Certain Recombinant Factor VIII Products; Determination To Review In Part a Final Initial Determination Finding No Violation of Section 337 and a Summary Determination; Schedule for Filing Written Submissions on One Issue Under Review and on Remedy, the Public Interest, and Bonding, 51463-51465 [2016-18464]
Download as PDF
Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices
INTERNATIONAL TRADE
COMMISSION
[Investigation No. 337–TA–956]
Certain Recombinant Factor VIII
Products; Determination To Review In
Part a Final Initial Determination
Finding No Violation of Section 337
and a Summary Determination;
Schedule for Filing Written
Submissions on One Issue Under
Review and on Remedy, the Public
Interest, and Bonding
U.S. International Trade
Commission.
ACTION: Notice.
AGENCY:
Notice is hereby given that
the U.S. International Trade
Commission has determined to review
in part (1) the final initial determination
(‘‘FID’’) issued by the presiding
administrative law judge (‘‘ALJ’’) on
May 27, 2016, finding no violation of
section 337 of the Tariff Act of 1930, as
amended (19 U.S.C. 1337); and (2) the
initial determination issued on February
26, 2016, granting a summary
determination of infringement of U.S.
Patent No. 6,100,061 (the ‘‘Summary
ID’’) (Order No. 30). On review, the
Commission has determined to reverse
the FID’s finding that the economic
prong of the domestic industry was not
met for either asserted patent. Other
issues remain on review.
FOR FURTHER INFORMATION CONTACT: Ron
Traud, Office of the General Counsel,
U.S. International Trade Commission,
500 E Street SW., Washington, DC
20436, (202) 205–3427. Copies of nonconfidential documents filed in
connection with this investigation are or
will be available for inspection during
official business hours (8:45 a.m. to 5:15
p.m.) in the Office of the Secretary, U.S.
International Trade Commission, 500 E
Street SW., Washington, DC 20436,
(202) 205–2000. General information
concerning the Commission may also be
obtained at https://www.usitc.gov. The
public record for this investigation may
be viewed on the Commission’s
electronic docketing system (EDIS) at
https://edis.usitc.gov. Hearing-impaired
persons are advised that information on
this matter can be obtained by
contacting the Commission’s TDD
terminal at (202) 205–1810.
SUPPLEMENTARY INFORMATION: On May
22, 2015, the Commission instituted this
investigation pursuant to section 337 of
the Tariff Act of 1930, as amended,
based on a complaint filed by Baxter
Healthcare Corporation and Baxter
Healthcare SA, both of Deerfield,
Illinois. 80 FR 29745 (May 22, 2015).
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:12 Aug 03, 2016
Jkt 238001
Baxalta Inc., Baxalta US Inc., and
Baxalta GmbH were added as
complainants after the filing of the
complaint. 80 FR 62569 (Oct. 16, 2015).
(The complainants are collectively
referred to as ‘‘Baxter.’’) The
Commission sought to determine
whether there is a violation of section
337(a)(1)(B) in the importation into the
United States, the sale for importation
into the United States, or the sale within
the United States after importation of
certain recombinant factor VIII products
by reason of infringement of any of
claims 19–21, 36, 37, and 39 of U.S.
Patent No. 6,100,061 (‘‘the ’061 patent’’);
claims 20 and 21 of U.S. Patent No.
6,936,441 (‘‘the ’441 patent’’); and
claims 1, 5, 8, 10, 14, and 18 of U.S.
Patent No. 8,084,252 (‘‘the ’252 patent’’).
80 FR at 29746. The Commission
directed the ALJ to make findings of fact
and provide a recommended
determination with respect to the
statutory public interest factors set forth
in 19 U.S.C. 1337(d)(1), (f)(1), and (g)(1).
Id. The notice of investigation named as
respondents Novo Nordisk A/S of
Bagsvaerd, Denmark and Novo Nordisk
Inc., of Plainsboro, NJ (collectively,
‘‘Novo Nordisk’’). Id. The Office of
Unfair Import Investigations (‘‘OUII’’) is
also a party to this investigation. Id.
On December 8, 2015, Baxter moved
for partial termination of this
investigation based on the withdrawal
of claims 21, 36, 37, and 39 of the ’061
patent; claims 1 and 10 of the ’252
patent; and claims 20 and 21 of the ’441
patent. That motion was granted,
leaving only claims 19 and 20 of the
’061 and claims 5, 8, 14, and 18 of the
’252 patent at issue. Order No. 23 (Dec.
10, 2016), unreviewed, Notice of
Commission Determination Not to
Review an Initial Determination
Granting a Motion for Partial
Termination of the Investigation with
Respect to Certain Claims (Jan. 6, 2016).
On September 17, 2015, the ALJ
issued Order No. 11, which construed
the terms ‘‘protein-free conditions’’ and
‘‘protein-free medium’’ in the asserted
claims of each asserted patent. On
December 4, 2015, Novo Nordisk moved
for reconsideration. On January 7, 2016,
the ALJ issued Order No. 25, which
granted the motion and reaffirmed her
previous claim constructions. On
January 11, 2016, Baxter filed a motion
requesting a summary determination
that the accused products infringe
claims 19 and 20 of the ’061 patent. On
February 26, 2016, the ALJ issued an
initial determination (‘‘ID’’) (Order No.
30), which granted the motion. On
February 29, 2016, Novo Nordisk filed
a petition requesting that the
Commission review Order Nos. 11, 25,
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
51463
and 30. On March 29, 2016, the
Commission determined to defer its
decision on whether to review those
orders until the date on which the
Commission determines whether to
review the ALJ’s final ID (FID). Notice
of Comm’n Determination to Extend the
Date for Determining Whether to Review
a Non-Final Initial Determination
Granting Complainants’ Motion for
Summary Determination that the
Accused Products Infringe U.S. Patent
No. 6,100,061 (Mar. 29, 2016).
On May 27, 2016, the ALJ issued the
FID, which found no violation of section
337 as to either remaining asserted
patent. Regarding the ’061 patent, the
ALJ concluded (1) claims 19 and 20 are
invalid as anticipated under 35 U.S.C.
102(g) and obvious under 35 U.S.C. 103;
(2) the economic prong of the domestic
industry requirement is not met; and (3)
the technical prong of the domestic
industry requirement is met by Baxter’s
Advate product. Regarding the ’252
patent, the ALJ concluded (1) Novo
Nordisk has not established the
invalidity of any asserted claim; (2)
Baxter failed to establish the economic
prong of the domestic industry
requirement; (3) the technical prong of
the domestic industry requirement is
met by Advate; and (4) Novo Nordisk’s
Novoeight is made by a process that
infringes claims 5, 8, 14, and 18.
On June 3, 2016, the ALJ issued her
Recommended Determination on
Remedy, Bonding, and the Public
Interest, which contingently
recommends both a limited exclusion
order (‘‘LEO’’) and cease and desist
orders (‘‘CDOs’’). If the Commission
finds a Section 337 violation, the ALJ
recommended that an LEO should be
issued that excludes recombinant factor
VIII products manufactured by
processes that infringe the asserted
claims. The ALJ further recommended
that the LEO should not extend to
products imported to support clinical
trials in the United States and that Novo
Nordisk should be required to certify to
U.S. Customs and Border Protection that
any imported Novoeight will be used
solely for such trials. The ALJ
additionally recommended that the LEO
provide for a grace period of 60 days
from the end of the Presidential review
period before the LEO is enforced.
Furthermore, the ALJ recommend that a
CDO containing the above exception
and grace period be directed to each
respondent. The ALJ also recommended
that no bond should be required during
the Presidential review period.
On June 13, 2016, Baxter and OUII
filed petitions for review of the FID, and
Novo Nordisk filed a contingent petition
for review. OUII and Baxter each
E:\FR\FM\04AUN1.SGM
04AUN1
51464
Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
petitioned for review of the ALJ’s
determination that Baxter did not meet
the economic prong of the domestic
industry requirement. Baxter
additionally petitioned for review of the
FID’s conclusions that the asserted
claims of the ’061 patent are anticipated
and rendered obvious. Novo Nordisk’s
contingent petition challenged the ALJ’s
construction of ‘‘protein-free’’ in the
asserted patents; the ALJ’s construction
of ‘‘selective pressure for the selective
marker’’ in the ’252 patent; and the
ALJ’s conclusion that Novo Nordisk
infringes the ’061 and ’252 patents. On
June 21, 2016, the parties filed
responses to the petitions. On July 5,
2016, Novo Nordisk filed its Statement
on the Public Interest, and on July 6,
2016, Baxter did the same. Members of
the public filed comments on the public
interest on June 27 and 28, 2016.
Having examined the record of this
investigation, including the FID and
Order Nos. 11, 25, and 30; the petitions
for review; and the responses thereto;
the Commission has determined to
review the FID in part and Orders Nos.
11, 25, and 30. Specifically, the
Commission has determined to review
the construction of ‘‘protein-free
medium’’ and ‘‘protein-free conditions’’
in Orders No. 11 and 25 and the ID
granting summary determination of
infringement of the asserted claims of
the ’061 patent in Order No. 30. The
Commission has also determined to
review the ALJ’s conclusion in the FID
that the asserted claims of the ’061
patent are anticipated and obvious. The
Commission has determined to review
and, on review, to reverse the ALJ’s
determination in the FID that the
economic prong of the domestic
industry requirement is not met as to
the ’061 and ’252 patents. The
Commission has determined not to
review the ALJ’s conclusion in the FID
that the ’252 patent is infringed.
The parties are requested to brief their
positions regarding the FID’s
determination that the ’061 patent is
anticipated, the relevant applicable law,
and the evidentiary record. In
connection with its review, the
Commission is particularly interested in
a response to the following:
The Federal Circuit has distinguished
printed publication prior art from prior use/
on sale prior art for purposes of the
enablement requirement of 35 U.S.C. 102 and
103. See In re Epstein, 32 F.3d 1559, 1567–
68 (Fed. Cir. 1994). Does this distinction have
implications for enablement for prior
inventions under 35 U.S.C. 102(g)?
In connection with the final
disposition of this investigation, the
Commission may (1) issue an order that
could result in the exclusion of the
VerDate Sep<11>2014
18:12 Aug 03, 2016
Jkt 238001
subject articles from entry into the
United States, and/or (2) issue one or
more cease and desist orders that could
result in the respondent being required
to cease and desist from engaging in
unfair acts in the importation and sale
of such articles. Accordingly, the
Commission is interested in receiving
written submissions that address the
form of remedy, if any, that should be
ordered. If a party seeks exclusion of an
article from entry into the United States
for purposes other than entry for
consumption, the party should so
indicate and provide information
establishing that activity involving other
types of entry either are adversely
affecting it or likely to do so. For
background, see Certain Devices for
Connecting Computers via Telephone
Lines, Inv. No. 337–TA–360, USITC
Pub. No. 2843 (December 1994)
(Commission Opinion).
If the Commission contemplates some
form of remedy, it must consider the
effects of that remedy upon the public
interest. The factors the Commission
will consider include the effect that an
exclusion order and/or cease and desist
orders would have on (1) the public
health and welfare, (2) competitive
conditions in the U.S. economy, (3) U.S.
production of articles that are like or
directly competitive with those that are
subject to investigation, and (4) U.S.
consumers. The Commission is,
therefore, interested in receiving written
submissions that address the
aforementioned public interest factors
in the context of this investigation.
The parties and the public are
requested to brief their positions
regarding the public interest. The
Commission is especially interested in
public comments from hemophilia A
patients and medical professionals with
experience in treating hemophilia A
patients. The Commission is
particularly interested in responses to
the following:
(1) What criteria are appropriate to
assess the scope of alternative
medications to Novoeight that are on the
market and that are available to new or
existing hemophilia A patients? For
example, given the increased safety of
third generation hemophilia A
medicines, should the relevant scope be
limited to third generation (or higher)
medications? Should the relevant scope
be limited to those alternative
medications suitable for patients of all
ages and suitable for prophylaxis
treatment? Applying these criteria,
please identify all available medications
that are suitable alternatives to
Novoeight.
(2) What is the likelihood that a
patient currently using Novoeight and
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
who has insurance coverage for
Novoeight will also have insurance
coverage for a comparable medication
that has similar therapeutic efficacy for
that patient?
(3) What costs will patients incur in
the process of switching from Novoeight
to a comparable alternative? For
example, does insurance typically cover
(and to what extent does insurance
cover) consultations with medical
professionals associated with the
switching process? Do the associated
consultations often take place at one of
the approximately 141 federally funded
Hemophilia Treatment Centers
(‘‘HTCs’’)? If so, do patients commonly
incur significant expenses in traveling
to those HTCs?
(4) What are the therapeutic and
safety advantages, if any, of choosing to
use Novoeight over Advate and/or other
competing medications available in the
U.S.?
(5) Do some patients have better
therapeutic outcomes with Novoeight
than other alternatives? If so, what
would the risks be of requiring a patient
to switch from Novoeight to a medicine
that is less effective for a given patient?
Could the risk of switching to a less
effective treatment include serious
health risks or death?
(6) How should the Commission take
into account hemophilia A patients’
well-documented fear of developing an
inhibitor upon switching hemophilia A
medications, given the potentially
serious consequences of developing an
inhibitor, regardless of the likelihood of
developing an inhibitor?
(7) How much weight should the
Commission give the fact that Novoeight
can be used by a patient for a longer
period after reconstitution, and that it
has a longer shelf life, than some other
medications? For example, how much
weight should the Commission give to
the fact that some patients may have
structured their lives around this
increased convenience and flexibility?
(8) Is the ALJ’s recommendation that
any remedial order should be delayed
for sixty days necessary and/or
sufficient to allow all individuals who
are currently using Novoeight to
transition to a different medicine? For
example,
(a) How much time is typically
needed to establish the viability of a
suitable alternative medicine for a
particular patient?
(b) How should the Commission
consider that some hemophilia A
patients may need additional time to
switch because (1) those patients have
upcoming scheduled surgeries, and/or
(2) those patients started using
Novoeight near the time of the issuance
E:\FR\FM\04AUN1.SGM
04AUN1
sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices
of any remedial order and should not
change hemophilia medications within
fifty days?
(c) If patients need to travel to and
schedule appointments at HTCs, is the
sixty day grace period sufficient?
(d) If all patients currently using
Novoeight need to begin seeking
alternative treatments at the same time,
is the availability of medical
professionals qualified to treat
hemophilia A sufficient to meet that
spike in demand such that all patients
can find alternative treatments within a
sixty day time frame?
(e) If the Commission were to limit a
remedy so that patients who cannot find
an alternative medicine within sixty
days (or other time period), despite
reasonable efforts, can continue to
obtain Novoeight, how could the
Commission do so without placing any
or only a minimal burden on patients or
medical professionals and still
guarantee access to Novoeight by those
patients? Could such a limit on the
remedy be crafted so that the parties,
Customs and Border Protection (‘‘CBP’’),
U.S. distributors and vendors, doctors,
and patients can maintain reliable
supplies of Novoeight for patients in
need?
(9) If the Commission were to tailor
any remedial order to allow current
users to continue to reliably obtain
Novoeight, how could the Commission
draft such an exception? Could such an
exception be crafted so that the parties,
CBP, U.S. distributors and vendors, the
appropriate decisionmakers, doctors or
other prescribers, and patients can
maintain reliable supplies of Novoeight
for patients in need while providing no
or only a minimal burden on medical
professionals and patients?
(10) If the Commission were to issue
a remedial order, to what extent should
the Commission craft the remedy so that
individuals who are seeking treatment
for hemophilia A for the first time and
for whom relevant alternative
medications are not suitable could
access Novoeight? For example,
(a) If such modification is appropriate,
how could it be accomplished?
(b) What standards should a physician
or other decisionmaker use to determine
whether such medicines are suitable for
the patient?
(c) Could such a limit on the remedy
be crafted so that the parties, CBP, U.S.
distributors and vendors, the
appropriate decisionmakers, doctors or
other prescribers, and patients can
maintain reliable supplies of Novoeight
for patients in need while providing no
or only a minimal burden on medical
professionals and patients?
VerDate Sep<11>2014
18:12 Aug 03, 2016
Jkt 238001
If the Commission orders some form
of remedy, the U.S. Trade
Representative, as delegated by the
President, has 60 days to approve or
disapprove the Commission’s action.
See Presidential Memorandum of July
21, 2005. 70 FR 43251 (July 26, 2005).
During this period, the subject articles
would be entitled to enter the United
States under bond, in an amount
determined by the Commission and
prescribed by the Secretary of the
Treasury. The Commission is, therefore,
interested in receiving submissions
concerning the amount of the bond that
should be imposed if a remedy is
ordered.
Written Submissions: The parties to
the investigation are requested to file
written submissions responding to the
above question regarding anticipation
under 35 U.S.C. 102(g) of the asserted
claims of the ’061 patent. Parties to the
investigation, interested government
agencies, and the public are encouraged
to file written submissions on the issues
of remedy, the public interest, and
bonding; and such submissions should
address the recommended
determination by the ALJ on remedy,
public interest, and bonding, and the
questions posed above. Complainants
are requested to submit proposed
remedial orders for the Commission’s
consideration. Complainants and OUII
are also requested to state the date that
the subject patents expire and the
HTSUS numbers under which the
accused products are imported.
Complainants are further requested to
supply the names of known importers of
the products at issue in this
investigation. The written submissions
and proposed remedial orders must be
filed no later than close of business on
August 19, 2016. Reply submissions
must be filed no later than the close of
business on August 26, 2016. No further
submissions will be permitted unless
otherwise ordered by the Commission.
Persons filing written submissions
must file the original document
electronically on or before the deadlines
stated above and submit eight true paper
copies to the Office of the Secretary by
noon the next day pursuant to section
210.4(f) of the Commission’s Rules of
Practice and Procedure (19 CFR
210.4(f)). Submissions should refer to
the investigation number (‘‘Inv. No.
337–TA–956’’) in a prominent place on
the cover page and/or the first page. (See
Handbook for Electronic Filing
Procedures, https://www.usitc.gov/
secretary/fed_reg_notices/rules/
handbook_on_electronic_filing.pdf).
Persons with questions regarding filing
should contact the Secretary (202–205–
2000).
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
51465
Any person desiring to submit a
document to the Commission in
confidence must request confidential
treatment. All such requests should be
directed to the Secretary to the
Commission and must include a full
statement of the reasons why the
Commission should grant such
treatment. See 19 CFR 201.6. Documents
for which confidential treatment by the
Commission is properly sought will be
treated accordingly. All information,
including confidential business
information and documents for which
confidential treatment is properly
sought, submitted to the Commission for
purposes of this Investigation may be
disclosed to and used: (i) By the
Commission, its employees and Offices,
and contract personnel (a) for
developing or maintaining the records
of this or a related proceeding, or (b) in
internal investigations, audits, reviews,
and evaluations relating to the
programs, personnel, and operations of
the Commission including under 5
U.S.C. Appendix 3; or (ii) by U.S.
government employees and contract
personnel, solely for cybersecurity
purposes. All nonconfidential written
submissions will be available for public
inspection at the Office of the Secretary
and on EDIS.
The authority for the Commission’s
determination is contained in section
337 of the Tariff Act of 1930, as
amended (19 U.S.C. 1337), and in part
210 of the Commission’s Rules of
Practice and Procedure (19 CFR part
210).
By order of the Commission.
Issued: July 29, 2016.
Katherine M. Hiner,
Acting Supervisory Attorney.
[FR Doc. 2016–18464 Filed 8–3–16; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Antitrust Division
United States v. Anheuser-Busch
InBev SA/NV et al.; Proposed Final
Judgment and Competitive Impact
Statement
Notice is hereby given pursuant to the
Antitrust Procedures and Penalties Act,
15 U.S.C. 16(b)–(h), that a proposed
Final Judgment, Stipulation, and
Competitive Impact Statement have
been filed with the United States
District Court for the District of
Columbia in United States of America v.
Anheuser Busch InBev SA/NV et al.,
Civil Action No. 1:16–cv–01483. On
July 20, 2016, the United States filed a
E:\FR\FM\04AUN1.SGM
04AUN1
Agencies
[Federal Register Volume 81, Number 150 (Thursday, August 4, 2016)]
[Notices]
[Pages 51463-51465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18464]
[[Page 51463]]
=======================================================================
-----------------------------------------------------------------------
INTERNATIONAL TRADE COMMISSION
[Investigation No. 337-TA-956]
Certain Recombinant Factor VIII Products; Determination To Review
In Part a Final Initial Determination Finding No Violation of Section
337 and a Summary Determination; Schedule for Filing Written
Submissions on One Issue Under Review and on Remedy, the Public
Interest, and Bonding
AGENCY: U.S. International Trade Commission.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Notice is hereby given that the U.S. International Trade
Commission has determined to review in part (1) the final initial
determination (``FID'') issued by the presiding administrative law
judge (``ALJ'') on May 27, 2016, finding no violation of section 337 of
the Tariff Act of 1930, as amended (19 U.S.C. 1337); and (2) the
initial determination issued on February 26, 2016, granting a summary
determination of infringement of U.S. Patent No. 6,100,061 (the
``Summary ID'') (Order No. 30). On review, the Commission has
determined to reverse the FID's finding that the economic prong of the
domestic industry was not met for either asserted patent. Other issues
remain on review.
FOR FURTHER INFORMATION CONTACT: Ron Traud, Office of the General
Counsel, U.S. International Trade Commission, 500 E Street SW.,
Washington, DC 20436, (202) 205-3427. Copies of non-confidential
documents filed in connection with this investigation are or will be
available for inspection during official business hours (8:45 a.m. to
5:15 p.m.) in the Office of the Secretary, U.S. International Trade
Commission, 500 E Street SW., Washington, DC 20436, (202) 205-2000.
General information concerning the Commission may also be obtained at
https://www.usitc.gov. The public record for this investigation may be
viewed on the Commission's electronic docketing system (EDIS) at https://edis.usitc.gov. Hearing-impaired persons are advised that information
on this matter can be obtained by contacting the Commission's TDD
terminal at (202) 205-1810.
SUPPLEMENTARY INFORMATION: On May 22, 2015, the Commission instituted
this investigation pursuant to section 337 of the Tariff Act of 1930,
as amended, based on a complaint filed by Baxter Healthcare Corporation
and Baxter Healthcare SA, both of Deerfield, Illinois. 80 FR 29745 (May
22, 2015). Baxalta Inc., Baxalta US Inc., and Baxalta GmbH were added
as complainants after the filing of the complaint. 80 FR 62569 (Oct.
16, 2015). (The complainants are collectively referred to as
``Baxter.'') The Commission sought to determine whether there is a
violation of section 337(a)(1)(B) in the importation into the United
States, the sale for importation into the United States, or the sale
within the United States after importation of certain recombinant
factor VIII products by reason of infringement of any of claims 19-21,
36, 37, and 39 of U.S. Patent No. 6,100,061 (``the '061 patent'');
claims 20 and 21 of U.S. Patent No. 6,936,441 (``the '441 patent'');
and claims 1, 5, 8, 10, 14, and 18 of U.S. Patent No. 8,084,252 (``the
'252 patent''). 80 FR at 29746. The Commission directed the ALJ to make
findings of fact and provide a recommended determination with respect
to the statutory public interest factors set forth in 19 U.S.C.
1337(d)(1), (f)(1), and (g)(1). Id. The notice of investigation named
as respondents Novo Nordisk A/S of Bagsvaerd, Denmark and Novo Nordisk
Inc., of Plainsboro, NJ (collectively, ``Novo Nordisk''). Id. The
Office of Unfair Import Investigations (``OUII'') is also a party to
this investigation. Id.
On December 8, 2015, Baxter moved for partial termination of this
investigation based on the withdrawal of claims 21, 36, 37, and 39 of
the '061 patent; claims 1 and 10 of the '252 patent; and claims 20 and
21 of the '441 patent. That motion was granted, leaving only claims 19
and 20 of the '061 and claims 5, 8, 14, and 18 of the '252 patent at
issue. Order No. 23 (Dec. 10, 2016), unreviewed, Notice of Commission
Determination Not to Review an Initial Determination Granting a Motion
for Partial Termination of the Investigation with Respect to Certain
Claims (Jan. 6, 2016).
On September 17, 2015, the ALJ issued Order No. 11, which construed
the terms ``protein-free conditions'' and ``protein-free medium'' in
the asserted claims of each asserted patent. On December 4, 2015, Novo
Nordisk moved for reconsideration. On January 7, 2016, the ALJ issued
Order No. 25, which granted the motion and reaffirmed her previous
claim constructions. On January 11, 2016, Baxter filed a motion
requesting a summary determination that the accused products infringe
claims 19 and 20 of the '061 patent. On February 26, 2016, the ALJ
issued an initial determination (``ID'') (Order No. 30), which granted
the motion. On February 29, 2016, Novo Nordisk filed a petition
requesting that the Commission review Order Nos. 11, 25, and 30. On
March 29, 2016, the Commission determined to defer its decision on
whether to review those orders until the date on which the Commission
determines whether to review the ALJ's final ID (FID). Notice of Comm'n
Determination to Extend the Date for Determining Whether to Review a
Non-Final Initial Determination Granting Complainants' Motion for
Summary Determination that the Accused Products Infringe U.S. Patent
No. 6,100,061 (Mar. 29, 2016).
On May 27, 2016, the ALJ issued the FID, which found no violation
of section 337 as to either remaining asserted patent. Regarding the
'061 patent, the ALJ concluded (1) claims 19 and 20 are invalid as
anticipated under 35 U.S.C. 102(g) and obvious under 35 U.S.C. 103; (2)
the economic prong of the domestic industry requirement is not met; and
(3) the technical prong of the domestic industry requirement is met by
Baxter's Advate product. Regarding the '252 patent, the ALJ concluded
(1) Novo Nordisk has not established the invalidity of any asserted
claim; (2) Baxter failed to establish the economic prong of the
domestic industry requirement; (3) the technical prong of the domestic
industry requirement is met by Advate; and (4) Novo Nordisk's Novoeight
is made by a process that infringes claims 5, 8, 14, and 18.
On June 3, 2016, the ALJ issued her Recommended Determination on
Remedy, Bonding, and the Public Interest, which contingently recommends
both a limited exclusion order (``LEO'') and cease and desist orders
(``CDOs''). If the Commission finds a Section 337 violation, the ALJ
recommended that an LEO should be issued that excludes recombinant
factor VIII products manufactured by processes that infringe the
asserted claims. The ALJ further recommended that the LEO should not
extend to products imported to support clinical trials in the United
States and that Novo Nordisk should be required to certify to U.S.
Customs and Border Protection that any imported Novoeight will be used
solely for such trials. The ALJ additionally recommended that the LEO
provide for a grace period of 60 days from the end of the Presidential
review period before the LEO is enforced. Furthermore, the ALJ
recommend that a CDO containing the above exception and grace period be
directed to each respondent. The ALJ also recommended that no bond
should be required during the Presidential review period.
On June 13, 2016, Baxter and OUII filed petitions for review of the
FID, and Novo Nordisk filed a contingent petition for review. OUII and
Baxter each
[[Page 51464]]
petitioned for review of the ALJ's determination that Baxter did not
meet the economic prong of the domestic industry requirement. Baxter
additionally petitioned for review of the FID's conclusions that the
asserted claims of the '061 patent are anticipated and rendered
obvious. Novo Nordisk's contingent petition challenged the ALJ's
construction of ``protein-free'' in the asserted patents; the ALJ's
construction of ``selective pressure for the selective marker'' in the
'252 patent; and the ALJ's conclusion that Novo Nordisk infringes the
'061 and '252 patents. On June 21, 2016, the parties filed responses to
the petitions. On July 5, 2016, Novo Nordisk filed its Statement on the
Public Interest, and on July 6, 2016, Baxter did the same. Members of
the public filed comments on the public interest on June 27 and 28,
2016.
Having examined the record of this investigation, including the FID
and Order Nos. 11, 25, and 30; the petitions for review; and the
responses thereto; the Commission has determined to review the FID in
part and Orders Nos. 11, 25, and 30. Specifically, the Commission has
determined to review the construction of ``protein-free medium'' and
``protein-free conditions'' in Orders No. 11 and 25 and the ID granting
summary determination of infringement of the asserted claims of the
'061 patent in Order No. 30. The Commission has also determined to
review the ALJ's conclusion in the FID that the asserted claims of the
'061 patent are anticipated and obvious. The Commission has determined
to review and, on review, to reverse the ALJ's determination in the FID
that the economic prong of the domestic industry requirement is not met
as to the '061 and '252 patents. The Commission has determined not to
review the ALJ's conclusion in the FID that the '252 patent is
infringed.
The parties are requested to brief their positions regarding the
FID's determination that the '061 patent is anticipated, the relevant
applicable law, and the evidentiary record. In connection with its
review, the Commission is particularly interested in a response to the
following:
The Federal Circuit has distinguished printed publication prior
art from prior use/on sale prior art for purposes of the enablement
requirement of 35 U.S.C. 102 and 103. See In re Epstein, 32 F.3d
1559, 1567-68 (Fed. Cir. 1994). Does this distinction have
implications for enablement for prior inventions under 35 U.S.C.
102(g)?
In connection with the final disposition of this investigation, the
Commission may (1) issue an order that could result in the exclusion of
the subject articles from entry into the United States, and/or (2)
issue one or more cease and desist orders that could result in the
respondent being required to cease and desist from engaging in unfair
acts in the importation and sale of such articles. Accordingly, the
Commission is interested in receiving written submissions that address
the form of remedy, if any, that should be ordered. If a party seeks
exclusion of an article from entry into the United States for purposes
other than entry for consumption, the party should so indicate and
provide information establishing that activity involving other types of
entry either are adversely affecting it or likely to do so. For
background, see Certain Devices for Connecting Computers via Telephone
Lines, Inv. No. 337-TA-360, USITC Pub. No. 2843 (December 1994)
(Commission Opinion).
If the Commission contemplates some form of remedy, it must
consider the effects of that remedy upon the public interest. The
factors the Commission will consider include the effect that an
exclusion order and/or cease and desist orders would have on (1) the
public health and welfare, (2) competitive conditions in the U.S.
economy, (3) U.S. production of articles that are like or directly
competitive with those that are subject to investigation, and (4) U.S.
consumers. The Commission is, therefore, interested in receiving
written submissions that address the aforementioned public interest
factors in the context of this investigation.
The parties and the public are requested to brief their positions
regarding the public interest. The Commission is especially interested
in public comments from hemophilia A patients and medical professionals
with experience in treating hemophilia A patients. The Commission is
particularly interested in responses to the following:
(1) What criteria are appropriate to assess the scope of
alternative medications to Novoeight that are on the market and that
are available to new or existing hemophilia A patients? For example,
given the increased safety of third generation hemophilia A medicines,
should the relevant scope be limited to third generation (or higher)
medications? Should the relevant scope be limited to those alternative
medications suitable for patients of all ages and suitable for
prophylaxis treatment? Applying these criteria, please identify all
available medications that are suitable alternatives to Novoeight.
(2) What is the likelihood that a patient currently using Novoeight
and who has insurance coverage for Novoeight will also have insurance
coverage for a comparable medication that has similar therapeutic
efficacy for that patient?
(3) What costs will patients incur in the process of switching from
Novoeight to a comparable alternative? For example, does insurance
typically cover (and to what extent does insurance cover) consultations
with medical professionals associated with the switching process? Do
the associated consultations often take place at one of the
approximately 141 federally funded Hemophilia Treatment Centers
(``HTCs'')? If so, do patients commonly incur significant expenses in
traveling to those HTCs?
(4) What are the therapeutic and safety advantages, if any, of
choosing to use Novoeight over Advate and/or other competing
medications available in the U.S.?
(5) Do some patients have better therapeutic outcomes with
Novoeight than other alternatives? If so, what would the risks be of
requiring a patient to switch from Novoeight to a medicine that is less
effective for a given patient? Could the risk of switching to a less
effective treatment include serious health risks or death?
(6) How should the Commission take into account hemophilia A
patients' well-documented fear of developing an inhibitor upon
switching hemophilia A medications, given the potentially serious
consequences of developing an inhibitor, regardless of the likelihood
of developing an inhibitor?
(7) How much weight should the Commission give the fact that
Novoeight can be used by a patient for a longer period after
reconstitution, and that it has a longer shelf life, than some other
medications? For example, how much weight should the Commission give to
the fact that some patients may have structured their lives around this
increased convenience and flexibility?
(8) Is the ALJ's recommendation that any remedial order should be
delayed for sixty days necessary and/or sufficient to allow all
individuals who are currently using Novoeight to transition to a
different medicine? For example,
(a) How much time is typically needed to establish the viability of
a suitable alternative medicine for a particular patient?
(b) How should the Commission consider that some hemophilia A
patients may need additional time to switch because (1) those patients
have upcoming scheduled surgeries, and/or (2) those patients started
using Novoeight near the time of the issuance
[[Page 51465]]
of any remedial order and should not change hemophilia medications
within fifty days?
(c) If patients need to travel to and schedule appointments at
HTCs, is the sixty day grace period sufficient?
(d) If all patients currently using Novoeight need to begin seeking
alternative treatments at the same time, is the availability of medical
professionals qualified to treat hemophilia A sufficient to meet that
spike in demand such that all patients can find alternative treatments
within a sixty day time frame?
(e) If the Commission were to limit a remedy so that patients who
cannot find an alternative medicine within sixty days (or other time
period), despite reasonable efforts, can continue to obtain Novoeight,
how could the Commission do so without placing any or only a minimal
burden on patients or medical professionals and still guarantee access
to Novoeight by those patients? Could such a limit on the remedy be
crafted so that the parties, Customs and Border Protection (``CBP''),
U.S. distributors and vendors, doctors, and patients can maintain
reliable supplies of Novoeight for patients in need?
(9) If the Commission were to tailor any remedial order to allow
current users to continue to reliably obtain Novoeight, how could the
Commission draft such an exception? Could such an exception be crafted
so that the parties, CBP, U.S. distributors and vendors, the
appropriate decisionmakers, doctors or other prescribers, and patients
can maintain reliable supplies of Novoeight for patients in need while
providing no or only a minimal burden on medical professionals and
patients?
(10) If the Commission were to issue a remedial order, to what
extent should the Commission craft the remedy so that individuals who
are seeking treatment for hemophilia A for the first time and for whom
relevant alternative medications are not suitable could access
Novoeight? For example,
(a) If such modification is appropriate, how could it be
accomplished?
(b) What standards should a physician or other decisionmaker use to
determine whether such medicines are suitable for the patient?
(c) Could such a limit on the remedy be crafted so that the
parties, CBP, U.S. distributors and vendors, the appropriate
decisionmakers, doctors or other prescribers, and patients can maintain
reliable supplies of Novoeight for patients in need while providing no
or only a minimal burden on medical professionals and patients?
If the Commission orders some form of remedy, the U.S. Trade
Representative, as delegated by the President, has 60 days to approve
or disapprove the Commission's action. See Presidential Memorandum of
July 21, 2005. 70 FR 43251 (July 26, 2005). During this period, the
subject articles would be entitled to enter the United States under
bond, in an amount determined by the Commission and prescribed by the
Secretary of the Treasury. The Commission is, therefore, interested in
receiving submissions concerning the amount of the bond that should be
imposed if a remedy is ordered.
Written Submissions: The parties to the investigation are requested
to file written submissions responding to the above question regarding
anticipation under 35 U.S.C. 102(g) of the asserted claims of the '061
patent. Parties to the investigation, interested government agencies,
and the public are encouraged to file written submissions on the issues
of remedy, the public interest, and bonding; and such submissions
should address the recommended determination by the ALJ on remedy,
public interest, and bonding, and the questions posed above.
Complainants are requested to submit proposed remedial orders for the
Commission's consideration. Complainants and OUII are also requested to
state the date that the subject patents expire and the HTSUS numbers
under which the accused products are imported. Complainants are further
requested to supply the names of known importers of the products at
issue in this investigation. The written submissions and proposed
remedial orders must be filed no later than close of business on August
19, 2016. Reply submissions must be filed no later than the close of
business on August 26, 2016. No further submissions will be permitted
unless otherwise ordered by the Commission.
Persons filing written submissions must file the original document
electronically on or before the deadlines stated above and submit eight
true paper copies to the Office of the Secretary by noon the next day
pursuant to section 210.4(f) of the Commission's Rules of Practice and
Procedure (19 CFR 210.4(f)). Submissions should refer to the
investigation number (``Inv. No. 337-TA-956'') in a prominent place on
the cover page and/or the first page. (See Handbook for Electronic
Filing Procedures, https://www.usitc.gov/secretary/fed_reg_notices/rules/handbook_on_electronic_filing.pdf). Persons with questions
regarding filing should contact the Secretary (202-205-2000).
Any person desiring to submit a document to the Commission in
confidence must request confidential treatment. All such requests
should be directed to the Secretary to the Commission and must include
a full statement of the reasons why the Commission should grant such
treatment. See 19 CFR 201.6. Documents for which confidential treatment
by the Commission is properly sought will be treated accordingly. All
information, including confidential business information and documents
for which confidential treatment is properly sought, submitted to the
Commission for purposes of this Investigation may be disclosed to and
used: (i) By the Commission, its employees and Offices, and contract
personnel (a) for developing or maintaining the records of this or a
related proceeding, or (b) in internal investigations, audits, reviews,
and evaluations relating to the programs, personnel, and operations of
the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S.
government employees and contract personnel, solely for cybersecurity
purposes. All nonconfidential written submissions will be available for
public inspection at the Office of the Secretary and on EDIS.
The authority for the Commission's determination is contained in
section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and
in part 210 of the Commission's Rules of Practice and Procedure (19 CFR
part 210).
By order of the Commission.
Issued: July 29, 2016.
Katherine M. Hiner,
Acting Supervisory Attorney.
[FR Doc. 2016-18464 Filed 8-3-16; 8:45 am]
BILLING CODE 7020-02-P