This case is before the court on the parties’ cross-motions for partial summary judgment. Plaintiffs claim that the government is liable pursuant to 28 U.S.C. § 1498(a) for alleged patent infringement which occurred during the provision of medical services under the Medicare Act. For the reasons set forth below, the court grants defendant’s cross-motion for partial summary judgment and denies plaintiffs’ motion for partial summary judgment.
FACTS
Plaintiff, Lester M. Larson, is the owner of Patent No. 3,490,444, entitled “Thermoplastic Splint or Cast,” issued on January 20, 1970, Patent No. 3,809,600, entitled “Thermoplastic Splint or Cast,” issued on May 7, 1974, and Patent Reissue 30,541, entitled “Thermoplastic Splint or Cast,” issued on March 10, 1981. These patents cover an apparatus for splints used in treating patients for broken bones, strains, arthritis, and burn injuries. The patents also cover a process for application of the splint to the patient, which is performed by a physician or other medical personnel under specified conditions. The dispute arose when health care providers participating in the government programs of Medicare, Medicaid, and the Civilian Health and Medical Program for the Uniformed Services (“CHAMPUS”) used plaintiffs’ splints in medical treatment.
Under 42 U.S.C. §§ 1395h and 1395u, the Secretary of Health and Human Services is given the authority to enter into contracts with carriers and fiscal intermediaries.
Once treatment is administered, Medicare, Medicaid, and CHAMPUS, through their carriers and fiscal intermediaries, determine the rates and amounts of payments to providers, and reimburse health care providers for the procedure rendered to the patient. 42 U.S.C. § 1395u(a)(l). Under Medicare, Medicaid and CHAMPUS, the government will not reimburse providers for medical procedures or services which are not “reasonable and necessary.” 42 U.S.C. § 1395y(a)(l)(A). The medical procedures for which reimbursement may be requested are broadly designated by code numbers. The details of treatment, however, remain with the patient and his or her provider. Therefore, Medicare, Medicaid, and CHAMPUS health care providers and their patients determine the course of medical treatment, including the choice of casts and splints if required for treatment. Under 42 U.S.C. § 1395, the government neither requires, recommends, nor suggests that providers use particular types, models, or brand names of casts and splints. Furthermore, even though a splint may be medically necessary, neither the law nor the government mandates any particular
DISCUSSION
Summary judgment is appropriate when there is “no genuine issue as to a material fact” so that the moving party “is entitled to judgment as a matter of law.” RUSCC 56(c) (1991). A genuine issue of material fact is one that would change the outcome of the litigation. Anderson v. Liberty Lobby, Inc.,
Pursuant to 28 U.S.C. § 1498(a), the United States Claims Court has exclusive jurisdiction over claims against the government for unauthorized use of patented inventions.
In their motion before the court, plaintiffs did not deny the lack of patent infringement “by” the government or the lack of express authorization or consent by the government for infringement. Nor did the government in its motion deny that these thermoplastic splints were used by health care providers who were reimbursed by the Medicare program. Plaintiffs’ arguments focused on the validity of the Medicare Act as a source of implied authorization or consent of patent infringement “for” the government on which to base liability pursuant to 28 U.S.C. § 1498(a). As this is a contention of law, and there are no genuine issues of material fact, the court agrees with the parties that the case is ripe for disposition by summary judgment. As plaintiffs conceded that there
Plaintiffs argued that the language of the Medicare Act supported the assertion that the infringing activity was “for” the benefit of the government. Plaintiffs contended that since the government has an interest in providing treatment to certain segments of the population, the government received a benefit from any service or medical product the cost of which is reimbursed under Medicare. However, plaintiffs could point to no law in support of their position. The defendant argued that although the government has some general interest in funding medical treatment for certain citizens, the government has no interest in the particular medical products used in treatment.
According to Medtronic, Inc. v. Catalyst Research Corp.,
Under Carrier Corp. v. United States, the Court of Claims held that a government contractor’s use of a patented device to remove refuse was not a use by the government. Carrier Corp. v. United States,
Medical care is provided for the benefit of the patient, not the government. Home Health Services, Inc. v. Currie,
Even assuming that Medicare providers’ activities were “for” the government, liability would not attach unless the infringing activity occurred with the government’s authorization or consent. Hughes,
Having conceded that there was no express authorization or consent by the government to infringe on the patents, plaintiffs based their argument on an implied authorization by necessity theory. An implied authorization to infringe may be found under the following conditions: (1) the government expressly contracted for work to meet certain specifications; (2) the specifications cannot be met without infringing on a patent; and (8) the government had some knowledge of the infringement. Bereslavsky v. Esso Standard Oil Co.,
Plaintiffs asserted that every action taken, or product used, in a medical procedure reimbursed by Medicare must have been necessary because Medicare only reimburses providers for “reasonable and necessary” medical services. Following this logic, plaintiffs argued that any patent infringement that occurred in the medical procedure must also have been “necessary,” and therefore “authorized” by the government under the Medicare Act. Furthermore, plaintiffs asserted that when the Medicare carrier rendered payment to the provider for reasonable and necessary medical care, the payment constituted acceptance of the use of the particular methods or products under the terms of the service contract between the government and the provider, thus constituting “consent” to infringe on a patent.
Under plaintiffs’ theory, health care providers are government agents who consented to the use of patented methods or supplies. Therefore, the government is bound by the actions of its agents. The problem with plaintiffs’ argument is twofold. First, health care providers under Medicare, Medicaid, and CHAMPUS are not government agents. The cornerstone of any agency relationship is the power of the principal to control the day-to-day functions of the agent. Jack Eckerd Corp. v. Dart Group Corp.,
Furthermore, as the defendant indicated; the Medicare reimbursement standard is stated in the negative, providing only that the government will not pay for medical procedures or services that are not “reasonable and necessary.” 42 U.S.C. § 1395y(a)(l)(A). The statute does not suggest that every minor decision made in the course of medical treatment must itself be necessary. For example, treatment of a broken arm may be necessary and reimbursable generally, but the use of any particular splint or particular method for applying it would not be necessary to make the orthotic procedure itself eligible for reimbursement. The defendant established that a Medicare participation agreement between the government and health care pro
The court finds that the government did not impliedly agree to any underlying infringement simply by approving payment of medical claims for general procedures. Therefore, because there is no orthotic procedure recognized by Medicare as “necessary” that requires the use of plaintiffs’ patents, the Medicare Act provides no basis to find implied consent to any provider’s alleged infringement.
After a careful examination of the record, and giving the proper presumption and preferences required by the law of summary judgment, the court finds that the government, acting through Medicare, Medicaid, and CHAMPUS, did not infringe on any patent held by plaintiffs. Therefore, the court denies plaintiffs’ motion for partial summary judgment and grants defendant’s cross-motion for partial summary judgment. Plaintiffs’ claims against the government acting through Medicare, Medicaid, and CHAMPUS are dismissed.
IT IS SO ORDERED.
Notes
. A health care provider is a physician, or hospital employing medical care workers including physicians.
. Carriers and fiscal intermediaries are government contractors who administer payments to health care providers. Carriers handle claims covered under Medicare’s Part B program. Fiscal intermediaries handle claims covered under Medicare’s Part A program.
. The statute provides:
Whenever an invention described in and covered by a patent of the United States is used or manufactured by or for the United States without license of the owner thereof or lawful right to use or manufacture the same, the owner’s remedy shall be by action against the United States in the United States Claims Court for the recovery of his reasonable and entire compensation for such use and manufacture.
For the purposes of this section, the use or manufacture of an invention described in and covered by a patent of the United States by a contractor, a subcontractor, or any person, firm, or corporation for the Government and with the authorization or consent of the Government, shall be construed as use or manufacture for the United States.
28 U.S.C. § 1498 (1988).
