IP strategy and regulatory controls - you don't have to be sued to get (generic) exclusivity in the US (Zocor returns)

(Ranbaxy v Michael O Leavitt, US Court of Appeals for the District of Columbia, 14 Nov. 2006)

Copyright Thursday, December 7, 2006 Duncan Bucknell Company

This one’s succinct but very important for those interested in the interplay between IP strategy and government regulatory control or pharmaceuticals in the USA.

The broad take-home is — if government regulatory control is relevant to your industry, then think long and hard about how it enhances or detracts from access to the market by you and your competitors. Then think again, strategically.

The US pharmaceutical strategy take-home is - a ‘first filer’ generic pharmaceutical company will not lose its 180 day marketing exclusivity merely because the relevant Orange Book patents have since been delisted. The Appeals Court ruled that notwithstanding that the patents had subsequently been delisted, the ‘first filer’ generic company would still be entitled to its exclusivity provided that one of the two trigger situations were met (litigation success or commercial launch).

Comment

If someone tells you that you can’t launch a product because they have a patent (or use a brand because they have a trade mark) — do you apologise and quietly walk away? (If you do, then probably best not to bother reading anything else I write.)

No, you check the patent or trade mark, the scope of the monopoly, its validity, etc etc (see the 6T’s framework here).

The same line of thinking applies to control imposed by regulatory authorities. To really enhance your IP Strategy, think about how you can make the most of these controls. Then, as Ranbaxy and Teva did in this case, think again about whether the regulatory authority is acting within the power delegated to it.

Background

In my earlier article, Pharmaceutical IP Strategy in the US - Merck's latest tactic for Zocor, I explained how in 2003, Merck had requested that the Orange Book patents listed in relation Zocor be delisted. Due to the FDA policy in dealing with this situation, Merck’s controversial tactic effectively removed the chance of generic exclusivity. I also wrote briefly about the background in Zocor Generic Exclusivity dispute continues on appeal in the US.

For those outside the pharmaceutical industry, the upshot of this case is that the FDA received a slap on the wrist (and two losses in Court) for applying a policy inconsistent with the governing legislation, and innovator companies can no longer use this tactic in the ongoing chess-game being played against generic companies.

Links

Article and further links (including a copy of the judgment) at Aaron Barkoff’s Orange Book blog.