Shot-gun patents

As a follow-up to the post of March 2007, The System IS the Sickness here’s an interesting report by the Sunshine Project which sums up some of the issues concerning patents for the H5N1 avian influenza virus, otherwise known as “Bird Flu.” It seems that some companies are patenting whole sequences of any Bird Flu virus sample that WHO or the CDC sends them, hoping by a kind of shot-gun strategy, to come out with a winning ticket in the patent lottery. They haven’t analyzed any of these sequences at all, they are just patenting them as the sequence them.  Indonesia, as I had noted last March, is unsure why it should contribute information that WHO hands over to the CDC who in turn hands that sample over to an American Pharma Company, who will extract royalties from whoever ends up producing the vaccine. There is no offer on the table to share royalties based on the information Indonesia provided with Indonesia, or to release that information into the public domain, so any company could use it. Indonesia could end up being unable to afford the treatments that their samples were instrumental in creating.

The report is a good summary and is especially interesting when it discusses how the science interacts with the legal/patent framework.

From the introduction of the report:

A dramatic rise in international patent applications related to influenza is underway. This
includes patent applications covering the virus itself, vaccines, treatments, and diagnostics.
As recently as 1993, years passed with little or no such patent activity. In 2006, however,
more than 30 international (Patent Cooperation Treaty) patent applications were filed on
influenza vaccines alone, making it the largest year on record – but not for long. World
Intellectual Property Organization (WIPO) data indicates that during the first half of 2007 as
many influenza vaccine patent claims have been filed as in the entirety of 2006, meaning that
this year is on track to at least double the record set in 2006.

Some patent applications cover genes and smaller pieces (sequences) of H5N1 and other
influenza virus strains and techniques for their use. Some key new technologies that are in
use or destined for use in future vaccines, such as reverse genetics, are under patent control.
Some other influenza vaccine technologies, such as adjuvants and cell culture methods, are
highly proprietary. These are used in both seasonal and pandemic vaccine production.

The most important patent claims related to pandemic influenza probably haven’t been
published, or even filed, yet. What are most important are the worrying trends and kinds of
claims being lodged. These indicate a near-term (and long-term) future in which H5N1
strains and all manner of technologies related to using them in vaccines will be patented.

Another thing I like about this report is that it explains how the science is interacting with the legal system/patent system. This passage is typical:

First, it is important to note that, unlike many other infectious diseases that can be controlled
by vaccines, influenza presents a fast-moving target. Flu is a small, single stranded, negative
sense RNA virus1 that quickly changes. This includes the HA and NA genes (sequences) used
in current vaccines. For vaccine makers, this necessitates changes – typically annual – in
seasonal influenza vaccines, meaning customers must submit to frequent revaccination to
maintain their immunity.

The exact form of the next naturally emerging pandemic strain(s) remains unknown and is not
predictable with confidence. Even though it is possible to generate examples of such strains in
a laboratory, lab strains are unlikely to be the same as those generated by nature.

Those observations have implications for intellectual property claims. Influenza HA and NA
genes are far less stable over time than, for example, essentially static human gene sequences
coding for susceptibility to a disease. This may limit the value of a patent claim on a
particular sequence, because that sequence’s similarity (homology) to potentially pandemic
strains in circulation is likely to diminish fairly quickly over time.

The changeable nature of influenza has led at least one major company (Merck) to seek new
influenza vaccines that do not rely on particular HA or NA sequences. Others have laid claim
to sequences and any other sequence that is similar, for example, 90% or more the same. As
described below, at least one other has responded by attempting to patent large numbers of
varying HA and NA genes. The various types of claims that have been filed are discussed in
more detail in “Types of Claims”, on page X.

Key genes and sequences of a pandemic strain certainly can be patented if the applicant
acquires them and recognizes their significance early enough. Scientists may correctly predict
the strains that will best confer immunity to an actual pandemic strain (e.g. a good case
scenario prepandemic vaccine). Alternatively, it is possible that a vaccine approach involving
a conserved sequence(s) may be developed and the critical sequence may be patented.

Indonesia, though wants a share in those royalties, or at least an understanding that they will be able to purchase the developed vaccines, given that they’ve been supplying all of the virus samples, doing the field work of getting the samples, etc. If the WHO’s very highest priority was the development of a vaccine, they would make the commitment that the future vaccine would be developed unencumbered by patents. This would work fine IF the labs doing the work to find a vaccine were in the public sector. Or if these labs were going to be awarded a prize for the discovery of the vaccine, that strategy could also work.

However, Public Sector solutions don’t fit in with the neo-liberal orthodoxy, so the only allowable solution for monetizing the vaccine for avian influenza is a privately-owned patent thicket, each company planting as many flags in the sand as possible, hoping that one or more of those flags will end up covering some strategic position. This of course would be an acceptable by-product of the process, if an effective vaccine is produced. However, one should understand the way that patent concerns inform clinical development. This fact was covered in an excellent book Steal this Idea: the corporate confiscation of creativity by Michael Perelman. Clinically inferior products have been brought to market because the patents were stronger than those for the clinically superior product. There are many examples of this happening. Such concerns could easily derail the development of an avian influenza vaccine. Let’s see how this develops.

Shot-gun patents

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