Lipitor Australia – unusual grounds invalidate Enantiomer Patent
first-instance judgment in the Australian part of the global Lipitor patent dispute was handed down earlier today (20
December 2006). Click here to go to the judgment.
as in many other countries, Ranbaxy challenged only the construction (and
therefore infringement) of the Basic patent, and lost.
though, having dropped the novelty and inventive step arguments at trial,
Ranbaxy still managed to invalidate the Enantiomer
patent based on two grounds which are rarely successful: False Suggestion and
lack of Utility.
not convince the Court that the patent was invalid on another unusual ground
(which is peculiar to Australia)
— lack of Manner of Manufacture for failure to meet the threshold
requirement of disclosing an invention.
However, Young J took up the opportunity to provide further guidance
on this complicated lacuna of Australian patent law.
highlights the importance of really digging into the specification and the
surrounding factual matrix when seeking to challenge a patent. As quoted (from Jim Hurst) in my recent article, Global Litigation Strategy and the art of war,
â€œthe best ideas often come late at night and only after tearing apart
the patent and the prior art on literally a line-by line basisâ€.
developments have also recently occurred in the UK
– click here for
the latest version of the Scorecard™ for the global Lipitor
The Basic patent
As in other
jurisdictions, the Court held that the Basic patent is not confined to racemic mixtures, but instead include the R-trans enantiomer and the S-trans enantiomer. In essence, this was because the skilled
addressee would have read the depiction of the Atorvastatin (Lipitor) molecule as including
either the Racemate or any one of the enantiomers. Young
J referred to several portions of the specification to support this
The Enantiomer patent (AU 628198)
False Suggestion or Misrepresentation
argued that Pfizer had made false representations in the patent specification
and in correspondence with the Australian Patent Office which materially
contributed to the Commissioner’s decision to grant the patent. In essence, the representations were that
the level of activity of the R-trans enantiomer was
ten times greater than the racemate. Whereas, the actual level was only two
times greater. The Court agreed that
the claims were invalid based on False Suggestion or Misrepresentation.
Lack of Utility
argued that the representations in the patent about a tenfold increase in
activity of the R enantiomer were a promise which
was not met by compounds falling within the claims (which only generate a
twofold increase). In finding the
claims invalid on this ground, the Court also took the opportunity to correct
a line of argument by Pfizer which misconstrued the test for Utility. (They had argued in parallel that the R enantiomer of Atorvastatin is
commercially useful. However, the test
is whether the invention meets the promise of the specification.)
Manner of manufacture
line of argument cantered through the transitional provisions of the 1990 Act
(the ‘198 patent was filed under the earlier, 1952 Act), and several
famous and famously confusing appellate decisions (Philips, Ramset, Microcell, NRDC and Merck & Co). Pfizer had argued that Ranbaxy’s line
of attack was foreclosed by the decision in Ramset Fasteners. The
Court disagreed, citing another High Court case, Philips v Mirabella as being directly on point and drew support
from the other cases.
this minor victory, Ranbaxy failed to convince the Court that the Enantiomer patent was in fact invalid on this ground.
the length of the judgment (134 pages), Young J managed to hand down his
judgment in less than 8 weeks after the end of the trial.
As noted in
my previous article (Value for money in global patent litigation), judgments
in Australian patent cases have historically been handed down 33 months after
trial, on average.