[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]



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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

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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

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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