In a 22-page decision (available here)
delivered on April 5, 2013, a Single Judge of the Delhi High Court denied interim
injunction to Merck in its suit for patent infringement against Glenmark
Pharmaceuticals. Merck’s patent IN209816 claimed the drug sitagliptin sold under the
name “Januvia/Janumet” which is used to treat non-insulin dependent diabetes
(Type 2), and restraint was sought against Glenmark’s “Zita/Zita-met”.
The suit was heard just 3 days
ago, on the 2nd of April. Glenmark, which was on caveat, was
represented in the Court by Dr.Abhishek Manu Singhvi, while Merck was being led
Mr.Parag Tripathi. Despite Glenmark’s request that it was only contesting the
grant of an ex parte relief, and not
with respect to the interim injunction itself, the learned Single Judge took
the view that Glenmark was prepared to argue the interim injunction itself, and
proceeded to hear the application. Here’s
the relevant portion:
“I may however record that the senior counsel for the defendant has
argued that the application for interim relief should not be disposed of and
the Court at this stage should consider only the aspect of grant of ex-parte
relief, saving the disposal of the application to after the reply thereto has
been filed but the said request was declined
as the defendant had come well prepared with the case which it was required to
meet and has chosen to make lengthy arguments in opposition and the Court
cannot repeatedly grant opportunities to the parties.”
On merits, Glenmark alleged that
Merck had 3 different patents in the US covering 3 products, namely
Sitagliptin, Sitagliptin Phosphate and another derivate of Sitagliptin respectively.
However in India, there is only one patent claiming Sitagliptin Hydrochloride,
and the applications for the other two derivates stand abandoned By Merck.
Consequently, according to Glenmark, the other two derivatives could not now be
claimed as part of the sole subsisting Indian patent. Para 156 of the Novartis
judgment on coverage
and disclosure was cited to support this argument.
Merck, on the other hand argued,
that the phosphate salt must be deemed to be included as part of the patent on
Sitagliptin in light of Section 3(d). Further, Merck drew attention to Glenmark’s
patent application in the US wherein it was stated that Sitagliptin Phosphate is
a pharmaceutically acceptable salt of Sitagliptin.
The Court narrowed down the issue
to the following question- “Does the
phosphate salt materially alter the working of the Sitagliptin? If no, then isn’t
the addition of the salt an immaterial variant?”
When the above question was posed
to Glenmark, the judgment says no satisfactory response was forthcoming. Here’s
the relevant portion:
“20. I had for this reason asked the senior counsel for the defendant
to explain as to how the combination by the defendant in its product of Phosphate
with SITAGLIPTIN amounted to a different treatment of Type-II Diabetes than
treatment by SITAGLIPTIN.
21. No satisfactory response was forthcoming.
22. To my mind, if the infringing product are made with the same object
in view which is attained by the patented article, then a minor variation does not
mean that there is no infringement. Trifling and unessential variations are to
be ignored. Conversely, a miniscule advancement could be recognized as an
invention.
These observations could lead any
reader to conclude that the Court was convinced that there was a prima facie case of infringement,
however, the following paras reflect the subsequent turn of the tide:
“23. Interestingly in the present case, the plaintiff Merck as patentee
of SITAGLIPTIN is also not marketing SITAGLIPTIN alone as a product and is
marketing Sitagliptin in combination with Phosphate just as the defendant is
doing. The senior counsel for the plaintiff in his opening argument, on being
asked to demonstrate infringement, had done so on the basis of identical
pharmaceutical composition of the product of the defendant as of the plaintiff.
24. However the defendant pointed out that the patent of the plaintiff Merck
was not in the pharmaceutical composition as described on plaintiff’s product
but only in a part thereof and which fact was not denied by the plaintiff.
Thus, similarity of pharmaceutical composition of the products cannot be a
ground for infringement.
25. Strangely, the plaintiff, neither in the plaint nor in the opening arguments
has pleaded/made out a case on which ultimately interim relief is claimed,
i.e., of Sitagliptin Phosphate being made by the defendant being made with the
same object as the patent of the plaintiff and the addition of Phosphate to the
patented SITAGLIPTIN not embodying any inventive advancement and the treatment
of Type-II diabetes by Sitagliptin Phosphate being no different from treatment
by SITAGLIPTIN.”
True, product to product
comparison is not the basis for infringement. That said, if the Court can form
a view on whether the phosphate salt is an immaterial variant of Sitagliptin,
wouldn’t the issue be answered? But again, Merck’s own treatment of the
products and existence of separate US patent did not help its case. This
coupled with the absence of a claim to product comparison to establishment
infringement, dissuaded the judge from granting an interim injunction. Here are
the relevant paras:
“28. The position which thus prevails today is that we have the
argument of the defendant of Sitagliptin Phosphate being a different product
than patented SITAGLIPTIN together with the plaintiff Merck’s admission to the same
effect in its patent applications aforesaid for Sitagliptin Phosphate. Though
the plaintiff when faced therewith has urged such patent applications to be a
mis-adventure, under wrong advise at least in India, but the plaintiff in the
plaint has not pleaded so.
29. I have wondered whether in the absence of the plaintiff having pleaded
so, can interim relief be granted on the basis of such explanation. The answer
has to be an emphatic no. It was for the plaintiff to plead the circumstances
in which its application for a separate patent in Sitagliptin Phosphate was
made and to explain away the admission made therein. The plaintiff has not done
so. Though it may be open for the plaintiff to at the trial explain so, but the
plaintiff certainly cannot be granted interim relief on a case not pleaded and
in the face of its admission of Sitagliptin Phosphate being a new invention
worthy of patent.”
But what surprises me is the
following observation of the Court:
“26. The plaintiff in a suit
restraining infringement of patent ought to have known the defence which the
defendant has put forth and ought to have met the same in the plaint, as has
been done in the arguments in rejoinder by arguing on “basic” and “improvement” patents. There is not an iota of pleading on the said aspect...”
How can a party be expected to anticipate
the arguments of the other side? I am not sure...
JSD - wonder whether Merck's task would have been easier if they had simply stuck to the fact that "using" is also an infringement. Therefore, any use of Sitagliptin in a commercial manner would be an infringement. Wonder whether the focus on product package identity to establish infringement diluted the strength of the claim. Sec. 48 is quite explicit. Any person who makes... "uses" a product covered by a patent is also infringing the patent. Does an argument that Glenmark's use of Sitagliptin covered by IN209XXX to make a formulation is an infringement - leave product package identity apart.
ReplyDeleteRegards,
GN
I completely agree. In fact, I would actually say that there wasnt anything terribly wrong with Merck's reliance on the product package. This is because the active ingredient needs to be clearly mentioned in the product packaging and what is mentioned is deemed to be true. Therefore, if Glenmark's product package mentioned Sitagliptin phosphate, there need not be any further infringement analysis, unless it is Glenmark's case that its product packaging is inaccurate...
DeleteBests,
Sai.
Thank you for the link and for another good read, JSD! I'm not a lawyer; and am adding my comments from an outside perspective of the Law. Having shielded myself, from possible opprobrium, thus:
ReplyDeleteMany things strike me as interesting in this case and in the judgment. It reads as if the judge felt compelled to rule against Merck on 'legalese' - that they had not made their objections, explicit, in the plaint. The criticism of why they did not use it in the plaint is in '26' - the judge's argument being that they 'should' have known how the defendant would argue (isn't that how we all prepare for battle) and they 'still' did not preempt the enemy by adding the counters to the expected defense in the plaint. To his mind, that hesitation by Merck indicated implicit doubt in their own position; doubt brought on by the patent already filed for for PD in the US. This is how I am reading it/ not sure I am right.
Having said that; could Merck have made it explicit that PD was no different from S? I think, yes. Here's why:
1. If Glenmark is saying that PD is different from S and there is no violation of patent therefore:
Are they saying that PD is a new and novel drug? (as claimed by Novartis in their case). If it is, (and sadly, contrary to Novartis, the judge here seems to have agreed (though, happily, not overtly)); then well, Glenmark should be subjected to the same clinical trials that S was put through and Glenmark cannot be allowed to enter the market on the coattails of the hard research and clinical results of S.
2. The argument that Merck filed S and PD as separate patents in the US and that was denied by India:
a) By denying separate patents; India therefore considered therefore S and PD as one drug/ therefore Glenmark is in violation
b) If the argument is now that, well, but the fact that Merck filed for separate patents; 'indicates' that they think S and PD as two drugs - that argument is invalid because irrespective of what Merck thought/thinks; separate patents were denied by India and both S and PD were considered the same. Merck, in agreement, of this ruling is selling the same S as PD through Sun as an 'authorized generic' at a lower price than S. Not sure under what conditions 'authorized generics' are allowed in India?
3. The point made in #27, I disagree with too - if Merck filed separate patents for salts in the US/ Europe that it only because those markets 'allow' that and accept salt variations as pharmacological alternatives. That is a perfectly legal position in those markets and not something that Merck should be held to here as manipulative behavior. Also this is not evergreening by Merck. It seems those patents for S, PD and DC were all filed at the same time.
4. Merck's Achilles heel,to my mind, is the relationship with Sun. Why when they had a patent for S did they eagerly(?) authorize Sun, to make the PD version? Albeit as a branded or authorized generic; but, yet. This was clearly only for maximizing profits. They took advantage of the Indian ruling of S and PD being the same and decided to maximize profitability by allowing a generic version of PD. It couldn't be a 'generic-S' because that would have been truly altruistic and cut into the profits of brand-S. So, enter generic-PD.
This relationship with Sun is what gave Glenmark a foot in the door to enter as PD.
I think, both Glenmark and Sun must be disallowed from making PD as generics.
Your thoughts? Thanks again for the share, Meena/menkris
Dear Meena,
DeleteThanks for the detailed comment! I agree with you. Also, I think one of the reasons for the decision may be that Courts havent understood the territorial nature of patent regime. US law may permit patents on polymorphs and salts, Indian law does not under Section 3(d). Therefore, the patentee's conduct in the US cannot be used as estoppel against him in India. The explanation to Section 3(d) clearly tells us that a polymorph or a salt is treated as the same as the base. Therefore, the phosphate salt is included in the patent, and the Court need not have concerned itself with the US patents. More importantly, if it did decide to consider the conduct of the patentee in the US, it ought to have deliberated on the nature of US law and the effect of Section 3(d) in India. It did neither. This itself could form a potential ground of appeal for Merck against the judgment.
As for the issue of pleadings, on one hand the Court takes the view that the Defendant can argue without a written statement of its defense, and on the other its requires two things from the Plaintiff- divine the defense of the Defendant and factor it in the Plaint, and also take a strict view of the contents of the Plaint when such view is not warranted in the facts of the case. After all, in para 23 the Court clearly observes that there was no satisfactory response from Glenmark on whether Sitagliptin phosphate was a different from Sitagliptin. If at the end of the day, Sitagliptin is the active ingredient which works inside the body even after the consumption of the phosphate salt, and there is no marked difference in efficacy, then the issue has been effectively addressed. Then why harp on pleadings? In the alternative, Since no ex parte relief could have been granted, the Court ought to have permitted Merck to amend its pleadings to satisfy the Court, and argue the matter.
Honestly, I dont think Merck's license to Sun on PD affects its prayer for interim injunction. After all, Sun is manufacturing it under a license from Merck. The issue which seems to have affected the Court's analysis is Para 31, which is as follows:
"31. No only so, the only response of the plaintiff to the plea of the
defendant of at least 9 to 10 other persons also marketing Sitagliptin
Phosphate, duly supported by documents handed over, was that instructions
on that aspect will have to be taken. However, the said plea also belies the
existence in favour of the plaintiffs of the ingredients of irreparable injury
and balance of convenience. Though, ordinarily infringement by others
does not constitute a ground for denial of the relief of injunction against an
infringer but it can be a consideration in the grant of interim injunction."
Merck's inaction against third parties on the PD form was treated as proof of lack of irreparable harm. I am not sure if this line of argument is correct because delay must be proven with respect to the defendant, and not against third parties who have not been proceeded against. It is possible that according to Merck, Glenmark is capable of denting its market share more than others who are selling the PD version. Therefore, is is Merck's prerogative as to who it chooses to prosecute for infringement. That is no ground for denial of interim injunction. I'd like to check the law on this point once more.
Hope this helps.
Best Regards,
Sai.
JSD - I agree that applicant conduct in different jurisdictions should not be used for estoppel for the issue of patentability. Each country/jurisdiction has the right to prescribe norms for patentable subject matter depending of course on the ubiquitous TRIPS. However, applicant conduct vis a vis novelty/inventive step (not obviousness, only inventive step) would be a factor.
DeleteAdditionally, a complete specification would be part of documents relevant for India. The patent specification on the salt application expressly states that the earlier application does not include the salt in question. I would believe that this express statement by applicant in a subsequently filed application is relevant for the purpose of determining the actual scope of the claims on an earlier patent, particularly of a general disclosure therein which is not supported by examples.
In any event, I still wonder why the Sec.3(d) inverse logic was used to establish infringement instead of the relatively straightforward "make"-"use" language of Section 48.
As ever,
Annoying Mouse
Dear Annoying Mouse,
DeleteInteresting point on the relevance of the disclosure made in the second application on PD. Let's explore this because I think it's an important point. I havent seen the salt application, but if the salt application indeed expressly states that the base application disclaims the phosphate salt, one would still have to go into the implications of rejecting such a claim under Section 3(d). If the patent office relied upon the base application to establish that there is no enhanced efficacy over Sitagliptin as claimed in '816, wouldnt that mean that the law(and hence explanation under Section 3(d)) has prevailed over the ostensible statement made by Merck in the salt application? Also, the '816 patent specification does not seem to exclude the phosphate salt. Here's a para from the '816 patent specification:
"When the compound of the present invention is basic, salts may be prepared from pharmaceutical^ acceptable non-toxic acids, including inorganic and organic acids. Such acids include acetic, benzenesulfonic, benzoic, camphorsuifonic, citric, clhanesulfonic, fumaric, gluconic, glutamic, hydrobromic, hydrochloric, isclhionic, lactic, maleic, malic, mandclic, methanesulfonic, mucic, nitric, pamoic, pantothenic, phosphoric, succinic, sulfuric, tartaric, p-toluenesulfonic acid, and the like. Particularly preferred are citric, hydrobromic, hydrochloric, maleic, phosphoric, sulfuric, fumaric, and tartaric acids. It will be understood that, as used herein, references to the compounds of Formula I are meant to also include the pharmaceutical^ acceptable salts."
Clearly phosphoric acids is a preferred embodiment,which therefore is a reference to the phosphate salt of Sitagliptin.
As for the "use" part, I agree. This is what i said in my last comment- "If at the end of the day, Sitagliptin is the active ingredient which works inside the body even after the consumption of the phosphate salt, and there is no marked difference in efficacy, then the issue has been effectively addressed. Then why harp on pleadings?"
Bests,
Sai.
Thanks Sai. Yes, indeed, it helps! I completely agree with your read of Para 31. Indeed; two wrongs don't and can't make a right. Curious as to who these co-infringers are (9 'to' 10 sounds rather vague for a court).
ReplyDeleteHowever, my feeling about Sun is still not shaken. To my mind: Merck has a real problem explaining Sun's generic PD. Sun is manufacturing under a license from Merck, yes; but Merck itself does not have the license to allow Sun (this is PD) since the patent was disallowed.
We do need some more details though to be certain. What is Sun's PD marketed as? A branded generic/ an authorized generic/ what? Since PD is not the exact-same formulation as Merck's S; then it really can only fit into a branded generic. And therein lies the can of worms and possibly also, where estoppel might make its presence felt. How does a branded generic enter the market when the brand patent is still in effect? India disallowed this after 2005, right?
If it's not a bother; would appreciate a further elaboration of the legal perspective on this? Thanks again, Sai! Glad to have found your excellent blog on T. Now following the blog :)
Meena,
DeleteTo your point on the rejection of Merck's salt patent application, I think my point in my comment to "Annoying Mouse" applies. Here it is:
"Interesting point on the relevance of the disclosure made in the second application on PD. Let's explore this because I think it's an important point. I havent seen the salt application, but if the salt application indeed expressly states that the base application disclaims the phosphate salt, one would still have to go into the implications of rejecting such a claim under Section 3(d). If the patent office relied upon the base application to establish that there is no enhanced efficacy over Sitagliptin as claimed in '816, wouldnt that mean that the law(and hence explanation under Section 3(d)) has prevailed over the ostensible statement made by Merck in the salt application? Also, the '816 patent specification does not seem to exclude the phosphate salt. Here's a para from the '816 patent specification:
"When the compound of the present invention is basic, salts may be prepared from pharmaceutical^ acceptable non-toxic acids, including inorganic and organic acids. Such acids include acetic, benzenesulfonic, benzoic, camphorsuifonic, citric, clhanesulfonic, fumaric, gluconic, glutamic, hydrobromic, hydrochloric, isclhionic, lactic, maleic, malic, mandclic, methanesulfonic, mucic, nitric, pamoic, pantothenic, phosphoric, succinic, sulfuric, tartaric, p-toluenesulfonic acid, and the like. Particularly preferred are citric, hydrobromic, hydrochloric, maleic, phosphoric, sulfuric, fumaric, and tartaric acids. It will be understood that, as used herein, references to the compounds of Formula I are meant to also include the pharmaceutical^ acceptable salts."
Clearly phosphoric acids is a preferred embodiment,which therefore is a reference to the phosphate salt of Sitagliptin."
Also, why would Sun seek and obtain a licence if the PD version was not covered by a patent? Also, the Patents Act does not bar the manufacture of a licensed generic version of a patented drug. After all, surely the consequence of the 2005 amendment cannot be to prevent a patentee from licensing the manufacture of a generic version of the patented drug. The amendment only prevents unauthorized generics. I hope I have answered your question. If I havent, please persist :)
Also, thanks for your kind words about the blog :) It is articulate readers like you who add more value to our posts with your industry insight. Therefore, keep the comments coming :)
Bests,
Sai.
JSD and other commentators,
ReplyDeleteCame late to see this post and got directed through your today's post on Ex Parte ad interim injunction. However, its a good post and off course the discussion on follow-on issues.
Do not know why Indian pleaders are obsessed with conduct/fate of the similar applications in foreign jurisdictions where there is no 3(d) like spoiled brat as in India. After all these are civil issues without requiring a character assassination like in criminal cases.How can the fact that patent denied/granted in US makes sense while you take a 3(d) analysis for patentability in India?
Argument on reverse/inverse logic of 3(d) to establish similarity between granted prior patents and patent denied to hold infringement would surely be at lower footing than a simple infringement analysis between patent claims and product/product- features. This is because 3(d), post Novartis judgment by SC, is a standard of patent eligibility assessment and thus hold no relevance for infringement analysis. At least I think so pending correction.
Also before making product to product comparison shouldn't it first be assessed that plaintiff product fits nicely into the claims of its relevant patent ?
And if at all any relevance from foreign soil is taken into consideration by the court, Merck must plead that Sun's formulation which is essentially same as that of defendant in India is nothing but a approved generic (licensed by Merck) and NOT a generic ANDA and dose not have para IV certification (non infringing Merck's patent or Merck's patent being invalid or Merck's patent not enforceable).
Regards.
TS