The CP solves certainty and broad public health needs better than the aff.

Courts should apply a rebuttable presumption that the public interest weighs in favor of denying injunctive relief for the following reasons.

1. Judicial Uniformity The most striking reason that courts should apply a rebuttable presumption that the public interest weighs in favor of denying injunctive relief in all cases that involve medically-related patents is judicial uniformity. Of the cases described in Part IV, one glaring conclusion is apparent: courts apply the traditional four factors unpredictably in these cases, even when devices are relatively identical.218 Even when important devices that help sustain life are involved (i.e., prosthetic heart valves, vascular stents, and hemodialysis machines), courts unpredictably apply the factors, with some courts granting injunctive relief despite public interest concerns and other courts denying injunctive relief due to public interest concerns.219 This lack of judicial uniformity creates many problems. First, patients and health practitioners are unable to predict when injunctions may occur and lack adequate time to prepare for the transition resulting from injunctions. Also, legal practitioners are unable to predict outcomes based on the facts related to their individual cases. Furthermore, courts waste scarce judicial resources to determine injunctive relief in each fact-intensive case, although no factual similarities among medicallyrelated patent cases can explain courts’ denial or grant of injunctive relief. If a rebuttable presumption was applied in medically-related cases, patients and health practitioners would no longer be blindsided by the sudden effect of a permanent injunction, legal practitioners would be able to better predict judicial outcomes based on the facts of their cases, and courts would no longer waste judicial resources to determine injunctive relief for each medically-related patent infringement case. Even if a rebuttable presumption in these cases was considered to be too expansive, courts should attempt to create predictable outcomes of injunctive relief based on specific factual differences. For example, courts could establish categorical denial or grant of injunctive relief based on certain factual trends (i.e., type of device or drug involved or medical condition treated by the device or drug).

2. Physician Preference Another reason that courts should apply a rebuttable presumption of public interest is because of physician preference for the infringing device. Doctors may prefer the infringing device for many reasons including superiority of the infringing device, greater knowledge of the infringing device, or, simply, greater ease of use of the infringing device.220 While courts have commonly used physician preference for support in denying preliminary injunctions, physician preference has rarely been used in support of denying permanent injunctions.221 Physician preference is important because, if a permanent injunction is granted and the physician can no longer use the preferred infringing device, there are potential risks to the patient in continuing treatment. For example, in Advanced Cardiovascular, physician preference was used as support in denying a permanent injunction because declarations by four cardiologists each expressed “concern for the success of their surgeries should [the infringing] products be removed from the market.” 222

3. Interest in Medical Competition A third reason supporting a rebuttable presumption of public interest is the public interest in medical competition. This interest has been used by both district courts and the Federal Circuit to deny injunctive relief in cases involving coronary stents.223 Other courts have used this interest to support a denial of injunctive relief or limiting injunctive relief.224 The theory behind this interest is the need for patients to have alternative safe medical devices.225 Patients need to have more alternatives in the medical device market in order to make informed decisions about their treatment.226 When injunctions occur, patients are at risk of having only one viable option on the market,227 and, even worse, patients may have no viable alternatives after a permanent injunction due to supply issues with the patented product.

4. Supply of the Patented Product Another reason supporting a rebuttable presumption of public interest is the risk of the patent holder being unable to meet patient demand once the infringing product is taken off the market. While some courts have noted this concern, it has found little use in supporting a denial of injunctive relief.228 Even if a patent holder is able to meet customer demand this could potentially prove costly to patent holders who are ill-equipped to handle the rise in demand. This could make injunctive relief seem more like a curse than a blessing. Some courts have attempted to ease these supply concerns by providing transition periods that delay the time that the permanent injunction goes into effect.229 If courts are unwilling to apply a rebuttable presumption of public interest in medicallyrelated patent cases, courts should allow for periods of transition in all medically-related infringement cases to protect the public from potential supply issues. Finally, while unrelated to the supply of the patent holder’s product, there have been expressed concerns regarding the unused supply of the infringing product when a permanent injunction ceases its distribution.230 This can lead to waste that ultimately harms the general public.231

5. Costs of Transition A fifth reason supporting a rebuttable presumption of public interest is the exorbitant costs of transition in the event of a permanent injunction. Patients may take on additional costs due to an increase in price for the alternative product or additional appointments with doctors to make the transition.232 Additionally, patients may even be encouraged not to make the transition, thus placing them at increased health risks.233 Patients are not the sole cost-bearing entity in a transition, however. Medical professionals can also experience exorbitant transitional costs including training of personnel to use the alternative device, increasing prices for the alternative device, and disposal of existing inventories of the infringing product.234

6. Other Considerations Underlying each preceding reason is the primary concern for patient safety. However, there are additional considerations that help support the necessity for a rebuttable presumption of public interest. These considerations include potential inequitable use of the patent by the patentee, potential harm when the patentee does not commercially practice the patent, or the harm to patient privacy and the physician-patient relationship in enforcing the injunction.235