Anthony M. Insogna

Jones Day

San Diego

Patent portfolio management and patent prosecution

Insogna leads Jones Day's IP practice, which comprises about 220 people in seven countries, to enforce and defend patents in complex high-stakes matters, devise patent portfolio strategies and conduct due diligence inquiries.

Clients include Celgene Corp., Merck Sharp & Dohmen Corp., AbbVie Inc., Acadia Pharmaceuticals Inc., ToolGen Inc. and others.

For New Jersey-based Celgene, acquired by Bristol-Myers Squibb Co. in 2019 for $74 billion in the largest such deal to date, Insogna and colleagues work to protect its top-selling cancer drugs that collectively generate billions of dollars in sales.

"I'm not an M&A lawyer, but the IP aspects of the Celgene acquisition were complex, as is usual for life sciences companies," Insogna said. He has represented Celgene since 1996, when it was a much smaller and different company with no approved drugs, he said. Now its leading product, Revlimid, which treats myeloma, is among the top three best-selling drugs worldwide.

"Today, the cases we handle are generally generic drug challenges under Hatch-Waxman," he said, referring to the 1984 federal law formally known as the Drug Price Competition and Patent Term Restoration Act that promoted the generic drug industry and encourages generic pharmaceutical companies to challenge patents owned by brand name firms like many of Insogna's clients.

"The challengers try to get their generics approved for sale by showing there is no patent issue for the FDA to consider," Insogna said.

For Revlimid, he represents Celgene in five inter partes reviews involving 17 separate cases enforcing 19 patents against seven generic drugmaker defendants.

Over the past year, Insogna and Jones Day successfully blocked institution of IPR petitions filed by generics against five Revlimid patents. One such case was Dr. Reddy's Laboratories Inc. v. Celgene Corp., IPR2018-015104 et seq. (PTAB, filed Aug. 3, 2018). The board rejected the challenges in February 2019.

Insogna and his team are coordinating worldwide efforts for client ToolGen, based in South Korea, a leader in development of the genome editing technology known as Crispr. Their representation involves worldwide patent prosecution, licensing and post-grant proceedings including invalidations and oppositions in Europe and Australia.

The matter is important, Insogna said, because the technology has radically impacted the scientific community due to its potential to revolutionize how genetics and molecular biology are conducted and how medical and agriculture advances are developed and applied. A leading case in the U.S. is In re ToolGen Inc., 2019-001990 (USPTO, appeal filed Dec. 13, 2017).

Insogna was a pre-med student who earned a masters in organic chemistry before law school.

"It helps a lot with what I do in the biotech and pharma space," he said. "One of the joys of being a patent lawyer is getting to stay on top of cutting edge science and to bring together science, law and business."

-- John Roemer