[Ip-health] Commentary by Paul Fehlner in Barron's: Pharma Companies Are Worried About Pooling Their IP. They Shouldn’t Be.

Thiru Balasubramaniam thiru at keionline.org
Sat Jun 27 08:38:46 PDT 2020



Pharma Companies Are Worried About Pooling Their IP. They Shouldn’t Be.

By Paul FehlnerJune 26, 2020 9:30 am ET

A World Health Organization-backed plan to help speed innovation and share
risks in developing Covid-19 treatments has provoked responses ranging from
dismissal to outright disdain. Albert Bourla, the CEO of Pfizer, called it
“nonsense” and “dangerous.” Gilead has apparently chosen to ignore it.
Thomas Cueni, director general of the International Federation of
Pharmaceutical Manufacturers and Associations, has said such plans add to
companies’ options to give access to Covid-19 products, but later
questioned whether another one was necessary.

The critics seem to focus on a perception that intellectual property rights
will somehow be undermined if the WHO helps pool scientific knowledge on
Covid-19. They’re wrong. As someone who’s worked on intellectual property
issues at the highest levels of a multinational pharmaceutical company, I
urge them all to take another look. Creating a global platform for
governments, funders, companies, and researchers to build collective
intelligence and equitably share the risks and rewards in innovation is the
right thing to do for every stakeholder involved.

The plan driving all this hostility is known as C-TAP, short for the
Covid-19 Technology and Access Pool. Proposed by Costa Rica, it was
implemented by the World Health Organization on May 29. C-TAP creates a
“one-stop shop” for technologies that are useful for the detection,
prevention, control, and treatment of the Covid-19 pandemic by pooling
scientific knowledge, data, and intellectual property rights on a voluntary
basis. C-TAP’s priorities are to encourage public disclosure of data and
clinical trial results, standardize contractual terms for access and
distribution, promote nonexclusive licensing, and enable technology
transfer to local manufacturers.

This initiative builds on an established consensus for sharing and
collaboration in response to Covid-19. The Covid-19 Therapeutics
Accelerator, a consortium of 15 multinational biopharmaceutical companies
and the Gates Foundation, offers compelling evidence that even commercial
entities recognize that collaboration means speed. The same can be said of
the National Institutes of Health public-private partnership led by
Director Francis Collins. So, too, the WHO Solidarity clinical trial for
Covid-19 therapeutics, with 35 countries participating and over 100
expressing interest.

Each of these collaborations is substantial on its own. But they represent
only a small percentage of the world’s capabilities. C-TAP could combine
these efforts with other global inputs to help speed progress on Covid-19

C-TAP’s best hope for acceleration would be to give researchers and
developers faster access to information, not just relief from patents.
Real-time access to data, regulatory dossiers, and manufacturing
processes—what the industry calls know-how—would accelerate development of
effective therapies, vaccines, diagnostics, and collateral technology.

Keeping know-how secret may confer a profitable advantage under ordinary
circumstances. But Covid-19 costs national economies billions of dollars,
so every day of delay may equal the potential profit of a single product.
Any responsible investor will know that this is a time to leave a little
money on the table rather than seeking short-term profit.

Funders seeking to maximize the impact of every dollar should
enthusiastically support an information-sharing platform. C-TAP amplifies
information. A study of 100 patients, pooled with data from other studies,
could yield data from 10,000 patients. A single regulatory dossier can
benefit from the experience of 10 others—and the next one, from 11.
Manufacturing can quickly scale globally from one center. This can happen
as soon as information is available, not the months or years it normally
takes for information held by one organization to trickle out to the
public. The benefits of an information pool accrue to everyone. Even
biopharmas who want to be first to market with an effective product could
benefit from faster development times.

Ironically, C-TAP anticipates the critics’ concerns. It leverages the value
of know-how for speed, which is the reason biopharma companies have already
joined other pools. By its terms, C-TAP recognizes and respects IP rights
around Covid-19 technology. This is no compulsory licensing scheme or
attack on patents. On the contrary, access to IP, including know-how, will
be under license.

And then there’s the point about a plan like this already existing. It’s
true that the Medicines Patent Pool, founded in 2010, does similar work by
voluntarily negotiating licenses for certain diseases. But that’s a good
thing, because MPP has committed to support C-TAP’s licensing program. MPP
has years of expertise and a history of success in enabling licensing of
therapeutics for developing markets. It is uniquely suited and qualified
for this role, as IFPMA acknowledges. Indeed, MPP can do pretty much
everything envisioned for C-TAP except actual handling of materials.

Covid-19 is an unprecedented and acute challenge to human health globally.
Global cooperation offers the best chance for the fastest effective
responses. By ensuring information transparency and respect for IP rights,
the Covid-19 Technology Access Pool offers just that chance.

Paul Fehlner is a co-founder and president/CEO of reVision Therapeutics. He
is also chief intellectual property officer at Axcella Health. He has been
involved in life sciences intellectual-property law since 1990, including
nine years as global head of IP for Novartis Pharma.

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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