Page 10 - Intellectual Property

S10 | MONDAY, APRIL 4, 2016 | Intellectual Property | NYLJ.COM

By A. Antony Pfeffer

And Catrina Wanning Wang

Post-Grant Proceedings Complicate

Pharmaceutical Litigation

S ince the passage of the America Invents

Act in 2011, various changes to the pat-
ent litigation landscape have occurred.
Perhaps the largest changes are a result of
post-grant proceedings, including inter partes
review (IPR), covered business method review
(CBM) and post-grant review (PGR). These
proceedings created an alternate forum and
system for challenging the validity of issued
U.S. patents. Their immediate effects were

felt in places such as the Internet, software
and electronics industries. However, these
proceedings are also having a growing impact
on life sciences litigation, particularly Hatch-
Waxman litigation. It is very important for all
companies involved in the pharmaceutical
industry to keep in mind the impact of these
post-grant proceedings when formulating
their intellectual property strategies.

In Hatch-Waxman litigation, pharmaceu-
tical companies are able to protect their
branded drug products by initiating litigation
prior to FDA approval of a generic drug. In
this way, it is possible that patent issues can
be resolved prior to the launch of a generic
drug and its disruptive impact on the market.
Within the bounds of forum and venue limita-

tions, the branded company chooses where
to enforce its patents. In district court, the
branded company enjoys the presumption of
validity mandating the presence of clear and
convincing evidence to invalidate its patent.
These advantages worked to the favor of the
branded drug companies.
Now, with the availability of IPRs, the gener-
ic company has the ability to challenge the

validity of these patents before the U.S. Patent
and Trademark Ofice’s (PTO’s) Patent Trial
and Appeal Board (PTAB). When choosing this ment suit, thus clearing the way for product appeals. This scenario makes it especially mid-2014, a substantial and rising number of
route, the generic company is going to a body launch immediately upon FDA approval. And important to develop a careful record at the post-grant proceedings of Orange Book-listed
that has invalidated the vast majority of the in the event that the IPR is not successful, PTO to maximize the chance of success on patents have taken place. Given the 18-month
patent claims across all technology areas on then the generic company maintains its ability appeal. If appeals are not exhausted before period from petitioning for institution of a
which it has decided to institute review (and to contest infringement and to raise certain the 30-month stay of FDA approval runs out, post-grant proceeding to inal written deci-
that have gone to a inal written decision).
validity challenges (e.g., enablement, writ- and the generic challenger launches at risk, sion, inal resolution of most of these cases at
These IPR proceedings, in the Hatch-Wax- ten description, patentable subject matter, then the brand-name manufacturer’s only the PTAB level has not occurred. To date only

man context, will largely be running in parallel anticipation or obviousness in light of prior recourse would be to seek an injunction on a handful of such proceedings have reached
with district court litigation, and will often use or sales).
generic sales.
a inal determination. The odds of success for
result in stays of the district court litigation. IPR proceedings also have the potential Post-grant proceedings have become an both sides have been even: The challenged
A determination of unpatentability for which to prolong district court litigation and to increasingly popular vehicle for contesting claims were upheld in nine of the proceed-
all appeals have been exhausted will allow possibly run out the 30-month stay of FDA the validity and scope of Orange Book-listed ings and held to be unpatentable in seven.
the generic challenger to obtain dismissal approval, allowing the generic drug manu- patents. Since the irst IPR petition was iled Almost all the inal determinations have been
of the brand-name manufacturer’s infringe-
facturer to launch at risk. Many courts have, over an Orange Book-listed patent in late 2012, appealed to the Federal Circuit.
either sua sponte or upon application of the almost 250 such petitions have been iled

defendant, stayed the district court litigation according to published industry analyses. Case Studies
A. ANTONY PFEFFER, a partner in Orrick, Herrington & pending completion of the PTO proceeding. In that same period, close to 350 petitions
Sutclife’s intellectual property group in New York, has If the district court litigation is stayed before for post-grant proceedings have been iled Novartis v. Noven: PTAB Breaks with
litigated Hatch-Waxman cases and has also repre- any brieing on the merits, then disputes over for drug patents generally (including Orange Federal Circuit Holding of Validity.
sented clients in IPR proceedings. CATRINA WANNING patent validity may well play out exclusively Book-listed patents), and slightly less than In February 2013, Noven Pharmaceuticals
WANG is an associate the group.
in the post-grant proceeding and subsequent
half of these petitions are granted. Starting in
notiied Novartis in a Paragraph IV Certii-