By Riëtte van Laack –

As we previously reported in January 2013, the Federal Trade Commission (“FTC”) determined that POM Wonderful, LLC’s advertising for its products violated the FTC Act and issued a cease and desist order restraining POM’s future advertising.

On March 8, 2013, POM filed a petition for review of the FTC’s Order in the D.C. Circuit.  Surprisingly, however, POM did not request a stay from FTC and, has not sought a stay from the D.C. Circuit.  Thus, the January 2013 cease and desist order has become effective.

Dispositive motions with regard to POM’s D.C. Circuit lawsuit are due on April 25, 2013.

By Kurt R. Karst –      

Over the past week we’ve been inundated with new items concerning generic drug labeling and whether federal law – the FDC Act and FDA’s implementing regulations – preempts state-law product liability claims (failure-to-warn, design defect, failure-to-conform/update, etc.) against generic drug manufacturers.  This is all happening just as the U.S. Supreme Court is set to hear Oral Argument on Tuesday, March 19th in Mutual Pharmaceutical Co. v. Bartlett (Docket No. 12-142), a design defect generic drug preemption case. 

At the heart of all of this is the U.S. Supreme Court’s decision in PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011), in which the Court ruled that FDA’s regulations preventing generic drug manufacturers from changing their labeling except to mirror the label of the brand-name manufacturer preempt state-law failure-to-warn claims against generic drug manufacturers, because it is impossible for generic drug manufacturers to comply with both federal and state duties to warn.  This is in contrast to the Court’s decision in Wyeth v. Levine, 555 U.S. 555 (2009), holding that a state-law tort action against a brand-name drug manufacturer for failure-to-warn is not preempted.

So here’s a run-down of the latest, including where things stand in the Bartlett case . . . .

Demahy v. Schwarz – Petition for Writ of Certiorari

This case has a lengthy history and involves the now familiar drug metoclopramide and allegations that a generic manufacturer’s version of the drug caused tardive dyskinesia in Petitioner Julie Demahy.  It is on its second petition to the U.S. Supreme Court.  In the first go-around (Docket No. 09-1501), the case was consolidated with Mensing, and the Court reversed a January 2010 decision from the U.S. Court of Appeals of the Fifth Circuit affirming a finding from the U.S. District Court for the Eastern District of Louisiana that Ms. Demahy’s state-law failure-to-warn claims are not preempted.  On remand, the Fifth Circuit mandated the district court to enter judgment in favor of the generic drug manufacturers.  In doing so, the Louisiana district court dismissed all of Ms. Demahy’s claims, including her allegations of design defect.  Ms. Demahy filed motions to alter the district court’s judgment and to revive her design defect claims.  Both motions were denied, and Ms. Demahy appealed the denials to the Fifth Circuit Court, which affirmed the district court decision in October 2012, stating that “Demahy’s only remaining claims had been characterized by the district court, this Court, and the Supreme Court as failure-to-warn claims.”  Moreover, said the Fifth Circuit, “even if we were to find that these claims survived [this Court’s] mandate . . . we would still affirm the district court insofar as the claims are, at base, failure-to-warn claims, which would be preempted in light of Mensing.”

In her petition for a writ of certiorari, Ms. Demahy presents the following question to the U.S. Supreme Court: “Are manufacturers of unreasonably dangerous generic drug products shielded from liability for design defect claims by virtue of federal preemption and PLIVA, Inc. v. Mensing?”  According to Ms. Demahy:

There is simply nothing in the district court’s order, or anywhere in the record, substantiating the [Fifth Circuit] court’s conclusion that Demahy’s design defect claims were somehow resolved in the course of the previous appeal.  To the contrary, there had never been any mention of these claims, and the court’s conclusion runs afoul of well-established law.

Moreover, according to Ms. Demahy, the Fifth Circuit court’s “determination that design defect claims are preempted by the duty of sameness at issue in Mensing” conflicts with the U.S. Supreme Court’s decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), in which the Court held that certain state-law tort claims involving medical devices cleared under the premarket notification (i.e., 510(k)) process are not preempted by federal law, and creates a split of authority with the First Circuit Court’s decision in Bartlett.  Even if the Court declines to grant certiorari in this case, Petitioner asks that the Court hold the case until the decision in Bartlett is issued.

Fulgenzi v. PLIVA, Inc. – U.S. Court of Appeals for the Sixth Circuit

The Sixth Circuit Court’s recent decision in Fulgenzi raised the profile of another state-law tort claim against generic drug manufacturers: failure-to-update.  The case, also involving the drug metoclopramide, stems from a decision from the U.S. District Court for the Northern District of Ohio, in which the district court ruled that allegations that a generic drug manufacturer failed to update labeling to conform to the labeling of the reference listed drug is just another failure-to-warn claim preempted by Mensing.  Specifically, a generic drug manufacturer did not include the statement “Therapy should not exceed 12 weeks in duration” after the reference listed drug labeling was updated to include the warning.

On appeal, Plaintiff-Appellant Eleanor Fulgenzi argued that the case presents an issue of first impression that the Sixth Circuit did not adddress in Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir. 2011), in which the Court did not find an exception to preemption for a state-law warning claim based on failure to comply with FDA regulations.  According to Ms. Fulgenzi, where a generic drug manufacturer could have independently added a warning through FDA’s Changes Being Effected (“CBE”) labeling regulations, a state-law claim based on that manufacturer’s failure to update its labeling through the CBE process to add a warning is not preempted on impossibility grounds.  Generic drug manufacturer PLIVA, Inc. argued that the case falls squarely within the four corners of Mensing and the Sixth Circuit’s Smith decision.  (Copies of the briefs in the case are available here, here, and here.)

The Sixth Circuit, as an initial matter, agreed with Ms. Fulgenzi that this is a case of first impression and that the Court’s Smith decision is not controlling.  “Although the Smith plaintiffs did raise the same arguments that Fulgenzi does here, they were raised only on supplemental briefing and, from the court’s opinion, it does not appear that they were considered.  As a result, we are not controlled by Smith and are faced with a question of first impression,” wrote the Court.  The Court then proceeded to conduct a preemption analysis in accordance with the principles articulated by the U.S. Supreme Court in Wyeth and Mensing.  Under that analysis, the Sixth Circuit found against preemption:

Mensing explains that the key question is “whether the private party could independently” comply with its state duty—without relying on the prior exercise of federal-agency discretion.  Wyeth, by contrast, holds that there is no impossibility as long as the approval comes after the independent action of the private party (especially where denial is speculative and unlikely).  In our case, not only could PLIVA have independently updated its labeling to match that of the branded manufacturer through the CBE process, but it had a federal duty to do so.  As a result, compliance with federal and state duties was not just possible; it was required.  Impossibility preemption is inappropriate in such a case.  It is true that the FDA had the authority to reject PLIVA’s labeling change after the fact.  But this is precisely the “possibility of impossibility” that Wyeth found insufficient to warrant preemption.  Indeed, as PLIVA had a clear federal duty to update its label, it is even less likely here that the FDA would have rejected the change.  This case, therefore, presents an even weaker case for impossibility preemption than Wyeth. [(Internal citations omitted; emphasis in original.)]

Fulgenzi is not the first instance in which a court has ruled against preemption in the faulire-to-update/failure-to-conform context.  Just a week before the Sixth Circuit ruled in Fulgenzi, the U.S. District Court for the Southern District of Texas denied a Motion to Dismiss filed by several generic defendants in yet another metoclopramide product liability case who argued that Mensing requires dismissal of the case.  “Generic Defendants were preempted by federal law from including additional warnings not approved by the FDA; however, they could, and indeed they were required to, ensure that their labeling contained the stronger, FDA-approved warnings for the name-brand drug,” wrote the district court in a March 7th decision.

Mutual Pharmaceutical Co. v. Bartlett – U.S. Supreme Court

The Bartlett case that will be argued in the U.S. Supreme Court this week (Docket No. 12-142) is a design defect generic drug preemption case that has garnered significant attention.  The question presented to the Court is whether the First Circuit Court erred when it ruled that federal law does not preempt state-law design defect claims concerning generic drug products because any conflict between federal and state law can be avoided if the the generic drug manufacturer stops selling its products.  As we previously reported, the First Circuit’s decision, which characterized Wyeth as a general no-preemption rule and Mensing as an exception to that rule, left a lot of jaws on the floor.

Mutual contends in its Surpeme Court brief that the case is controlled by a straightforward application of Mensing.  Bartlett contends, among other things, in her brief that the case differs fundamentally from the “negligence-based failure-to-warn claims” preempted in Mensing. In Mensing, says Bartlett, “state law undisputedly required the manufacturers affirmatively to improve the drug’s label.  Here, however, the only state-law obligation is to compensate consumers for injuries caused by an unreasonably dangerous product.  Nothing in federal law prohibits petitioner from paying compensatory damages to Ms. Bartlett.”  In a recent reply brief, Mutual has characterized this as Bartlett’s abandonment of the First Circuit’s stop-selling theory and simply wrong at every turn.

Many parties have come to Mutual’s defense.  Amicus briefs have been submitted by the Washington Legal Foundation and Allied Educational Foundation, several generic drug manufacturers, the Product Liability Advisory Council, Inc., DRI–The Voice of the Defense Bar, the Chamber of Commerce of the United States of America and PhRMA, and GPhA.

Perhaps the most interesting amicus brief is that of the United States.  The United States, which has been allocated time during Oral Argument, takes the position that Mensing controls the case and that the First Circuit Court’s stop-selling theory cannot be squared with Mensing, “which reflects an implicit judgment that the optio of withdrawing from a market is not sufficient to defeat impossibility preemption in this context.”  That being said, however, the amicus brief includes at footnote 2 an ominous remark: “FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances.  If such a regulatory change is adopted, it could eliminate preemption of failure-to-warn claims against generic-drug manufacturers.”  What might that “regulatory change” be?  We don’t know just yet; however, we understand that shortly after Mensing, FDA assembled a taskforce to analyze its regulations in light of the decision.  In addition, as we previously reported, in August 2011 Public Citizen submitted a citizen petition to FDA requesting that the Agency, in response to Mensing, amend its regulations to permit ANDA sponsors to revise their labeling through the CBE and Prior Approval Supplement procedures.  Although possible, it seems unlikely that FDA will propose new regulations or substantively respond to the Public Citizen petition before the Supreme Court hands down its decision in Bartlett.

By James R. Phelps –

George Miller Burditt died on March 13, 2013 following a heart attack.  He was 90 years of age.  With his passing the food and drug bar lost one of its most distinguished members.

People were drawn to George by his friendly, gracious manner.  He inspired trust in his clients and all those having dealings with him. In litigation, he relentlessly represented his clients, but opposing counsel would count him as a friend. 

He worked hard.  There was no 9 to 5 aspect to the work.  He tirelessly extended whatever effort the client’s needs required, and grateful clients saw the results.

George developed his practice as the food and drug bar was itself developing.  He gave much of his time to promote the understanding of food and drug law.  He wrote hundreds of papers and gave hundreds of speeches on the subject.  For 25 years he was general counsel to the Food and Drug Law Institute.  For decades he worked closely with the Association of Food and Drug Officials, providing training and serving on the board of the AFDO Foundation. The Regulatory Affairs Professional Society recognized his contributions with its highest honor.  He taught food and drug law for many years as an adjunct professor at Northwestern University.

Work, however, did not consume the complete man.  He played as hard as he worked, mostly in some kind of competition.  There was basketball in his youth, then tennis in his maturity.  He was a great competitor in cribbage and bridge.  And he loved gin rummy, where he was not as good as he thought he was.

Yet the foregoing was only a part of George’s busy life.

He obtained his undergraduate and law degrees from Harvard University, and he loved the school.  As an alumnus, he stayed engaged and did so much that he was made Grand Marshal one year.  A room in the law school has been named after him.

He was immersed in the civic life of Illinois, serving eight years in the Illinois House of Representatives, and acting at one time as the deputy leader of his party in that house.  He also represented the Republican Party as a candidate for U.S. senator.  In Chicago, he was honored by having a street named after him.

He leaves a large and loving family:  4 children, 11 grandchildren, 6 great-grandchildren (and 2 more on the way!)  His wife Barbara died many years ago; he found a wonderful companionship in his subsequent marriage to Mary Jayne (“MJ”) Mallory.

The last few years of George’s life were made difficult by a fall that resulted in impaired use of his legs.  The wheelchair did not dampen his spirit, however, and he remained as charming and as interested in the world as always.  In the last weeks of his life he was exchanging witty e-mails with old colleagues.

A life lived well.  George Miller Burditt, Requiescat in Pace.

By Alexander Varond –

On March 12, 2013, FDA released a draft version of a revision to the February 2000 final guidance entitled “Formal Dispute Resolution: Appeals Above the Division Level.”  We refer to the draft version as “Revision 1.”  Revision 1 retains the original title and many of the recommendations first published in the February 2000 guidance.
 
The most significant update in Revision 1 is the extent to which FDA emphasizes that new information or analyses should not be submitted as part of a formal dispute resolution request (“FDRR”).  Note, however, that this concept is not a major departure from FDA’s February 2000 guidance; in fact, the key language from that version remains in Revision 1:

Because all FDA decisions on any dispute must be based on information already in the relevant administrative file (§ 10.75(d)), no new information should be submitted as part of a request for reconsideration or appeal.

FDA added considerable language regarding the necessity for sponsors to present any new data or new analyses of data at the division level before incorporating those data or analyses into an FDRR.  The new language includes the following key points:

• “New analyses of data previously reviewed should be considered new information, and therefore should be submitted to the division for review before being submitted as support for an appeal.”

• “In addition, the FDA will not consider an appeal if information that has not been previously reviewed by the division has been submitted in support of the appeal.”

• “[W]hen the FDA [requests] additional clarifying information from the sponsor [as part of an FDRR], this does not mean new information that has not been reviewed by the division . . . .”

In addition, FDA explained that FDRRs will not be reviewed if the appealed issues are also currently under review at the division level.

Less substantive issues addressed by Revision 1 include an explanation of the review timelines for drugs subject to the Generic Drug User Fee Act and CBER-regulated products, updates to the FDRR submission procedure, and a clarification of the review timelines for responding to human drug application FDRRs related to PDUFA products.

By Kurt R. Karst –      

Briefing is underway in K-V Pharmaceutical Company’s (“KV’s”) appeal of a September 2012 decision from the U.S. District Court for the District of Columbia that stymied the company’s efforts to “restore” orphan drug exclusivity for the pre-term birth drug MAKENA (hydroxyprogesterone caproate) Injection, 250 mg/mL, the compounded version of which is known as “17P.”  In its Opening Brief, KV presses its case that FDA’s decision not to take enforcement action against 17P compounders and the Agency’s issuance of a March 30, 2011 press release to that effect (referred to KV in its brief as “FDA’s Statement”) is the equivalent of an order or license reviewable in court, and that FDA caved to political pressure when it decided not to take enforcement action against 17P compounders.   

As we previously reported (here and here), KV filed a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction alleging that FDA and the Department of Health and Human Services violated myriad provisions of the FDC Act, the Administrative Procedure Act (“APA”) § 706(2), and the Due Process Clause of the Fifth Amendment to the U.S. Constitution by failing to take sufficient enforcement action to stop the unlawful competition with MAKENA by pharmacies that compound 17P.  FDA filed a Motion to Dismiss arguing, among other things, that KV’s claims are not justiciable for lack of standing, and that even if KV can establish standing, certain Agency statements concerning compounded 17P are not subject to judicial review under the APA because FDA’s decisions not to take enforcement action are committed to the agency’s discretion under Heckler v. Chaney, 470 U.S. 821 (1985).  In Chaney, the U.S. Supreme Court held that “an agency’s decision not to prosecute or enforce, whether through civil or criminal process, is a decision generally committed to an agency’s absolute discretion,” and as such, is presumed to be unreviewable under the APA. 

After finding that KV alleged sufficient facts to support standing, the D.C. District Court found KV’s first three Counts concerning orphan drugs (FDC Act § 527(a)), compounding (FDC Act § 503), and new drug approval (FDC Act §§ 505(a) and 301(d)) unreviewable, because APA § 701 “precludes judicial review of final agency action, including refusals to act, when review is precluded by statute or ‘committed to agency discretion by law,” and because Chaney is controlling.  Addressing Count IV of KV’s Compliant alleging that FDA violated FDC Act § 801(a) by permitting foreign-manufactured active pharmaceutical ingredient to be imported into the United States for compounding into 17P, the court found that the Count failed to state a claim.

Interestingly, another D.C.  District Court decision, also on appeal to the D.C. Circuit, Beaty v. FDA, 853 F. Supp. 2d 30 (D.D.C. 2012), appeal docketed sub nom. Cook v. FDA, Nos. 12-5176, 12-5266 (D.C. Cir. May 31, 2012), came out the other way for FDA when the Agency pressed Chaney as a defense.  In that case, the court found that FDA “ignore[d] an administrative directive” when the Agency exercised enforcement discretion with regard to the importation of unapproved sodium thiopental for use by state Departments of Corrections to carry out death sentences by lethal injection.  (See our previous post here.)

KV argues in its Opening Brief that the case falls outside of the Chaney framework for three reasons:

First, FDA’s Statement involves active solicitation of unlawful conduct, not mere non-enforcement.  Second, FDA’s Statement announces a policy applicable to more than 1,000 compounders, not a single-shot decision not to proceed in a particular case involving a particular party or parties.  Third, FDA’s action in making a public statement intended to elicit unlawful conduct that otherwise would not have occurred is an abdication of FDA’s responsibility to administer the FDCA.

Moreover, says KV, even if Chaney applies, “its rebuttable presumption of unreviewability is rebutted here” because the factors identified in the Supreme Court’s decision as supporting enforcement discretion, such as enforcement priorities and quality of evidence, are absent.  “FDA’s Statement does not invoke any of the factors to which enforcement discretion applies.”

By Carmelina G. Allis –

With information technology taking on an increasingly important role in the healthcare system, software app developers are focusing their efforts on developing programs intended to facilitate health, wellness, and disease management.  Some of these apps are developed for and implemented by corporations, hospitals, and providers to promote general health and wellness among their employees or members, or to create a team effort between users, family members, and healthcare providers to establish wellness goals to improve overall health.  Other forms of health and wellness apps are developed for use by the general population for a fee or at no cost, and can be easily accessed via a desktop computer, a smartphone, or an iPad.

These health and wellness apps come in different configurations, and their contents can often be tailored and constructed to meet the needs of the customer.  The apps may help the user establish certain health goals, such as a weight or an exercise objective, and can be configured to track or trend data for review by the user and/or others, such as a doctor, nurse, nutritional advisor, a personal trainer, or friends in a support network.  Other apps can assist users establish wellness plans to manage chronic conditions like asthma, heart disease, Crohn’s disease, or diabetes, by promoting and providing access to activities (e.g., dietary or exercise plan suggestions) and general information.

With the advent of FDA’s regulation of mobile software technology, a legal question that often arises is whether these health and wellness apps are subject to FDA regulation as medical devices.  So how can a software developer recognize whether its health and wellness app is a medical device under the Federal Food, Drug, and Cosmetic Act (“FDC Act”)?
 
Historically, products intended for use for general health and wellness that are intended to help change a person’s lifestyle in healthy way have not been subject to FDA regulation unless they are intended for medical purposes.  A product, such as software, may be subject to FDA regulatory requirements if it meets the definition of a “device” in section 201(h) of the FDC Act.  A “device” is defined as “an instrument, apparatus, implement, machine, contrivance . . . which is . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man,” among other things.  FDC Act § 201(h).  Thus, a software product may be subject to FDA regulation as a “device” if the developer of the software (or the person responsible for its labeling) markets, promotes, labels, or advertises the software for diagnosis, prevention, or treatment of disease or other conditions (e.g., stroke, pregnancy, high blood pressure, migraines).

At present, FDA does not have a comprehensive policy or guidance on the regulation of software devices.  The regulatory status of software devices, however, has been discussed in various FDA documents, such as the agency’s “Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications,” which was issued on July 11, 2011 (see our previous post here).  Although the guidance on mobile apps is a draft document subject to revision by FDA and not intended for implementation, it provides a window into the agency’s current thinking on the matter.

According to this draft guidance, it appears that FDA will continue to apply the medical purpose / general health and wellness distinction to mobile apps (and, by logical extension, other software based products).  For example, according to the draft guidance, software apps that have the following functionalities will not be regulated by FDA:

• Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness, if not intended to cure, treat, diagnose, or mitigate a specific disease, disorder, patient state, or any specific, identifiable health condition.
• Mobile apps that are used as dietary tracking logs and appointment reminders, or provide dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to a healthy lifestyle and wellness and are not intended to cure, mitigate, diagnose, or treat a disease or condition.

Draft Mobile Medical App Guidance at 11.

The key to avoid regulation is that the software app cannot be intended for medical purposes.  Thus, for example, an app that is intended to be used “to maintain general wellness by supporting a low-sugar or low-carbohydrate diet to maintain a healthy lifestyle” would likely fall under the general health and wellness non-regulated area.  On the other hand, if that same app is intended to be used to help patients “manage their diets to prevent the progression of prediabetes to diabetes and lower the risk of heart disease,” then the product would more likely be subject to FDA regulation as it is intended to treat a condition (i.e., prediabetes) to mitigate or prevent a disease (i.e., diabetes or cardiovascular disease).

Examples of software products intended for use by consumers that the draft guidance says may be subject to “device” regulation include:

• Apps that allow users to input their health information and through the application of formulas, data comparisons, or processing algorithms, issue a diagnosis or treatment recommendation that is specific to that person, such as his or her risk for colon cancer or heart disease, or recommend that the patient take a certain medication or seek a particular treatment.
• Software that is intended to be used to physically or wirelessly connect to and download information from a diagnostic device like a glucose meter to allow the user to display, store, analyze, and/or keep track of his or her medical data values.

Draft Mobile Medical App. Guidance at 14.

In short, if an app is intended to maintain and establish general health and wellness, FDA has said that the product will not likely meet the “device” definition and would therefore not be subject to regulation.  Otherwise, if an app is promoted or intended to be used by a patient or health facilitator as an instrument in the cure, mitigation, diagnosis, or treatment of a disease or condition, the app could be subject to FDA regulation.  Of course, FDA has not finalized its draft mobile app guidance, so things could change.  However, FDA has long kept its distance from devices merely intended to promote health and wellness while subjecting devices intended to prevent or treat disease to regulatory requirements.  It seems unlikely that this well established distinction would be omitted from the final guidance.

By Kurt R. Karst –      

We thought it would only be a matter of time until the Federal Trade Commission (“FTC”) decided to voice its views in a lawsuit filed last September by Actelion Pharmaceuticals Ltd. and Actelion Clinical Research, Inc. (collectively “Actelion”) in the U.S. District Court for the District of New Jersey seeking declaratory relief that Actelion is under no affirmative duty or obligation to supply prospective ANDA applicants with its brand-name drug products TRACLEER (bosentan) Tablets and ZAVESCA (miglustat) Capsules for purposes of bioequivalence testing and ANDA submission.  That  time has come, and just on the heels of the Counterclaim Plaintiffs’ (Apotex Corp., Roxane Laboratories, Inc., and Actavis Elizabeth LLC) opposition to Actelion’s Motion for Judgment on the Pleadings and to Dismiss Antitrust Counterclaims (see our previous post here). 

As we’ve previously noted, the case is the first preemptive lawsuit filed by a brand-name company whose drug products are covered by restricted distribution programs – either under a Risk Evaluation and Mitigation Strategies (“REMS”) program with Elements To Assure Safe Use created by the 2007 FDA Amendments Act, such as with TRACLEER, or under a restricted distribution program adopted and implemented by the brand-name manufacturer, such as with ZAVESCA.  The Counterclaim Plaintiffs allege that Actelion abused its monopoly power in violation of Sections 1 and 2 of the Sherman Act and the New Jersey Antitrust Act for refusing to deal with them and provide product sample for ANDA submission purposes.  Actelion has maintained all along that it is the company’s “right to choose with whom it does business,” that it is a “fundamental right of a business to choose for itself with whom to deal and to whom to supply its products,” and that precedent is on its side.

On March 12th, the FTC announced that it filed an amicus brief in the case.  It requests that the court “carefully consider the unique regulatory framework governing the pharmaceutical industry and the potential ramifications for consumers of prescription drugs when considering Actelion’s Motion for Judgment on the Pleadings and to Dismiss Antitrust Counterclaims.  The allegations in the case, says the FTC, “highlight a troubling phenomenon: the possibility that procedures intended to ensure the safe distribution of certain prescription drugs may be exploited by brand drug companies to thwart generic competition.”  This possibility was previously raised in a June 2009 citizen petition (Docket No. FDA-2009-P-0266) requesting that FDA “establish procedures to facilitate the availability of generic versions of drug products subject to a [REMS] and enforce the FDC Act to prevent companies from using REMS to block or delay generic competition.”  FDA has not substantively responded to the petition.  It was also raised in a lawsuit (see our previous post here) that was ultimately dismissed after a settlement was reached.  If the court adopt’s Actelion’s legal position, write the FTC, it “threatens to undermine the careful balance created by the Hatch-Waxman Act,” “potentially preserve[s] a brand firm’s monopoly indefinitely, and “could prove costly for consumers of prescription drugs.”

Moving on to Actelion’s legal arguments, the FTC says that refusing to sell to generic rivals may, in fact, constitute exclusionary conduct in violation of Section 2 of the Sherman Act, and that restricted distribution agreements are not immune from antitrust scrutiny and may violate Section 1 of the Sherman Act.  Although the FTC does not say whether it thinks there was a violation of the antitrust laws in this case, it does say that the Counterclaim Plaintiffs should have their day in court. Citing the two general principles of antitrust law that Actelion relies on in its motion – “first, that a private firm is ordinarily free to choose with whom it does business; and second, that vertical agreements, such as those between a manufacturer and its distributors, rarely pose any competitive concern” – the FTC says that they are not absolute principles:

Under certain circumstances, potentially including those alleged in the counterclaims here, a monopolist’s refusal to sell to its rivals may violate Section 2 of the Sherman Act, and vertical agreements may violate Section 1. . . .  While the evidence may not ultimately support any of the Sherman Act claims in this case, the FTC respectfully submits that they are not barred as a matter of law.

Now that the FTC has chimed in, the case will likely take on an even higher profile.  Other amicus briefs may already be in the works.

UPDATE:

• The Generic Pharmaceutical Association has also filed an amicus brief in the case.  The brief does not weigh in on the antitrust issues raised in the case, but rather, focuses on the intent of the Hatch-Waxman Amendments.

By Karla L. Palmer –

The National Association of Attorneys General (“NAAG”) today sent a letter to the U.S. Food and Drug Administration’s Margaret Hamburg urging the Agency to adopt standards requiring manufacturers and marketers of generic prescription opioids to develop tamper-resistant versions of such products.  Signed by 48 state and territorial Attorneys Generals, the letter applauds FDA for “expeditiously proposing guidelines establishing clear standards for manufacturers who develop and market tamper- and abuse-resistant opioid products while considering incentives for undertaking the research and development necessary to bring such products to market.”  (See our previous post on FDA's draft guidance on abuse-deterrent opioids.)  It also encourages FDA to assure that generic versions of “such products are designed with similar [tamper-resistant] features.” 

The letter warns that nonmedical users of opioid products are now shifting away from the new tamper-resistant formulations as well as to illegal drugs.  It notes that there is “great concern” in the law enforcement community that many non-tamper-resistant generic products are available for abuse when only a few products have been formulated with tamper-resistant features.  The Attorneys General referred specifically to a concern with the possibility that generic versions of extended-release opioid prescription drugs and other non-tamper-resistant products may reach the market.

The press release announcing the Attorneys General letter states that prescription drug abuse is a significant danger that is reaching “epidemic levels in many states.  It specifically notes that “[o]pioids relieve pain and codeine, hydrocodone (e.g., Vicodin) and oxycodone (e.g., OxyContin, Percocet) fall into this medication class.”

In recent months, FDA has denied without comment several citizen petitions concerning generic versions of drug products approved with formulations intended to be abuse-deterrent.  FDA's denial of one such petition concerning OxyContin has prompted a petition for reconsideration.  In another case concerning oxymorphone (Opana), FDA is scheduled to rule in May on a petition concerning whether a non-abuse-deterrent formulation of the drug was removed from the market for reasons of safety or effectiveness.

By Ricardo Carvajal –

FDA recently denied a citizen petition (Docket No. FDA-2011-P-0484) that asked the agency to take numerous actions with respect to mercury in commercial fish.  In part, the petition asked FDA to establish an action level, regulatory limit, or tolerance of 0.5 ppm  (the current action level is 1.0 ppm) , revise FDA/EPA’s fish consumption advice accordingly, and require posting of that advice at the point-of-sale. 

In its response, FDA reviewed evidence bearing on the adverse effects that allegedly can result from exposure to methylmercury, including neurological effects, coronary heart disease, kidney failure, and genetic damage.  For certain adverse effects, the petition included no evidence to support its assertions, so FDA relied on evidence of which the agency is aware. 

FDA noted that 99.9 percent of adults have been exposed to methylmercury below the Acceptable Daily Intake Level ("ADI"), which includes a 10-fold margin of safety.  FDA has therefore seen no need to enforce the current action level to reduce exposure to methylmercury.  FDA then reviewed relevant case studies, published studies, and information provided in the petition.  FDA concluded that the petition failed to provide sufficient evidence that commercial fish with more than 0.5 ppm of mercury pose a reasonable possibility of  injury to the general population or to susceptible subpopulations (e.g., young children).  In addition, FDA noted that there is substantial evidence that consumption of fish is associated with neurodevelopmental and other benefits, even taking into account potential exposure to methylmercury.

FDA also declined to require posting of the FDA/EPA fish consumption advisory at the point-of-sale because the petition did not provide a basis for a determination that such information is “material” within the meaning of section 201(n) of the Federal Food, Drug, and Cosmetic Act.

Many of us at Hyman, Phelps & McNamara, P.C. will miss a cherished former colleague and worthy opponent: Rick Blumberg, the Deputy Chief Counsel for Litigation at FDA, who died Thursday, March 7th, of complications from a stroke.  He handled litigation for FDA for more than 40 years, and directed it for more than 20 years.  He was plain-spoken and aggressive, but always courteous, usually funny, and quick to respond.

Rick, a relentless and brilliant advocate for FDA, taught us, and many other attorneys in the food and drug bar, as a colleague, a boss, or as an attorney on the other side of negotiations or litigation.  For some of us, as our careers evolved, he was first a colleague, then an opponent, then a fellow speaker at industry panels.  Throughout, with fierce loyalty to the agency he represented, he was deliberate in choosing the words he spoke, articulate in describing his position, and perceptive about – if not always sympathetic to –the needs of regulated industry.  And while we did not always agree with him, there are few who tried to protect the public interest and welfare more than Rick.

He will be missed.

By Carmelina G. Allis –

On February 28, 2013, FDA’s Center for Devices and Radiological Health (“CDRH”) issued what appears to be an unprecedented joint FDA/Federal Trade Commission “untitled letter” in the form of an email (an “untitled email”) to on-line distributors of decorative contact lenses alleging that they have been selling and marketing decorative or cosmetic contact lenses in violation of federal laws, and threatening criminal prosecution if corrective action is not implemented.  Contact lenses (including decorative/color and corrective lenses) are regulated as medical devices pursuant to section 520(n) of the FDC Act.  In general, decorative and cosmetic contact lenses are regulated as Class II prescription devices subject to the 510(k) requirements.

An untitled attachment to the email alleges that the devices are adulterated and misbranded pursuant to the FDC Act because they are being offered for sale in the U.S. without FDA marketing authorization.  It also alleges that the on-line distributors’ sale of contact lenses to consumers without a valid prescription is in violation of the Fairness to Contact Lens Consumers Act, 15 U.S.C. § 7601 et seq., and the Contact Lens Rule, 16 C.F.R. Part 315, both of which are enforced by the FTC.  Violation of the FTC rule may result in significant civil monetary penalties.

According to CDRH’s email, FDA’s Office of Criminal Investigations ("OCI") and FTC reviewed the on-line distributors’ websites and determined that they were offering decorative contact lenses for sale in violation of federal law.  OCI is the office within FDA that conducts and coordinates investigations of suspected criminal violations of the FDC Act and other related statutes, including violations of Title 18 of the United States Code.  The FTC regulates the advertising (as opposed to the labeling) of non-restricted medical devices pursuant to the Federal Trade Commission Act, 15 U.S.C. §§ 52-55.

CDRH’s email to contact lens distributors purports to be an “untitled letter.”  It has been posted on CDRH’s “Promotion and Advertising Untitled Letters” webpage and neither the email nor its attachment says “Warning Letter.”  However, we believe that this email (and attachment) is mischaracterized by FDA as an untitled letter.  It contains language advising that failure to take prompt correction may result in enforcement action, and specifically warns that “[f]irms that fail to take corrective action may also be referred to FDA’s Office of Criminal Investigations for possible criminal prosecution” for violations of the FDC Act and other federal laws.

As described in Chapter 4 of FDA’s Regulatory Procedures Manual ("RPM"), “Warning Letters are issued for violations of regulatory significance.  Significant violations are those violations that may lead to enforcement action if not promptly and adequately corrected.”  In contrast, an untitled letter is generally the initial correspondence between FDA and the regulated industry that “cites violations that do not meet the threshold of regulatory significance for a Warning Letter.  Therefore, the format and content of an Untitled Letter should clearly distinguish it from a Warning Letter.”  RPM, Ch. 4.

Companies should not take lightly language threatening criminal prosecution.  We are not aware of similar language contained in other untitled letters issued by CDRH.  We should also note that statements indicating OCI involvement in an enforcement action are generally not included in device Warning Letters.  This CDRH “untitled email” is certainly an unprecedented approach.

As part of CDRH’s Transparency Initiative, the Center has committed to posting on its website advertising and promotion untitled letters issued as of October 1, 2011.  As of the date of this blog, this notification to on-line distributors of decorative contact lenses is the only letter/email posted.

By Kurt R. Karst –      

Earlier ths week, Apotex Corp., Roxane Laboratories, Inc., and Actavis Elizabeth LLC  (collectively “Counterclaim Plaintiffs”) filed their opposition to Actelion Pharmaceuticals Ltd.’s and Actelion Clinical Research, Inc.’s (collectively “Actelion’s”) Motion for Judgment on the Pleadings and to Dismiss Counterclaims in a lawsuit filed last September in the U.S. District Court for the District of New Jersey seeking declaratory relief that Actelion is under no affirmative duty or obligation to supply prospective ANDA applicants with its brand-name drug products TRACLEER (bosentan) Tablets and ZAVESCA (miglustat) Capsules for purposes of bioequivalence testing and ANDA submission.  As we previously reported (here, here, and here), the case is the first preemptive lawsuit filed by a brand-name company whose drug products are covered by restricted distribution programs – either a Risk Evaluation and Mitigation Strategies program with Elements To Assure Safe Use created by the 2007 FDA Amendments Act, such as TRACLEER, or a restricted distribution program adopted and implemented by the brand-name manufacturer, such as ZAVESCA.  The Counterclaim Plaintiffs have alleged that Actelion abused its monopoly power in violation of Sections 1 and 2 of the Sherman Act and the New Jersey Antitrust Act.

Actelion maintains that it is the company’s “right to choose with whom it does business,” and that this “fundamental right” dooms the Counterclaim Plaintiffs’ antitrust counterclaims and clearly support Actelion’s request for declaratory relief.  Moreover, says Actelion, citing Verizon Communications, Inc. v. Law Offices a/Curtis V. Trinko, LLP, 540 U.S. 398 (2004) for purposes of Sherman Act Section 2, any exceptions to the rule that a unilateral refusal to deal by an alleged monopolist does not give rise to antitrust liability (i.e., where a refusal to do business is contrary to a prior course of dealing, or where a refusal relates to an “essential facility”) do not apply in this case. And, says Actelion, there are alternatives to the ANDA approval route that companies can use, such as the submission of a “full” 505(b)(1) NDA or a 505(b)(2) NDA.

As an initial matter, Counterclaim Plaintiffs allege in their 70-page opposition memorandum that Actelion’s reliance on Trinko to support its case is misplaced.

Actelion’s entire argument rests on its belief that Trinko immunizes a firm from antitrust scrutiny for refusing to deal with its would-be competitors.  Although this interpretation of Trinko is incorrect, Actelion’s argument fails in any event because its refusal to sell Counterclaim Plaintiffs drug samples is merely one component of the larger exclusionary scheme challenged here. . . . [Actelion’s] conduct goes far beyond a typical “refusal to deal” and falls well within the classic definition of unlawful monopolization. . . .  The problem with Actelion’s heavy reliance on Trinko is that it at best only addresses Actelion’s liability for refusing to sell drug samples directly to Counterclaim Plaintiffs.  The Third Circuit [in LePage’s, Inc. v. 3M, 324 F.3d 141 (3d Cir. 2003)], however, has held that the proper inquiry is whether the defendant’s alleged actions “considered together” evidence an overall anticompetitive scheme. (Internal citations omitted)

Applying this Third Circuit standard, say Counterclaim Plaintiffs, the court must deny Actelion’s motion. 

Counterclaim Plaintiffs go on to argue that even if this were a pure “refusal to deal” case, Trinko does not create a bright-line rule to justify Actelion’s requested relief.  For starters, say Counterclaim Plaintiffs, “unlike Trinko, where there was already a scheme of regulation in place to safeguard the public interest . . . no such regulatory scheme exists to serve as ‘an effective steward of the antitrust function’ here.” (Internal citation omitted)  Moreover, both of the Trinko exceptions (i.e., prior course of dealing and essential facilities) are available and applicable here, argue Counterclaim Plaintiffs.

As to Actelion’s argument that, for purposes of applicability of the essential facilities exception, companies can avail themselves of an alternative to the ANDA approval route and seek FDA approval of an NDA, Counterclaim Plaintiffs say that argument is nonsensical.  First, insofar as it means companies submit “full” 505(b)(1) NDAs, the argument undermines the Hatch-Waxman Amendments.  Second, insofar as it means companies submit 505(b)(2) applications for a generic version of the drugs, “Actelion’s claim . . . is simply wrong,” because that route is not available for duplicates of approved brand-name drugs.  Moreover, it bears noting that a 505(b)(2) application for an alternative version of a brand-name drug may require the sponsor to obtain sample of the drug for purposes of conducting bridging studies. 

By Anne K. Walsh –

On March 4, 2013, less than three months after oral argument, the Ninth Circuit issued its ruling in United States v. Harkonen, a closely watched case implicating First Amendment issues in the off-label promotion context.  As we previously reported (here and here), in 2009, a jury had convicted Harkonen of wire fraud for issuing a press release fraudulently describing clinical trial results about the drug Actimmune.  The District Court in the Northern District of California sentenced Harkonen to 3 years probation, 6 months home detention, community service, and a $20,000 fine.  Both parties appealed to the Ninth Circuit.

Harkonen challenged the conviction, arguing that the First Amendment barred his prosecution.  The Ninth Circuit applied a two-part analysis: (1) whether sufficient evidence supports the verdict; and (2) if so, whether the facts as found by the jury establish the core constitutional facts.  The Ninth Circuit emphasized that the First Amendment does not protect fraudulent speech.  Therefore, the court identified the core constitutional issue in Harkonen’s case as whether there was sufficient evidence to support the jury’s finding that the press release was fraudulent.  Deferring to the jury’s findings on the elements of the wire fraud charge, the Ninth Circuit affirmed the wire fraud conviction. 

Interestingly, the Ninth Circuit footnoted that “Harkonen presented the evidence that most firmly supported his case for the first time at sentencing.”  This is likely a reference to expert declarations Harkonen sought to introduce purporting to show a plausible scientific (and thus truthful) basis for the statements contained in the allegedly fraudulent press release.  The Ninth Circuit noted that it was limited to considering evidence that was before the jury, and therefore could not consider the expert declarations first raised at Harkonen’s sentencing.

The Court also rejected Harkonen’s other arguments, one of which relied on a 1902 U.S. Supreme Court case for the proposition that “genuine debates over whether a given treatment caused a particular effect” could not be considered fraudulent.  American School of Magnetic Healing v. McAnnulty, 187 U.S. 94 (1902).  “Harkonen’s request that we reverse his conviction because he was engaging in a genuine scientific debate is hardly different than arguing that he is innocent; genuine debates of any sort are, by definition, not fraudulent.”

On its cross-appeal, the Government argued that the district court had erroneously ruled on the “intended loss” and “vulnerable victim” enhancements in the U.S. Sentencing Guidelines.  Originally the Government had asked for a 10-year prison sentence and a $1 million fine.  The Ninth Circuit did not provide much explanation, but simply stated that the district court made clear its conclusions in imposing a shorter sentence with no imprisonment.

On the heels of the Second Circuit’s decision in United States v. Caronia, some had thought that the Ninth Circuit would provide the requisite circuit split to allow the Supreme Court to take on the First Amendment issue raised in Caronia.  The Harkonen case is distinguishable, however, because the jury convicted Harkonen of wire fraud, which required a finding that the statements Harkonen made were fraudulent.  Therefore, unlike Caronia, the Harkonen case did not present a potential First Amendment defense based on truthful and non-misleading statements about an unapproved use.  For more information about the potential ramifications of Caronia, see the HP&M Webinar.

As for Harkonen, the saga continues.  Not only did he lose this appeal and recently have his state medical license revoked, he now faces potential exclusion from federal health care programs, which would effectively preclude him from working in the pharmaceutical industry during the period of exclusion.  

By Ricardo Carvajal –

The Notification of Opportunity to Initiate a Voluntary Recall that FDA recently issued to a pet treat manufacturer gives a good indication of the type of evidence and circumstances that can prompt the agency to exercise its new mandatory recall authority.  Before mandating a recall under FDCA section 423, FDA must first determine that there is a reasonable probability that the food is adulterated under section 402 or misbranded under section 403(w) and that use of or exposure to the food will cause serious adverse health consequences or death to humans or animals.  FDA must then give the manufacturer the opportunity to initiate a voluntary recall. 

In this instance, FDA determined that the food in question was adulterated under section 402(a)(1), in that the food was contaminated with Salmonella, and also adulterated under section 402(a)(4), in that the food was manufactured under insanitary conditions whereby it may have been contaminated with Salmonella.  FDA relied on testing of finished products conducted by the State of Colorado’s Department of Agriculture that purportedly showed the presence of Salmonella.  Those products were collected at the manufacturing facility and also off the shelves at leading retailers.  FDA also relied on its own testing of finished products, and of environmental testing that purportedly showed contamination of food contact surfaces.  FDA made heavy use of genetic analysis to draw links between Salmonella-positive samples from different products manufactured at different times, and also between products and environmental swabs.  In addition, FDA relied on evidence of insanitary conditions allegedly observed throughout the facility.

In a hint at potentially worse consequences, FDA’s Notification stated: “Your facility created, caused or was otherwise responsible for this reasonable probability of adulteration under section 402” – the standard for the suspension of a facility’s registration under section 415.

By Kurt R. Karst –      

Finally!  A Hatch-Waxman lawsuit that is not overly complex and not difficult to unravel.  Late last week, Sun Pharma Global FZE, Caraco Pharmaceutical Laboratories, Ltd., and Sun Pharmaceuticals Industries, Ltd. (collectively “Sun”) filed a Complaint and a Motion for a Temporary Restraining Order and a Preliminary Injunction in the U.S. District Court for the District of Columbia (Case No. 1:13-cv-00277-ABJ) against FDA seeking, among other things, entry of a judgment declaring that the company is entitled to 180-day exclusivity for a generic version of Novartis Corporation’s ZOMETA (zoledronic acid) Injection, 4 mg/5 mL (or 0.8 mg (base)/mL).

ZOMETA is approved under NDA No. 021223 and is listed in the Orange Book with three product entries.  Product 001 is identified as “EQ 4MG BASE/VIAL” and was approved on August 20, 2001.  It is a lyophilized version of the drug that is no longer marketed, and is listed in the discontinued section of the Orange Book.  Product 002 – the product at issue in the lawsuit – is identified as “EQ 4MG BASE/5ML.”  It was approved on March 7, 2003 and is a non-lyophilized version of the drug.  Finally, Product 003 is identified in the Orange Book as “EQ 4MG BASE/100ML.”  It was approved on June 17, 2011, and, like Product 002, is currently marketed.

Product 002 is listed in the Orange Book with two patents: (1) U.S. Patent No. 4,939,130 (“the ‘130 patent”), which expired on September 2, 2012, but is subject to a period of pediatric exclusivity that expired on March 2, 2013; and (2) U.S. Patent No. 8,324,189 (“the ‘189 patent”), which expires on May 29, 2025, and is subject to a period of pediatric exclusivity that expires on November 29, 2025.  The ‘130 patent has been listed in the Orange Book for Product 002 since 2003.  (It was originally scheduled to expire on July 24, 2007, but was granted a patent term extension.)  The ‘189 patent was issued on December 4, 2012, and, according to Sun, was timely listed in the Orange Book on January 2, 2013. 

FDA’s Paragraph IV Certifications List identifies June 11, 2008 as the first date on which an ANDA containing a Paragraph IV certification was submitted to FDA seeking approval of Product 002.  That product is identified on FDA’s list as ZOMETA (zoledronic acid) Injection “0.8 mg (base) /mL,” which corresponds to 4 mg/5 mL.  Because the first ANDA containing a Paragraph IV certification was submitted to FDA years before the ‘189 patent was listed in the Orange Book (or even issued), such ANDA must have included a Paragraph IV certification to the ‘130 patent.  Moreover, because the first ANDA for a generic version of Product 002 was submitted to FDA after December 8, 2003, 180-day exclusivity is governed by the Medicare Modernization Act (“MMA”).  Under the MMA, 180-day exclusivity eligibility can be forfeited under one (or more) of the six forfeiture provisions at FDC Act § 505(j)(5)(D).

Sun reportedly submitted ANDA No. 202746 to FDA on January 10, 2011 containing a Paragraph III certification to the ‘130 patent, and reportedly amended that ANDA on January 3, 2013 with a Paragraph IV certification to the ‘189 patent.  According to Sun, the company “should be awarded First Filer status because when Sun filed its Paragraph IV certification [the ‘189 patent], no other ANDA for Zometa® Product 002 was previously filed that contained a Paragraph IV certification and there is no basis in the law or regulations for FDA to approve any other ANDA’s until FDA determines whether SUN has first to file status.” (Emphasis in original)  FDA has already tentatively approved several ANDAs for generic ZOMETA, and the Agency is likely poised to approve several ANDAs for generic versions of Product 002 on Monday now that the period of pediatric exclusivity on the ‘130 patent has expired.  (ANDA No. 202746 is not on the list of tentatively approved applications.)   

Despite Sun’s allegations, the facts in this case seem to point in another direction.  According to a patent infringement lawsuit Novartis filed in July 2008 against Teva Parenteral Medicines Inc. (“Teva”) in the U.S. District Court of Delaware (Case No. 1:08-cv-00459), Teva submitted two ANDAs – ANDA Nos. 078576 and 078580 – for generic versions of ZOMETA (apparently Product 001 and Product 002) containing Paragraph IV certifications to the ‘130 patent.  Based on ANDA submission dates identified in the court docket, that would make Teva the first applicant eligible for 180-day exclusivity.  But 180-day exclusivity for Product 002 (as well as Product 001) has been forfeited.  Indeed, there appear to be several bases for forfeiture. The most obvious forfeiture is patent expiration (FDC Act § 505(j)(5)(D)(i)(VI)); however, failure to obtain tentative approval (FDC Act § 505(j)(5)(D)(i)(IV)), ANDA withdrawal (FDC Act § 505(j)(5)(D)(i)(II), and amendment of certification (FDC Act § 505(j)(5)(D)(i)(III) may also be possibilities.  In other words, Sun’s lawsuit may be short-lived.  As this case moves forward over the next day, we will post periodic updates.

UPDATE:

• The following Minute Order was entered late on March 1st: “During a telephone conference held on this date at which counsel for plaintiff as well as counsel from FDA and DOJ participated, counsel for defendants represented to the Court that FDA will not approve any ANDAs for the drug product at issue in this case until the Court has had an opportunity to address plaintiff's motion for temporary restraining order and preliminary injunction [Dkt. # 2] during a hearing on March 4, 2013.  Accordingly, consistent with the Court's oral ruling during the telephone conference, it is ORDERED that defendants shall file a response to plaintiff's motion by 10:00 am on Monday March 4, 2013. A hearing is scheduled for March 4, 2013 at 11:00 am in Courtroom # 3 before Judge Amy Berman Jackson.”
• On March 1st, FDA issued a letter decision finding that 180-day exclusivity for generic ZOMETA Product 002 was forfeited.
• On March 1st, Sun submitted a citizen petition to FDA requesting that the Agency not approve any affected ANDAs.
• On March 3rd, Sun supplemented its Motion for a Temporary Restraining Order and a Preliminary Injunction motion.
• The following Minute Order was entered on March 3rd: “It is ORDERED that defendants file with the Court by March 4, 2013 at 10:00 am, any application containing a Paragraph IV certification for the same drug for which plaintiffs claim first filer status that was submitted before plaintiffs' application, as well as any documents that reflect notice provided to Novartis of the application that the FDA has deemed to be the first.”
• The following Minute Order was entered on the morning of March 4th: “In light of the in camera submission made by defendants on this date in response to the Court's Minute Order of March 3, 2013, it is ORDERED that before the hearing scheduled for 11:00 am on this date, defendants provide a redacted copy of the documents included in the submission to counsel for plaintiffs, or be prepared to explain to the Court at the hearing why that is not possible.”
• On the afternoon of March 4th, the court issued a Notice of Dismissal stating: “Pursuant to Rule 41(a)(1)(A)(i) of the Federal Rules of Civil Procedure, Plaintiffs Sun Pharma Global FZE, Caraco Pharmaceutical Laboratories, Ltd., and Sun Pharmaceuticals Industries, Ltd., hereby dismiss the above captioned action.”