2—Market transparency competition: public interest prong is key—empirics.

The Supreme Court admonished the practice of categorically defining the limits of patentability.175 In the absence of a categorical approach, permanent injunctions in patent cases must be based on a case-by-case assessment.176 Two recent cases, however, demonstrate a possible shift in courts’ remedial approach to medical device and medical process infringement cases; in addition, these decisions are inconsistent with the findings discussed above regarding courts’ predictability in interpreting and applying the eBay test.177 Accordingly, it seems that the ruling in eBay impacts the biotechnology and medical device industries more significantly than other high tech industries. A. Conceptus v. Hologic In Conceptus, Inc. v. Hologic, Inc.,178 a recent decision from the Northern District of California, the court denied a permanent injunction in a dispute between two medical device companies producing transcervical hysteroscopic sterilization devices.179 The court found that Hologic’s contraceptive device did not infringe the Conceptus’ patented device.180 Conceptus, however, had also secured patent protection on the method by which treating physicians implanted the sterilization device in the patient’s body.181 The court found that 175 “[T]raditional equitable principles do not permit such broad classifications . . . . Just as the District court erred in its categorical of equitable relief, the Court of Appeals erred in its categorical grant of such relief.” eBay, 547 U.S. at 393-94; see Janutis, supra note 149, at 604-05. 176 eBay, 547 U.S. at 393-94. 177 See generally Conceptus, Inc. v. Hologic, Inc., No. C 09-02280 WHA, 2012 WL 44064 (N.D. Cal. Jan. 9, 2012); Bard Peripheral Vascular v. W.L. Gore & Assoc., Inc., No. CV-03-0597-PHX-MHM, 2009 WL 920300 (D. Ariz., Mar. 31, 2009); see also supra note 175 and accompanying text. 178 Conceptus, 2012 WL 44064, at *2. 179 Id; see also Conceptus, Inc. v. Hologic, Inc., 771 F. Supp. 2d 1164 (N.D. Cal. 2010) (“The Adiana system [Hologic], like the Essure System [Conceptus], supposedly involves the minimally invasive transcervical placement of a contraceptive device into woman’s fallopian tubes. . . . [Both systems are] intended to produce intrafallopian occlusion . . . .”). 180 Conceptus, 2012 WL 44064, at *2 (“The insert itself was accused as well but it was found to infringe in pretrial rulings.”); Conceptus, 771 F. Supp. 2d at 1177 (holding that even applying the rule provided in Graver, the two devices were not similar enough to merit a finding of infringement); see also Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 608 (1950) (“[I]f two devices do the same work in substantially the same way, and accomplish substantially the same result, they are the same, even though they differ in name, form, or shape.”). 181 Conceptus, 771 F. Supp. 2d at 1170-71 (“Claims 37 and 38 (as well as independent claim 36, which 296 B.U. J. SCI. & TECH. L. Vol. 20:2 Conceptus held valid patents on method claims associated with the insertion of the contraceptive device.182 Subsequently, the jury found that, by selling its device, Hologic induced doctors’ direct infringement of the patented method, and thereby incurred liability for both direct and indirect infringement of “certain method claims of Conceptus’ patent.”183 In denying Conceptus’ motion for permanent injunctive relief, the judge noted: The public interest would undoubtedly be harmed by an injunction. Enjoining the sale of Adiana would leave only one product for transcervical hysteroscopic sterilization. Public health has benefitted, and will continue to benefit, from having a choice of products for transcervical hysteroscopic sterilization. This is especially important because the products are different. Removing Adiana from the market would have eliminated an important alternative for patients.184 Conceptus and Hologic compete directly and, at the time of the dispute, produced the only transcervical hysteroscopic sterilization devices available on the market.185 Still, the court held that public interest in increased choice of medical devices is so strong that it is best served by denying a permanent injunction.186 The court’s reasoning fails to follow the consistent pattern typically followed by those courts applying the eBay decision.187 they reference) cover a contraceptive method: 36. An intrafallopian contraceptive method comprising of: transcervically introducing a pre-formed resilient structure into a target region of a fallopian tube; imposing an anchoring force against a tubal wall of the fallopian tube by resiliently engaging in inner surface of the tubal wall with the resilient structure; and permanently affixing the resilient structure within the fallopian tube with a lumen-traversing region of the resilient structure so that at least a portion of the fallopian tube is open. 37. A method as claimed in claim 36, wherein the affixing step comprises promoting tissue ingrowth of the tubal wall surrounding the resilient structure. 38. A method as claimed in claim 37, wherein the tissue ingrowth occludes the fallopian tube to inhibit contraception.”) (emphasis omitted). 182 Id. at 1177-79. 183 The jury awarded damages of about $18 million. Conceptus, 2012 WL 44064, at *2. Conceptus moved for permanent injunctive relief and enhanced money damages. Id. See also 35 U.S.C. § 271(b)-(c) (2012). 184 Conceptus, 2012 WL 44064, at *3 (emphasis added). 185 Conceptus, 771 F. Supp. 2d at 1179 (“In this action, Hologic does not dispute the fact that Conceptus’ Essure product and Hologic’s Adiana product were the only two transcervical intrafallopian contraception methods on the U.S. market during the relevant time period.”). 186 Conceptus, 2012 WL 44064, at *3. 187 See Janutis, supra note 149, at 604 (explaining that, following the Supreme Court’s holding in eBay, lower courts do not often deny permanent injunctions 2014 The Future of Medical Device Patents 297 Not only were Conceptus and Hologic direct competitors and the only two companies producing transcervical hysteroscopic sterilization devices at the time, Conceptus’ Essure system was the company’s only marketed device.188 The facts of Conceptus are perfectly in line with the reported trend of granting injunctive relief, even pursuant to a more stringent interpretation of direct competition.189 The court clearly grounded its decision on the notion that permanent injunction relief would seriously disservice the public.190 Further, the decision seems to echo Justice Kennedy’s concerns about the suspect nature of method patents.191 One way to interpret Conceptus is that the public interest is best served by denying permanent injunction when the infringed patent is merely a medical method.192 The next case, however, indicates the trend of denying injunctive relief expands beyond medical procedure patents. B. Bard Peripheral Vascular v. W.L. Gore & Associates In Bard Peripheral Vascular v. W.L. Gore & Associates,193 the Federal Circuit affirmed the district court decision denying a permanent injunction despite a finding of willful infringement of a validly held medical device patent.194 At issue in this extremely complicated dispute was a patent for “prosthetic vascular grafts fabricated from highly-expanded polytetrafluoroethlyne (‘ePTFE’) vascular grafts.”195 The district court denied Bard permanent injunctive relief but the jury awarded $102,081,578.82 for lost profits and $83,508,292.20 for reasonable royalties.196 Following the jury verdict, Bard where the parties are direct competitors and a jury finds infringement of a valid patent.) 188 Conceptus, 2012 WL 44064, at *2. 189 See supra Part IV.C. 190 Conceptus, 2012 WL 44064, at *3. 191 Id. (noting that the insert itself infringes nothing; rather, it is merely “the procedure for inserting it was found by the jury to infringe the method claims in suit.”). Justice Kennedy expressed doubts regarding potentially vague method patents; however, he only specifically pointed to business method patents as cause for concern. eBay, Inc. v. MercExchange, L.L.C., 547 U.S. 388, 396-97 (2006) (Kennedy, J., concurring). 192 Conceptus, 2012 WL 44064, at *3. See generally eBay, 547 U.S. at 396-97 (Kennedy, J., concurring). 193 Bard Peripheral Vascular v. W.L. Gore & Assocs., 670 F.3d. 1171 (Fed. Cir. 2012). 194 Id. at 1193. 195 Id. at 1175 (“This has been a long and arduous journey for the parties in this litigation, but this should be the final curtain of the saga, which commenced in 1974 with the filing of the patent application that eventually matured as U.S. Patent No. 6,436,135.”). 196 Id. at 1178. 298 B.U. J. SCI. & TECH. L. Vol. 20:2 moved for permanent injunctive relief.197 The court held that the public was best served by the availability of different options in the medical field regardless of evidence showing that the devices were interchangeable in the market.198 Perhaps imprecisely, the court construed the fourth prong of the eBay test as requiring that the public interest favor the injunction.199