On April 2013,
Glenmark launched the generic version of Merck’s popular antidiabetic drug
Januvia (Sitagliptin) and Janumet (combination of sitagliptin and Metformin).
Subsequently Merck filed a suit against Glenmark seeking interim relief. The
Delhi HC (Justice Rajiv Sahai Endlaw) denied interim relief to Merck. After
denial of interim relief, Merck was also briefly engaged in mediation with
Glenmark over the Januvia patent. Readers may recall that we had blogged about
it here here and here. Aggrieved by the denial of interim relief Merck also
filed an appeal, seeking injunction.The Delhi High court division bench granted
the interim injunction. This post aims to analyze the interim injunction order.
IN209816 (product patent claiming Sitagliptin) is the subject of the present
suit.(Long post warning*)
Merck’s
arguments:
Merck
contended that Sitagliptin Phosphate Monohydrate cannot be prepared without
manufacturing the active ingredient, the Sitagliptin molecule. Merck also
alleged that Glenmark willfully infringed the suit patent.
Glenmark’s
arguments
Glenmark
alleges that the patent is invalid under Section 64(1) of the Indian patents
act:
The patent is
lacks inventive step over prior art, patent. Glenmark further alleged that the
suit patent is a “cut and paste job” from these two patents, specifically
European Patent 1406622 and WO2001034594 A1.
The complete
specification of the patent does not sufficiently and fairly describe the
invention and the method by which it is to be performed, since the patent does
not describe the preparation of the Sitagliptin free base or Sitagliptin
phosphate monohydrate, but only its hydrochloride salt
Strangely
enough, Glenmark also contended that the suit patent is not useful and
lacksindustrial applicability because Sitagliptin free base is itself unstable.
Glenmark also stated that the Sitagliptin phosphate monohydrate was the
molecule used in the clinical trial, and not Sitagliptin Free Base.
The claim goes
much beyond the limited disclosures in the specification, and thus the claim is
over-broad or an impermissible Markush claim that creates a false monopoly.
Glenmark
alleges that Merck did not comply with its obligation under Section 8 of the
act to disclose patent applications made for the “same or substantially the same
invention”. It was alleged that Merck did not disclose 5948/DELNP/2005 (for
Sitagliptin Phosphate Monohydrate), 1130/DELNP/2006 (Sitagliptin Phosphate
Anhydrate), 2710/DELNP/2008 (Sitagliptin plus Metformin) or subsequent
international applications for these compounds either.
I wonder;
where does one draw the line for Section 8 disclosure? What amounts to
“disclosure of same or substantially same inventions” is a grey area! In my
opinion 5948/DELNP/2005, 2710/DELNP/2008,1130/DELNP/2006 and their foreign equivalents
are subject matters of separate patents and are not divisionals and do not
claim priority from the original product patent IN209816.If section 8 requires
one to disclose all related applications in the relevant arena – this is a
separate patent landscape project in itself.
Curiously,
Glenmark also argues that Sitagliptin phosphate monohydrate is qualitatively
different from the Sitagliptin free base – it has enhanced pharmaceutical
qualities (the reverse Section 3(d) argument so to speak!).This, according to
Glenmark, means that the manufacture of Sitagliptin phosphate monohydrate does
not violate a patent for the Sitagliptin free base simpliciter.
Courts
observations:
In an
exceedingly well reasoned judgement the Division bench (Justice Ravindra Bhat
and Justice Najwi Wazir) of the Delhi High court made the following
observations:
Regarding
prior art the court notes that irrespective of whether the two patents are
similar or not, EP 1406622 was published on after the priority date for the
suit patent, and therefore does not qualify as prior art.
Regarding
sufficiency of disclosure in the complete specification, the court observed
that the patent sufficiently discloses the Sitagliptin free base, which in
itself is clear, precise. The question whether the suit patent sufficiently
discloses Sitagliptin phosphate monohydrate was left open.
Regarding
industrial applicability, the court rightly observed that while the patent claims
disclose the Sitagliptin free base, the description relating to the issue of
industrial applicability recognizes that the Sitagliptin free base will be
attached to some carrier (salt form). That carrier, however, is NOT the crux of
the invention but only an inert component that does not add value to the
therapeutic or medical value, which is the true core of the invention. It would
be a far cry to hold that Sitagliptin is useless for any known purpose. The
Court also noted that Sitagliptin was not known before, and its introduction
allows for the inhibition of the DPP IV enzyme in such a manner as previously
unknown, whether through one inert carrier or another.
Regarding
Markush claims, , for the limited issue in these interim hearings the Court
notes that the Markush formula and all combinations “share a common use or
property” and “ share common structure factors relevant to determine the
validity of a Markush patent, as per the Draft Guidelines of Indian patent
office. The court opined that whilst it may be appealing at first blush to
limit a pharmaceutical patent only to the exact and precise compounds and
chemical structures disclosed, that may render genuine medical inventions to
naught.
Regarding
Section 8 (foreign filing disclosures) the court observed that Merck in the
modified Form 3, disclosed foreign filings for patent related to combinations
of Sitagliptin and metformin. The Court further stated that Section 8 only
mandates the disclosure of patent applications outside India and not within. This
is clear from the wording of Section 8 itself.
Conclusion:
The court also
frowned upon Glenmark’s at risk launch and observed that the fact that Glenmark
did not utilize the opposition mechanisms weighed in favour of grant of interim
injunction.
The court
carefully and meticulously evaluated the three factors involved in grant of
interim injunctions.
Prima facie
case: The court succinctly captured the crux of the case and noted that Merck
had established a strong prima facie case on the merits of the suit claim. It
is established that Glenmark uses Sitagliptin free base as the active component
in its chemical formulation. The court was totally unimpressed with the
unsubstantiated argument advanced by Glenmark that their generic version uses
Sitagliptin Phosphate monohydrate, which is manufactured directly without using
the Sitagliptin free base. The court further stated that the fact that Merck
unsuccessfully pursued a separate patent for Sitagliptin Phosphate is
irrelevant .Thus; prima facie infringement of Merck’s patent is established, in
the opinion of this Court.
Irreparable
injury: Whether the claimant would suffer irreparable injury in the absence of
interim injunction?- It may be argued that no injunction should be granted
since all damages from loss of sales can be compensated monetarily ultimately.
For this argument – the court countered that, prices may not recover after the
patentee ultimately prevails, even if it is able to survive the financial
setback (or “hit”) during the interim, which may take some time. The victory
for the patentee therefore should not be pyrrhic but real.
Balance of
convenience: The court must look at the public interest in granting an
injunction, as access to drugs, is an important factor especially in case of a
condition as prevalent as diabetes. Here, the price difference between the
commercial products sold by Glenmark and MSD is not so startling as to compel
the court to infer that allowing Glenmark to sell the drug, at lower prices
would result in increased access. The court observed In the Hoffman la Roche
case the price differential was about 300% and therefore in that case, held
that balance of convenience did not lie in favour of grant of injunction as the
possibility of several thousand being denied access to the generic drug was
real.
http://spicyip.com/2015/03/delhi-high-court-grants-interim-injunction-restrains-glenmark-from-selling-generic-version-of-anti-diabetic-drug-januvia-sitagliptin.html
