In
This Issue:
· Yeda v. Abbott: 20-Year Dispute Regarding
Expired Patent for TBP-II Decided in Favor of Abbott
· FDA Approves Amgen’s Biosimilar for Humira
· National Cancer Challenge Winners Announced
· Method of Cryopreservation is Patent Eligible
Contact Us:
Walter
Schlapkohl, Ph.D., Esq.
wschlapkohl@gbpatent.com
703-716-1191 (phone)
703-716-1180 (fax) |
Abbott’s
Disclosure of Partial N-terminal Sequence and Other Protein Properties in
Priority Application Sufficient to Obtain Priority Benefit and Avoid
Invalidity
On September 20, 2016, the U.S. Court of Appeals for the
Federal Circuit upheld a district court’s finding that written description
support to obtain benefit for claims covering a TNF-α-binding protein (TBP-II)
could be satisfied inherently where there was no dispute that the only
protein containing the N-terminal sequence set forth in the priority
application is the same protein as claimed in the patent (Nos. 2015-1662,
2015-1663).
Yeda Research and Development Co., Ltd. had appealed two
decisions by the U.S. District Court for the District of Columbia, in which
the District Court held that Abbott’s U.S. Patent No. 5,344,915 is not
invalid as anticipated. The invalidity
turned on whether the ‘915 patent would obtain the benefit of the filing
dates from either of two German priority applications for claims directed to
a TNF-α-binding protein having a specific N-terminal sequence. By obtaining the benefit of either German
priority application, Abbott could avoid prior art that would otherwise
anticipate its claims.
Neither priority application disclosed the full N-terminus
as claimed in the disputed patent. However, the priority applications did disclose a partial N-terminal
sequence, a protocol for obtaining the protein from its biological source, as
well as, for example, its molecular weight and biological activity. In its decision, the Federal Circuit held
that the disclosure of at least one of the priority applications inherently
disclosed the remaining amino acids in the N-terminal sequence and that the
disclosure serves as adequate written description support for the patent
claiming TBP-II.
FDA Approves Amgen’s Biosimilar for AbbVie’s Humira
On September 23, 2016, the Food and Drug Administration
(FDA) gave its fourth approval regarding a biosimilar to Amgen Inc.’s
“Amjevita” (adalimumab-atto). The
biosimilar was approved for all seven indications requested, including
rheumatoid arthritis, plaque psoriasis, and Crohn’s disease. Amgen filed for
marketing approval for the biosimilar in November 2015 and FDA accepted
Amgen’s abbreviated Biological License Application in January 2016. The product was approved as a biosimilar,
not as an “interchangeable” product.
AbbVie Inc., the holder of at least 10 (and possibly as
many as 61) patents that cover the blockbuster originator product Humira, has
alleged infringement by Amgen in a proceeding against AbbVie before the U.S.
District Court for the District of Delaware. AbbVie is seeking to stop Amgen from manufacturing and marketing its
newly-approved biosimilar and asserts that Amgen has failed to comply with
certain provisions related to the “patent dance” as required by the Biologics
Price Competition and Innovation Act (BPCIA). Amgen asserts that the patents
at issue are invalid and/or not-infringed, and has filed a counterclaim asserting
that it is actually AbbVie which has failed to comply with certain provisions
of the “patent dance.”
National Cancer Challenge Winners Announced
On September
19, 2016, the USPTO announced the winners for the Cancer Moonshot
Challenge. The Challenge, which is
part of Vice President Biden’s broader National Cancer Moonshot initiative,
was launched in August with the aim of leveraging the USPTO’s patent data to
find creative, new ways to fight cancer. The USPTO’s patent data can often be an early indicator of meaningful
areas of research and development. The Challenge called for contestants to
provide visualizations of patent data that would “illuminate trend lines for
new insights”.
Dolcera won the
first place prize of $5,000 for its visualization of the relationship between
levels of research funding, patenting and testing on one hand, and the
genetics and epidemiology of cancer on the other. Booz Allen Hamilton and Omnity won second
place and $3,000. Thomson Reuters and
Georgetown Lombardi Comprehensive Cancer Center took the third place price of
$2,000.
Earlier this
year the USPTO launched the “Cancer Immunotherapy Pilot Program,” to fast-track examination for cancer
therapies. Petitions under this
program may be filed without a government fee and are being accepted through
June 2017.
Method of Cryopreservation is Patent Eligible
According to a July decision by the U.S. Court of Appeals
for the Federal Circuit, method claims directed to hepatocyte
cryopreservation are patent eligible. Hepatocytes are a type of liver cell often used in testing,
diagnostic, and treatment methods.
In Rapid Litig. Mgmt.
Ltd. v. CellzDirect, Inc., the Federal Circuit found that even though the
claims recited a natural law (that hepatocytes are
capable of surviving multiple freeze-thaw cycles), the claims were
nevertheless directed to a new, useful technique for their preservation that
produces a “tangible and useful result.” The patent at issue, U.S. Patent No. 7,604,929, was based on the
inventors’ discovery that some fraction of hepatocytes is capable of surviving
multiple freeze-thaw cycles. With the
discovery in hand, the inventors developed an improved process for preserving
them, which was the subject of the claims in the ‘929 patent. Prior to this, the prevailing belief was
that hepatocytes could be frozen only once and then had to be either utilized
or discarded.
The decision by the Federal Circuit, which vacated and
remanded the decision of the district court finding the ‘929 patent invalid
under §101, was a welcomed affirmation of patent subject matter eligibility
for life science patent holders in what remains a contentious area of recent
patent case law. |