The issuance of a patent does not ensure that it is valid or enforceable. Therefore,
even if we are issued a patent, it may not be valid or enforceable against third parties. Issued patents may be challenged, narrowed, invalidated or circumvented. In addition, court decisions may introduce uncertainty in the enforceability or scope
of patents owned by pharmaceutical and biotechnology companies. Thus, any of our patents, including patents that we may rely on to protect our market for approved drugs, may be held invalid or unenforceable by a court of final jurisdiction.
In addition, the issuance of a patent does not give us the right to practice the patented invention. Third parties may have
blocking patents that prevent marketing of our products or working our own technology. We endeavor to identify early third-party patents and patent applications which may be blocking to a product or technology, to minimize this risk. However,
relevant documents may be overlooked or missed, which may in turn impact of the freedom to commercialize the relevant asset.
Varlitinib
Licensed from Array
On July 12, 2011, we entered into
a collaboration and license agreement with Array, relating to Arrays
pan-HER
inhibitor,
ARRY-543,
which we refer to as ASLAN001 or
varlitinib
, pursuant to
which we obtained an exclusive, worldwide license to develop products incorporating
varlitinib
as an active ingredient for the treatment or prevention of any diseases or conditions in humans, pursuant to an agreed development plan, and an
exclusive, worldwide license to pursue a commercial licensing program in relation to such products. On January 3, 2018, we entered into a new license agreement with Array, which replaces and supersedes our previous collaboration and license
agreement, pursuant to which we obtained an exclusive, worldwide license to develop, manufacture and commercialize
varlitinib
for all human and animal therapeutic, diagnostic and prophylactic uses.
With respect to
varlitinib
, we exclusively licensed from Array a family of patents which includes composition of matter patents.
These patents disclose a genus and also explicitly discloses
varlitinib
. More specifically, as of May 15, 2019, this patent family included four issued patents in the United States, 58 issued patents in a number of foreign countries and
jurisdictions, including Argentina, Australia, Canada, China (at least three patents), Chile, Colombia, Europe, Hong Kong, Indonesia, India, Iceland, Israel, Japan, South Korea, Macau, Mexico, Norway, New Zealand, Philippines, Russia, Singapore,
Ukraine, South Africa, and Taiwan, one pending patent application in the United States and three pending patent applications in a number of foreign countries, including Brazil, Egypt and Venezuela. The scope of the claims may differ in the various
countries. The issued patents in this family and the pending patent applications, if issued, are expected to expire in August 2023 in the United States and August 2024 outside the United States, subject to the payment of renewal fees, excluding any
additional term for patent term adjustments or patent term extensions.
The first patent application filed in China was not
granted based on a technicality of Chinese practice. Subsequently filed divisional patent applications were granted. If the validity of one or more of the granted divisional patents is challenged, then one or more of these patents may ultimately be
considered invalid.
In addition, we exclusively licensed from Array a family of patents derived from WO2007/059257, filed
November 15, 2006, which relate to the synthetic process of making
varlitinib
and a key intermediate in that process. As of May 15, 2019, this patent family includes two issued patents in the United States, 17 issued patents in a
number of foreign countries and jurisdictions, including China, Colombia, Europe, Hong Kong, Iceland, India, Israel, Japan, South Korea, Mexico, Norway, Russia, Singapore, and Ukraine, one pending patent application in the United States and one
pending patent application in Brazil. The scope of the claims may differ in the various countries. The issued patents in this family and the pending patent applications, if issued, are expected to expire in November 2026, subject to the
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