PHM-Exch> Need to Review Basic Concepts of Patent System Medicines

[Claudio Schuftan]

ES NECESARIO REVISAR CONCEPTOS BASICOS SOBRE PATENTES
C'EST NECESSAIRE DE REVOIR QUELQUES PRINCIPES SUR PATENTS

From: South Centre <south at southcentre.org>

*SouthViews*

*No.24,              25 July 2012*
* **www.southcentre.org* <http://www.southcentre.org/>

* *

*Beyond ‘Patent Quality’: Basic Concepts of the Patent System Need To Be
Reviewed**       *excerpts*
*

………………………………………………………………

*By Carlos M. Correa*

A proposal has been made to initiate a debate on ‘patent quality’ at the
World Intellectual Property Organization (WIPO). The expression
‘patent quality’
ambiguously alludes to a growing problem, faced in both developed and
developing countries alike: the overwhelming majority of patents are
applied for and granted over incr emental developments on existing
technologies. Although the patent system is supposed to reward
inventiveness, in many cases patents cover minor improvements or trivial
ideas.

Although the intrinsic value of the technology protected under such patents
is low, they are often strategically used to generate or keep monopolistic
positions that affect competitors and consumers. Thus, the proliferation of
patents that do not make a genuine technical contribution limits legitimate
competition and undermines innovation. An investigation conducted by the
European Commission on the pharmaceutical industry, for instance, concluded
that:

· Filing numerous patent applications for the same medicine (forming so
called "patent clusters" or "patent thickets") is a common practice… to
delay or block the market entry of generic medicines.

· …individual medicines are protected by up to nearly 100 product-specific
patent families, which can lead to up to 1,300 patents and/or pending
patent applications across the Member States.

· patent litigation cases increased by a factor of four between 2000 and
2007; generic companies prevailed in 62% of 149 litigated cases that lasted
from six months to more than six years.

· European governments and consumers paid around 3 billion Euros in excess
between 2000 and 2007 (in relation to 219 drugs) due to abuses in the
exercise of patent rights.

The acquisition of a large number of patents around a single technology has
become common practice. Contrary to the ordinary belief that one product
will deserve one patent, a single medicine may be covered by hundreds of
patents. Thus, a WIPO study identified around 800 patents on ritonavir, an
important component in the treatment against HIV/AIDS. In order to preserve
a monopolistic position after the expiry of basic patents, pharmaceutical
companies routinely apply (and often obtain) patents on derivatives, dosage
forms, new uses, etc. of existing medicines thereby ‘evergreening’ the
original patents.
A number of factors explain the proliferation of patents with low or no
inventive contribution. Two of them are of particular relevance. On the one
hand, large companies  devote significant resources to pursue patent
strategies that deliberately aim at limiting the competitors’ room to
operate. They include “*Blanketing*” (creating a jungle or a minefield of
patents), “*Flooding*” (taking out multiple patents, major as well as
minor, in a field), “*Fencing*” (acquiring a series of patents that block
certain lines or directions of research and development) and “*Surrounding*”
(an important central patent is fenced by other less important patents).

A research conducted in five developing countries (Argentina, Brazil,
Colombia, India and South Africa) on patenting in the pharmaceutical field
revealed several aspects of the functioning of the patent system that raise
significant concerns. Some of the findings of the study were as follows:

· Pharmaceutical patents are overwhelmingly concentrated in the hands of
foreign companies (with the exception of India).
· There is a significant proliferation of patents over minor technical
changes that are often used to create undue constraints on legitimate
competition that negatively affect access to medicines.

· Many patents and patent applications do not mention the International
Nonproprietary Name (INN) of known drugs, thereby making patent searches
and oppositions extremely difficult and costly.


 Stipulating rigorous criteria to assess novelty, inventive step and
industrial applicability will help prevent patent abuses.

Once a patent is granted it is generally presumed to be valid until
otherwise decided by the courts. Substantial resources (both financial and
technical) are necessary to invalidate a patent. This is a difficult or
impossible task for small and medium companies, non governmental
organizations or individuals (e.g. patients) that may be directly affected
by wrongly granted patents. In addition, invalidation procedures may take
years during which the patent can be legally enforced, even if under legal
challenge.
*Important changes in the way the system is designed and operates are
necessary to achieve this objective. They include:

*

·  To integrate patent policies into national development policies,
including in relation to access to medicines and to environmentally sound
technologies;

·  To increase the capacity available in patent offices and courts to
properly examine patent applications, and introduce substantive examination
where it does not exist;

·  To provide patent examiners incentives to objectively examine patent
applications and thereby avoid a bias towards approval;

·  To ensuring that the inventive step analysis takes into account prior
expert knowledge. Patents should only be granted when a real contribution
to the state of the art has been made;
·  To clearly distinguish ‘inventions’ from ‘discoveries’; if genetic
materials are deemed patentable, to limit the protection to the function/s
disclosed in the patent claims;


· More rigorous standards may be applied to examine pharmaceutical patents
(given their impact on access to drugs) than those in other sectors;

·  To empower the competition authorities to take effective action in cases
of abuses of patent rights.
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