent Certification Requirements (Paragraph IV certifications)
Orphan Drug Designations (ODD)

Our team has also advised on drug approval and generics competition in other jurisdictions worldwide.

Torrey Pines Law Group, PC serves technology innovators with protecting intellectual property, obtaining regulatory approvals and clearances, and making deals and closing technology transactions throughout the U.S., including in major technology hubs such as San Diego, San Francisco, Palo Alto, San Jose, Silicon Valley, Boston, Cambridge, Chicago, Minneapolis, Houston, Dallas, Atlanta, Denver, Seattle, Portland, Boulder, Orlando, the Research Triangle (Raleigh, Durham, and Chapel Hill), the Mid-Atlantic (New Jersey, New York, Philadelphia, Maryland, Virginia, and Washington, DC), Pittsburgh, Cleveland, Ann Arbor, and throughout Southern California in Los Angeles, Orange County, Irvine, Torrey Pines, Sorrento Valley, and La Jolla.

We have experience with international intellectual property, regulatory and transactional matters pending in Beijing, Shanghai, Shenzhen, and Guangzhou China; Tokyo, Japan; Berlin, Munich and Frankfurt Germany; Tel Aviv Israel; Mumbai, Bengaluru, and New Delhi India; London and Edinburgh United Kingdom; Vancouver, Toronto, Calgary and Montreal Canada; Dublin, Ireland; Cape Town, South Africa; Mexico City and Tijuana Mexico; Brussels, Belgium; Copenhagen, Denmark; Paris, France; Madrid and Barcelona Spain; Moscow, Russia; Santiago, Chile; Montevideo, Uruguay; Buenos Aires, Argentina; Sao Paulo and Rio de Janeiro Brazil; Seoul, South Korea; Taipei, Taiwan; Hong Kong; Hanoi, Vietnam; Bangkok, Thailand; Kuala Lumpur, Malaysia; Milan, Italy; Singapore; Sydney, Melbourne, Perth and Adelaide Australia; Auckland, New Zealand; Oslo, Norway; Stockholm, Sweden; Helsinki, Finland; Kiev, Ukraine; Budapest, Hungary; Vienna, Austria; Prague, Czechia; Geneva and Lausanne Switzerland; Bahrain; Doha, Qatar; Abu Dhabi and Dubai UAE; and Jeddah, Saudi Arabia.

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