81 FR 51463 - 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

INTERNATIONAL TRADE COMMISSION

Federal Register Volume 81, Issue 150 (August 4, 2016)

Page Range		51463-51465
FR Document		2016-18464

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.

Federal Register, Volume 81 Issue 150 (Thursday, August 4, 2016)

[Federal Register Volume 81, Number 150 (Thursday, August 4, 2016)]
[Notices]
[Pages 51463-51465]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-18464]

[[Page 51463]]

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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.

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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
http://www.usitc.gov. The public record for this investigation may be
viewed on the Commission's electronic docketing system (EDIS) at http://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, http://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

Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices 51463

INTERNATIONAL TRADE Baxalta Inc., Baxalta US Inc., and and 30. On March 29, 2016, the
COMMISSION Baxalta GmbH were added as Commission determined to defer its
complainants after the filing of the decision on whether to review those
[Investigation No. 337–TA–956]
complaint. 80 FR 62569 (Oct. 16, 2015). orders until the date on which the
Certain Recombinant Factor VIII (The complainants are collectively Commission determines whether to
Products; Determination To Review In referred to as ‘‘Baxter.’’) The review the ALJ’s final ID (FID). Notice
Part a Final Initial Determination Commission sought to determine of Comm’n Determination to Extend the
Finding No Violation of Section 337 whether there is a violation of section Date for Determining Whether to Review
and a Summary Determination; 337(a)(1)(B) in the importation into the a Non-Final Initial Determination
Schedule for Filing Written United States, the sale for importation Granting Complainants’ Motion for
Submissions on One Issue Under into the United States, or the sale within Summary Determination that the
the United States after importation of Accused Products Infringe U.S. Patent
Review and on Remedy, the Public
certain recombinant factor VIII products No. 6,100,061 (Mar. 29, 2016).
Interest, and Bonding
by reason of infringement of any of On May 27, 2016, the ALJ issued the
AGENCY: U.S. International Trade claims 19–21, 36, 37, and 39 of U.S. FID, which found no violation of section
Commission. Patent No. 6,100,061 (‘‘the ’061 patent’’); 337 as to either remaining asserted
ACTION: Notice. claims 20 and 21 of U.S. Patent No. patent. Regarding the ’061 patent, the
6,936,441 (‘‘the ’441 patent’’); and ALJ concluded (1) claims 19 and 20 are
SUMMARY: Notice is hereby given that claims 1, 5, 8, 10, 14, and 18 of U.S. invalid as anticipated under 35 U.S.C.
the U.S. International Trade Patent No. 8,084,252 (‘‘the ’252 patent’’). 102(g) and obvious under 35 U.S.C. 103;
Commission has determined to review 80 FR at 29746. The Commission (2) the economic prong of the domestic
in part (1) the final initial determination directed the ALJ to make findings of fact industry requirement is not met; and (3)
(‘‘FID’’) issued by the presiding and provide a recommended the technical prong of the domestic
administrative law judge (‘‘ALJ’’) on determination with respect to the industry requirement is met by Baxter’s
May 27, 2016, finding no violation of statutory public interest factors set forth Advate product. Regarding the ’252
section 337 of the Tariff Act of 1930, as in 19 U.S.C. 1337(d)(1), (f)(1), and (g)(1). patent, the ALJ concluded (1) Novo
amended (19 U.S.C. 1337); and (2) the Id. The notice of investigation named as Nordisk has not established the
initial determination issued on February respondents Novo Nordisk A/S of invalidity of any asserted claim; (2)
26, 2016, granting a summary Bagsvaerd, Denmark and Novo Nordisk Baxter failed to establish the economic
determination of infringement of U.S. Inc., of Plainsboro, NJ (collectively, prong of the domestic industry
Patent No. 6,100,061 (the ‘‘Summary ‘‘Novo Nordisk’’). Id. The Office of requirement; (3) the technical prong of
ID’’) (Order No. 30). On review, the Unfair Import Investigations (‘‘OUII’’) is the domestic industry requirement is
Commission has determined to reverse also a party to this investigation. Id. met by Advate; and (4) Novo Nordisk’s
the FID’s finding that the economic On December 8, 2015, Baxter moved Novoeight is made by a process that
prong of the domestic industry was not for partial termination of this infringes claims 5, 8, 14, and 18.
met for either asserted patent. Other investigation based on the withdrawal On June 3, 2016, the ALJ issued her
issues remain on review. of claims 21, 36, 37, and 39 of the ’061 Recommended Determination on
patent; claims 1 and 10 of the ’252 Remedy, Bonding, and the Public
FOR FURTHER INFORMATION CONTACT: Ron
patent; and claims 20 and 21 of the ’441 Interest, which contingently
Traud, Office of the General Counsel,
patent. That motion was granted, recommends both a limited exclusion
U.S. International Trade Commission, order (‘‘LEO’’) and cease and desist
leaving only claims 19 and 20 of the
500 E Street SW., Washington, DC orders (‘‘CDOs’’). If the Commission
’061 and claims 5, 8, 14, and 18 of the
20436, (202) 205–3427. Copies of non- finds a Section 337 violation, the ALJ
’252 patent at issue. Order No. 23 (Dec.
confidential documents filed in recommended that an LEO should be
10, 2016), unreviewed, Notice of
connection with this investigation are or issued that excludes recombinant factor
Commission Determination Not to
will be available for inspection during VIII products manufactured by
Review an Initial Determination
official business hours (8:45 a.m. to 5:15 processes that infringe the asserted
Granting a Motion for Partial
p.m.) in the Office of the Secretary, U.S. Termination of the Investigation with claims. The ALJ further recommended
International Trade Commission, 500 E Respect to Certain Claims (Jan. 6, 2016). that the LEO should not extend to
Street SW., Washington, DC 20436, On September 17, 2015, the ALJ products imported to support clinical
(202) 205–2000. General information issued Order No. 11, which construed trials in the United States and that Novo
concerning the Commission may also be the terms ‘‘protein-free conditions’’ and Nordisk should be required to certify to
obtained at http://www.usitc.gov. The ‘‘protein-free medium’’ in the asserted U.S. Customs and Border Protection that
public record for this investigation may claims of each asserted patent. On any imported Novoeight will be used
be viewed on the Commission’s December 4, 2015, Novo Nordisk moved solely for such trials. The ALJ
electronic docketing system (EDIS) at for reconsideration. On January 7, 2016, additionally recommended that the LEO
http://edis.usitc.gov. Hearing-impaired the ALJ issued Order No. 25, which provide for a grace period of 60 days
persons are advised that information on granted the motion and reaffirmed her from the end of the Presidential review
this matter can be obtained by previous claim constructions. On period before the LEO is enforced.
contacting the Commission’s TDD January 11, 2016, Baxter filed a motion Furthermore, the ALJ recommend that a
terminal at (202) 205–1810. requesting a summary determination CDO containing the above exception
SUPPLEMENTARY INFORMATION: On May
sradovich on DSK3GMQ082PROD with NOTICES

that the accused products infringe and grace period be directed to each
22, 2015, the Commission instituted this claims 19 and 20 of the ’061 patent. On respondent. The ALJ also recommended
investigation pursuant to section 337 of February 26, 2016, the ALJ issued an that no bond should be required during
the Tariff Act of 1930, as amended, initial determination (‘‘ID’’) (Order No. the Presidential review period.
based on a complaint filed by Baxter 30), which granted the motion. On On June 13, 2016, Baxter and OUII
Healthcare Corporation and Baxter February 29, 2016, Novo Nordisk filed filed petitions for review of the FID, and
Healthcare SA, both of Deerfield, a petition requesting that the Novo Nordisk filed a contingent petition
Illinois. 80 FR 29745 (May 22, 2015). Commission review Order Nos. 11, 25, for review. OUII and Baxter each

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51464 Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices

petitioned for review of the ALJ’s subject articles from entry into the who has insurance coverage for
determination that Baxter did not meet United States, and/or (2) issue one or Novoeight will also have insurance
the economic prong of the domestic more cease and desist orders that could coverage for a comparable medication
industry requirement. Baxter result in the respondent being required that has similar therapeutic efficacy for
additionally petitioned for review of the to cease and desist from engaging in that patient?
FID’s conclusions that the asserted unfair acts in the importation and sale (3) What costs will patients incur in
claims of the ’061 patent are anticipated of such articles. Accordingly, the the process of switching from Novoeight
and rendered obvious. Novo Nordisk’s Commission is interested in receiving to a comparable alternative? For
contingent petition challenged the ALJ’s written submissions that address the example, does insurance typically cover
construction of ‘‘protein-free’’ in the form of remedy, if any, that should be (and to what extent does insurance
asserted patents; the ALJ’s construction ordered. If a party seeks exclusion of an cover) consultations with medical
of ‘‘selective pressure for the selective article from entry into the United States professionals associated with the
marker’’ in the ’252 patent; and the for purposes other than entry for switching process? Do the associated
ALJ’s conclusion that Novo Nordisk consumption, the party should so consultations often take place at one of
infringes the ’061 and ’252 patents. On indicate and provide information the approximately 141 federally funded
June 21, 2016, the parties filed establishing that activity involving other Hemophilia Treatment Centers
responses to the petitions. On July 5, types of entry either are adversely (‘‘HTCs’’)? If so, do patients commonly
2016, Novo Nordisk filed its Statement affecting it or likely to do so. For incur significant expenses in traveling
on the Public Interest, and on July 6, background, see Certain Devices for to those HTCs?
2016, Baxter did the same. Members of Connecting Computers via Telephone (4) What are the therapeutic and
the public filed comments on the public Lines, Inv. No. 337–TA–360, USITC safety advantages, if any, of choosing to
interest on June 27 and 28, 2016. Pub. No. 2843 (December 1994) use Novoeight over Advate and/or other
Having examined the record of this (Commission Opinion). competing medications available in the
investigation, including the FID and If the Commission contemplates some U.S.?
Order Nos. 11, 25, and 30; the petitions form of remedy, it must consider the (5) Do some patients have better
for review; and the responses thereto; effects of that remedy upon the public therapeutic outcomes with Novoeight
the Commission has determined to interest. The factors the Commission than other alternatives? If so, what
review the FID in part and Orders Nos. will consider include the effect that an would the risks be of requiring a patient
11, 25, and 30. Specifically, the exclusion order and/or cease and desist to switch from Novoeight to a medicine
Commission has determined to review orders would have on (1) the public that is less effective for a given patient?
the construction of ‘‘protein-free health and welfare, (2) competitive Could the risk of switching to a less
medium’’ and ‘‘protein-free conditions’’ conditions in the U.S. economy, (3) U.S. effective treatment include serious
in Orders No. 11 and 25 and the ID production of articles that are like or health risks or death?
granting summary determination of directly competitive with those that are (6) How should the Commission take
infringement of the asserted claims of subject to investigation, and (4) U.S. into account hemophilia A patients’
the ’061 patent in Order No. 30. The consumers. The Commission is, well-documented fear of developing an
Commission has also determined to therefore, interested in receiving written inhibitor upon switching hemophilia A
review the ALJ’s conclusion in the FID submissions that address the medications, given the potentially
that the asserted claims of the ’061 aforementioned public interest factors serious consequences of developing an
patent are anticipated and obvious. The in the context of this investigation. inhibitor, regardless of the likelihood of
Commission has determined to review The parties and the public are developing an inhibitor?
and, on review, to reverse the ALJ’s requested to brief their positions (7) How much weight should the
determination in the FID that the regarding the public interest. The Commission give the fact that Novoeight
economic prong of the domestic Commission is especially interested in can be used by a patient for a longer
industry requirement is not met as to public comments from hemophilia A period after reconstitution, and that it
the ’061 and ’252 patents. The patients and medical professionals with has a longer shelf life, than some other
Commission has determined not to experience in treating hemophilia A medications? For example, how much
review the ALJ’s conclusion in the FID patients. The Commission is weight should the Commission give to
that the ’252 patent is infringed. particularly interested in responses to the fact that some patients may have
The parties are requested to brief their the following: structured their lives around this
positions regarding the FID’s (1) What criteria are appropriate to increased convenience and flexibility?
determination that the ’061 patent is assess the scope of alternative (8) Is the ALJ’s recommendation that
anticipated, the relevant applicable law, medications to Novoeight that are on the any remedial order should be delayed
and the evidentiary record. In market and that are available to new or for sixty days necessary and/or
connection with its review, the existing hemophilia A patients? For sufficient to allow all individuals who
Commission is particularly interested in example, given the increased safety of are currently using Novoeight to
a response to the following: third generation hemophilia A transition to a different medicine? For
The Federal Circuit has distinguished
medicines, should the relevant scope be example,
printed publication prior art from prior use/ limited to third generation (or higher) (a) How much time is typically
on sale prior art for purposes of the medications? Should the relevant scope needed to establish the viability of a
enablement requirement of 35 U.S.C. 102 and be limited to those alternative suitable alternative medicine for a
sradovich on DSK3GMQ082PROD with NOTICES

103. See In re Epstein, 32 F.3d 1559, 1567– medications suitable for patients of all particular patient?
68 (Fed. Cir. 1994). Does this distinction have ages and suitable for prophylaxis (b) How should the Commission
implications for enablement for prior treatment? Applying these criteria, consider that some hemophilia A
inventions under 35 U.S.C. 102(g)? please identify all available medications patients may need additional time to
In connection with the final that are suitable alternatives to switch because (1) those patients have
disposition of this investigation, the Novoeight. upcoming scheduled surgeries, and/or
Commission may (1) issue an order that (2) What is the likelihood that a (2) those patients started using
could result in the exclusion of the patient currently using Novoeight and Novoeight near the time of the issuance

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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 http://www.usitc.gov. The public record for this investigation may be viewed on the Commission's electronic docketing system (EDIS) at http:/ /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.
FR Citation		81 FR 51463