A Q&A with Dom Conde of Fitzpatrick, Cella, Harper & Scinto

What is special about Fitzpatrick's Hatch-Waxman ANDA practice?

Fitzpatrick is a go-to firm for branded pharmaceutical companies involved in ANDA litigation. Because of this, we have likely filed more ANDA cases than any other firm in the country. We have unsurpassed depth of skill and talent, with 80 ANDA litigators, most of whom have chemistry, biotechnology or biology degrees. This includes more than 10 first-chair litigators who are all very well known names in the industry.

Both clients and opponents respect Fitzpatrick for our focused trial strategy. We are known for clearly presenting highly technical evidence in a persuasive manner. As most ANDA cases are bench trials, our litigators look at every matter from the viewpoint of how the judge – a highly educated lay person – will see it, and that informs our entire approach. In court, we are not about demonstrating how smart we are, but focused on presenting the best case possible.

What is special about Fitzpatrick's IPR practice?

Fitzpatrick was one of the first firms to recognize that, particularly in the pharmaceutical space, patent owners could successfully prevent the institution of an IPR and effectively stop a patent challenge in its tracks. At a time when other practitioners thought even challenging the institution of an IPR was futile, we identified several techniques to do just that. This included finding critical gaps of proof the petition, showing how a petitioner did not adequately or properly address the evidence presented during prosecution, or showing how the petitioner's expert opinion was unsupported by the evidence.

We have gone on to successfully implement these techniques on behalf of our clients, while showing leadership to the patent bar as a whole on this issue

What IPRs are Fitzpatrick most proud of in 2015-16?

Our clients want to defeat any request for an IPR because it will likely prevent further challenges. As a practical matter, if the Patent Office denies an IPR petition where a lower burden of proof is applied, it is unlikely that a district court will find the patent invalid applying the higher, clear and convincing standard.

For this reason, we are particularly proud of our success over the past year in stopping IPRs cold.

Last year, for example, Fitzpatrick prevented the institution of IPR petitions filed on four patents that protect its highly successful INOmax® nitric oxide product. INOmax® is used to treat newborn babies that have respiratory failure associated with pulmonary hypertension. The petitions were denied, in part, because we demonstrated that the petitioner failed to address key evidence showing that the invention was surprising and unexpected to even experts in the field.

Similarly, this past April we defeated an attempt by Par Pharmaceutical to institute an IPR of a patent that covers Novartis's Zortress®, which is a highly successful product for preventing transplant rejection.

Also, this year, for a patent licensed by our client Pernix Therapeutics, we were able to stop an IPR petition filed by a large hedge fund. That was an important win because the hedge fund has no other mechanism to challenge the patent.

Finally, in August 2016, we prevented an IPR from being instituted against a patent held by Sanofi. In that decision, the Patent Office agreed with us that the petitioner's arguments were based on impermissible hindsight.

Describe Fitzpatrick's courtroom ethics.

Like any reputable firm, unethical courtroom behavior is not tolerated at Fitzpatrick. But beyond that, we also take pride in our reputation as a firm that judges know is credible. Having the respect of the court is particularly important in ANDA cases, because nearly all of them are bench trials decided by the judge. Playing games during discovery or prior to trial ultimately will boomerang not only on the lawyers, but also their clients. So it is very important that judges view the firm as trustworthy and honest, and we have achieved that goal.

What defining figures (i.e. Henry Renk) have shaped Fitzpatrick's firm culture?

Since the first cases were filed in the 1980s, Bob Baechtold and Henry Renk have been leading lawyers for branded pharmaceutical companies in ANDA litigation. They both have successfully handled dozens of matters for many different clients, and are very well-known for being skilled courtroom lawyers and appellate advocates. They trained most of our first-chair litigators, and provided an example of excellence, not only for lawyers at the firm, but for the entire ANDA bar as well.

What trends has Fitzpatrick been riding in the past 12 months and how has the firm responded?

There have been at least three significant trends in the past year or so. First, there has been a large increase in IPR challenges by generic companies against the patents owned by our branded pharmaceutical clients. In areas outside the ANDA space, many times when an IPR is filed the case is stayed pending the outcome. But with ANDA cases, they are almost never stayed because the district court usually needs to reach a decision prior to the expiration of the FDA stay on the approval of the ANDA applications at issue. The increase in IPR filings has made the ANDA litigations more complicated at least because the IPR and litigation proceed in parallel. We have addressed this complexity by developing strategies that will work in both forums simultaneously.

Second, generic companies are challenging more patents based on patent eligibility (e.g., pursuant to the Alice, Myriad and Mayo cases). Those challenges are usually directed to methods of using drugs. And, the challenges have been in the form of motions to dismiss, which are filed soon after the complaint. We have successfully defeated those motions in part by showing that they were filed too soon and discovery was needed.

Third, we are seeing a substantial uptick in analyzing biotechnology patents for our clients. Now that parties are filing biosimilar applications with the FDA, more of our clients are turning to us to develop and implement strategies for eventual litigation of their portfolios of biotechnology patents. The procedural and substantive litigation dynamics with biosimilar cases are different from ANDA cases. We are in the forefront of counseling our clients on those differences, and developing successful strategies for biosimilar litigation.

What sets Fitzpatrick off from its competitors?

Our enormous talent and vast amounts of experience in the ANDA space sets us apart from other firms. In addition, our ability to represent our clients in all aspects of patent law including prosecution, IPRs and interferences allow our clients to use our firm to handle and coordinate all of their patent needs.

What are the defining characteristics of a Fitzpatrick attorney?

Our lawyers are aggressive. We also pride ourselves as seeing issues that others miss and having an in-depth knowledge of all of the facts in case, which allows us to make the best arguments and avoid potential pitfalls. While most lawyers can be "aggressive," many do not fully think through the consequences of that posture. We strive to avoid this problem by thinking through the issue and analyzing how our adversary will counter the arguments. This allows us to make the correct strategic choice.

Describe Fitzpatrick's experience in pharmaceuticals.

We have a very broad range of experience representing pharmaceutical clients. Fitzpatrick has decades of experience with pharmaceutical patent preparation and prosecution, and conducting due diligence work. We also handle the full range of patent-related litigation for pharmaceutical and biotech clients.

Describe Fitzpatrick's strategy for growth in the near and long term.

In addition to continuing to do great work on our ANDA cases, we are also focusing in on representing our clients in biotechnology matters. It is an exciting area of litigation that is becoming more prominent than ever before.