Where Generics Meet Name Brands

Staci Julie unifies intellectual property attorneys as one team for global pharmaceutical giant Teva

Staci Julie wanted to be a chemist. As a student at the University of Delaware, she earned a BA in chemistry, but she also learned that it wasn’t what she was meant to be doing. “A life in the lab was not for me,” she says. So, Julie earned her JD from Georgetown University Law Center in 2000 and looked for ways to merge her love of science with her expertise in law. She found it at Teva Pharmaceuticals. As an intellectual property attorney, she helps Teva protect its portfolio of brand-name and generic medications that are used by millions of patients across the globe.

Julie is the senior VP and chief intellectual property counsel for the Israel-based company—the world’s largest generic medicines producer. Teva has more than 1,800 molecules in a wide range of generic products in nearly every therapeutic area, and the company also produces new, branded medicines. And that mix of branded and generic medicines offers special challenges to Julie and her team.

Julie came to Teva after leaving her first legal job, a position at the IP boutique firm Fish & Neave, which has since merged with the firm Ropes & Gray. Teva had been one of her clients at Fish & Neave since 2000, and she moved in-house in 2004. Hired as an associate director, Julie moved up the ladder to reach her current position in 2013.

She now manages and supervises all aspects of IP for the company, including both the brand and generic sides of the business. Julie oversees a team of about 150 people in more than a dozen different countries. “Every time zone is covered,” she says. Julie and her team are responsible for developing IP strategies to protect and defend brands and to enable generics to get to market as quickly as possible. She also advises the business side on IP matters whenever the company is looking to acquire assets, be it other companies or individual products.

In her time with the company, Julie has seen a lot of growth and transformation in the IP team that she now leads. “When I joined Teva, it was primarily in the generics business,” Julie says. “As we have grown, through acquisitions and our own research and development, we now have more brand products.” IP had to grow with that, so through outside recruitment and internal development, she has brought on more staff with brand patent experience.

IP approaches each of those sides differently. With branded medicines, the time lines are much longer from development to coming to market. “With a brand, you are creating something new that you want to protect against competition,” Julie says. “So, you need to develop strategies with R&D that will maximize the protection and potential life span of the product.” Generics, on the other hand, move much more rapidly from development to regulatory approval and marketing. “A generic is still new, but the main issue is how you deal with what the brand company has already done and navigate around the brand company’s IP so that you can get to market as quickly as possible,” she says.

There are two ways to do that. The first is by proving that the generic does not use the brand company’s IP. The other is by determining that the brand’s IP protection is invalid. That was the case, recently, when an appellate court ruled in favor of Teva and lifted an injunction and allowed the company to launch a new generic . “Once the injunction was lifted, we were able to launch this product and quickly get our generic version into the hands of consumers,” she says. The case is not completely over yet, though, as the plaintiffs, Bayer and Merck, have asked for Supreme Court review, which Julie notes is rarely granted in patent cases.

Julie has similar cases pending or underway all over the world, and she recently won cases in Europe, Israel, Australia, and elsewhere. That global reach has been part of the growth she has overseen. “As we have grown geographically, we needed to add IP knowledge and bodies on the ground in some of these new areas,” she says. “IP is local. You can have a product that sells all over the world, but ultimately, you have to rely on local laws. We need people who know the local laws and how to use them to our advantage.”

It’s also an advantage to have expertise on both the branded and generic sides integrated into a cohesive unit. “We are one IP team with brand and generic personnel under one umbrella organization,” Julie says. Other companies often separate those functions. “I see benefits in having one group,” she says, citing the example of an oncology drug the company acquired that, at the time, had no patent protection. “We looked at it and were able to craft an IP strategy that led to the issuance of seven patents that we were able to successfully enforce, preventing generics from coming to market,” she says.

“We could do that because our brand people have a generic mind-set and our generic people have a brand mind-set,” she continues. “That shows the value of what our team is doing. If we work together and understand both sides of the business, that gives Teva a competitive advantage. A blended group is a real asset for the company.”

That will be critical as the company moves forward. Healthcare is rapidly changing, and Teva is changing with it. “We are moving into the biologic sphere and getting more involved in medical devices and beginning to venture into e-health ventures,” she says. “We need to add people with the right scientific background to think and talk about these things, so that someone like me, a chemist, might understand.” As a result, the IP group has brought on electrical and mechanical engineers and other specialists to complement its biologists and chemists. “We still work in a tech world and a pharma world, but these worlds are starting to blur,” she says. As a result, she is striving to create strategies to deal with the merging of the tech and pharmacy worlds. “I am a big science fiction fan, and science fiction is quickly becoming reality in the blurred space,” she says. “We have to figure out where we are going and how to enable these products to come to market.”