In
This Issue:
· Cert Denied in Apotex v. Amgen.
· Jury Verdict of $2.54 Billion
in Idenix Pharm. LLC v. Gilead Sciences
Inc.
· Are Subject Matter Eligibility Changes Looming in 2017?
Contact Us:
Walter
Schlapkohl, Ph.D., Esq.
wschlapkohl@gbpatent.com
703-716-1191 (phone)
703-716-1180 (fax)
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Supreme
Court Denies Apotex’s Petition for Writ of Certiorari But
May Still Consider Issues Raised in Amgen
v. Sandoz
Apotex filed a petition for a writ of certiorari with the
U.S. Supreme Court on September 9, 2016.
Apotex’s petition presented two questions for the Court to consider:
(1) whether the Federal Circuit erred in holding that biosimilar applicants
that make all disclosures necessary under the Biologics Price Competition and
Innovation Act (BPCIA) for the resolution of patent disputes must also
provide the reference product sponsor with a 180-day notice of commercial
marketing; and (2) whether the Federal Circuit improperly extended by six
months the statutory 12-year exclusivity period provided to reference product
sponsors by holding that a biosimilar applicant cannot give effective notice
of commercial marketing under 42 U.S.C. § 262(l)(8)(A) for its biosimilar product until it receives an FDA
license. On December 12, 2016, the
Supreme Court denied Apotex’s petition without comment.
Nevertheless, questions remain with regard to the Federal
Circuit’s interpretation of the BPCIA’s 180-day notice of commercial
marketing provision and the proper handling of the patent dispute resolutions
under the BPCIA. This is because the
Supreme Court still has the option of addressing similar issues raised in Amgen v. Sandoz, 794 F.3d 1347 (Fed. Cir. 2015).
In that case
the Federal Circuit held that (1) Sandoz did not violate the BPCIA by failing
to disclose its abbreviated Biological License Application and manufacturing
information to Amgen (the reference product sponsor), and (2) that a
biosimilar applicant may only provide effective notice of commercial
marketing of its biosimilar after
the FDA has licensed its product. The
parties filed cross-petitions for writ of certiorari with the U.S. Supreme
Court.
On June 20,
2016, the Supreme Court invited the Solicitor General to file a brief
expressing the views of the United States in the Amgen v. Sandoz case. The
Solicitor General replied to the Court’s invitation on December 7, 2016, recommending
that the Court should hear the case.
--By Walter
Schlapkohl
Gilead Sciences Ordered to Pay $2.54 Billion to Merck &
Co.
On December 15, 2016, a federal jury concluded that Gilead
Sciences Inc. must pay $2.54 billion to Merck & Co. for patent
infringement, the largest U.S. patent-infringement
verdict ever (Idenix Pharm. LLC v.
Gilead Sciences Inc., D. Del., No. 14-846, jury verdict 12/15/16).
Prior to this, the largest jury verdict in U.S. history was a $1.67
billion judgment Abbott Laboratories was to pay to Johnson & Johnson,
which was later thrown out on appeal.
Gilead has indicated that they will “vigorously challenge”
the jury’s decision.
The record-breaking verdict is the latest development in a
global patent dispute between Gilead and Idenix regarding hepatitis C treatments.
In 2009, Merck’s subsidiary, Idenix Pharmaceuticals Inc.,
patented a potentially lifesaving compound used to treat hepatitis C. Merck’s drug, called Zepatier, was approved
in 2016. Pharmasset Inc., a Gilead
subsidiary, began producing and selling its own treatments for hepatitis C in
2013. The infringing products, Sovaldi
and Harvoni, account for more than half of Gilead’s revenue.
Merck alleged that Pharmasset’s founder “betrayed” the CEO
of Idenix (allegedly his “best friend”) by sharing proprietary information
about the patented compound with Pharmasset scientists, which Pharmasset then
used to create its hepatitis C treatments.
Gilead asserted that Pharmasset did not take anything from Idenix and
instead developed its own compound during the course of three years of
research.
At trial, Merck’s lawyer described the case to jurors as
“a story of betrayal” among former friends.
The story resonated with the jury, who instructed Gilead to pay Merck
$2.54 billion, an amount based on a 10% royalty rate on total sales of
Gilead’s hepatitis C treatments.
Moreover, the jury found the infringement to be willful, leaving open
the possibility that the damage award may be increased up to three times the
amount (up to $7.62 billion).
--By
Aaron Gerger
Are Subject Matter Eligibility Changes Looming in 2017?
On November 2, 2016, the USPTO issued a memo to the
examining corps on subject matter eligibility. Although the memo was issued in response to
the McRO and BASCOM Federal Circuit decisions – both software cases – the
memo also included instructions to examiners to avoid relying on
non-precedential decisions such as the SmartGene
case (SmartGene, Inc. v. Advanced
Biological Labs., 555 Fed. Appx. 950 (Fed. Cir. 2014)) unless the facts of
the application under examination “uniquely match” those in SmartGene. In SmartGene,
the independent claims at issue were directed to a method, a system, and a
computer program, respectively, for guiding the selection of a treatment
regimen for a patient with a known disease or medical condition.
The USPTO will likely revise its guidelines related to
subject matter eligibility in the first quarter of 2017 in response to
roundtable discussions with stakeholders held in 2016. The life science industry is hopeful that the
USPTO will change its guidelines to allow more subject matter in view of
recent Federal Circuit eligibility wins in cases such as Rapid Litig. Mgmt. Ltd. v. CellzDirect Inc., BASCOM Glob. Internet Servs. Inc. v. AT&T Mobility LLC, McRO Inc. v. Bandai Namco Games Am. Inc.,
and Amdocs (Israel) Ltd. v. Openet
Telecom Inc. In Rapid Litig. Mgmt., 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 liver cell preservation that produces a “tangible and useful
result.”
While patent legislation does not appear to be a priority
with either the Trump administration or the Congress in 2017, the USPTO will
likely have a new director by the end of the year, and both biotech and
software industry stakeholders are hopeful that the incoming director will
favor increased patent protection for software and biotech cases.
--By Walter Schlapkohl
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