Life Sciences

When the Stakes Are Highest: Hard work drives enviable track record in Hatch-Waxman litigation

MCC: Share a little bit with us about your practice at Fish & Richardson and how the firm works with life sciences companies.

Singer: Fish has the premier patent litigation practice in the world, handling approximately twice as many patent cases as our nearest competitor. Our life sciences practice includes Hatch-Waxman and other patent litigation for leading pharmaceutical companies. We have won many appellate victories that have had broad-ranging impact on the development of patent law in the life sciences arena.

We help innovator drug companies maximize returns on their investments during market exclusivity periods. From the earliest stages of Hatch-Waxman litigation, we bring together the most experienced teams within the ranks of our firm to strategize the best way to achieve our clients’ objectives. With over 80 Ph.D.s on staff, we can create an integrated team that deeply understands all the scientific issues throughout the product development and protection process.

This is an area that requires expertise across a wide range of legal areas. We have vast expertise in everything from pre-suit investigations to PTO actions, Orange Book tactics, Title I strategies of the Hatch-Waxman Act, ANDA filings (especially certification requirements pursuant to Paragraph IV), and FDA affairs, which is invaluable to our clients in pharmaceutical litigation. Hatch-Waxman may be the door to the courthouse, but once you are in front of a judge or jury, you must still litigate the underlying science, and it is there that the Fish differential becomes evident.

MCC: You have an impressive list of clients in the life sciences industry. Tell us about some of your most recent successes.

Singer: Three recent cases come to mind.

In April 2015, I argued and won a motion to dismiss in a very important ongoing case for GlaxoSmithKline over “skinny labels” for their COREG drug, which is used to treat heart failure and high blood pressure. This is a case that many people in the pharmaceutical industry will be watching over the next couple of years since it raises the issues of permissible marketing by generics of products where their labels “carve-out” patent indications, but nonetheless are used for those indications in the marketplace.

Last fall, I led the jury trial of a case for Cephalon and Aptalis over the launch-at-risk of Mylan’s generic drugs for AMRIX, a skeletal muscle relaxant. While the case settled after final arguments, it was one of the very few Hatch-Waxman cases to make it to a jury over damages. Preceding that, we’d had a bench trial, multiple appeals, and even a TRO proceeding in the matter, so it really ran the gamut from A to Z. Needless to say, while it is confidential, our clients were very pleased with the settlement.

Finally, there is the ongoing six-year saga for Allergan over its glaucoma drug COMBIGAN, which has over $200 million in annual sales. I argued and won an appeal in December 2014 over attempts by Sandoz to get out of an injunction against market entry by amending their label. Their attempts to short-circuit a trial were rejected by the Federal Circuit, which refused to rehear the case en banc in April 2015, and now Allergan will have the chance to litigate the case in the Eastern District of Texas. We have already won twice at the Federal Circuit, and the injunction against Sandoz’s original generic remains intact until 2022, when Allergan’s patent expires.

MCC: You spent eight years litigating a groundbreaking patent case for Mayo Clinic that culminated in a unanimous win at the U.S. Supreme Court in 2012. Why was that case so important, and what has the impact been since on the pharmaceutical industry?

Singer: The Mayo case is one of the most important patent cases of the last 50 years. Over much skepticism, we pressed a Section 101 defense to the patents at issue, and this was the first successful use of 101 in a patent litigation in decades. (Most of the other prior major 101 cases came out of the Patent Office). It established the definitive Section 101 patenting test, which was later extended in the U.S. Supreme Court’s Alice decision to computer-related patents.

I think that its impact on the pharmaceutical industry has been a net positive. While some diagnostic patents have taken a beating – including those owned by some clients I’ve counseled – it has otherwise led to practitioners more carefully claiming their inventions a little less broadly, such that they leave room for other innovators to build on their discoveries.

MCC: How does Hatch-Waxman litigation differ from other kinds of patent litigation?

Singer: Hatch-Waxman litigation is a completely different animal. Under the Hatch-Waxman Act, drug companies may file an Abbreviated New Drug Application (ANDA) with the FDA to seek approval for generic versions of already-approved drugs by submitting bioequivalence studies instead of clinical studies, which is a much cheaper method than the normal FDA process. Generic manufacturers must certify one of several things to win FDA approval with an ANDA – that the listed drug is not patented, that the patent has expired, or that the patent is invalid or will not be infringed by the generic drug. Branded companies that own the patents and believe the generic will infringe must then sue to enforce their patent rights and prevent the approval of the infringing generic.

Because ANDA cases do not involve damages stemming from sales of drugs already on the market, they are typically bench trials, which means you are trying the case to a very sophisticated audience of one – a U.S. federal judge. The opponents are also typically very sophisticated themselves, and there are usually multiple defendants, so it can be challenging navigating all the issues they raise. These cases can also be tough because of the current political environment. For example, pharmaceutical pricing is a sensitive issue, and these cases almost always touch on that “hot potato” issue even though they are patent cases.

Lastly, and perhaps most importantly, these cases always have a lot at stake. We help our branded pharma clients protect drugs that treat deadly diseases and that typically have very large annual sales. When you look at the life of the patent – which can be upwards of 10 years or more – it’s easy to see why these battles are so hard fought. There are literally billions of dollars at risk in most of these cases. When a generic version of a drug hits the market, it will typically secure somewhere between 50 and 80 percent of the market, so there is a lot at stake for both parties.

MCC: I’m a branded pharmaceutical company and have just received my first Paragraph IV letter. What do I do now?

Singer: Give me a call! No, seriously, the first thing to do is to make sure you have experienced counsel by your side from day one so you can get your company ready for litigation. Basic things like document retention, witness location and experts can be taken care of quickly and easily, but sometimes are forgotten. It is also important to begin the process of educating the company about the road the company is now on. First-time Paragraph IV cases are bumpy rides usually – not necessarily because of anything having to do with the case itself, but because it’s all new and the stakes are extraordinarily high.

MCC: What changes have you seen in the past few years, and what trends are currently driving Hatch-Waxman and other pharmaceutical litigation?

Singer: The biggest change is how inter partes review (IPR) has affected the litigation landscape. IPRs have given would-be challengers to pharmaceutical patents a powerful tool to short-circuit the Hatch-Waxman litigation process. The whole IPR process is set up to limit patent holders defense of their inventions – the burden of proof is lower, inventors don’t testify, and consideration of real-world factors like how drugs are received in the marketplace get short shrift.

While IPR has been great for knocking out patents only a patent “troll” sees value in, the confined nature of the proceeding really works to the detriment of many innovators. This is especially true in the life sciences area, where companies invest vast sums of money in developing potentially life-saving drugs in exchange for the market exclusivity that a patent gives.

MCC: What advice would you give to innovator drug companies that are looking to protect their intellectual property?

Singer: Take the time and invest the money required to write stronger patent applications. Hire the absolute best patent prosecutor you can find – someone who understands the science behind your technology and has done extensive work in your industry. And, of course, hire litigation counsel that is experienced in the life sciences. Oftentimes I get into litigation and find that the best parts of an invention story are either not in the patent or barely mentioned. I know budgets are tight, but spending too little on a patent application will likely cost you more in the end.

MCC: Fish’s Life Sciences practice is regularly singled out as one of, if not the best in the industry, and you have personally been recognized many times over as a top attorney in the field and one who is known for high-level client service. What is the secret to your success?

Singer: Hard work, plain and simple. It’s a privilege every time someone hires me, whether they are from a small company or a giant one. I remember very well knocking on lots of doors when I was younger and the struggle to convince people that I was someone they should take a chance on. At the end of the day, while Fish has a great brand, people are hiring you, and not some amorphous entity. So, I try to remember that every day.

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