Astra: the bad news continues [more]

I had earlier blogged on Astra's Indian patent problems, here.
Pharmabiz now reports on another Astra patent application rejection [article written by dear friend, Ashwini Sandu along with Raju Kumar].

This time its omeprazole formulation application.
Straight from Pharmabiz:

"... in Torrent Pharmaceuticals Limited v. Astra Aktiebolag (1354/DEL/98 dated May 21, 1998), at issue was the claimed formulation which was similar to the formulation taught by the prior art except that the claimed invention recited a selective quality of HPMC as the preferred binding agent and/or separating layer whereas the prior art taught HPMC generally.
Therefore, the question before the controller was whether the use of specific quality of HPMC used in the claimed formulation made it patentable over the prior art.
The Controller found that there was apparently no difference between the claimed formulation and the formulation taught by the prior art apart from the alleged selection of HPMC quality, which led to an improvement in the consistency of production of coated tablets having more than 75% release rate.

Hence, the claimed invention was deemed novel and not obvious in view of the asserted advantages.
However, the Controller took cognizance of the fact that the claimed invention did not show any improvement in therapeutic efficacy compared with the prior art. Accordingly, it was found that the benefit claimed by the invention in dispute was not accruable to the user in terms of the therapeutic quality of the product but only to the manufacturer in terms of the consistency in production. Accordingly, the claimed invention was found to fail the requirements of Section 3(d) of the Patents Act…”

The present application [1354/DEL/98] relates to Omeprazole/ Esomeprazole formulations containing specific type of HPMC. This is the same as US6090827. This is a NON Orange book patent for Esomeprazole/ Omeprazole.

So, the total tally of Astra rejections now looks like this:
a) 1354/DEL/98 Relating to Omeprazole/ Esomeprazole formulations --> Rejected;
b) 1344/DEL/1998 : Esomeprazole tri-hydrate [Nexium] product patent application --> Rejected;
c) 841/DEL/1996 : Gifitinib/ Gefitinib [Iressa] product patent application --> Rejected.

Insulin - Wockhardt's opposition to Lilly's human insulin

Pharmabiz has an interesting article on Patent Oppositions, [article written by dear friend, Ashwini Sandu along with Raju Kumar].

While most of the cases referred are known to our readers via this blog/ other news sources, I found an interesting discussion on a Lilly application, which was hitherto not covered here as well as in news/ print media.

Straight from Pharmabiz:
"...Thus, in Eli Lilly and Company v. Wockhardt Ltd., [675/Cal/1995] dated June 14, 1995 the Controller held that a correct application of the problem solution approach rules out an inadvertent application of an impermissible ex post facto analysis and this has been one of the guiding principles of the Patent Offices in the assessment of inventive step.

The problem solution approach comprises:
(i) determining the closest prior art;
(ii) establishing the objective technical problem to be solved; and
(iii) considering, whether or not the claimed invention, starting from the closest prior art and the objective technical problem, would have been obvious to a person skilled in the art.

The Controller held it clearly inherent within these stages for problem-solution determination to assess the inventive step involved examining the inventive step to looking forward from the prior art rather than looking backward from the claimed invention. It is this approach to the assessment of inventive step that brings out the technical contribution made by the claimed invention to the advancement of the state of the art.

The Controller further held that the problem formulated in the assessment of inventive step may contain no pointers to the claimed invention, which would otherwise lead to an application of the impermissible hindsight analysis of the inventive step...."

I read the application number but since I did not know as to what product was covered, I did some searching and believe that the underlying application is Lilly's Human Insulin [675/Cal/1995]. Sadly, the article does not give the outcome of the Opposition [i.e. Controller’s final decision].

Other details:
1)
Lilly filed the patent application [675/Cal/1995] for Insulin analog formulations. The application/ invention related to parenteral rapidly on setting formulations comprising human insulin analogs in a hexamer conformation, zinc ions, and at least three molecules of a phenolic derivative selected from the group consisting of m-cresol, phenol, or a mixture of m—cresol and phenol.
This application was filed from a US application: 08/260,634 having a priority of 16/June/1994. The US application later matured into US5474978 [the Orange book listed patent for Human insulin – parenteral; branded as Humalog(R)].

2)
This application was [possibly] not filed as a single EP application. There are individual country patents for this invention [e.g. GB2291427B/ FR2741078B etc.

There could have been following outcomes to the Indian opposition:
a) Lilly lost the application altogether/ or was required to amend claims, in either of which cases it may have gone for an appeal [if it wanted to];
b) Wockhardt may have lost the pre-grant opposition, in which case, the application now proceeds to grant and the battle then continues in the form a post grant opposition.
c) Alternatively, it could have been that Lilly conceded some claim ground and amended its claims in such a manner that Wockhardt is NOT affected by the amended claims and hence we may not see any thing more on this case :-)

PLEASE note that since the Opposition decision is NOT available with me, hence I am only guessing the above outcomes.

Interestingly, Lilly also following patent Indian applications on Human Insulin related subject matter:
677/CAL/1995;
566/CAL/1996 &
802/KOLNP/2004.

With [at least] the above three applications, I have a feeling that the present [675] decision is not the last that we have heard of Wockhardt/ Lilly and Insulin :-)

PEG Interferon: Post grant opposition

Roche was amongst the first recepients of product patents in the pharma space. It received product patent [IN198952] in India in 2006 for its product - Pegasys [pegylated interferon alpha 2a].

While the Pegasys product patent is under post grant opposition by Wockhardt; an NGO Sankalp too filed a post grant opposition in May 2007 against this product.
Copy of Sankalp's Opposition.

India - IPAB: the saga continues... Natco appeals :-)

Today's Times of India [Hyderabad edition] carried a news article on Natco. [link not available as yet]. It states that Natco has appealed to the Supreme Court against the Chennai High Court decision to allow IPAB to decide on Novartis/ Natco litigation for Imatinib patent application.

Since the High Court had allowed for a hearing without the technical member, the best recourse for Natco was to go the Supreme Court and it has now done so. I had earlier posted here that I find it surprising as to how can a Board decide on a technical matter without a technical member present. To me a plain reading of S.116 requires a technical member to be a part of the Appeal Board, if the appeal has been instituted under the Patent Act.

Some readers of the blog went on to argue that Chennai High Court was right under the Trade marks Act, where an Appeal Board could function without a technical member.

My reading of S.117B does NOT show that the Appeal Board [as needed under S.116 of Patent Act] is over ruled/ can be replaced by a TM Appeal Board. Hence a Board constituted under the TM Act may very well be legally correct for a TM Appeal, it does not make the present situation right.

Personally, since I come from the industry, I have an issue with the 2 member non-technical board. If we allow this now, then we are condoning a lapse in law. S.116 is NOT subjective. Either we stick to it or we start a process of erosion…

India: Cialis : Tadalafil patent application rejection

Earlier history:
Lilly had recd. an EMR for its application [85/DEL/1995] on the drug Cialis [Tadalafil].
Ajanta had filed a petition against this EMR at the Calcutta High Court.
The Court had at that time stayed the EMR. Following the Court order, a letter was sent to the Drug Controller General of India (DCGI) by the Patent Controller's office, communicating that the EMR granted to Eli Lilly was stayed.

Subsequently, in 2006, a hearing was held at the Patent Office on the merits of the under lying patent application. A decision was issued in March 2007 rejecting Lilly's application. However, Lilly has secured a process patent in India on Cialis, which means it can produce the same drug but through a different process.

UPDATE [15/DEC/2007]:
Ajanta has appealed to the Intellectual Property Appellate Board (IPAB) against the grant of the process patent to Lilly. Meanwhile, Lilly has moved a revision petition against the rejection of its patent application.
News item from Business Standard.

Atazanavir - India

I had blogged on Atazanavir's Indian story here.
I have now been given more information by Leena Menghaney from MSF.

Atazanavir: India patent status
Three applications/ Patents:

1. Antivirally active heterocyclic azahexane derivatives
US Patent: 5849911, Issue date: 1998-12-15
Application: 08/831,630, Filing date: 1997-04-09
Indian application No. 805/MAS/97
Novartis Finance Corporation
Impact: on generic production of atazanavir, could have been granted in India despite section 3(d)

Current patent status in India: Was opposed by Indian PLHA groups.
Copy of opposition brief from Lawyer’s Collective.
Indian Patent office has now informed that the patent application was deemed abandoned in India.
Copy of the letter from Patent Office.

2. Bisulfate salt of HIV protease inhibitor
US Patent: 6087383, Issue date: 2000-07-11
Application: 09/217,538, Filing date: 1998-12-21
Bristol-Myers Squibb Company
Corresponding Indian Patent application not found as yet

3. Title: Process for preparing Atazanavir Bisulphate and Novel Forms
Indian application No. 6425/DELNP/2006 A
Application by BMS in India in 2006
Priority Data: PCT/US2005/015333
U.S. Priority Data

60/568,043	United States	2004-05-04
60/607,533	United States	2004-09-07
11/119,558	United States	2005-05-02

Patent status: not granted yet, but no opposition filed

Abacavir Hemisulfate - Indian pre grant opposition documents

Glaxo filed a patent application [872/CAL/98] for Abacavir Hemisulfate Salt [corresponding to Orange Book listed US6294540] with the Kolkata Office. This application was opposed by the Indian Network for People living with HIV/ AIDS [INP+].

Post the filing of Opposition, Glaxo has withdrawn the mentioned application. The Kolkata Patent Office vide a letter dated 01/Oct/2007 has confirmed that the application has been withdrawn by Glaxo.

Opposition brief from INP+;
Kolkata Patent Office letter declaring withdrawal of application by Glaxo.

Glaxo's earlier withdrawals from Indian Patent office, here [Combivir and Trizivir].

AstraZeneca's Iressa patent application rejected in India

AstraZeneca's filed its patent application at the Indian Patent Office for its drug Iressa [Gifitinib/ Gefitinib] in 1996 and the same was under going pre-grant opposition proceedings by generic companies - Natco Pharma Ltd and J M Pharmaceuticals Ltd.

The Patent Office has now issued a rejection for the patent application, based on the submission of the generic companies that the drug has been in the public domain before the company filed its patent in India.

News report from Mint, here.

A little sleuthing shows* the following:
The Orange Book shows that Iressa has 3 listed patents.
I believe that the Indian application could* be the one corresponding to the 3rd OB patent [US 5770599]. That being the case, I think* that the Indian application [currently rejected] is 841/DEL/1996.
The rejection of this product patent is not the end. My research suggests that there are at least two more process patent applications:
1419/DEL/2003 &
1420/DEL/2003
that cover processes to make Gifitinib/ Gefitinib.

* = Please note that the above are at best, guesses, since neither side[s] nor the Indian patent office has as yet declared the application number that was rejected.
I will be obliged if any of you readers can send me details/ copy of the decision or any additional information.

The Chennai High Court gives an 'interesting' decision

The Economic Times reports:

The Madras High Court has cleared a government proposal to exclude a technical member of the Intellectual Property Appellate Board (IPAB) from hearing Swiss drug giant Novartis’ appeal against the rejection of patent for its anti-cancer drug Glivec. Chief justice AP Shah and justice V Ramasubramanian okayed leaving out S Chandrasekaran, former controller general of patents, from the panel and letting IPAB’s chairman and vice-chairman hear the appeal.
...
Novartis, which in August had filed a petition insisting that Mr Chandrasekaran should not hear its appeal as he had refused the Glivec patent in the first place, welcomed the development. The proposal was approved by all interested parties except Natco Pharma.

To me this is an 'interesting' decision simply because the Appeal Board will now give a technical decision without a technical member deciding the same...

I am just speechless and also the fact that I do not want to PUKE right now...

Readers who want to have a thourough back ground into this matter would do well to visit the Economic Times link above and more importantly visit this article by friend, Shamnad.

Chennai High Court order for Gleevec

Friends,

Here is the Chennai High Court order rejecting Novartis' challenge to S.3d of the Indian patent act as well as stating that section 3(d) is not unconstitutional. It also ruled that it is not competent to adjudicate upon whether or not section 3(d) is TRIPS compliant.

Shamnad Basheer had written interesting analysis on this decision here and here and hence I am not analysing the order further.

Chennai Patent Office for Gleevec

The Novartis/ Imatinib/ Gleevec pre-grant opposition saga started at the Chennai patent office.

Natco had filed a pre-grant opposition for this patent application.
The Examiner had issued an order against Novartis.

Here is a copy of that order.

Salient points:
Application in question: 1602/MAS/1998
This application claims: a beta crystal form of methanesulphonic acid salt of 4-(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-[4-pyridin-3-yl]pyrimidin-2-ylamino]phenyl]-benzamide commercially called as imatinib mesylate.
The base salt – Imatinib was known / disclosed earlier in EP-A-056409, published on October 6, 1993, and its equivalent US5521184.

Main grounds:
a) Anticipation:
The Controller held that the earlier base compound covered the salt form and that the salt form normally exists in the beta crystalline form which is the most thermodynamically stable product.

b) Obviousness:
On the basis of the reports of the Indian Institute of Technology, and Indian Institute of Chemical Technology, the Controller held that the salt prepared using instructions of the 1993 Patent inherently exists in beta crystalline form. Hence the product claims were held to be obvious over the aforesaid technical reports.

c) S. 3(d):
The Controller held that the present claimed product was a only a new form of a known substance without having any significant improvement in efficacy, hence not patentable under section 3(d) of the Patents Act, 1970.

d) Claiming priority from Swiss document:
Switzerland became a Convention Country in September, 1998. Hence no priority can be claimed from a Swiss application prior to this date.

In view of the above, the application was rejected and the Opposition was upheld.

First post

Friends,

This blog is for all Indian patent system users who want to keep a track of Patent office/ Court decisions regarding patents.

This is a collaborative venture between me [Sandeep K. Rathod] and my dear Advocate friend Feroz [Feroz Ali].

I have a separate blog focusing on the generic pharmaceutical business with a focus on IP issues and Feroz has his blog that focuses on the legal aspects of pharmaceutical and biotechnology patents in India.

Why this blog?
This blog is a forum to share, contribute and disseminate information relating to any contentious patent decision rendered by any judicial or quasi judicial body in India. Though we have named this blog as 'indianpatentoppositions' for reasons of easy web search and familiarity, we do not intend to confine the reporting of decisions of patent oppositions alone.

We both will try and host as many patent decisions from the Patent office as well as the Courts, as we can lay our hands on, but both of us would appreciate if you readers would share the patent office decisions that you have.

You are free to contribute or bring to our attention any contentious decision relating to patents. As the fundamentals of patent law are the same for all inventions, including pharmaceutical inventions, we would be glad to know about any decision on patent law and would be happy to post the same (if a scanned copy is send to us) and review the decision (if the details of its reporting, say in PTC or IPLR or other journal is brought to our notice). You may also bring to our attention any decision reported in any journal by sharing with us its citation. We shall review the decision on this blog.

Why should you contribute?
As you would be aware, the Indian Patent Office, unlike certain other patent offices does not host the opposition decisions rendered by it. Being in a legal system which works on a system of following precedents, the reporting of patent decisions will go a long way in the development of the Indian patent law, regardless the binding effect of these decisions. We know very well that the Patent Controller is not bound by his own decisions. But a like decision following established principles of patent law will be hard to ignore, when brought to notice, and will compel the deciding authority to give reasons, if it is to differ with its own earlier decision. All this would certainly be beneficial for any one who is interested in the Indian patent system in general and in pharmaceutical patents in particular.

We understand that knowledge of a patent decision can sometimes come in different circumstances. If you (or your company) have been successful in any contentious proceeding relating to patents, we will be glad to inform the world on your behalf by posting the decision on this blog. If you (or your company) are not entirely satisfied with a decision, this forum will be a fit place to disclose to the world and bring public attention to the relevant decision. Our work model is solely based on quid pro quo.

What can be contributed?
Being public documents, irrespective of the fact whether they are reported or not, we would be delighted to post any contentious patent decision on this blog. We would appreciate if you could send scanned copies or re-typed copies of the decisions with you. Should you only have hard copies, you may send legible photocopies of the same by post to us. We shall do our best to post them on this blog.

Please note: Patent Office decisions are public domain documents and their sharing would not be a problem from your employers' legal dept. as well.

Please let us know if you would like us to disclose your identity. We will be glad to acknowledge each one of you (and the organisation you represent). If you choose anonymity, we will respect that too. The only thing that drives us is our strong conviction that these decisions are public documents and everyone has a right to know.

Sincerely,
Sandeep and Feroz