[Ip-health] Patents on Ritonavir, the August 16, 2011 WIPO Study

Jamie Love james.love at keionline.org
Fri Oct 21 18:22:19 PDT 2011


Thank you Lutz Mailander for the clarification.

As you know, there are national laws or rules in existing or proposed trade
agreements for drug regulatory authorities to:

provide a transparent and effective system to
(1) identify a patent or patents covering an approved pharmaceutical product
or its approved method of use;
(2) provide notice to a patent holder of the identity of another person who
intends to market a product that is the same as, or similar,
(3)  ensure that a patent holder may seek, prior to granting of marketing
approval to an allegedly infringing product, available remedies, such as
delays in registration and injunctions.

Given that there are 805 patent families for ritonavir, how easy will it be
for a developing countries, or indeed any country, to manage such an
obligation?

  Jamie

On Fri, Oct 21, 2011 at 3:06 AM, Mailander, Lutz <Lutz.Mailander at wipo.int>wrote:

> Thank you for the attention given to our report on Ritonavir.
>
> I may add to the below statement on the 805 "patents":
>
> It is 805 patent families. The excel table that comes with the report
> includes also all INPADOC family members, ie the extensions to various
> jurisdictions. Some families comprise many such extensions. There is also a
> link to Espacenet where you can easily look up the up-to-date INAPADOC
> family information.
>
> We selected all such families that somehow claim inventive subject matter
> related to Ritonavir, ie the substance is an essential component of the
> subject matter defined by the claims. Patents just mentioning it as an
> example among other options or just mentioning it in the description were
> not included.
>
> We would like to invite comments on the correctness of the list of
> researched patents or other observations.
>
> I would also like to draw your attention to the very detailed explanation
> of the search methodology.
>
> Following a request from DNDI, we have commissioned an add-on for
> identifying among the 805 all the prodrug related patents. It may be ready
> in about 6 weeks.
>
> We will shortly publish a second report on Atanazavir.
>
>
> Bes regards
>
> Lutz Mailänder
>
> Head Patent Information Section
> Global IP Infrastructure Sector
> WIPO - World Intellectual Property Organization
>
> 34, chemin des Colombettes
> 1211 Geneva 20 - Switzerland
> +41 22 338 9849
>
>
>
>
> -----Original Message-----
> From: ip-health-bounces at lists.keionline.org [mailto:
> ip-health-bounces at lists.keionline.org] On Behalf Of Jamie Love
> Sent: jeudi, 20. octobre 2011 14:18
> To: Ip-health
> Subject: [Ip-health] Patents on Ritonavir, the August 16, 2011 WIPO Study
>
> A few days ago, I posted a link to a KEI blog about "USPTO issued patents
> mentioning ritonavir in the patent claim."
> http://www.keionline.org/node/1297.   I have since expanded the KEI blog
> entry, for example, by identifying 42 patents connected to the NIH contract
> that led to the development of ritonavir, and the 11 additional patents
> with
> Bayh-Dole Act rights associated with them.
>
> In my blog I simply looked at the 236 patents that either cited ritonivir
> in
> the patent clams (194) or that mentioned the NIH contract (42).  Esteban
> Burrone subcalled my attention to the August 16, 2011 WIPO study on the
> patent landscape by Landon IP, which is available here:
>
> http://www.wipo.int/patentscope/en/programs/patent_landscapes/reports/ritonavir.html
> .
>  According to the WIPO/Landon study:
>
> "There have been over 800 patents filed since the initial PCT application
> WO1994014436 to protect different aspects of Ritonavir and its methods of
> use. A large number of documents filed subsequent to the initial
> application
> still protect the structure of Ritonavir as described in the initial
> application. As one would suspect, subsequent patent filings continue to
> narrow the focus of protection of Ritonavir by incorporating novel aspects
> to the subject of Ritonavir. The implications of patent protection are
> important for developing countries to consider. Simply licensing the
> initial
> key documents will not provide adequate freedom to operate because of the
> breadth of coverage by subsequent patents."
>
> There are all sorts of policy and health ramifications associated with the
> proliferation of patents on ritionavir, including of course, a deeper
> appreciation for why it is important that countries reject efforts in trade
> agreements to shrink national flexibility on standards for granting
> patents.
>  Many of these patents do not meet the higher standards for granting
> pharmaceutical patents in India, for example, but do qualify in many other
> countries, both developed and developing.  This is a topic that will be
> discussed in the TPPA negotiations this month in Peru, where President
> Obama
> and USTR will push their proposal to mandate granting more patents,
> including by imposing this new obligation on TPPA member countries such as
> Vietnam, Peru, Thailand, Malaysia, and Chile:
>
> "In addition, the Parties confirm that: patents shall be available for any
> new forms, uses, or methods of using a known product; and a new form, use,
> or method of using a known product may satisfy the criteria for
> patentability, even if such invention does not result in the enhancement of
> the known efficacy of that product."
>
> The WIPO study also sheds some light on the potential benefits of the
> Medicines Patent Pool licenses for patents on cobicistat, a new Gilead drug
> that is expected to offer similar benefits to ritonavir.
>
> These are the 805 patents that WIPO says "protect different aspects of
> Ritonavir and its methods of use."
>
> Number, Publication Year, Assignee, Title
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> WO1995006061, 1995, MONSANTO CO | SEARLE & CO, RETROVIRAL PROTEASE
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> WO1995007696, 1995, ABBOTT LAB, PHARMACEUTICAL COMPOSITION OF HIV-PROTEASE
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> WO1995009614, 1995, ABBOTT LAB, PHARMACEUTICAL COMPOSITION
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> EP0728481, 1996, BAYER AG, Use of quinoxaline and protease inhibitors in a
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> WO1996039398, 1996, ABBOTT LAB, PROCESS FOR THE PREPARATION OF AN HIV
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> WO1997001349, 1997, ABBOTT LAB, USE OF RITONAVIR (ABT-538) FOR IMPROVING
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> WO1997021685, 1997, ABBOTT LAB, RETROVIRAL PROTEASE INHIBITING COMPOUNDS
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> WO1997037657, 1997, SHIONOGI & CO., LTD, ANTI-HIV COMPOSITION CONTAINING
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> WO1997046222, 1997, MERCK & CO INC, PEDIATRIC FORMULATION FOR HIV PROTEASE
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> WO1998000393, 1998, ABBOTT LAB, PROCESS FOR THE PREPARATION OF AN ACTIVATED
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> WO1998000410, 1998, ABBOTT LAB, PROCESS FOR THE PREPARATION OF A
> DISUBSTITUTED THIAZOLE
> WO1998003476, 1998, NOVARTIS AG, ANILINOPEPTIDE DERIVATIVES
> WO1998004290, 1998, BOSTON UNIVERSITY TRUSTEES, COMPOSITIONS COMPRISING AN
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> US5905068, 1999, ABBOTT LAB, Retroviral protease inhibiting compounds
> WO1998014436, 1998, BRISTOL MYERS SQUIBB PHARMA CO,
> 4,4-DISUBSTITUTED-1,4-DIHYDRO-2H-3,1-BENZOXAZIN-2-ONES USEFUL AS HIV
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> SAME
> US5874430, 1999, BRISTOL MYERS SQUIBB PHARMA CO,
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> WO1998017282, 1998, VERTEX PHARMA, METHODS OF USING SUCROSE OCTASULFATE TO
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> WO1998020009, 1998, BRISTOL MYERS SQUIBB PHARMA CO,
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> WO1998020888, 1998, JAPAN ENERGY CORPORATION, AIDS REMEDY
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> WO1998022106, 1998, ABBOTT LAB, PHARMACEUTICAL COMPOSITION
> WO1998028330, 1998, AVENTIS PHARMA S.A, NOVEL CYCLOSPORIN DERIVATIVES,
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> WO1998033067, 1998, UNIVERSITY OF MARYLAND BIOTECHNOLOGY INSTITUTE,
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> WO1998047492, 1998, VERTEX PHARMA, NANOSIZED ASPARTYL PROTEASE INHIBITORS
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> WO1998052571, 1998, GSK LLC, ANTIVIRAL COMBINATIONS CONTAINING THE
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> BIOAVAILABILITY
> OF STABLE CRYSTAL POLYMORPHS OF A COMPOUND
> WO1999009005, 1999, CYTOKINE PHARMASCIENCES INC, HIV MATRIX PROTEIN
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> WO1999008676, 1999, WARNER LAMBERT CO | HE KAN | HOLLENBERG PAUL | WOOLF
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> WO1999011635, 1999, BRISTOL MYERS SQUIBB PHARMA CO,
> 5,5-DISUBSTITUTED-1,5-DIHYDRO-4,1-BENZOXAZEPIN-2(3H)-ONES USEFUL AS HIV
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> WO1999012569, 1999, ALCAFLEU MANAGEMENT GMBH & CO, METHODS FOR INCREASING
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> WO2002095005, 2002, GENETIC IMMUNITY, LLC, THERAPEUTIC DNA VACCINATION
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> WO1999025352, 1999, MERCK & CO INC, COMBINATION THERAPY FOR THE TREATMENT
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> US6040434, 2000, INABA TADANOBU | FAYZ SHIRIN | STEWART DAVID JOHN,
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>
> --
> James Love.  Knowledge Ecology International
> http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
> Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.  Sometimes I am
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-- 
James Love.  Knowledge Ecology International
http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.  Sometimes I am using
my MaxRoam number: +447937390810
twitter.com/jamie_love



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