About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline

39 Biotechnology L. Rep. 1 (2020)

handle is hein.journals/bothnl39 and id is 1 raw text is: Selected Developments in Biotechnology Law
and the Biotechnology Industry
By STEVEN J. ZWEIG

FEDERAL CIRCUIT THROWS OUT
LARGEST U.S. PATENT VERDICT
In 2016, Merck & Co., Inc. won a US$2.54 billion
verdict against Gilead Science, Inc. The verdict-the
largest ever in a U.S. patent case-was based on a
finding that Gilead's hepatitis C drugs Sovaldi and
Harvoni infringed Merck's patent on a hepatitis C
treatment it had acquired when it bought Idenix Phar-
maceuticals.
However, that jury verdict was then thrown out
by a federal judge in Delaware two years later, on
the basis that Merck's patent was invalid for lack
of disclosure. The judge held that the disclosure
was inadequate because an excessive amount of ex-
perimentation would be required to create the pat-
ented drug.
The Federal Circuit then heard Merck's appeal of
that decision and recently upheld it, agreeing with
the lower court that the patent lacked adequate dis-
closure and so was invalid.
FEDERAL CIRCUIT AFFIRMS HOSPIRA'S
INFRINGEMENT OF AMGEN'S EPOGEN
While US$70 million is not US$2.54 billion
(the verdict overturned above), it's still a signifi-
cant amount of money. It's also the amount that
the Federal Circuit recently (December 16, 2019)
confirmed that Hospira will have to pay for in-
fringing on Amgen's Epogen patent through the
creation of batches of a drug substance for Hospi-
ra's biosimilar. Among other arguments advanced,
Hospira tried to argue that its creation of 21 batches
Steven J. Zweig is the Managing Editor of Biotechnology
Law Report.

of the substance was protected by the Safe Harbor
provision under 35 U.S.C. § 271(e)(1), but the Fed-
eral Circuit rejected that argument for 14 of the 21
batches, finding that they were not manufactured
solely for uses related to the development and sub-
mission of information to the Food and Drug
Administration (FDA)-and hence were outside
the Safe Harbor.
WORLD HEALTH ORGANIZATION
PREQUALIFIES ITS FIRST
BIOSIMILAR MEDICINE
Breast cancer is the most common form of can-
cer for women. A very effective early stage treat-
ment, trastuzumab, a monoclonal antibody, costs
$20,000 on average for a treatment regime. That
cost puts it out of reach for many women, espe-
cially in developing countries.
The World Health Organization (WHO) has in-
cluded trastuzumab on its WHO Essential Medicines
List since 2015. But essential or not, if patients can't
afford it, it will not help them. Trastuzumab biosimi-
lars cost, on average 65% less than the originator
medicine, making it much more affordable. Several
biosimilars have been on the market, but even at a
65% discount, they are still too expensive for many
when purchased privately.
Prequalification by the WHO of a biosimilar ver-
sion of trastuzumab produced by Samsung Bioepis
NL B.V. in the Netherlands provides the WHO's im-
primatur and furnishes quality assurance: it's a deter-
mination that the WHO finds it comparable to the
originator medicine in terms of quality, efficacy,
and safety. That in turn will make it eligible for
purchase by United Nations agencies and increase
the likelihood of purchase by national health pro-
grams, which will further drive down the cost and
increase availability.

1

39 Biotechnology Law Report 1
Number 1, 2020
© Mary Ann Liebert, Inc.
DOI: 10.1089/bir.2019.29154.sjz

News Briefs

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Short-term subscription options include 24 hours, 48 hours, or 1 week to HeinOnline.

Contact us for annual subscription options:

Already a HeinOnline Subscriber?

profiles profiles most