Cipla Files Post-Grant Opposition for Lapatinib Patent

After Erlotinib and Sorafenib, Cipla is targeting yet another anticancer drug Lapatinib marketed by Glaxo under the brand name Tykerb. Moneycontrol reports that Cipla has filed a post grant opposition against Lapatinib patent on grounds of obviousness and lack of inventiveness. Cipla CEO Amar Lulla said: “If we win the opposition, we will begin production of the product, Lapatinib, immediately and launch it within a couple of months. It will also be priced substantially lower than what GSK charges in India.” Last year we hinted that Cipla may possibly target patented drugs, mostly tyrosine kinase inhibitors.

Minor Modification & Structural Similarity Not Sufficient to Establish Obviousness - II

Continuing from our earlier preliminary post on Erlotinib pre-grant opposition, we now discuss the pre-grant opposition judgment in detail. Following Natco’s pre-grant opposition, the Assistant Controller prominently discussed the obviousness arguments in detail. Natco argued that the compound of the present invention is an obvious derivative derived from 4- Anilinoquinazoline nucleus and such compounds have been covered by earlier patents EP 0566226A1, EP0602851A1, EP0635507A1, EP0635498A1, EP0520722A1 published before the priority date of the present invention. Natco further argued that combination of simple functional groups like alkoxy, alkyl, alkynyl, halo to already known basic nucleus or compound is obvious to a person of ordinary skill in the art. Interestingly, while arguing obviousness Natco provided a chemical structure and argued that Erlotinib is easily derived from the structure when a person skilled in the art made obvious substitution of R1 with CH3CH2CH2O (2-methoxy), R2 with CH3OCH2CH2O (2-methoxyethoxy), R3 with H (hydrogen) and R4 with 3-ethynyl (not one, not two there are four conditional substitutions of functional group to render Erlotinib obvious). However, Natco nowhere argued that what may have motivated the person skilled in the art to arrive at obvious substitution of R1, R2, R3 and R4. Natco further broadly argued that prior art compounds are structurally similar to Erlotinib and hence rendering Erlotinib obvious. In counter statement, the Applicant (Pfizer) argued that Natco created their own chemical structure to establish that the claimed compound is an obvious derivation of said structure which is actually not found in any of the prior art citation. Applicant further emphasized inventiveness of substituting an “ethynl group” at methane position of phenyl group. After hearing both Natco and Pfizer (Applicant), the Controller decided that Natco probably failed to properly evaluate the strength of the invention. He further concluded that sometimes the modification in the prior art technologies which appear to be minor may bring great revolutions in the world which could never be predicted by the society of intellectuals. Also adding that a structural similarity as deduced by Natco for a compound (Erlotinib) having great medicine value may not be accepted to establish Erlotinib as obvious. During hearing Natco also brought section 3(d) argument but the Assistant Controller rightly argued that once the invention has been found inventive (non-obvious) it cannot be held non-patentable under section 3(d).

Natco also challenged the issuance of patent on the ground of insufficient disclosure arguing that the Application failed to disclose polymorphic form of Erlotinib. Natco further added that it is very pertinent and relevant to have the details of the current form for the product claimed in the current application. In reply, Applicant strongly objected Natco arguments stating that the object of the invention was to provide a potent EGFR inhibitor Erlotinib and not to provide polymorphic form of the compound of the present invention. The Assistant Controller without any further thought rejected Natco’s insufficient disclosure argument. We, in fact, wonder what can be more frivolous argument than Natco’s objection for insufficient disclosure asking XRD data in the patent application covering the active drug substance (not polymorphic form).

We finally end our post with some intriguing questions for our readers to think about. Why Cipla’s counsel argued the Court to disregard the IPO finding in favor of Roche? Why Cipla argued that the Controller merely addressed arguments on “novelty” and did not even considered obviousness arguments during the pre-grant opposition? Are such arguments misleading to the Court? Was it intentionally done to deceive the Court proceedings? Or was it done to tarnish pre-grant opposition judgment of the Controller?

Minor Modification & Structural Similarity Not Sufficient to Establish Obviousness - I

Erlotinib PreGrant Opposition

Roche lawsuit against Cipla for willful infringement of Indian Patent No. 196774 covering anticancer drug compound Erlotinib still seems to be not reached any conclusion and is likely to be not near from over with next hearing scheduled on February 24, 2009. In counter attack, Cipla raised invalidity and non-infringement defenses against the ‘774 patent. Having earlier lost to obtain temporary injunction order, Roche later appealed against the Delhi High Court order rejecting temporary injunction on the ground of public interest. An Appellate Bench comprising Chief Justice AP Shah and Justice S. Muralidhar finished hearing the arguments and reserved its judgment. Readers interested knowing more detail on this may visit Shamnad’s blog who excellently and extensively covered Erlotinib litigation proceedings.

Recently we just got hold-on Erlotinib pre-grant opposition judgment and thought of posting an analysis over it. This pre-grant opposition is of great significance to Erlotinib litigation proceedings as Cipla’s counsel repeatedly and notably referred to it (read post by SpicyIP) and even argued the Court to disregard the Indian Patent Office (IPO) finding in favor of Roche particularly on the ground that the Controller (of Patents) merely addressed argument on “novelty” and did not even considered obviousness arguments during the pre-grant opposition. However, on reviewing Erlotinib pre-grant opposition judgment we found Cipla’s argument contradicting and fallacious. Not only the Controller considered the obviousness ground but specifically and prominently discussed the same during the pre-grant opposition hearing.

The pre-grant opposition was filed by Natco Pharma Ltd. and decided by the Assistant Controller on 4^th July 2007 after hearing made on 27^th June 2007. In its pre-grant opposition, Natco challenged the issuance of patent against the claims of Erlotinib Application 537/DEL/1996 on the grounds of obviousness and insufficient disclosure. Natco particularly cited EP 0566226A1, EP 06335507A1, EP 0635498A1, and EP 0520722A1 to support its obviousness arguments. However, on the date of hearing Natco filed an interlocutory petition to place additional non-patent literatures on record and to question amendments made in claims during the examination under sections 57 and 59 of the Patents Act, 1970. The Assistant Controller considered the petition to allow additional non-patent literatures to be taken on record to examine the strength of opposition but rejected Natco’s argument against claim amendment. While rejecting argument against claim amendment, the Assistant Controller argued that the amended claims are well within the preview of the original claims and are more restrictive in scope as compared to originally filed claims, and such amendment are not prohibited under section 57 and 59.

Special Thanks!

Patent Circle would personally like to extend a special thanks to Mr. Sandeep Rathod (author of Generic Pharmaceuticals and IP blog) who time to time provided us with valuable information to help us in bringing important piece of news for our readers. He notably provided us with Valganciclovir pre-grant opposition judgment and Sorafenib High Court order. We sincerely acknowledge his contribution to Patent Circle.

Valganciclovir PreGrant Opposition: A Case of Frivolous Objection II

Continuing from our earlier post where we discussed how the NGOs frivolously objected Valganciclovir patent application under section 25 (1) (f) based on their irrational presumption that any compound not published but invented before 1995 is a pre-1995 public disclosure, we now focus on another ground of objection raised by the NGOs under section 25(1)(h). Section 25(1) (h) allows an opponent to challenge the issuance of patent if the applicant –

(1) failed to disclose to the Controller of Patents the information required under section 8, or

(2) furnished the information which in any material was false to his knowledge.

Here again, the NGOs rather than providing evidences to show that Roche failed to disclose the information under section 8 or furnished any false information, argued that Roche delayed in providing information under section 8 (which is, in fact, not a valid ground under section 25(1)(h)). Roche while replying to pre-grant opposition argued that section 25(1)(h) does not give right to the opponent to challenge whether the information required by section 8 has been disclosed within the prescribed time period, especially in the light of the fact that the Patent Applicant has already sought, and obtained, leave of the Controller for the condonation of delay under rule 137 on 23^rd May 2006, which was well before the filing of the Opponent’s Written Statement. Roche also argued that from the filing of the instant application in 1995 and up to the last date of deciding the application, the procedure for filing information and taking extension for filing the said information with a petition to the Controller were changed number of times during the period 1995 to 2007 (around 12 years).

The Chennai Patent Office agreed with Roche’s argument that the ground of opposition under section 25(1)(h) is only limited to (1) the applicant failed to disclose to the Controller the information required by section 8, and (2) has furnished the information which in any material particular was false to his knowledge. The Chennai Patent Office further added that the delay in filing the information to the Patent Office is purely procedural aspect during prosecution of the application and not at all ground for opposition under section 25(1)(h). Also adding that the Controller has the power to extent the time and condone the irregularity in the procedure, if the applicant prays for such an action with a relevant petition and fees. Hence, the opposition under section 25(1)(h) is not maintainable.

Now after reviewing the Valganciclovir pre-grant opposition, we do not find any reasonable ground on which the Assistant Controller would have earlier considered giving a hearing opportunity to the NGOs on such frivolous grounds. Obviously Assistant Controller has sufficient knowledge skills to evaluate such frivolous grounds and to decide whether there is a further need for hearing opportunity or not. If such was the arguments made in the pre-grant opposition then the Assistant Controller was reasonably correct in denying opportunity for hearing to the NGOs and creating unnecessary delay in the issuance of patent. It seems to be this pre-grant opposition was just an attempt to delay the Chennai Patent Office proceedings and/or to mislead the Patent Office with irrational arguments. However, what is quite annoying that when the NGOs failed to convince the Chennai Patent Office they approached the Chennai High Court to assure that the Chennai Patent Office waste its precious time discussing their frivolous arguments. We feel extremely sorry for the Assistant Controller who despite made correct observations got bitter pill from the Chennai High Court.

Valganciclovir PreGrant Opposition: A Case of Frivolous Objection I

It seems to be that the Chennai Patent Office was quite correct in its approach not to consider giving opportunity of hearing for Valganciclovir pre-grant opposition filed by the Tamil Nadu Networking People with HIV/AIDS and the Indian Network for People living with HIV/AIDS (collectively hereinafter referred as ‘the NGOs’) which not only lacked substance to challenge the issuance of patent but also irrationally burdening the Indian Patent Office with legally absurd and unsupported objections. No doubt it takes no special efforts to make public statement quoting Valganciclovir a pre-1995 molecule not qualifying for patent protection but when it comes to patent law one do require pre-dated publications to corroborate the statement. This is what Valganciclovir pre-grant opposition seems to reflect that the NGOs just went on stating pre-1995 objection without any proper understanding and records to prove it. In their application for pre-grant opposition, the NGOs made objections on the following grounds namely:

(1) That the subject of any claim of the complete specification is not an invention within the meaning of this Act, or is not patentable under this Act under section 25(1)(f); and

(2) That the applicant has failed to disclose to the Controller of Patents the information required by section 8 or has furnished the information which in any material was false to his knowledge under section 25(1)(h).

The objections was raised relying on four supporting evidences submitted by the NGOs which include a copy of press release from Hoffman-La-Roche dated 2^nd April 2001, a copy of European Patent No. EP 0694547A2, a copy of online European Patent Register, and a copy of US Patent No. 6083953. What is notably important to note that none of the supporting evidences was published before the priority date (and even the filing date) of Valganciclovir Application 959/MAS/1995 which is sufficiently enough for someone of Assistant Controller rank in the Indian Patent Office to acknowledge the fact that none of the evidences even adequate to uphold the pre-1995 objection. Now before going further into objections raised by the NGOs let us discuss what exactly pre-1995 argument mean? After India amended its patent law to allow patent applications for drug compounds under mail-box provision, it was well considered that drug compounds known prior to 1995 are not eligible for patent protection. In other words, it is consider that any drug compound known or published prior to 1995 (in short pre-1995 public disclosure) is not to be granted patent in India (the argument reasonably acceptable in patent law that any invention publicly known or published in literature cannot be patented). Based on such theory, the NGOs objected Valganciclovir patent application, however, while submitting the pre-grant opposition the NGOs went a step ahead on pre-1995 argument to conclude that any compound even though not published or reported prior to 1995 but was invented before 1995 is a pre-1995 public disclosure and not eligible for patent protection in India. Quoting section 25(1)(f), the NGOs argued that the Valganciclovir patent application ought to be rejected as it claims priority from a pre-1995 convention country application (precisely referring to Valganciclovir priority document i.e. US Serial No. 08/281,893 dated July 28, 1994). Again it is a well-known fact that a patent application is not considered to be in public domain till it is published which is usually made on completion of 18 months from the date of filing of application. Now considering that Valganciclovir priority document was filed on July 28, 1994 then the possible earliest date for its publication would have been January 27, 1996 (reasonably beyond 1995). Further to prove their pre-1995 argument, the NGOs submitted documents which are published on much later date of filing of Valganciclovir Indian Application. Obviously after reviewing the NGOs pre-1995 argument (i.e. an invention not published but invented before 1995 is a pre-1995 public disclosure) and inappropriate documents submitted to corroborate the objection, the Assistant Controller would have been in no better position to dismiss the pre-grant opposition. But what is even more interesting that the NGOs were so damn confident about their arguments that they in fact approached the Chennai High Court to order the Chennai Patent Office to consider their frivolous objections.

Patent Office Rejects Valganciclovir PreGrant Opposition

The Chennai Patent Office has dismissed the pre-grant opposition [download] made by the Tamil Nadu Networking People with HIV/AIDS and the Indian Network for People living with HIV/AIDS (collectively hereinafter referred as the ‘the NGOs’) against the Application No. 959/MAS/1995 claiming antiviral drug compound Valganciclovir. The Chennai Patent Office was hearing the Valganciclovir pre-grant opposition after been directed by the Chennai High Court [download] to consider and hear the pre-grant opposition made by the NGOs who earlier filed a petition against the Chennai Patent Office decision for denying opportunity for hearing under the Section 25 (1) of the Patents Act, 1970 before the issuance of Patent No. 207232 for Valganciclovir. However, Roche later challenged the Chennai High Court order in the Supreme Court of India. The Supreme Court modified the order to add that “while deciding the above application (959/MAS/1995), the Assistant Controller shall take into account the pre-grant opposition filed in this case (which is on record) by respondent nos. 1 and 2 (NGOs) herein.” Also adding “The third respondent (Assistant Controller of Patent & Designs) need not consider any other pre-grant objection pursuant to this judgment.”