Acorda Therapeutics v. Mylan Pharms., 2015-1456 (Fed. Cir. March 18, 2016)
AstraZeneca v. Mylan Pharms, 2015-1460 (Fed. Cir. March 18, 2016)
Where is an ANDA applicant subject to personal jurisdiction when the only act of infringement is "artificial" infringement under 35 U.S.C. § 271(e)(2)(A)? This question has generated a great deal of interest recently--especially since the Supreme Court's Daimler decision two years ago. In a precedential opinion on Friday, the Federal Circuit answered the question and determined that personal jurisdiction exists in any state where the ANDA applicant intends to market its product--essentially everywhere in the United States.
Mylan filed ANDAs in connection with Ampyra® (dalfampridine), Onglyza® (saxagliptin), and Kombiglyze® (saxagliptin/metformin). Acorda markets Ampyra® for the treatment of multiple sclerosis while AstraZeneca markets Onglyza® and Kombiglyze® for the treatment of type 2 diabetes. Both Acorda and AstraZeneca sued Mylan in Delaware, and Mylan filed motions to dismiss for lack of personal jurisdiction in both cases.
Both motions were denied. In the dalfampridine case, Judge Stark held that Mylan was subject to both general and specific personal jurisdiction. In the saxagliptin case, Judge Sleet held that Mylan was subject to specific personal jurisdiction, but not general personal jurisdiction. Mylan sought and obtained interlocutory review by the Federal Circuit of both of those orders. The appeal attracted six amicus filings, including briefs from GPhA, Teva, BIO, and PhRMA.
The Federal Circuit majority opinion limited its analysis to specific personal jurisdiction. The court began with the rule from International Shoe: specific personal jurisdiction may be exercised over a defendant "when the defendant has certain minimum contacts with the forum such that the maintenance of the suit does not offend traditional notions of fair play and substantial justice." Further, "the minimum contacts requirement focuses on whether the defendant's suit-related conduct creates a substantial connection with the form State."
In short, the Federal Circuit held that specific personal jurisdiction may be exercised over Mylan because "the minimum-contacts standard is satisfied by the particular actions Mylan has already taken--its ANDA filings--for the purpose of engaging in that injury-causing and allegedly wrongful marketing conduct in Delaware."
The fact that the infringement at issue in the cases was "artificial" infringement under 35 U.S.C. § 271(e)(2)(A) was used by the Federal Circuit to support its holding. The court explained that this statute is directed to the real-world consequence of marketing a generic in competition with the brand name drug: "concrete, non-artificial acts of infringement." Having determined that infringement under section 271(e)(2)(A) carries real-world consequences (and is more than an "artificial" construct), the Federal Circuit analogized the lawsuits against Mylan for intended future actions to "suits for retrospective relief based on past acts" and noted that the Supreme Court has defined minimum contacts in those retrospective contexts:
In a formulation worded to address suits for retrospective relief based on past acts, the Supreme Court has said that the minimum-contacts requirement is met when the defendant "purposefully directed" activities at the forum, and the litigation results from alleged injuries that "arise out of or relate to" those activities.
The Federal Circuit explained that Mylan's ANDA filings constituted activities purposefully directed at Delaware and that the lawsuits resulted from injuries that the plaintiffs would sustain by Mylan's activity:
Mylan's ANDA conduct is "suit-related" and has a "substantial connection" with Delaware because the ANDA filings are tightly tied, in purpose and planned effect, to the deliberate making of sales in Delaware (at least) and the suit is about whether that in-State activity will infringe valid patents. Thus, Mylan's ANDA filings constitute formal acts that reliably indicate plans to engage in marketing of the proposed generic drugs. Delaware is undisputedly a State where Mylan will engage in that marketing if the ANDAs are approved. And the marketing in Delaware that Mylan plans is suit-related: the suits over patent validity and coverage will directly affect when the ANDA can be approved to allow Mylan's Delaware marketing and when such marketing can lawfully take place.
Although the majority opinion did not address the issue of general personal jurisdiction, Judge O'Malley's concurring opinion did. Judge O'Malley wrote that a straightforward application of Supreme Court precedent also establishes general personal jurisdiction in these cases. It may be, however, that the question of general personal jurisdiction is now moot given the court's analysis of specific personal jurisdiction.
Momenta and Sandoz v. Teva, No. 2014-1274 (Fed. Cir.)
Momenta and Sandoz v. Amphastar, No. 2014-1276 (Fed. Cir.)
In a precedential opinion today, in companion cases concerning generic enoxaparin, the Federal Circuit reached two decisions that pharmaceutical companies should take note of:
1. Teva's enoxaparin is not "made by" a patented process within the meaning of § 271(g) because the process is used merely "to ensure that the intended product or substance has in fact been made." In other words, the process simply "provides information regarding a substance that has already been made but does not transform it."
2. The safe harbor of § 271(e)(1) does not apply to Amphastar's "routine quality control testing of each batch of generic enoxaparin as part of the post-approval, commercial production process."
Momenta and Sandoz, which were the first to market a generic version of Sanofi's anticoagulant Lovenox (enoxaparin), asserted U.S. Patent No. 7,575,886 against Teva and Amphastar. The '886 patent claims methods for analyzing enoxaparin to determine whether it has the appropriate chemical structure. Momenta alleged that Teva's and Amphastar's enoxaparin manufacturing processes infringe the '886 patent.
The Federal Circuit's decision concerning § 271(g) was a split decision, with Judges Wallach and Moore in the majority and Judge Dyk dissenting. According to the majority opinion, Momenta argued that its patented method "is used [by Teva] to select and separate batches of intermediate drug substance that conform to USP requirements for enoxaparin from batches that do not," and that selected batches are then used to make the finished drug product. The majority concluded, "Although Momenta's arguments are not without merit, it is more consonant with the language of the statute, as well as with this court's precedent, to limit § 271(g) to the actual 'ma[king]' of a product, rather than extend its reach to methods of testing a final product or intermediate substance to ensure that the intended product or substance has in fact been made."
Judge Dyk, in dissent, argued that "the quality control testing method of the '886 patent is a necessary intermediate step in the manufacture of enoxaparin." He warned:
Patents on purification methods or the quality control method at issue here, which may be integral to the regulatory or commercial viability of a product, but which do not create or transform a product, combine components, or confer new properties, could be freely infringed simply by outsourcing those processes abroad. Congress could not have intended to create this loophole when it sought to protect process patent owners from foreign competitors using U.S. manufacturing processes abroad.
The Federal Circuit's decision concerning the 271(e)(1) safe harbor is especially interesting because the court previously reached the opposite conclusion during the preliminary injunction phase of the case (Momenta I). There, the court found that Amphastar's testing according to the patented method was protected by the safe harbor because it was "necessary both to the continued approval of the ANDA and to the ability to market the generic drug." The majority in that case distinguished the facts from those in Classen, where the court held that § 271(e)(1) "does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained." In Momenta I, Judge Moore wrote the opinion for the majority, which included Judge Dyk, while Chief Judge Rader vigorously dissented.
This time around, the panel (which again included Judges Dyk and Moore) unanimously held that § 271(e)(1) does not exempt Amphastar's testing. The court states, "With the benefit of additional briefing in the current appeals, which reflects the full district court record developed by all parties after the preliminary injunction phase, we conclude Amphastar's submissions are appropriately characterized as 'routine.'" According to the court, "The conclusion in Momenta I that Amphastar's commercial use of Momenta's patented method falls within the safe harbor of § 271(e)(1) would result in manifest injustice. Amphastar points to no case, until Momenta I, extending immunity under § 271(e)(1) to encompass activities related to ongoing commercial manufacture and sale." Thus, the court vacated the district court's grant of summary judgment to Amphastar and remanded the case.
Amgen v. Sandoz, No. 15-1499 (Fed. Cir. May 5, 2015)
In a per curium Order today, the Federal Circuit granted Amgen's Emergency Motion for an Injunction Pending Appeal, stalling, at least temporarily, Sandoz's commercial launch of Zarxio, a biosimilar version of Amgen's Neupogen (filgrastim). Zarxio is the first biosimilar product approved by FDA under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). FDA approved Zarxio on March 6, and Sandoz agreed not to commercially launch the product until May 11 or a Federal Circuit ruling in its favor.
The primary issue in the case is whether the pre-litigation information-exchange provisions of the BPCIA are mandatory, as Amgen argues, or optional, as Sandoz contends. The BPCIA states that a biosimilar applicant "shall provide" a copy of its FDA application and manufacturing information to the Reference Product Sponsor (RPS)--here, Amgen. The statute further states that in the event that a biosimilar applicant fails to provide its application and manufacturing information, the RPS may file a declaratory judgment action against the applicant. Sandoz argues that a biosimilar applicant therefore has a choice: either provide a copy of its application and manufacturing information to the RPS and proceed to the subsequent information-exchange provisions of the BPCIA (including the exchange of patent lists, invalidity and non-infringement contentions, etc.), or accept the consequence of a declaratory judgment action filed against it.
Amgen filed suit against Sandoz last October, alleging state-law claims of unfair competition and conversion based on Sandoz's alleged failure to comply with the BPCIA, as well as patent infringement. With Sandoz's biosimilar application proceeding quickly toward FDA approval, Amgen filed a motion for preliminary injunction against Sandoz in February. On March 19, the district court denied Amgen's motion, ruling that the information-exchange provisions of the BPCIA are optional and that Sandoz fully complied with the law.
Amgen immediately appealed to the Federal Circuit, and, two days after the district court denied Amgen's motion for injunction pending appeal, filed the emergency motion that the court granted today. Amgen's appeal attracted the support of three amicus filings, by BIO, AbbVie, and Janssen, while GPhA, Celltrion, and Hospira filed amicus briefs in support of Sandoz.
Amgen and Sandoz requested an expedited appeal schedule, which the Federal Circuit granted. Briefing is complete, and the court scheduled oral argument for June 3rd. The standard for granting a motion for injunction pending appeal is high--"whether the movant has made a strong showing of likelihood of success on the merits." It therefore appears likely that that Federal Circuit will ultimately reverse the district court and rule that the pre-litigation information-exchange provisions of the BPCIA are mandatory.
McAndrews Shareholder Sandra Frantzen will be one of the featured speakers at American Conference Institute's "Summit on U.S. Biosimilars" conference in Munich, Germany, April 20-21. Ms. Frantzen will be speaking on "Incorporating Inter-Partes Review and New USPTO Procedures into Branded and Biosimilar Litigation Strategies."
Other speakers include in-house counsel and executives from AbbVie, Boehringer Ingelheim, IPM Biotech, PAREXEL, Sandoz, and Sanofi, as well as outside counsel from U.S. and European firms.
The complete agenda is as follows:
Orange Book Blog readers can save €100 with discount code OBB100. For more information or to register, please visit the conference website.
Apotex Inc. v. Daiichi Sankyo, Inc., Nos. 2014-1282, 2014-1291 (Fed. Cir. Mar. 31, 2015)
Apotex, Inc. sued Daiichi Sankyo Co., Ltd. and Daiichi Sankyo, Inc. in the United States District Court for the Northern District of Illinois for a declaratory judgment of non-infringement of a Daiichi-owned, but Daiichi-disclaimed, patent, if Apotex were to manufacture or sell a generic drug bioequivalent of Daiichi’s Benicar®. On March 31, 2015, a three-judge Federal Circuit panel unanimously reversed the district court’s dismissal for lack of case of controversy. The Federal Circuit found that Apotex has a concrete, potentially high-value stake in obtaining a declaratory judgment, and that both Daiichi and generic manufacturer Mylan Pharmaceuticals, Inc. have a concrete, potentially high-value stake in denying Apotex that judgment and thereby delaying Apotex’s market entry.
The factual background is key to understanding the debate. Daiichi listed two patents covering Benicar® in the Orange Book. The first, U.S. Patent No. 5,616,599, covers the active ingredient of the drug, and expires on April 25, 2016. Because Daiichi provided the FDA with pediatric test results, the FDA must wait a further six months, until October 25, 2016, to approve a generic version of the drug. The second, U.S. Patent No. 6,878,703, covers methods of treatment, and expires on November 19, 2021.
In April 2006, Mylan filed an ANDA with a paragraph IV certification that both the ’599 and ’703 patents were invalid or not infringed by Mylan’s proposed generic drug. In July 2006, for reasons that remain unexplained, Daiichi disclaimed all claims of the ’703 patent, as permitted under 35 U.S.C. § 253. Daiichi then sued Mylan for infringing the ’599 patent. Only validity was disputed in the case, and after trial, the court upheld the validity of the ’599 patent and entered judgment of infringement against Mylan. With the validity of the ’599 patent intact, Mylan’s earliest date for market entry is October 26, 2016, six months after the ’599 patent expires. Note that as a result of the court’s decision, Mylan did not have a lawfully-maintained paragraph IV certification with respect to the ’599 patent.
In June 2012, Apotex filed its own ANDA with a paragraph III certification stating that the ’599 patent is valid and a paragraph IV certification that Apotex would not infringe the now-disclaimed ’703 patent. Essentially, Apotex sought approval to enter the market for generic versions of Benicar® at the same time as Mylan—on October 26, 2016.
The wrinkle is that Daiichi did not sue Apotex for infringing the disclaimed ’703 patent, and the FDA has not removed the ’703 patent from the Orange Book. Under § 355(j)(5)(B)(iv), because Mylan was the first ANDA filer and Mylan has lawfully maintained a paragraph IV certification regarding the ’703 patent, Mylan is presumptively entitled to 180 days’ exclusivity before facing competition from another generic manufacturer. Thus, if Mylan were to enter the market for generic version of Benicar® on October 26, 2016, it would presumptively be entitled to exclusivity until April 23, 2017.
By filing its declaratory judgment action, Apotex sought to enforce a provision provided in § 355(j)(5)(D)(i)(I)(bb)(AA) for forfeiture of Mylan’s 180-day exclusivity period if Mylan has not marketed its generic drug 75 days after a court has entered a final decision from which no appeal (certiorari aside) has been or can be taken that the ’703 patent is invalid or not infringed.
The parties did not dispute that allowing Apotex to enter the market earlier would likely transfer sales from Daiichi and Mylan to Apotex. But Daiichi maintained that there was no case or controversy because it could not assert its disclaimed ’703 patent against Apotex, and Mylan additionally argued that Apotex lacks a “tentative approval” from the FDA for its ANDA and thus any delayed-market-entry injury is unduly speculative.
The Federal Circuit found, in contrast to the district court, that a case or controversy did exist, because the drug sales over a potential six-month period of exclusivity are concrete and substantial. The court contrasted the present parties’ substantial, concrete stakes in a judgment of non-infringement with cases in which a case or controversy was missing because the plaintiffs had generalized or bystander interest in others’ compliance with law.
The Federal Circuit also provided a common sense reasoning regarding the fact that the now-disclaimed ’703 patent is the only barrier to Apotex entering the market at the same time as Mylan. Had Daiichi never listed the ’703 patent in the Orange Book, Mylan would not be eligible for an exclusivity period. Thus, Apotex seeks through its declaratory judgment action to eliminate the entry barrier created by Daiichi’s listing of the ’703 patent that Daiichi subsequently disclaimed.
ACI's "Paragraph IV Disputes Master Symposium" returns to Chicago next week, September 30 to October 1. According to ACI, this is an "advanced forum for brand name and generic counsel on the intricacies of Hatch-Waxman litigation."
The agenda includes the following presentations:
ACI is also offering two pre-conference workshops on Monday, September 29: "PTO Procedures Practice Boot Camp for Paragraph IV Litigators" and "A Judge's Perspective on Effectively and Ethically Communicating with the Court in Paragraph IV Matters," which will feature four former federal judges.
Mention discount code OBB200 to save $200 on registration. For more information, please visit the conference website.
Tyco Healthcare et al. v. Mutual Pharm. et al., No. 2013-1386 (Fed. Cir.)
In 2006, Mutual filed an ANDA for a generic version of Restoril (temazepam), including a paragraph IV certification to Tyco's U.S. Patent No. 5,211,954. Tyco filed suit against Mutual under 35 USC 271(e)(2), Mutual responded with antitrust counterclaims (which the court temporarily stayed pending resolution of the case), and the case proceeded to judgment.
The district court found in 2009 that Mutual did not infringe the '954 patent under section 271(e)(2) because Mutual's product, when manufactured to the ANDA's specification (i.e., where temazepam has a specific surface area of at least 2.2 m2/g), could not infringe the patent (which claims temazepam having a specific surface area of 0.65-1.1 m2/g).
On August 5, 2009, the day after the district court entered its judgment of noninfringement, Tyco filed a citizen petition urging the FDA to change the criteria for evaluating the bioequivalence of generic temazepam products in order to "help ensure therapeutic equivalence." On September 8, 2009, while the citizen petition was still pending, the FDA approved Mutual's ANDA. The FDA denied Tyco's citizen petition in its entirety five months later.
After the Federal Circuit affirmed the district court's later decision that the '954 patent was invalid for obviousness, the district court lifted the stay of Mutual's antitrust counterclaims. In an opinion on January 18, 2013, the district court granted summary judgment to Tyco on Mutual's counterclaims, which, according to the Federal Circuit, were based on four arguments:
In a 2-1 decision last week (over Judge Newman's dissent), the Federal Circuit affirmed two aspects of the district court decision and vacated two others. The court affirmed the summary judgment against Mutual's claim that no reasonable litigant could have expected Tyco's patent to be upheld as valid and affirmed the summary judgment against Mutual's Walker Process fraud claim. The court vacated the summary judgment that Tyco's infringement claim under 271(e)(2) was not sham and that Tyco's citizen petition to the FDA was not a sham.
The premise of Mutual's argument that Tyco's 271(e)(2) infringement claim was a sham was that Mutual's ANDA specified that the temazepam in Mutual's ANDA product would have a specific surface area outside of the range claimed in the '954 patent. The Federal Circuit stated that "it is not unreasonable for a patent owner to allege infringement under section 271(e)(2)(A) if the patent owner has evidence that the as-marketed commercial ANDA product will infringe, even though the hypothetical product specified in the ANDA could not infringe." But the court found that there was conflicting evidence concerning the specific surface area of the temazepam in Mutual's ANDA product, and remanded for the district court to "determine whether Mutual has shown that the subjective element of the sham-litigation test has been satisfied."
Similarly, the Federal Circuit found that there were disputed issues of fact precluding summary judgment with respect to whether Tyco's citizen petition was a sham. The court stated:
Particularly probative of whether the citizen petition was reasonable is the FDA's response, which denied the petition in terms indicating that, in the FDA's view, it was wholly without merit. The FDA found that Tyco had "provided no evidence from clinical trials, pharmacokinetic studies, bioequivalence testing, or any other source . . . . Instead the petition relies entirely on uncorroborated generalities and theoretical speculation to support its critical point."
The court also noted that "Mutual's expert reviewed the citizen petition and concluded that 'Tyco did not have a scientific basis to conclude that Mutual's production would not be bioequivalent to Restoril.'" The court concluded, "The testimony of Mutual's expert and the FDA's response to the citizen petition are sufficient evidence from which a reasonable finder of fact could conclude that Tyco's citizen petition was objectively baseless."
With regard to the subjective prong of the test, the Federal Circuit found it significant that Tyco filed the citizen petition just one day after the district court granted summary judgment of noninfringement. Mutual argued that "filing the citizen petition at that late date caused the FDA to delay the approval of Mutual's ANDA, and thus resulted in a further period of market exclusivity for Tyco." Mutual also pointed to an email from Tyco's R&D group stating that a temazepam formulation that was bioequivalent to Restoril could be made from temazepam having a different specific surface area. The court concluded, "The timing of the citizen petition and the email are sufficient evidence from which a reasonable finder of fact could determine that Mutual had satisfied the subjective element necessary to show that Tyco's citizen petition was a sham."
The Federal Circuit found, however, that there was an open issue "as to whether the filing of the citizen petition caused any antitrust injury to Mutual." Thus, the court remanded the case with instructions for the district court to "determine whether Mutual suffered an anticompetitive harm in the form of a delay in the approval of its ANDA due to the filing of Tyco's citizen petition with the FDA."
We are proud that McAndrews Shareholder Nabeela Rasheed will be one of the featured speakers at American Conference Institute's inaugural "Women Leaders in Life Sciences Law" conference in Boston, July 28-29. Dr. Rasheed will be speaking on "Thinking Like a Leader: Updates on the Substantive Legal Developments Affecting Life Sciences Companies in 2014 and Beyond."
The conference will also include these presentations:
In addition, ACI will be hosting two post-conference working groups on July 29: "I Wish Someone Had Told Me: Advice from Life Sciences General Counsel on Embracing Influence and Power and Running a Successful Legal Department" and "Combating Gender Sterotypes in the Life Sciences Legal Community: Open Forum and Working Group on Overcoming Implicit Bias."
Orange Book Blog readers can receive $200 off the registration fee with discount code OBB 200. For more information or to register, please visit the conference website.
A group of twelve attorneys from McAndrews, Held & Malloy will be attending BIO 2014 in San Diego this week, and we're hosting a cocktail reception on Tuesday night. Please join us if you'll be attending BIO!