[Ip-health] My blog on the WIPO / IFPMA medicines patent database

James Love james.love at keionline.org
Fri Sep 28 12:27:48 PDT 2018


This was how the sanction was proposed in 2006-2007.

"As flawed as the Orange Book system is, however, it could easily be
modified to work better. In particular, a listing of patents could be
required or encouraged in various ways. For example, drug registration
authorities could require or encourage the disclosure, without linking the
disclosure to drug registration, by providing that patent owners could not
enforce undisclosed patents against generic competitors. Although this
approach would likely still result in the listing of patents of dubious
quality or relevance, the drug registration authorities would not use the
listing to block generic competitors."

------------
Measures to Enhance Access to Medical Technologies, and New Methods of
Stimulating Medical R & D* UC Davis Law review, Vol. 40, No. 3, March 2007

Parts of this paper are an elaboration of James Love, Four Practical
Measures to Enhance Access to Medical Technologies, in NEGOTIATING HEALTH
(Pedro Roffe et al. eds., 2006).

https://lawreview.law.ucdavis.edu/issues/40/3/developing-drugs-for-developing-word/DavisVol40No3_Love.pdf

1. Transparency of Relevant Patents

In many countries, there is considerable uncertainty regarding the
existence of patents on particular medicines. In some countries, patent
searches are both costly and time consuming, particularly in cases where
the records of the national or regional patent office are poorly organized
or difficult to reach or search. There are many different ways that
governments and regional or global organizations could facilitate more
transparency of the status of patents on medicines.

The United States, for instance, maintains an Orange Book that lists
patents that companies identify as relevant to medicines sold in the U.S.
market. The disclosures in the Orange Book are voluntary. The incentive to
disclose is related to the patent enforcement mechanism linked to the
Orange Book. The U.S. Food and Drug Administration (“FDA”) will not
register a generic competitor so long as there are patents listed in the
Orange Book.

While the Orange Book improves transparency of patent filings, it is
routinely misused. Companies often list patents of dubious merit and
relevance. As a consequence, the improper listing of patents is often the
subject of litigation and antitrust enforcement actions. The FDA is
needlessly embroiled in disputes over the listing of Orange Book patents
because of the link to drug registration. Unfortunately, the U.S.
government is promoting this flawed system in regional and bilateral free
trade agreements (“FTA”).

As flawed as the Orange Book system is, however, it could easily be
modified to work better. In particular, a listing of patents could be
required or encouraged in various ways. For example, drug registration
authorities could require or encourage the disclosure, without linking the
disclosure to drug registration, by providing that patent owners could not
enforce undisclosed patents against generic competitors. Although this
approach would likely still result in the listing of patents of dubious
quality or relevance, the drug registration authorities would not use the
listing to block generic competitors. The patent owners would have to seek
enforcements in national court systems, as is the case now in most
countries, and everywhere for nonpharmaceutical inventions.


Regional or multilateral bodies concerned with health care, such as the
African Union, the Pan American Health Organization, the World Bank, the
Joint United Nations Program on HIV/AIDS, the Global Fund, regional patent
pools, or the World Health Organization (“WHO”) could also play an
important role in requiring or encouraging patent listings. For example,
donors for AIDS treatments could meet with the handful of companies that
develop key AIDS drugs and insist that they disclose the relevant patent
numbers and countries where the patents are approved. This information
could then be published on the Internet.

The task of disclosure could also be managed by local, regional, or
multilateral patent offices, including the Patent Cooperation Treaty
(“PCT”), which is administered by the World Intellectual Property
Organization (“WIPO”). While patent offices have not played a traditional
role in such disclosures, it is increasingly difficult to ignore the
enormous problems presented by the lack of transparency of patent status.

One advantage of a global system would be the availability of information
about the differences in the patent landscape for the same drug sold in
different countries. Countries that face a high number of patents may seek
to understand why such patents are not listed for other jurisdictions. The
global authority could also do a more efficient job of “delisting” patents
that are not relevant.


On Fri, Sep 28, 2018 at 2:31 AM Ellen 't Hoen <
ellenthoen at medicineslawandpolicy.net> wrote:

> Yes I raised the issue of the biologics in my blog.
>
> I also think we need a discussion about the consequences for compagnies
> that refuse to disclose patent status information. One principle could be
>  ‘disclose or forfeit your right to enforce’.
>
> The issue of INN’s missing from patents is certainly something WIPO can
> fix. I remember a very good presentation at the last WIPO SCP on this topic.
>
> ————————————————————
> *Medicines Law & Policy*
> www.medicineslawandpolicy.org
> E-mail: ellenthoen at medicineslawandpolicy.net
> Twitter: @ellenthoen
>
>
> On 27 Sep 2018, at 18:59, James Love <james.love at keionline.org> wrote:
>
> German's points are well taken, noting also that biologic drugs are
> largely outside of the PAT-INFORMED remit for now.
>
>  One benefit of the WIPO/IFPMA project is that demonstrates the
> disclosures are  a reasonable ask from companies, and might be something
> that the PCT and governments  could address by requiring the INN
> disclosures.
>
> On Thu, Sep 27, 2018 at 12:42 PM German Velasquez <
> gvelasquez.gva at gmail.com> wrote:
>
>> It is probably a good step as Ellen says, the only thing that worries me
>> is
>> to leave "transparency" on a voluntary basis ... what would happen
>> tomorrow
>> if paying taxes were voluntary ...
>>
>> g.velasquez
>>
>>
>> 2018-09-27 14:09 GMT+02:00 Ellen 't Hoen <ellenthoen@
>> medicineslawandpolicy.net>:
>>
>> > Dear IP-Health readers,
>> >
>> > Here is my blog on the new WIPO / IFPMA medicines patent database.
>> >
>> > https://medicineslawandpolicy.org/2018/09/wipo-and-pharma-in
>> > dustry-launch-global-medicines-patent-database/
>> >
>> > Kind regards,
>> >
>> > Ellen ‘ t Hoen
>> > ______________________________________
>> >
>> > Ellen 't Hoen LLM PhD
>> >
>> > Medicines Law & Policy
>> >
>> > www.medicineslawandpolicy.org
>> >
>> > e-mail: ellenthoen at medicineslawandpolicy.net <mailto:
>> > ellenthoen at medicineslawandpolicy.net>
>> > twitter:@ellenthoen
>> >
>> > My book: goo.gl/wcvAgh <https://goo.gl/wcvAgh>
>> >
>> >
>> >
>> > _______________________________________________
>> > Ip-health mailing list
>> > Ip-health at lists.keionline.org
>> >
>> http://lists.keionline.org/mailman/listinfo/ip-health_lists.keionline.org
>> >
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>
>
> --
> James Love.  Knowledge Ecology International
> http://www.keionline.org <http://www.keionline.org/donate.html>
> twitter.com/jamie_love
>
>

-- 
James Love.  Knowledge Ecology International
http://www.keionline.org <http://www.keionline.org/donate.html>
twitter.com/jamie_love


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