Clause 8: Tom Irving on Litigating the First Hatch-Waxman Case and Mentoring Thousands in the Patent Field

If you’ve ever attended a major intellectual property (IP) conference and found yourself captivated by an exceptional performance during a review of recent patent court decisions, chances are you witnessed the unmatched expertise and passion of Tom Irving. After over 47 years of focusing on pharmaceutical patents, Tom has the unique vantage point of someone who saw the field explode after the passage of the Hatch-Waxman Act and the creation of the Federal Circuit.  Widely regarded as a legend of the patent bar and a virtuoso of Federal Circuit decisions, Tom Irving has made an indelible mark on the legal profession.

In this podcast episode, Tom – who recently joined the Marbury Law Group as a Senior Partner- sits down with Eli to discuss his illustrious career, the evolving landscape of patent law, his unwavering dedication to mentoring other attorneys, and his plans to retire in 2054.

On Judge Newman

“Many of the women in our profession stand on her shoulders. She was the Chief Patent Counsel of FMC in Philadelphia, in the 1970s, when no women had important posts in patent law! So, I’m a huge fan of hers. Okay, she dissented against me in Chen v. Bouchard, but nobody’s perfect.”

Broader Does Not Necessarily Mean Better, Especially in Pharma

“You need your narrow [claims], to basically hold your own in the ANDA litigation. And for 505(b)(2), you need a little bit of flexibility, you need a little bit of breadth. But I like to have that little bit of breadth in different patents, so they’re not all muzzled in there together. So, kind of a fun thing is [to see] what breadth can you get?”

On the Increased Hostility Towards Big Pharma

“I always thought in my naive way: ‘Well, these people don’t understand these drugs that save your life.’ And if we’re going to cut off Big Pharma, are new drugs going to come along to save your life? Maybe not. So, I’ve never bought into the antagonism. I’m grateful for the prescription drugs I’m given, and they do sustain and make my life better. And I appreciate that.”

Dealing with Continuous Changes in Patent Law

“No, the D word should not be used. I’ve always felt well, things are changing. Unlike property law, or maybe domestic relations, the patent law seems to be a little bit of a different view every time. I say, well, why don’t you keep the case alive, so that we can fully protect your rights. And I think those are magic words. So, you never use the D word; say yeah, things are changing.”

How He Met Renowned Patent Examiner P.J. Federico

“He and Judge Rich got together and wrote the 1952 Act. That was, to me, absolutely incredible. So, they wrote it in ‘52. Then I come into the profession in 1975 working for Finnegan. And so, the first thing I ever did was I presented a public paper on old cases. And he got a copy of that paper. This was before the idea of electronics. I put a bunch of copies at the back, and so he calls me up and says, ‘Oh, Mr. Irving? This is PJ Federico.’ Why, I thought I’d heard the voice of God!”

Words of Wisdom

“Have fun!  Life is too short to be miserable. So, find a spot where you can have fun. And then if you’re having fun, it’ll be good.”

Also on this episode, Tom weighs in on:

  • Chief Judge Moore’s efforts to oust Judge Newman from the Federal Circuit
  • How general patent practice firms getting into patent law spurred the growth of the pharma patent practice
  • Working on the first Hatch-Waxman litigation
  • Advice for building valuable patent portfolios
  • Why pharma patents generally manage to survive post grant proceedings at the PTAB
  • The cost of drugs
  • How Tom predicted issues raised by Salazar v. AT&T Mobility LLC
  • Whether the Federal Circuit should issue more en banc decisions
  • Should the Federal Circuit be responsible for uniformity in decisions?
  • Being law firm partners with Federal Circuit Judge Kara Stoll & her recent Salazar decision
  • Being mentored by PJ Federico and others
  • Advice for mentoring others
  • Who should consider retiring



Warning & Disclaimer: The pages, articles and comments on do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author as of the time of publication and should not be attributed to the author’s employer, clients or the sponsors of

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