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

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).


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.


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


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

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