Patent/FDA Expert Highlights Evolution of Drug Patent Law

By Dana A. Elfin

It has been 33 years since Congress passed the Hatch-Waxman Act, and the pharmaceutical industry and brand-generic patent litigation have changed greatly since the act’s passage.

Shashank Upadhye, a principal in Amin Talati Upadhye, a boutique law firm concentrating on patent and FDA matters that he co-founded in 2014, discussed the impact of some of those changes with Bloomberg BNA’s Dana Elfin May 12.

In 1984, the Hatch-Waxman Act, formally titled the Drug Price Competition and Patent Term Restoration Act, amended the Federal Food, Drug, and Cosmetic Act (FDCA) to establish guidelines to expedite the approval of generic drugs. The act created a process for generic drug manufacturers to challenge branded drug patents, and it led to a new legal practice area for lawyers representing both branded and generic drug companies.

Since then, increasing consolidation in the pharmaceutical industry has meant fewer in-house jobs and fewer pharmaceutical clients for law firms, Upadhye said. In addition, the traditional distinction between branded and pharmaceutical companies has eroded as many drug companies now have both branded and generic product lines, he said. That change has led to internal conflict at some companies, he said, as they attempt to represent both the generic and branded sides.

In addition, the creation of inter partes review (IPRs), a type of post-grant patent review proceeding to allow third-party challenges of patent validity, as an alternate venue for patent challenges has affected the Hatch-Waxman practice area, Upadhye said, but it’s too early to assess its full impact, he said.

Upadhye also discussed his experiences working as an FDA/intellectual property lawyer both in-house and in private practice settings. Upadhye was in-house as vice president of intellectual property for three pharmaceutical companies: Apotex Inc., Sandoz Inc. and Eon Labs, and also for Cook Group Inc., a medical device company. He also worked at large multinational law firms and helmed his own consulting and mediation practice as an independent patent, FDA, and pharmaceutical strategies consultant.

This interview has been edited for clarity and length.

Intellectual Property/FDA Practices Intertwine

Bloomberg BNA: How did you get your start in the FDA/IP area?

Upadhye: Purely by accident. When I was at the Cook Group, I handled patent and FDA matters related to medical devices under the Hatch-Waxman Act, such as safe harbor issues, patent term extensions and device approvals.

I wrote a law review article on the Hatch-Waxman Act, but it was mostly device-related. So, it really started with that article on the Hatch-Waxman Act.

When I joined Sonnenschein Nath & Rosenthal [now SNR Denton], I worked with talented partners who did “brand” side patent work. I got involved with Paragraph IV cases there on the brand side. After that, I joined Locke Lord Bissell & Liddell LLP [then Lord Bissell & Brook] to work on the generic side of those cases and then worked for many years in-house at generic pharmaceutical companies.

[ Editor’s note: In traditional district court litigation, generic drug manufacturers file Paragraph IV certifications to certify that their proposed generic products won’t infringe a brand-name maker’s patent and/or challenge the patent as invalid. Once notified of the patent challenge (known as a Paragraph IV challenge), the patent owner has 45 days to sue the generic for infringement in federal district court.]

Bloomberg BNA: What attracted you to the practice area?

Upadhye: I love this area because of the interaction between two very distinct bodies of law.

The interaction of the two bodies of law have allowed me to really dig into complicated areas, find areas to explore (or explode), shape or push the law into new frontiers.

Because I’m the author of the treatise, “Generic Pharmaceutical Patent and FDA Law,” now in its tenth edition, that I update yearly, I have to keep abreast of the law.

Bloomberg BNA: The Hatch-Waxman Act dates back to 1984. Are there still growth opportunities in the practice area?

Upadhye: Though I was not in practice in 1984 when the Hatch-Waxman Act was first enacted, it was the lawyer’s full employment act because it was so full of holes and questions that it spawned decades of legal work.

In 2003, the Medicare Modernization Act [MMA] was enacted and similarly became the lawyer’s full employment act because it spawned new areas of legal work. Similarly, each new major amendment to either the patent law in the America Invents Act [AIA] or the FDCA has not filled all the gaps or addressed the major concerns, so lawyers in this area still have jobs.

Pharmaceutical Industry Consolidating

Bloomberg BNA: The pharmaceutical industry has been consolidating. How has this affected the availability of legal work in the area?

Upadhye: The area of biggest concern is that historically many law firms have aligned themselves behind one or two core clients. But if that client is merged and the other company handles outside counsel, your firm could be on the short end. You now have a practice group with little to no future work.

Also, consolidation means there are simply fewer in-house jobs. So that either pushes current in-house into smaller companies or into law firms.

Bloomberg BNA: There has also been an increasing blurring of the lines between generic and brand-name companies over the years. Has this affected the practice of law in the Hatch-Waxman area?

Upadhye: On the generic side, the company needs to make arguments to win, but that win could create a precedent that is used against it later on when the company is on the brand side.

For example, how can Sandoz Inc. [the generics unit of branded company Novartis AG] make an argument against Pfizer Inc. when that might create a precedent [generic drug company Teva Pharmaceutical Industries Ltd.] could use against Novartis? It’s hard and becoming more common as there are more brand versus brand suits.

As a law firm, you want to win your case with the best arguments you can make. But your client is super-sensitive to the arguments now. This is why it is important that we align with the client needs.

Patent Trial and Appeal Board

Bloomberg BNA: In 2011, the America Invents Act (AIA) established the inter partes review process at the Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) as a cheaper, faster alternative to district court branded-generic patent litigation. Has the availability of IPRs affected Hatch-Waxman practice?

Upadhye: I think it is way too early and there are not enough data points yet to conclusively say that IPRs have changed the fabric of the Paragraph IV litigation space.

And IPRs are for invalidity only. Many Paragraph IV suits involve noninfringement so there is no need for an IPR.

The PTAB has killed a lot of patents but those are by and large in the electrical-software space. Depending how you classify patents, there are about 180 or so “pharma-biotech” IPRs. Given that pharma is usually conservative, there hasn’t been a tremendous uptick in IPRs as pharma is still watching to see how the rules and precedent are shaping up.

That said, the IPR is good for invalidation. What I try to be very conscious of is the perception influence in a trial court.

For example, if I am a defendant in a Paragraph IV suit and file an IPR petition, which is then denied institution, the brand may then argue to the trial judge in the district court patent litigation that the patent can’t be invalid because the defendant couldn’t even meet the lower preponderance standard in an IPR petition before a board of expert patent judges. So, while an IPR petition denial is not dispositive of the court case, it has a bad perception.

But we have also seen instances where the board has upheld the patents in the IPR but the trial court has still invalidated the patents. We have also seen instances where the trial court upheld the patents but the Board struck them down.

Advice for Hatch-Waxman Lawyers

Bloomberg BNA: What advice would you give new lawyers seeking to practice in the IP/FDA area? What kind of work experiences should they be seeking?

Upadhye: My advice is largely unremarkable. First, for patent people, try to do as much prosecution and litigation as you can. You are a better litigator if you do or have done prosecution work. You are a better prosecutor if you have done litigation work.

Second, find a great mentor. If you are in a large law firm, that’s hard because of the movement of partners. Find someone who can help guide you.

Third, continue to develop your professional credentials. Read everything you can and demonstrate your expertise by speaking or publishing. Seek quality work. If you are in litigation, make sure you do some pro bono litigation cases so that you can hone skills. Paragraph IV cases rarely go to trial, so you need other cases that you can manage start to finish.

Bloomberg BNA: In your view, what are some of the most valuable skills a Hatch-Waxman lawyer can have?

Upadhye: An incessant desire to learn, assimilate and apply. There are so many moving parts in the realm of Hatch-Waxman that you constantly need to adapt. Aside from that, communication, responsiveness, quality, the ability to present complex things in smaller, simpler, easier to digest formats, are all necessary skills.

Lawyers also need to recognize where their strengths lie. Not every patent attorney is geared to be an in-court litigator. Different people have different tools in their personal toolbox.

When you recognize what your strengths are, you can develop depth of skills in that area versus trying to horizontally acquire skills that may lie outside your strengths.

I also suggest that people read cases. I know people are busy, but you have to read cases as they come out.

Bloomberg BNA: Do litigators in the Hatch-Waxman area also need a deep knowledge of FDA regulatory law and patent prosecution before the Patent and Trademark Office to effectively practice in this area? How do they get to know the regulatory side?

Upadhye: The patent people need to do both litigation and prosecution. On the FDA side, I think it is critical for several reasons.

First, the statutes necessarily are intertwined. Second, from the generic side, the goal is to get the product to the market.

I always counsel clients that my job is to help get the white bottle onto the shelf. A clever patent strategy is useless if the product is stuck in the FDA regulatory review cycle. A clever FDA strategy is useless if you can’t win the patent case.

In-House Opportunities, Challenges

Bloomberg BNA: You’ve held top in-house positions at three major pharmaceutical companies and started out in-house at medical device company Cook Group Inc. What are the main challenges of working in-house?

Upadhye: With in-house, it’s very often a 24-hour job. From day one, no matter how much previous knowledge of the underlying business you may have, there is always another learning curve. Your legal department cannot interject itself into the process and grind it to a halt to wait for you or your team to come up to speed.

The challenge is compounded when you run a department globally because, just as the work day finishes in New Jersey or Toronto, it’s the beginning of the day in Australia and then in India/China, and then Europe.

In addition, each company has its existing way of doing business and you have to find out quickly how you need to interact with the other business units or functions. Aligning is key. You must figure out how to align your team into the other teams.

Another challenge with in-house is juggling priorities. With in-house, you have so many priorities. Do you handle a Paragraph IV case first and put other projects like supply chain contracts or labor issues on the back burner? Do you prioritize a cGMP [current good manufacturing issue] before handling patent litigation?

Bloomberg BNA: You started out in-house at Cook Group Inc., right out of law school. Tell me about that experience.

Upadhye: When I first went in-house, I had great legal skills. But I didn’t have great corporate interaction skills. I was also very young. So it was a mixed blessing to be able to go in-house as a top lawyer so young but then not have all the needed people skills.

Initially, it was hard for me to insert myself into a company’s executive team. The remainder of the team were experienced executives. They had been groomed in talent management, corporate handling, running meetings and making decisions. I made many mistakes by either being too indecisive (for fear of alienating people) or too decisive (without getting key stakeholder approval). I had to learn how not just manage down but also manage up.

Bloomberg BNA: What were some of the most valuable lessons you learned as an in-house lawyer?

Upadhye: I learned that it’s critical to develop good relations with the key stakeholders. I made mistakes early by alienating key stakeholders. You have to build bridges.

I always try to find a solution—a way out, or a way in. The solution may not be elegant, but the client comes first. The company is entitled to continue to run its business its own way.

The valuable lesson I took away is that, even to this day, I try to find a business way out of legal problems.

Bloomberg BNA: Compare the in-house experience with the private practice experience.

Upadhye: In private practice, you generally have discrete and finite projects, like a Paragraph IV litigation. Once it’s over, that’s it. So there is a defined start and stop.

Also, in private practice, there is a limit to knowing the business. You can only be involved to a limit.

Bloomberg BNA: What are the biggest challenges in private practice?

Upadhye: The biggest challenge in private practice is to know your client’s business and help find working solutions. The challenge in private practice is that you have a client and, as a private lawyer, you might think XYZ is the best solution, but the client is free to ignore your advice. In private practice, I can only steer or guide. Many lawyers, naturally, think of their legal solution first versus thinking about what’s best for the client.

Large global firms also have the incessant desire to raise rates at the expense of the client’s relationships. Large law firms have massive expenses and overhead. There are also multiple channels of law firm bureaucracy you have to go through at a large firm. Large law firms also present ever-increasing conflicts that become unresolvable or too political internally to resolve.

Also, many lawyers do not understand how to manage projects or how to manage expectations and priorities. So they do not understand deliverables.

Regrettably, law firm lawyers are rarely managed. I am blessed that I had great formal and informal coaching on how to lead, how to align, communication and on learning styles and have taken lots of project management training.

Challenges of Starting a Firm

Bloomberg BNA: You started your own boutique firm concentrating in intellectual property and Food and Drug Administration matters in 2014. What are the advantages of running your own firm?

Upadhye: The benefits of the boutique firm where my partners and I are in charge is that we get to run our law firm the way we see it best. In a large global firm, each lawyer is a cog in the machine. In a large law firm, the intellectual property and Food and Drug Administration lawyers are usually not in charge.

Also, at my smaller boutique firm, there are rarely conflicts. Plus, given that I am a founding partner at this firm, and that my partners “get it” with respect to client origination, client work and long-term relationships, we are very creative in how we can staff, bill, manage client work. We can do things that big law firms just cannot do.

Bloomberg BNA: Describe the biggest challenges and opportunities in growing your own firm.

Upadhye: The biggest challenge in growing the firm is actually about people management. We can grow for the sake of growing, but what happens if business slows? Do you let people go right away? We don’t like to play games with people’s lives and livelihood. So we are careful in how we grow, how much work we have, what work is coming down the road, what experiences we can give our people.

We like to think that our biggest assets are our people. When they are personally and professionally satisfied, it makes for a great firm. So we take great care to train, expose, interact and socialize with our colleagues.

Our plan is to grow strategically without comprising our core values or vision plan. Therefore, it makes sense that our growth is controlled, with the proper related practices being added to our core IP and FDA practices. Our intent is to grow in the related practice areas, such as our government investigations practice, Federal Trade Commission regulations, and FDA cGMP compliance practice.

We don’t see ourselves adding practice subject matters just for the sake of it. It has to make sense.

Bloomberg BNA: How many lawyers does the firm have now?

Upadhye: We currently have 21 professionals, 19 of whom are lawyers.

We have grown terrifically since December 2014, when we had about 10 professionals. We added depth into our FDA and regulated industries practices by adding our new partner Ivan Wasserman into our new Washington, D.C. office. We added depth to our traditional IP practice by adding outstanding litigators and patent professionals. We added depth into our commercial litigation/class action group by hiring a former assistant U.S. attorney and commercial litigation associates.

Bloomberg BNA: Do you have mandatory billing minimums for lawyers in your firm?

Upadhye: Unlike most law firms, we don’t have mandatory minimum billing targets. In my view, mandatory targets are a breeding ground for duplicate work, inefficiency and senior lawyers doing junior level work.

We have a sense of course of how much work there is, but we don’t focus on mandatory targets. The lack of mandatory billables allows us to train, coach and spend time to review work and increase the depth of our work without necessarily costing the client more money. We take the long-term view.

To contact the reporter on this story: Dana A. Elfin in Washington at

To contact the editor responsible for this story: Brian Broderick at

Copyright © 2017 The Bureau of National Affairs, Inc. All Rights Reserved.