In the pharmaceutical world—and especially in the rare-disease arena—patents and other intellectual property (IP) are essential to the market viability of an emerging product. They also provide protections against theft, counterfeiting, and a host of other challenges. As vice president of IP at Horizon Therapeutics, Wendy Petka is at the forefront of keeping those protections intact. Her path to IP work, however, was somewhat circuitous.
“Originally, I set out to be a medical doctor,” she recalls. Petka earned a bachelor’s degree in chemistry at Chatham University, a small liberal arts school near Pittsburgh. “I worked part-time at nearby Presbyterian University Hospital as a virology technician and then a pharmacy technician. And it helped me realize that I really didn’t want to follow my intended career path.”
As an undergraduate, Petka spent approximately two years working in University of Pittsburgh’s on-campus chemistry lab facility, through a cross-registrational program with Chatham. There, she pursued her own research project (focused on various aspects of polymers) supported by a summer scholarship awarded from American Chemical Society Polymer Division. “The mix of chemistry, physics, mathematics and engineering fascinated me,” she says.
She went on to earn both a master’s degree and a PhD in polymer science and engineering from the University of Massachusetts at Amherst. Her doctoral research was in the genetic engineering of protein-based polymers, including the design and manipulation of DNA, expression and purification of proteins, and characterization of protein properties.
Early in her career, she worked at Applied Biosystems and 3M’s Specialty Materials Division in scientific capacities, but also interacted regularly with the legal departments. “I was able to help write patents, and realized that patent law would enable me to work in an evolving story of innovation,” she says.
To achieve her new goal Wendy Petka earned a JD from the Fordham University School of Law, while gaining experience in the legal world at Fish & Neave LLP. She built an extensive in-house resume at Sangamo Therapeutics, Cepheid, Theravance Biopharma, and Boehringer Ingelheim before joining Horizon in 2021.
In her current position, Petka and her team focus on patents, trademarks, trade secrets, and copyright protections. Petka sees herself as a sort of “connector,” because she’s involved in so many interdisciplinary activities.
“For example, my IP team will meet with our colleagues in research and development [R&D] to get a sense of how their work is shaping up,” she says. “But we also collaborate in process development—how the product will be produced—with regulatory experts and medical team members. And as a product nears its launch date, we’ll also be involved with the marketing department.”
As a patent for a new product develops, Wendy Petka’s work melds science and law. “R&D is a big part of our equation,” Petka says. “They might start with a large group of molecules—perhaps as many as one hundred different types—that show promise for curing a disease or pathology. As R&D designs experiments and develops hypotheses, they’ll whittle that initial group of molecules to just a few, and then down to one.”
She explains that the intellectual property group will follow each step of the R&D process so they can understand and thoroughly document each phase of development. “Even the failures can be important,” she notes.
That work becomes the basis for the patent application, which Petka describes as “an innovative story that explains, ‘here is what I created, and this is how I want to protect it,’” she adds. “It’s a challenging job, because science and the law are always changing.”
The protections that patents and trademarks grant are essential in this highly competitive marketplace. “Brands can develop strong associations with their products,” Petka explains. “But a brand can fall into such common usage—Kleenex, for example—that a person might think they’re buying the actual brand, even when they aren’t.”
Patents and trademarks provide a degree of risk mitigation against offshore companies producing imitation versions of patented products. “It also promotes consumer safety,” Wendy Petka adds. “Adulterated drugs, especially those not approved by the FDA [Food and Drug Administration] or other regulators, often make it into the marketplace. Our trademark protections, for example, can assure customers that our medications are of high quality, and made with proper regulatory oversight.”
Petka’s colleagues outside the company have been impressed by her work. “She brings a sense of clarity, organization, and insight to a patent portfolio covering multiple life-enhancing commercial products and early-stage drug-discovery programs,” says Michael Hostetler, patents and innovations partner at Wilson Sonsini Goodrich & Rosati. “The ability to provide valuable counsel in both of these realms definitely sets Wendy apart.”
Horizon’s rapid growth—in 2021, it attained net sales of $3.23 billion, an increase of 47 percent over the previous year—is primarily driven by net sales of two Horizon medicines, KRYSTEXXA and TEPEZZA, and expansion of its pipeline.
“While some companies focus on only small molecules or certain types of antibodies, Horizon takes the big-picture view,” Petka says. “We look at a disease or an unmet medical need, and then figure out how to best serve the situation. We’re looking for the best science, regardless of the source.”
A good part of the funding for new innovative products and acquisitions comes from product sales themselves, but the exclusivity of a patent is limited. “The clock is ticking on a patent from the moment it is filed and subsequently issued, not when the product finally reaches the marketplace. That gives pharma companies only a limited window to recoup their initial investment,” she notes.
And that’s a key reason for the industry pushback on Congressional efforts to control drug costs.
“Before passage of the Inflation Reduction Act [IRA], Congress had been signaling to the FDA and the US Patent office that they suspected misuse of the patent system was contributing to rising drug costs, ” Wendy Petka says. “Provisions in the IRA seem to weaken the relationship between patent and regulatory exclusivities, and removes some financial incentives to invest in future innovation.”
She explains that some pharma companies are concerned that the new regulations might prevent them from recouping their development investments before the patent protection expires, which could lead to a loss in innovation overall.
“It’s an interesting time,” she says. “We must take a hard look at how we will protect innovation in the future.”