[Ip-health] Stiglitiz et al piece on Obama pressuring India

Tahir Amin tahir at i-mak.org
Wed Feb 11 11:42:52 PST 2015


Mickey,

There is always going to be human error in the examination of patents, so
such methods of treatment and any new use type patent claims will get
through. Note the latter is caught by section 3d.

That said, from the sample of patents I have seen, and it's a fair amount
for pharmaceuticals, the law and examination practice to date shows
applicants are dropping these types of claims early on now.  Initially at
the beginning, around 2005-8, when the law was still new and playing out
such claims were left in to chance by applicants. So one can see such
provisions in the law and the examination practice carrying the out the law
being a deterrent from the outset and actually saving examiners the time so
they can focus on other aspects. This is an important point when we talk
about countries using flexibilities, as what is equally important is how
such flexibilities are used in practice i.e. examination.

There's not enough work going on in this area as compared to how
legislation should be drafted/worded.  At least in terms of who is guiding
these examiners/patent offices. Unfortunately, the WIPOs and trilateral
patent offices of the US/EPO and Japan dominate here in standard setting or
not educating local examiners about how their laws may differ to universal
standards. There needs to be greater politicisation of patent office
examiners in developing countries, not just fancy language in laws that
include some of the TRIPS flexibilities.

Cheers

Tahir

On 11 February 2015 at 10:34, Michael H Davis <m.davis at csuohio.edu> wrote:

>  Tahir thanks for that clarification. I am still under the impression
> that India will occasionally patent a known product if it has a new
> pharmaceutical use, as in the EU. Right or wrong?
>
>  Mickey
> ______________________________________
> Prof. Mickey Davis
> 216/687-2228(phone)
> 917/771-0235 (cell)
>
> Mailing Address:
> Cleveland State University
> 2121 Euclid Avenue, LB 234
> Cleveland, OH 44115-2214
>
> Campus Location:
> Cleveland-Marshall College of Law
> 1801 Euclid Avenue
> Law Building, LB 234
>
> Admitted to practice before the United States Patent and Trademark Office,
> Reg. No. 45,863
>
>
> -------- Original message --------
> From: Dean Baker <dean.baker1 at verizon.net>
> Date:02/11/2015 10:10 AM (GMT-05:00)
> To: Tahir Amin <tahir at i-mak.org>,Michael H Davis <m.davis at csuohio.edu>
> Cc: ip-health <ip-health at lists.keionline.org>
> Subject: Re: [Ip-health] Stiglitiz et al piece on Obama pressuring India
>
>  Hi Tahir,
>
> the point is well-taken. We certainly shouldn't be supported the view that
> more monopolistic patent laws are "stronger."
>
> regards,
>
> Dean
>
> On 2/11/2015 9:40 AM, Tahir Amin wrote:
>
>   Hi Michael,
>
>  India's Patent Act does exclude from patentability such methods - section
> 3(i)
>
>
>
>
> *Section 3(i) - any process for the medicinal, surgical, curative,
> prophylactic 1[diagnostic, therapeutic] or other treatment of human beings
> or any process for a similar treatment of animals to render them free of
> disease or to increase their economic value or that of their products.*
>
>  Indeed, from our experience of monitoring patent claims in India as
> compared to their corresponding claims in other countries, it is noticeable
> such method  of use/treatment claims are removed on filing in India or
> rejected during examination.
>
>  Dean, a timely piece, but I was wondering whether sentences like this can
> be misleading in creating the correct narrative for media etc depending on
> the viewpoint:
>
> "If the Obama administration succeeds in forcing India to strengthen its
> patent laws"
>
>  To most of us working on these issues in India and elsewhere we would
> say "if Obama succeeds in weakening India's patent laws", because it is
> actually strong in weeding out the junk?
>
>  Best
>
>  Tahir
>
> On 11 February 2015 at 09:21, Michael H Davis <m.davis at csuohio.edu> wrote:
>
>> What Stiglitz doesn't mention is that India could take full advantage of
>> TRIPS by excepting pharmaceutical methods completely from patent protection.
>>
>> My new article explains this in detail.
>>
>> EXCLUDING PATENTABILITY OF THERAPEUTIC METHODS, INCLUDING METHODS USING
>> PHARMACEUTICALS, FOR THE TREATMENT OF HUMANS UNDER TRADE RELATED ASPECTS
>> OF
>> INTELLECTUAL PROPERTY RIGHTS ARTICLE 27(3)(A)
>> Michael H. Davis
>>
>>
>> http://www.hofstralawreview.org/wp-content/uploads/2015/01/DD.1.Davis_.final2_.pdf
>> ______________________________________
>> Prof. Mickey Davis
>> 216/687-2228(phone)
>> 917/771-0235 (cell)
>>
>> Mailing Address:
>> Cleveland State University
>> 2121 Euclid Avenue, LB 234
>> Cleveland, OH 44115-2214
>>
>> Campus Location:
>> Cleveland-Marshall College of Law
>> 1801 Euclid Avenue
>> Law Building, LB 234
>>
>> Admitted to practice before the United States Patent and Trademark
>> Office, Reg. No. 45,863
>>
>>
>> -------- Original message --------
>> From: Dean Baker <Dean.Baker1 at verizon.net>
>> Date:02/11/2015 9:06 AM (GMT-05:00)
>> To: ip-health <ip-health at lists.keionline.org>
>> Cc:
>> Subject: [Ip-health] Stiglitiz et al piece on Obama pressuring India
>>
>>
>> http://www.project-syndicate.org/commentary/obamacare-india-generic-drugs-by-dean-baker-et-al-2015-02
>>
>>
>>   Obama Versus Obamacare
>>
>>   *
>>
>>
>>   *
>>
>>
>>
>>   *
>>
>>
>>
>>
>>   *
>>
>>
>>
>>
>>
>>   *
>>
>>
>>
>>
>>
>>
>>   *
>>
>>
>>
>>
>>
>>
>>
>> NEW YORK – The US Patient Protection and Affordable Care Act
>> <
>> http://www.gpo.gov/fdsys/pkg/BILLS-111hr3590enr/pdf/BILLS-111hr3590enr.pdf
>> >,
>> President Barack Obama’s signature 2010 health-care reform, has
>> succeeded in extending insurance coverage to millions of Americans who
>> would not otherwise have it. And, contrary to critics’ warnings, it has
>> not pushed up health-care costs; in fact, there is some hope that the
>> cost curve may finally be bending downward.
>>
>> But whether “Obamacare” succeeds in curbing excessively high health-care
>> costs is not assured. That will depend on the Obama administration’s
>> other policies, particularly in an area that might seem unrelated: the
>> United States’ ongoing discussions with India over intellectual
>> property. And here, Obama appears determined to undermine his own
>> signature reform, owing to pressure from the powerful US pharmaceutical
>> lobby.
>>
>> Pharmaceutical costs account for an increasingly large component of US
>> health-care spending. Indeed, outlays for prescription drugs, as a share
>> of GDP, have nearly tripled in just 20 years. Lowering health-care costs
>> thus requires greater competition in the pharmaceutical industry – and
>> that means allowing the manufacture and distribution of generic drugs.
>> Instead, the Obama administration is seeking a trade deal with India
>> that would weaken competition from generics, thereby making lifesaving
>> drugs unaffordable for billions of people – in India and elsewhere. This
>> is not an unintended consequence of an otherwise well-intentioned
>> policy; it is the explicit goal of US trade policy.
>>
>> Major multinational pharmaceutical companies have long been working to
>> block competition from generics. But the multilateral approach, using
>> the World Trade Organization, has proved less effective than they hoped,
>> so now they are attempting to achieve this goal through bilateral and
>> regional agreements. The latest negotiations with India – the leading
>> source of generic drugs for developing countries – are a key part of
>> this strategy.
>>
>> In the 1970s, India abolished pharmaceutical patents, creating an
>> advanced and efficient generics industry capable of providing affordable
>> medicines to people throughout the developing world. That changed in
>> 2005, when the WTO’s Agreement on Trade-Related Aspects of Intellectual
>> Property Rights
>> <http://www.wto.org/english/docs_e/legal_e/27-trips_01_e.htm> (TRIPS)
>> forced India to allow drug patents.
>>
>> But, in the view of America’s pharmaceutical industry, TRIPS did not go
>> far enough. The Indian government’s desire to enhance its trade
>> relations with the US thus provides the industry an ideal opportunity to
>> pick up where TRIPS left off, by compelling India to make patents easier
>> to obtain and to reduce the availability of low-cost generics.
>>
>> So far, the plan seems to be working. Last fall, during his visit to the
>> US, Indian Prime Minister Narendra Modi agreed to establish a working
>> group to reevaluate the country’s patent policy. The US participants in
>> the group will be led by the Office of the US Trade Representative,
>> which serves the pharmaceutical companies’ interests, rather than, say,
>> the National Academy of Sciences, the National Science Foundation, or
>> the National Institutes of Health.
>>
>> How might India tighten its patent system? For starters, it could lower
>> its standards for what is considered a “novel” product, and thus one
>> that merits intellectual-property protection. As it stands, India sets
>> the bar quite high, resulting in its refusal to grant patents for new
>> combinations of existing drugs. India could also stop issuing compulsory
>> licenses to allow other companies to produce a patent holder’s drug, in
>> exchange for a fee – an arrangement permitted under TRIPS, but anathema
>> to the drug industry.
>>
>> India’s current policies allow drugs to be sold at a small fraction of
>> the monopoly prices commanded by patent holders. For example, the
>> Hepatitis-C drug Sovaldi is sold for $84,000 per treatment in the US;
>> Indian manufacturers are able to sell the generic version /profitably/
>> for less than $1,000 per treatment. The generic price is still a huge
>> expense for people living on a few dollars a day; but, unlike the US
>> price, it is manageable for many governments and aid organizations.
>>
>> This is hardly an isolated example. Low-cost generics have made it
>> possible to treat tens of millions of HIV/AIDS patients in the
>> developing world.
>>
>> In fact, the threat of competition from Indian generics is partly
>> responsible for major pharmaceutical companies’ decision to make some of
>> their drugs available to the world’s poor at low prices. If the US
>> compels India to tighten its patent rules substantially, so that they
>> resemble US rules more closely, this outcome could be jeopardized.
>>
>> Of course, if America’s strong patent regime were, as its proponents
>> claim, the best way to foster innovation in the pharmaceutical industry,
>> the Obama administration’s policy toward India could perhaps be
>> justified. But that is not the case.
>>
>> Because patents are essentially government-granted monopolies, they lead
>> to the same inefficiencies and rent-seeking behavior as any other such
>> market distortion. A patent that raises the price of a drug a
>> hundred-fold has the same effect on the market as a 10,000% tariff. In
>> such cases, drug companies gain a powerful incentive to mislead doctors
>> and the public about their products’ safety and effectiveness, and even
>> to promote their drugs for inappropriate uses, often using innovative
>> side-payments
>> <
>> http://www.nytimes.com/2014/12/08/business/paid-to-promote-eye-drug-and-prescribing-it-widely-.html?ref=business
>> >
>> to persuade doctors to prescribe them.
>>
>> Furthermore, patent-supported research encourages secrecy, as companies
>> disclose only the information needed to acquire patents. Yet openness is
>> crucial for efficient scientific progress. Many economists, including
>> the authors
>> <
>> http://articles.economictimes.indiatimes.com/2012-05-21/news/31801096_1_drug-prices-drug-companies-life-saving-medicines
>> >,
>> have suggested
>> <
>> https://academiccommons.columbia.edu/download/fedora_content/download/ac:153560/CONTENT/jgm.2010.21.pdf
>> >
>> a variety of alternatives <http://www.ncbi.nlm.nih.gov/pubmed/19088104>
>> to patent-supported R&D and testing that avoid these problems.
>>
>> If the Obama administration succeeds in forcing India to strengthen its
>> patent laws, the change would harm not only India and other developing
>> countries; it would also enshrine a grossly corrupt and inefficient
>> patent system in the US, in which companies increase their profits by
>> driving out the competition – both at home and abroad. After all,
>> generic drugs from India often provide the lowest-cost option in the US
>> market once patent terms have expired.
>>
>> Obama was right to push for a health-care reform that would increase the
>> sector’s efficiency and accessibility. In its dealings with India, the
>> Obama administration is pursuing a policy that flouts these goals, with
>> consequences not just for India and the US, but for the entire world.
>>
>>
>> --
>> Dean Baker (baker at cepr.net)
>> Co-Director
>> Center for Economic and Policy Research 1611 Connecticut Ave., NW
>> Washington, DC 20009
>> 202-293-5380 (ext 114)
>> 202-332-5218 (H)
>>  www.cepr.net<http://www.cepr.net>
>>
>> _______________________________________________
>> Ip-health mailing list
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>> _______________________________________________
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>>
>
>
>
> --
>  Tahir Amin
> Co-Founder and Director of Intellectual Property
> Initiative for Medicines, Access & Knowledge (I-MAK)
> *Website:* www.i-mak.org
> *Email:* tahir at i-mak.org
> *Skype: *tahirmamin
> *Tel:* +1 917 455 6601/+1 646 884 7418/+44 771 853 9472
>
>
>
>
>
>
> --
> Dean Baker
> Co-Director, Center for Economic and Policy Research
> 1611 Connecticut Ave, NW
> Washington, DC 20009202-293-5380 (ext 114) www.cepr.net
>
>


-- 
Tahir Amin
Co-Founder and Director of Intellectual Property
Initiative for Medicines, Access & Knowledge (I-MAK)
*Website:* www.i-mak.org
*Email:* tahir at i-mak.org
*Skype: *tahirmamin
*Tel:* +1 917 455 6601/+1 646 884 7418/+44 771 853 9472



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