[Federal Register Volume 63, Number 85 (Monday, May 4, 1998)]
[Notices]
[Pages 24557-24558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11682]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96E-0189]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; LIPOSORBER<Register> LA-15 System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for LIPOSORBER<Register> LA-15 System and is 
publishing this notice of that determination as required by law. FDA 
has made the determination because of the submission of an application 
to the Commissioner of Patents and Trademarks, Department of Commerce, 
for the extension of a patent which claims that medical device.

ADDRESSES: Written comments and petitions should be directed to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health 
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-6620.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Pub. L. 100-670) generally provide 
that a patent may be extended for a period of up to 5 years so long as 
the patented item (human drug product, animal drug product, medical 
device, food additive, or color additive) was subject to regulatory 
review by FDA before the item was marketed. Under these acts, a 
product's regulatory review period forms the basis for determining the 
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A 
testing phase and an approval phase. For medical devices, the testing 
phase begins with a clinical investigation of the device and runs until 
the approval phase begins. The approval phase starts with the initial 
submission of an application to market the device and continues until 
permission to market the device is granted. Although only a portion of 
a regulatory review period may count toward the actual amount of 
extension that the Commissioner of Patents and Trademarks may award 
(half the testing phase must be subtracted as well as any time that may 
have occurred before the patent was issued), FDA's determination of the 
length of a regulatory review period for a medical device will include 
all of the testing phase and approval phase as specified in 35 U.S.C. 
156(g)(3)(B).
    FDA recently approved for marketing the medical device 
LIPOSORBER<Register> LA-15 System. LIPOSORBER<Register> LA-15 System is 
indicated for use in performing low density lipoprotein cholesterol 
(LDL-C) apheresis to acutely remove LDL-C from the plasma of high risk 
patient populations for whom diet has been ineffective and maximum drug 
therapy has either been ineffective or not tolerated. Subsequent to 
this approval, the Patent and Trademark Office received a patent term 
restoration application for LIPOSORBER<Register> LA-15 System (U.S. 
Patent No. 4,637,994) from Kanegafuchi Kagaku Kogyo Kabushiki Kaisha, 
and the Patent and Trademark Office requested FDA's assistance in 
determining this patent's eligibility for patent term restoration. In a 
letter dated August 7, 1996, FDA advised the Patent and Trademark 
Office that this medical device had undergone a regulatory review 
period and that the approval of LIPOSORBER<Register> LA-15 System 
represented the first permitted commercial marketing or use of the 
product. Shortly thereafter, the Patent and Trademark Office requested 
that FDA determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for 
LIPOSORBER<Register> LA-15 System is 3,598 days. Of this time, 1,995 
days occurred during the testing phase of the regulatory review period, 
while 1,603 days occurred during the approval

[[Page 24558]]

phase. These periods of time were derived from the following dates:
    1. The date a clinical investigation involving this device was 
begun: April 18, 1986. FDA has verified the applicant's claim that the 
date the investigational device exemption (IDE) required under section 
520(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)) 
for human tests to begin became effective April 18, 1996, the date that 
the IDE for a similar, related product, LIPOSORBER<Register> LA-40 
System, was approved.
    Although the device was subsequently modified, the results of the 
initial clinical investigations on the earlier model, 
LIPOSORBER<Register> LA-40 System were included in FDA's analysis of 
the approved product's safety and effectiveness. The test on the 
earlier model is, therefore, part of the testing phase.
    Additionally, the product is of a type which, under present 
regulations, would require IDE approval prior to the start of clinical 
investigations, and normally the initiation of the testing phase for a 
medical device is determined by reference to the approval phase of the 
relevant IDE.
    2. The date an application was initially submitted with respect to 
the device under section 515 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360e): October 3, 1991. The applicant claims March 24, 
1988, as the date the premarket approval application (PMA) for the 
LIPOSORBER<Register> LA-40 System (PMA 880019) was initially submitted, 
which applicant argues should be used in place of the PMA for 
LIPOSORBER<Register> LA-15 System (PMA 910018). FDA records indicate 
that PMA 880019 was received by the agnecy on March 25, 1998, but this 
PMA was never filed, and it was withdrawn by the applicant on April 3, 
1996. The applicant claims that PMA 910018 was submitted on March 26, 
1991, but FDA records indicate that it was submitted on October 3, 
1991.
    The applicant argues that the PMA for the LA-40 device should be 
used as the start of the approval phase for the LA-15 device, because 
its liposorber technology and adsorbent are identical to those 
described in the patent for which applicant is requesting extension, 
U.S. Patent No. 4,637,994. The LA-15 device contains additional 
components of a plasma separator, the tubing system for plasmaphereses 
and the apheresis unit.
    However, the patent term restoration regulations define the 
approval phase of medical device in terms of the actual approved 
product, not an earlier tested product. For example, while the patent 
term restoration statute does define drug product as the active 
ingredient of a new drug, ``product'' for ``medical devices'' has been 
defined as ``[a]ny medical device * * * subject to regulation under the 
Federal Food, Drug, and Cosmetic Act'' (35 U.S.C. 156(f)). Given that 
the LA-40 device was withdrawn by applicant from further regulatory 
consideration, the LA-15 device is the only applicable medical device 
subject to FDA regulations.
    Regarding the definition of regulatory review period for the start 
of the approval phase of a medical device, the regulations state ``* * 
* the period beginning on the date the application was initially 
submitted with respect to the device under section 515 and ending on 
the date such application was approved under such Act * * *'' 35 U.S.C. 
156(g)(3)(B); see also 21 CFR 60.22(c)(2)(i). In this case, the only 
PMA which submitted, filed, and approved under section 515 of the 
Federal Food, Drug, and Cosmetic Act was PMA P910018, which was 
submitted on October 3, 1991, and is, therefore, the appropriate date 
the approval application was initially submitted for 
LIPOSORBER<Register> LA-15 System.
    3. The date the application was approved: February 21, 1996. FDA 
has verified the applicant's claim that PMA P9910018 was approved on 
February 21, 1996.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the U.S. 
Patent and Trademark Office applies several statutory limitations in 
its calculations of the actual period for patent extension. In its 
application for patent extension, this applicant seeks 1,825 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before July 6, 1998, submit to the Dockets 
Management Branch (address above) written comments and ask for a 
redetermination. Furthermore, any interested person may petition FDA, 
on or before November 2, 1998, for a determination regarding whether 
the applicant for extension acted with due diligence during the 
regulatory review period. To meet its burden, the petition must contain 
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the 
format specified in 21 CFR 10.30.
    Comments and petitions should be submitted to the Dockets 
Management Branch (address above) in three copies (except that 
individuals may submit single copies) and identified with the docket 
number found in brackets in the heading of this document. Comments and 
petitions may be seen in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

    Dated: March 31, 1998.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 98-11682 Filed 5-1-98; 8:45 am]
BILLING CODE 4160-01-F