A self-described technology geek who pursued an interest in forensic chemistry until discovering patent law, Lora Teska has been passionately focused on intellectual property since the mid-1990s. “People think everything that could be invented already has been, and that’s just not true,” she says. “It’s amazing how much more can be done. That’s what I still think is exciting about patent law.”
Teska’s IP work has pushed her to become familiar with all kinds of products, from bilge pumps to neonatal testing kits. More recently, drugs and medical devices were her focus while she served as IP counsel for AMAG Pharmaceuticals.
Not long ago, she left the company, but her time there and elsewhere has afforded her an acute awareness of IP best practices and their impact on business development—an awareness she’s ready to take wherever she goes next. Here, she shares a few of the lessons she’s learned so far.
1) Find a patent field that’s compelling
Though Teska admittedly enjoys learning about devices and products of all sorts, she found the challenges of pharmaceutical IP uniquely engaging. “Pharma patents are the only ones eligible for patent-term extension,” she says, but she adds that it’s often a “double-edged sword” to get patents filed as early as possible when clinical trials don’t go according to plan. “There’s a real regulatory overlap that’s interesting.”
Finding a stimulating patent field also made Teska more invested in her company’s performance in that field. During her time with AMAG from 2014 to 2017, she helped oversee the company’s rapid development and expanded its legal team at the same time. “They had a merger with Lamar Health and increased their development activities through acquisition and licensing of new products,” she says. “That’s when we added four more attorneys and another paralegal.”
2) Remember that Regular communication among team members is key
Teska remembers being the IP representative on a team that also included staff from finance, tax, legal, HR, and a number of other business departments. She remembers regular meetings where business-development candidates were discussed in detail, whether Teska’s team was interested in the candidates’ technology or looking to acquire them completely.
“As things heated up, we would get more involved in the due diligence activities,” she says. “Everyone would drill down in their specific functions to investigate and really flesh out the details. This is where I initially became involved in the business-development process.”
3) Understand the nuances of what you’re working with
When doing due diligence for business development or an investigation, Teska emphasizes the need to be thorough. “You have to ask all the questions, completely understanding both how the technology works and how it’s going to be used,” she says. “You have to ask, ‘Will this be used exactly the same way each time? Or will anything be modified?’ If you’re going to change a dosage, for instance, then you need to know from a patent standpoint whether or not you’re going to be able to do that.”
4) Keep a watchful eye on the competition
Teska was once doing IP for a company that had developed a blood-cleaning device designed to reduce pathogens. She and her team learned, though, that another company was doing something similar, and their guard went up.
“We were very diligent in protecting all parts of the process—everything from the chemicals to the machine that essentially cleans the pathogens,” Teska says. “But, we were also trying to understand as much as possible about our competitor’s process, to make sure our IP would preclude them from being able to use our process.”
Incidentally, neither company involved was able to secure FDA approval for its product, which leads to Teska’s final lesson.
5) Come to terms with regulatory struggles
According to Teska, the pharmaceutical industry’s primary defense of high drug costs is that so much time and money is involved in the IP process—that is, getting the drugs to market in the first place. “As a consumer, I want to pay lower prices, too,” she says, “but as a member of the pharma industry, I understand where the justification comes from—for not only the ones that are successful but the millions that fail.”
Being a part of the development process can be a harrowing experience. Though she’s no longer with AMAG, Teska is still eagerly awaiting the outcome of several of the company’s pending FDA applications. “You get so involved in the product,” she says. “You know its potential use and benefit for the patient, but the FDA can always come back with questions or want clarifications. From a legal standpoint, it’s out of your control.”
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Polsinelli:
“Polsinelli is grateful for the opportunity to work with Lora Teska and the entire AMAG team on intellectual property matters. Lora understands how patent exclusivity impacts the value of an acquisition. Her firm grasp of the law, in combination with her keen business acumen, allows her to provide practical solutions to complex issues. It is my honor and pleasure to be a part of Lora’s team.”
—Kate Doty, Shareholder
