Biglaw, Life Science

Developing The Story Of Patent Litigation: Q&A With Cooley's Ellen Scordino

This Biglaw partner brings pharma experience to law firm cases.

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Ellen ScordinoIn law school, Ellen Scordino was drawn to the narrative aspects of the profession. Trained as a chemist, she originally planned to focus on regulation but quickly decided that, first and foremost, she wanted to be a trial attorney.

Trial lawyers, of course, have a story to tell. And Scordino brings to bear her experiences at Copley Pharmaceuticals and Purdue Pharma — her understanding of how both new and generic drugs get made — to bear on her practice. In 2014, Scordino joined Cooley LLP — recently named one of the top life sciences patent law firms by Lake Whillans, Above the Law and MedCity News — in Boston.

Talk about your scientific background and how it has shaped your approach to the law.

I started at a generic pharmaceutical company as an analytical chemist and learned how they go about development and identifying the right formulation that will match the branded drug’s profile. I then moved to a branded company, Purdue Pharma, and worked there for several years. Although it was technically the same job — supporting formulation development — the analytical methods and development work were very different.

Having a pharma industry background when you work on Hatch-Waxman cases or cases for that industry, you understand the technology very well, and you also understand what the story is. To be successful in litigation, you have to be able to convey a good story. Having experience in the industry allows me to flesh that out and go beyond the technical and scientific aspects of the patent, with a focus on the importance of the drug to a particular patient population and/or community.

You’ve been with Cooley for just over two years now. How is the firm’s life sciences practice different from other law firms?

Cooley has represented life sciences companies of all sizes for 35 years. They might be public, they might be private, but they’re all sizes and span a broad industry spectrum: folks right at the beginning of finding a new chemical entity that’s going to treat a certain disease state to someone who says, “There’s a chemical entity out there, and we’ve found either a new use for it or a new way to deliver it that will make a difference to patients.” That spectrum of clients is a little bit different from what I was used to at my prior firms.

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What folks don’t know about Cooley is that it really does have a robust Hatch-Waxman practice. We’ve had several settled and several ongoing Hatch-Waxman cases where we’ve represented the branded pharmaceutical company. We’re involved in arbitrations and other disputes that come with representing smaller companies that may have out-licensed their molecules or compounds. We work with those companies from patenting at the R&D stage through the licensing stage, and if there’s a dispute about the license, we’re there as well. It’s a robust practice that has a lot of different tentacles that allow us to holistically approach our clients. That’s a distinguishing feature with Cooley.

It’s fun to be part of teams that really work hard from the infancy of the company. They could go public or they could be out-licensing, but we work with them from start to finish.

What trends do you see in the pharmaceutical industry?

There have been interesting trends with companies researching and developing new delivery systems for old drugs or new indications. Statistically we see many more of these types of filings with the FDA.

What about within patent litigation?

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We are seeing more inter partes review proceedings. The pharma-biotech industry perhaps lagged a couple of years behind the high-tech companies in embracing the challenge procedures that were set forth in the America Invents Act, but now it is not uncommon. I’m involved in several IPRs filed by defendants in conjunction with Hatch-Waxman litigation. Those can be used as settlement leverage or simply to open the space when there’s no non-infringement defenses.  They do change the dynamics between parties and might make settlement discussions more forthcoming.

Biosimilars and the biotech industry are filing IPRs a little bit differently. Pharma and generic companies are filing them generally after the Hatch-Waxman case has begun. For biotech companies, the trend seems to be in favor filing the IPRs in advance of their own regulatory filing: Just by example, a biosimilar company like Coheris BioSciences is challenging a bunch of Humira patents before, or as, they’re doing their regulatory filing to help clear the path.

In traditional patent litigation in district courts, the average number of cases is still, at least for 2014-2015, increasing. There was a 68 percent increase in Abbreviated New Drug Applications compared to the previous five years. It’s still a fertile practice area. There was a period of time when people thought Hatch-Waxman cases would decrease and the world was moving toward biologics and biosimilars. I don’t think we’ve seen that. Traditional Hatch-Waxman cases are continuing.

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