Lipitor generic predictions

As Nov 30 approaches and Pfizer prepares to lose exclusivity on Lipitor, analysts are offering a variety of theories
[Settelement bwt Ranbaxy and Pfizer]
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….Two of Ranbaxy’s India plants have been banned by the USFDA. While Ranbaxy is confident of a positive resolution with the USFDA, there’s no clarity yet if this resolution will include approval for generic Lipitor, analysts echo this worry.
An HSBC report said, “The key downside risk to our call is the forfeiture of Lipitor exclusivity and potential heavy fine payment to FDA
But looking at the larger picture, analysts feel Ranbaxy will gain from the lifting of the ban, since this will open doors for the launch of over 30 branded generic drugs from these plants.
As far as Lipitor is concerned, Ranbaxy will have a fight on its hands. It will face tough competition from authorised generic Watson and Pfizer, which is aggressively trying to save prescriptions by tying-up with many pharmacy benefit managers…..
[Money control]
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On the other hand, pfizer going to make lipitor available at generic drug price to ensure that patients taking Lipitor continue to receive the brand name drug for the next six months (till May 2012), even as lower-cost generic versions of Lipitor become available from December 1.
Pfizer partnered with several US pharmacies with health plans that pays around the same price for the branded product as for a generic version.
Pfizer strategy include discounts, direct to consumer sale, co-pay cards, rebates, conversion to OTC etc

[Link] [Link 1] [Link 2] [Link 3]

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Presumption of patent validity in granting interim injunction

[Order] [SpicyIP]

A granted patent can not be presumed to be valid. The presumption of patent validity is very less when defendant shows substantial doubts on violation of procedures in patent grant and credible challenge on patentibility and also when patent is granted recently.

In a recent verdict given by Delhi high court, Judge denied request to grant interim injunction filed by Patentee. In this case, Patent No: 240893 (1683/MUMNP/2008); Assignee: Tenxc Wireless Inc, Title: ASYMMETRICAL BEAMS FOR SPECTRUM. EFFICIENCY.

In this case, defendant established credible challenge to patent on various aspect such as 1) Patentability of invention was not examined under section 3(d) and 3(f)?; 2) Whether claimed invention is novel and inventive or not based on certain prior art?; and 3) Patent is not granted by USPTO and EPO on the grounds of lack of novelty and inventive step.

Court made certain observation on the record of the patent office 1) Patent office did not examine the patent application under Section 12 and 13 of the act (Sections 12 and 13 of the Act are mandatory); 2) Patent Office did not examine whether the invention falls under any of the categories of non-patentable inventions under Sections 3 and 4 of the Act; 3) No valid publication under Section 11A as there was an error in the first publication; 4) A Canadian patent equivalent was not disclosed as required under section 8; 5) The patent was granted by a non-speaking order (????); 6) Patent Office has granted the patent to the plaintiffs in undue haste without following the due process of law; 7) patent is a recent one; 8) The findings of the ISR and IPRP are not binding on the Indian Patent Office.

The important challenge seems to be hastened grant of patent by violating of procedural steps of conducting search and examination on patent grant.

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Bayer Vs Controller of patents

[SpicyIP] [Order]

Yesterday, a interesting news is posted in SpicyIP blog.  Bayer challenges ambiguity in statutory language of “prima facie case” of section 87(1). Controller has published Natco’s compulsory license as per section 87(1) as prima facie case made out (published on Aug 12th 2011). Patentee/Person interested can oppose within two months (can be extended U/S 87(2)) from the publication date [Rule 98(1)]. Note: We recall that in imatinib case Novartis has challenged the ambiguity in term “efficacy” of section 3(d).

PS: DIPP recently initiated discussion paper on compulsory license (CL) for deciding whether or not any guidelines required for granting CL and finally concluded that no additional guidelines are required.

Update: Bombay high court disposed of this writ petition by considering that patent infringement proceeding is pending before Delhi High court against the same respondent and asked the petitioner to file the petition before Delhi High court. Time to file opposition for CL is extended till 18-11-2011. (Order)

Update (on 22nd Nov): Bayer has petitioned before Delhi high court on 16th Nov 2011. Delhi high court ordered that the impugned order is mere prima facie view that a case under Section 84(1) of the Patents Act has been established and petitioner is still entitled to contest the said proceedings before the Controller of Patents in the opposition. This petition is dismissed/withdrwan [Order] [Blog post]. 

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Claim format Indian patent applications

In a recently uploaded decision in ipindia which is related to Humira dosing regimen patent, patent applicant successfully traverse 3(e) and 3(i) grounds of opposition. Patent application no 6618/DELNP/2006 and titled: “MULTIPLE-VARIABLE DOSE REGIMEN FOR TREATING TNF -RELATED DISORDERS“, Patent applicant is Abbott and opponent is Glenmark.

Inventive step of this application is related to multiple variable dosing method for treating TNFa disorders (pls refer PCT claims) and their Indian national phase application claims are amended to contain claim preamble of “pharmaceutical composition” with dosing restriction.

This 6618 application is opposed on various grounds including 3(e) and 3(i). As per controllers opinion, opposing under 3(i) is not applicable, since claims are related to pharmaceutical composition. Opposition under 3(e) is traversed by submitted expert evidence (Dr. Hoffman affidavit who is one of the inventor) and synergism between TNFa inhibitor and methotrexate.

Indian patent office grants such use/dosing regimen invention in a claim format of “pharmaceutical composition”. Another example is recently published patent grant of 249114 (1693/DEL/1998) assigned to smithkline beecham. This application is filed with claim preamble of “method of treating” and subsequent granted claims preamble is “Pharmaceutical composition for use in the treatment of“.

Important message here is invention related to use/dosing regimen/combination can be patented by pharmaceutical composition claim format such as pharmaceutical composition comprising X for the treatment of disorder Y with dosing/combination/ratio/some inventive step limitation.

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Ranbaxy-MMV-Antimalarial

Today Economic times reported that Ranbaxy received conditional approval for combination of its NCE molecule (Arterolane) and piperaquine phosphate.

Drug Controller General of India ( DCGI) Surinder Singh said the marketing licence was subject to the condition that the Chinese plant from where Ranbaxy imported key ingredients for the drug was inspected and approved. Though the final phase of its clinical trial used the same ingredients from China and has been cleared for both safety and efficacy, the government wants to play it safe. “Since it (the drug) will be widely used we want to check for our satisfaction,” Singh said.

[Businesswire]

Arterolane maleate is patent protected in India. Arterolane is licensed from Medicines for Malaria venture (MMV) and Ranbaxy will have worldwide rights for the registration and commercialisation of the product. Arterolane falls in the chemical class of Synthetic Peroxide Anti-Malarial Drug.

Arterolane seems to be protected by 245779 (1514/DEL/2004)  titled “Spiro and Dispiro 1, 2, 4-Trioxolane Antimalarials” granted recently on 02/02/2011. The ‘779 patent is presently assigned to Allergan.

PS: WIPO recently launched a database called WIPO Re:Search aims to provide access to intellectual property for developing products to treat Neglected tropical diseases (NTD).

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Google reader problem

Recently Google announced that some upcoming changes to Google reader. I have been using Google reader for my blog PATENTDAILY to instantly share important news and make prefect topic wise news display/aggregation.

Now Google removed my most used features like “Shared items” and linking to blog etc.

This new Google reader not going to help anymore,  now this is only useful for reading news channels. It take some to time find other sources to update news regularly.

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Breach of agreement-Onyx Vs Bayer-Sorafenib derivative

This is about breach of contract/collaborative agreement between onyx and bayer.

[Press release]

Recently Onyx and Bayer announced settlement agreement regarding the drug called “Regorafenib”(BAY73-4506). Regorafenib is structurally similar to sorafenib except a Fluoro substitution on sorafenib moiety.

Sorafenib

Regorafenib

 Image of Chemical Structure  Image of Chemical Structure

 Background:

According to onyx complaint filed on May 15 2009, in 1994 Onyx and bayer entered collaborative agreement to develop cancer drugs. Under this collaboration, Onyx and bayer would develop compound which inhibits Ras kinase. Onyx began  searching Ras pathway inhibitor from its own library of compounds in house and found a weak inhibitor N34213. This N34213 basic structure is the key information to develop thousand of compounds for further evaluation. Sorafenib is result of their research. Both companies have shared development cost to commercialize sorafenib. Onyx says sorafenib and its halogenated derivatives were also within the scope of their agreement and identified before termination date Jan 2000.

Onyx also alleges that bayer secretly developed fluoro substituted sorafenib without knowledge of onyx and also is broadly covered in sorafenib patent (7,351,834) itself (filed on 1999).  Full complaint is available here.

Finally on settlements agreement, Bayer agreed to pay onyx royalty on sale of regorafenib.

Bayer has separately filed and prosecuting a patent application on regorafenib as selection patent (US20050038080).

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New Patentscope interface

Wipo recently announced that New Patentscope interface will replace old patentscope. This new patentscope comes certainly with some additional features.

WIPO call it as “New customizable search interface

Some obvious improvements are:

Easily switch over interface between  Search interfaces and others like Weekly publication page, Translation assistance etc

National collections of many countries (Brazil, ARIPO etc) are available for search in one integrated search

Unlike Espacenet, Patentscope enable users to export of search results up to 100 in *.csv format

Search results are displayed with options of further refinement (like display only PCT applications, Display results only from particular IPC class, Display documents only from particular assignee/inventor)

Word stemming (“riding”, “rides”, “horses” ==> “ride”, “ride”, “hors”), Fuzz search ~ (finds similar words like roam foam)

Additional options in Simple search like “Number/ID” (earlier only PCT numbers), supports various date formats (2001, 200107, 20010701, 01.07.2001)

Enabling search with proximity search (searching two words within particular word count) – (to explore more)

“Structured search” has become “Field combination search” with additional options in drop down menu (like office code, All numbers/ID, IPC N Inventive etc)

Free account enable users to save their search strategies (not sure for how many days/How many in numbers).

To explore use of “Cross lingual expansion” and “Translation assistance”

We will hope that India’s national collections will also be available in Patentscope soon.

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Fosamprenavir – opposition – india

Indian patent journal of this week (Sep 16th, 2011) has a post grant opposition filed under section 25(2).

Lupin has filed post grant opposition to 240930 (2210/Cal/1998) under section 25(2)  on June 08, 2011. The ‘930 patent seems to cover Fosamprenavir, is assigned to Vertex Pharma and titled “Prodrugs of aspartyl protease inhibitors“. The ‘930 patent is equivalent to US patent 6,436,989 and expires on Dec 2018 in india. The same patent is opposed by Ranbaxy too. Ranbaxy filed opposition on Sep 2010. Notice of opposition (Form 7) filed by Ranbaxy is available on iPAIRS site.

Fosamprenavir is phosphoric acid derivative of amprenavir (prodrug), approved in USA.

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Azilsartan medoxomil – opposition – India

Indian patent journal (of September 9th 2011) has some new post grant oppositions filed under section 25(2) of Patent Act 1970. The controller may generally publish such post oppositions filed under section 25(2)in official journal.

Ranbaxy, Lupin and MSN have filed post grant opposition under section 25(2) for a patent covering medoxomil salt of Azilsaratan. The patent No. 242537 which is granted from 2785/KOLNP/2006, and titled “Benzimidazole derivative and a process for the preparation thereof“, claims medoxomil salt of Azilsaratan. This ‘537 patent is equivalent to OB listed patent of US 7157584 and expires on Feb 2025 in India. In USA, Azilsaratan is newly approved Angiotensin receptor II antagonist which is marketed by Takeda.

Along with the above mentioned one, two more post grant opposition information are published.

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