Orange Book Blog

Federal Circuit Changes Course, Denies Stay of Injunction of Mylan's Generic AMRIX Sales

In Re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation, No. 2011–1399 (Fed. Cir. 2011)

This case has an unusual history.  Here is a brief summary of recent events:

• April 8: U.S. District Court for the District of Delaware enjoins Mylan from launching its generic AMRIX until the court issues its opinion on the patent infringement and validity issues in the case
• April 17: 30–month stay of FDA approval of Mylan's cyclobenzaprine ANDA expires
• April 18: FDA grants final approval of Mylan's ANDA
• May 12: District court issues its opinion (following seven-day bench trial held in September and October of 2010), finding asserted claims of the patents-in-suit invalid for obviousness (link)
• May 13: Mylan launches its generic AMRIX with 180–day exclusivity
• May 20: District court grants Cephalon's motion for a temporary restraining order, explaining that “plaintiffs' success on appeal is just as likely as not” (link)
• May 24: District court issues an Injunction Order, enjoining Mylan's further sales of generic AMRIX; enjoining Cephalon's licensing of an authorized generic version of AMRIX; and ordering Mylan and Cephalon to recall any already-sold generic AMRIX from the market
• May 25: Federal Circuit issues an Order (1) directing Cephalon to file a response to Mylan's motion for a stay, pending appeal, of the district court injunction; and (2) granting “Mylan's request for an immediate stay . . . to the extent that the injunction is temporarily stayed pending the court's receipt of the response and the court's consideration of the papers submitted.”

In an Order issued today, the Federal Circuit granted Mylan's motion for a stay, pending appeal, of the district court's injunction—but only in part.  Citing a 1987 Supreme Court case, the Federal Circuit stated the standard for obtaining a stay:

The party requesting a stay bears the burden of showing that the circumstances justify an exercise of that discretion based on consideration of four factors, the first two of which are the most critical: (1) whether the stay applicant has made a strong showing that he is likely to succeed on the merits; (2) whether the applicant will be irreparably injured absent a stay; (3) whether issuance of the stay will substantially injure the other parties interested in the proceeding; and (4) where the public interest lies.

In view of these factors, the court concluded:

Based on the arguments in the motions papers, and without prejudicing the ultimate disposition of this case by a merits panel, we determine that Mylan has met their burden to obtain a stay, pending appeal, of the district court's injunction in part.  We deem it proper to stay the injunction as to Paragraph 3 of the Injunction Order only.  Mylan's motion to stay the remainder of the injunction provisions is denied.

Paragraph 3 of the Injunction Order directed Mylan and Cephalon to “take all reasonable steps to recall their respective generic cyclobenzaprine extended-release products promptly from the market. . . .”  It is not clear why, if “Mylan has met their burden to obtain a stay,” the Federal Circuit lifted only that part of the injunction requiring Mylan to recall its generic AMRIX from the market, and not also the part ordering Mylan to stop selling its generic AMRIX.

In any event, it appears that Mylan must now stop selling its generic AMRIX.  Presumably Mylan has been selling its generic AMRIX since it launched on May 13, meaning that it has received the benefit of 56 days of its 180–day exclusivity period.  Due to the Federal Circuit's calendar for oral argument, however, the appeal won't be heard until September at the earliest.  Meanwhile, Mylan's 180–day exclusivity period will continue to run.  Thus, it is unclear whether, even if Mylan prevails on appeal, it will have any exclusivity remaining by the time the Federal Circuit issues its opinion in the case.

District Court Grants TRO Against Mylan's Generic Amrix--After Finding Patents Invalid

In Re: Cyclobenzaprine Hyldrochloride Extended-Release Capsule Patent Litigation, No. 09-md-2118-SLR (D. Del. 2011)

In a strange turn of events, the district court that just eight days earlier found the asserted claims of the patents on Amrix invalid, granted a motion for a temporary restraining order against Mylan.

As we previously reported, on May 12, following a seven-day bench trial conducted last September and October, the U.S. District Court for the District of Delaware held that the asserted claims of U.S. Patent Nos. 7,387,793 and 7,544,372 are invalid due to obviousness.  This decision cleared the way for Mylan, the first paragraph IV filer, to launch its generic version of Amrix.  As we reported, Mylan did so on May 13, triggering its 180-day exclusivity period.

Notwithstanding that they lost after trial, on May 15 the plaintiffs filed a motion for a temporary restraining order.  This was followed by three rounds of briefs by each side--including briefs filed each day last week--until the district court granted the motion last Friday.

Given that one of the legal requirements for granting a TRO is a "likelihood of success on the merits," and the district court previously found after a full trial that the plaintiffs lost on the merits, it is very surprising that the court granted the TRO.  Did the court, after reconsideration, find that its decision was wrong on the merits?  No--in its Memorandum Order, the court defended each of the findings that plaintiffs asserted to be erroneous.  But inexplicably, the court concluded that "plaintiffs' success on appeal is just as likely as not," and therefore "this factor marginally supports a temporary restraining order."

Later on Friday, Mylan filed an Emergency Motion for Reconsideration, stating that the court "committed fundamental, material errors of law."  Specifically, according to Mylan, the court "did not find that Plaintiffs were likely to succeed on the merits but rather that 'plaintiffs' success on appeal is just as likely as not.'  As a matter of law, this sort of 50-50 assessment is insufficient to establish a likelihood of success and destroys the basis for the TRO."  Mylan, of course, is concerned that its 180-day exclusivity period will tick away while it's prevented from marketing.

While the court granted the plaintiffs' motion, it has not yet entered an order enjoining Mylan.  The court has scheduled a hearing for tomorrow at 9:00 am, and presumably will hear argument on Mylan's emergency motion.

UPDATES:

• On May 24, Mylan filed a supplemental brief in support of its Emergency Motion for Reconsideration
• Later on May 24, in this Order, the district court denied Mylan's Emergency Motion for Reconsideration
• Also on May 24, in this Order, the district court entered an injunction against Mylan
• Still later on May 24, Mylan filed a Notice of Appeal to the Federal Circuit
• On May 25, in this Order, the Federal Circuit stayed the district court's May 24 injunction

District Court Dismisses Mylan's Complaint Against FDA Concerning Generic Lipitor

Mylan Pharms. v. FDA and Ranbaxy Labs., No. 11-566-JEB (D.D.C. 2011)

In an Opinion released earlier today, the U.S. District Court for the District of Columbia dismissed Mylan's lawsuit that sought to force FDA to act on Ranbaxy's ANDA for generic Lipitor (atorvastatin) and determine whether Ranbaxy forfeited its 180-day exclusivity for the product.  The court granted FDA's motion to dismiss for lack of subject matter jurisdiction and denied Mylan's motion for a preliminary injunction.

In granting FDA's motion to dismiss, the court concluded that Mylan lacks standing to sue and that Mylan's claims are not ripe.  With respect to standing, the court found it important that Mylan does not have tentative approval of its own ANDA for atorvastatin, and therefore Mylan's injury is not imminent. In addition, according to the court, Mylan's task of establishing standing was made "substantially more difficult because they allege the FDA unlawfully delayed acting on Ranbaxy's ANDA rather than their own."  The court further found that Mylan's lack of tentative approval made its claims unripe, since they "rest upon contingent future events that may not occur as anticipated or may not occur at all."

The court, however, left open the possibility that Mylan could refile its claims at a later date:

By dismissing Plaintiffs' claims now, the Court does not foreclose the possibility that Plaintiffs may seek a judicial remedy at a future date -- e.g., when Plaintiffs' claims are truly fit for review.  As the FDA points out, "Nothing prevents Mylan from seeking judicial recourse if and when FDA renders a final exclusivity decision that is not to Mylan's liking."

Under the terms of a settlement with Pfizer, Ranbaxy will launch its generic Lipitor on November 30, 2011 (provided that its ANDA has been approved by then).  By filing this lawsuit, Mylan had sought to launch its own generic Lipitor as early as June 28, 2011.

RELATED READING:

• Dow Jones
• Reuters

District Court Set to Decide Whether Ranbaxy Forfeited 180-Day Exclusivity on Generic Lipitor

Mylan Pharms. and Matrix Labs. v. FDA, No. 11-566 (D.D.C.)

Last month, Mylan filed suit against the FDA in the U.S. District Court for the District of Columbia, seeking a declaration that there is no applicable period of 180-day exclusivity for generic Lipitor (atorvastatin) that would block approval of Mylan's atorvastatin ANDA; and an injunction preventing FDA from withholding final approval of Mylan's ANDA on the basis of Ranbaxy's 180-day exclusivity.  Within days, Mylan filed a motion for preliminary injunction.  FDA and Ranbaxy (as Intervenor) then filed motions to dismiss Mylan's complaint.  Briefing on the motions was recently completed, and the briefs are available below.

The crux of Mylan's suit is that "FDA has arbitrarily, unreasonably, and unlawfully failed to decide whether the Agency will enforce the terms of its Application Integrity Policy ("AIP") against the atorvastatin ANDA application submitted by Ranbaxy."  According to the Complaint, "FDA found that Ranbaxy engaged in a pattern and practice of submitting to FDA drug applications containing false and unreliable data generated from Ranbaxy's Paonta Sahib, India manufacturing site, where, Ranbaxy markets its generic LIPITOR."  Mylan contends that "if FDA enforces the AIP against Ranbaxy's ANDA, then the plain language of the FDA Act and the AIP require FDA to deny Ranbaxy's ANDA, and terminate any period of 180-day marketing exclusivity originally provided to Ranbaxy."

According to Mylan, Ranbaxy cannot market generic Lipitor before November 2011 (due to a settlement with Pfizer), meaning that if Ranbaxy has 180-day exclusivity, other generic makers could not enter the market until May 2012.  But in the absence of Ranbaxy's 180-day exclusivity, Mylan could launch its generic Lipitor as early as June of this year.  Mylan further states that "upon market entry of generic LIPITOR, it is estimated that U.S. consumers, the government, and third party payors could save between $10.9 million and $18.6 million per day, which equates to between $3.97 billion and $6.8 billion in potential savings per year."

FDA, in its motion to dismiss, responds that Mylan lacks standing, because it has not (yet) been injured; Mylan's claims are not ripe, because its own ANDA is not ready for approval; FDA's enforcement discretion is not subject to judicial review; and Mylan fails to state a claim for unreasonable delay under the Administrate Procedure Act.

A hearing on the motions is scheduled for April 28th at 9:30 a.m.  The court should issue a decision shortly thereafter.

Filings:

• Mylan v. FDA Complaint
• Mylan Motion for Preliminary Injunction
• FDA Motion to Dismiss and Opposition to Motion for PI
• Ranbaxy Motion to Dismiss and Opposition to Motion for PI
• Mylan Reply i/s/o Motion for PI and Opposition to Motion to Dismiss
• FDA Reply i/s/o Motion to Dismiss
• Ranbaxy Reply i/s/o Motion to Dismiss
• Mylan Surreply in Opposition to Motion to Dismiss
  

Apotex Establishes Declaratory Judgment Jurisdiction in Lipitor Patent Challenge, Threatening the Pfizer-Ranbaxy Settlement, but Pfizer Reloads

Pfizer Inc. et al. v. Apotex Inc. et al., No. 08-7231 (N.D. Ill. 2010)

The litigation between Pfizer and Apotex over Apotex's ANDA for a generic version of Lipitor (atorvastatin calcium) presents the fairly typical scenario of a later ANDA filer (Apotex) trying to trigger the 180-day exclusivity of the first filer (in this case, Ranbaxy).

Pfizer and Ranbaxy settled their Lipitor ANDA litigation in 2008, agreeing that Ranbaxy would not market its generic version of Lipitor until November 30, 2011.  Later ANDA filers like Apotex, therefore, must wait until at least mid-2012 to launch their own generic Lipitor--unless one of them triggers Ranbaxy's exclusivity earlier.  In order to do so, the later filer must obtain a final decision of noninfringement or invalidity of the Lipitor patents.  But this isn't easy to do if the patent owner doesn't sue the later filer:  the later filer must obtain a declaratory judgment, which requires establishing declaratory judgement jurisdiction.

In this case, Pfizer listed six patents in the Orange Book for Lipitor.  Apotex filed a Paragraph III certification on U.S. Patent No. 4,681,893 (expiring March 2010) and Paragraph IV certifications on the other five.  Pfizer sued Apotex on only two of the five challenged patents.  In its Answer, Apotex filed declaratory judgment counterclaims of noninfringement and invalidity of all five challenged patents, as it must have in order to trigger Ranbaxy's exclusivity.  Pfizer then filed a motion to dismiss Apotex's counterclaims with respect to the three patents that Pfizer did not assert against Apotex (the "Unasserted Patents"), on the grounds that they did not present a "case" or "controversy" as required by Article III of the Constitution.  In an Opinion and Order filed June 30, the district court denied Pfizer's motion, allowing Apotex's declaratory judgment counterclaims--and its attempt to trigger Ranbaxy's exclusivity--to proceed.

In its motion to dismiss, Pfizer argued that Apotex lacked standing to assert its counterclaims.  To establish standing, a plaintiff must demonstrate (1) an injury-in-fact, (2) that is fairly traceable to the defendant's conduct, and (3) that can be redressed by the court.  Apotex alleged two injuries-in-fact:  first, by not suing on the Unasserted Patents while reserving the right to do so in the future, Pfizer created uncertainty as to Apotex's legal rights under its ANDA; second, by refusing to litigate all of its patents and settling its litigation with Ranbaxy, Pfizer erected a barrier to FDA approval of Apotex's product, thereby barring Apotex from entering the market.  Pfizer countered that Apotex's alleged injuries were "not sufficiently imminent in light of Apotex's Paragraph III certification to the '893 patent, which prevents the FDA from approving Apotex's ANDA until the '893 patent expires."

Siding with Apotex, the court found that the facts of this case were more like those in Teva v. Novartis (where the Federal Circuit held that the "threat of litigation" on unasserted patents and the "legal undertainty" caused when a patent holder sues an ANDA filer on some but not all of Orange Book-listed patents create a justiciable controversy) and Caraco v. Forest (where the Federal Circuit held that blocking a generic drug company from selling a noninfringing product presents a justiciable controversy) than in Janssen v. Apotex (in which the Federal Circuit found no justiciable controversy because Apotex had stipulated to infringement and validity of one of the Orange Book-listed patents).

On July 14, Pfizer filed a motion for reconsideration of the district court's June 30 decision.  In addition, today Pfizer filed a second motion to dismiss, arguing that the circumstances have changed in two important ways since the court's June 30 decision:  first, "in light of the Court's decision Pfizer has now given Apotex a covenant not to sue on the Formulation Patents [two of the three Unasserted Patents] and thus there is no possibility of a future lawsuit on these patents"; and second, "also in light of the Court's decision, Pfizer has brought a counter-counterclaim against Apotex on [the third Unasserted Patent, U.S. Patent No. 5,969,156], which expires, including pediatric exclusivity, in January 2017, after the expiration of the Formulation Patents and after the November 30, 2011 date that Ranbaxy may enter the market under its settlement with Pfizer."

According to Pfizer, "the earlier-expiring Formulation Patents and the Ranbaxy settlement with its November 30, 2011 license date cannot prevent Apotex from overcoming Ranbaxy's 180-day exclusivity rights unless and until Apotex prevails on the '156 patent."  Thus, Pfizer argues that any alleged injury to Apotex is "based solely on the possibility that the '156 patent is not infringed or is invalid" and "such a speculative injury is 'conjectural' and 'hypothetical', and does not rise the level of 'concrete and actual or imminent'," as required to be justiciable.

Of course, the longer the case lasts, the less likely Apotex is to obtain the declaratory judgment that it seeks, get the judgment affirmed by the Federal Circuit, and trigger Ranbaxy's exclusivity.  Pfizer might simply run out the clock.

RELATED READING:

• The American Lawyer

District Court Declines to Stay Integrilin Case, Putting Teva At Risk of Forfeiting 180-Day Exclusivity

Millenium Pharms. and Schering Corp. v. Teva, No. 09–105 (D. Del. 2010)

Under the “failure to market” forfeiture provision, the first ANDA filer forfeits its exclusivity is it fails to market its ANDA product within 75 days of a Federal Circuit decision of patent invalidity or noninfringement.  See 21 U.S.C. 355(j)(5)(D)(i)(I)(bb)(AA).  This presents a dilemma to ANDA applicants who wish to file a Paragraph III certification on a patent that will not expire until far in the future—specifically, more than 75 days after a Federal Circuit decision would be reached.

In this case, Teva filed an ANDA for generic versions of Integrilin (eptifibatide), an antiplatelet drug that is used to reduce the risk of acute cardiac ischemic events.  Teva’s ANDA included Paragraph III certifications to U.S. Patent Nos. 5,686,570 and 5,756,451, which expire in 2014; and Paragraph IV certifications to U.S. Patent Nos. 5,807,825, 5,747,447 and 5,968,902, which expire in 2015.

Teva duly provided notice of its Paragarph IV certifications to Millenium and Schering, who last year responded by filing suit for infringing the ‘825, ‘447 and ‘902 patents under 35 U.S.C. 271(e)(2).  Last month, believing that the case will take roughly 2.5 years to litigate, and not wishing to forfeit its 180–day exclusivity, Teva filed a motion to stay the action until May 11, 2012 (2.5 years before the patents-in-suit will expire).  In its motion, Teva relied on last year’s decision by the Northern District of Illinois in Abbott v. Matrix, which granted a motion to stay in similar circumstances.

Unfortunately for Teva, the District of Delaware saw things differently.  Last week, the court denied Teva’s motion.  According to the court:

Given that Plaintiffs have demonstrated more than “a fair possibility” that they will be harmed by the entry of a stay, Defendants must show that they have a “clear case of hardship or inequity” in order to justify the granting of a stay.  Admittedly, Defendants have shown that they will be harmed if a stay is not entered, as they will likely forfeit their 180-day exclusivity period.  Defendants, however, have only themselves to blame for this result.  Defendants were aware of the statutory preconditions necessary for them to obtain the 180–day exclusivity period, and were aware of the potential that this could be forfeited given the timing of the filing of their ANDAs.  Although Defendants did not file this suit, they were well aware that their ANDA triggered the start of a 45-day period for Plaintiffs to defend the validity of their patents, and, in this sense, did control the timing of the present litigation.  Rather than wait until they could fully take advantage of their position as first filer, however, Defendants sought to prematurely reserve their place at the front of the line, and now seek an order from this Court that allows them to preserve that position.  This is not the type of hardship or balance of inequities that can appropriately convince this Court to issue a stay in the present proceedings.  Although Defendants may suffer a hardship, it is one of their own creation and, therefore, we do not think that it can outweigh the harm caused to Plaintiffs by granting this stay.

 ADDITIONAL READING:

• Millenium brief in opposition to Teva motion
• Teva reply brief
• Shearlings Got Plowed

Non-Patent Exclusivity and 180-Day Exclusivity Forfeiture Slides Posted

Last week, I gave a talk about non-patent exclusivity at ACI's FDA Boot Camp conference in Boston.  The talk covered new chemical entity (5-year) exclusivity; new clinical trial (3-year) exclusivity; orphan drug exclusivity; pediatric exclusivity; and generic drug (180-day) exclusivity.  You can download a copy of my slides here.

In June, I gave a talk about forfeiture of 180-day exclusivity at IIR's Generic Drugs Summit conference in Washington.  The talk included a discussion of the "failure to market" forfeiture provisions, particularly the FDA's Acarbose and Granisetron decisions.  You can download a copy of those slides here.

In a "Surprising" Victory, Barr and Mylan Invalidate Boehringer Ingelheim's Patent on Mirapex

Boehringer Ingelheim v. Barr and Mylan, No. 05-700-JJF (D. Del. 2008)

Last week, following a bench trial held in March, the U.S. District Court for the District of Delaware held that Boehringer Ingelheim's patent on Mirapex (pramipexole dihydrochloride) is invalid for obviousness-type double patenting.  Mirapex, indicated for the treatment of Parkinson's disease and Restless Leg Syndrome, has annual U.S. sales of approximately $380 million.

Barr Labs filed its ANDA for a generic version of Mirapex in 2005 with paragraph IV certifications to Boehringer's U.S. Patent Nos. 4,843,086 and 4,886,812.  Mylan filed its ANDA, with paragraph IV certifications to the same patents, shortly thereafter.  Barr's approval letter confirms that Barr was the first to file, and therefore is entitled to 180-day exclusivity.

Boehringer responded by filing suit against Barr and Mylan, and the cases were consolidated for trial.  The '086 patent expired while the litigation was pending, leaving only the '812 patent in suit.

The district court's opinion explains that the "basic premise of double patenting is that the same invention cannot be patented twice."  Here, the '086 patent claimed methods of treating certain diseases by administering tetrahydrobenzthiazoles, while the '812 patent claims the tetrahydrobenzthiazole compounds themselves, including the active ingredient in Mirapex, pramipexole dihydrochloride.  The court concluded that "although there are differences between the '812 patent and the '086 patent, . . . those differences are insufficient to support the patentability of the '812 patent in light of the '086 patent."

Of course, obviousness-type double patenting can be avoided by a terminal disclaimer.  Interestingly, Boehringer filed a terminal disclaimer of the '812 patent on the second day of trial of the case, on March 12, 2008.  Boehringer terminally disclaimed:

only the terminal part of the statutory term of the '812 patent which would extend beyond the 1,564 days after the full statutory term of the '086 patent as that term is defined in 35 U.S.C. § 154, so that by virtue of this disclaimer, the '812 patent will expire on October 8, 2010.

Boehringer received a 1,564-day extension under 35 USC § 156 due to FDA regulatory review of Boehringer's New Drug Application for Mirapex.  As a result of this patent term extension, the original expiration date of the '812 patent, December 12, 2006, was extended to March 25, 2011.  Thus, by its terminal disclaimer, Boehringer disclaimed five and a half months of patent term--the period of time between the expiration date of the '086 patent and the original expiration date of the '112 patent.

Boehringer argued that the terminal disclaimer obviated Barr and Mylan's double-patenting argument.  However, the court noted that "a dual problem is presented in that the terminal disclaimer was not only filed at or near the conclusion of trial in this action, but it was also filed after the expiration of the earlier '086 patent."  Citing two cases, the court observed that "the Federal Circuit has at least suggested in dicta that for a terminal disclaimer to be effective, the earlier filed patent must not have expired at the time of the filing of the disclaimer."  Boehringer tried to distinguish these cases "because neither case involved a terminal disclaimer in the context of a Section 156 patent term extension," but the court was not persuaded.  The district court held that Boehringer's terminal disclaimer was ineffective to moot the double patenting issue because it was filed after the '086 patent had expired.

According to an investor note from Bernstein Research, the decision was surprising because the district court was not expected to "make a controversial opinion on what is likely to be a precedent-setting ruling by the appellate court on patent extensions and terminal disclaimers."  In addition, the note indicates that Bernstein expects Barr to "maximize the value of the challenge through settlement."  According to Bernstein, "the most likely settlement is that Barr would have a date-certain launch of generic Mirapex in 2010 with an agreement protecting it from both an authorized generic and a potential Boehringer win on appeal."

The "failure to market" forfeiture provisions, however, will likely complicate any settlement discussions.  Under the MMA, the 180-day exclusivity period may be forfeited if the first applicant does not launch its generic drug product within 75 days after "a court enters a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken that the patent is invalid or not infringed."  If Boehringer and Barr settle the case, for example, with an agreement that Boehringer will not appeal, Barr's 180-day exclusivity would be forfeited later this summer.  For at least this reason, Boehringer is expect to appeal the district court decision.

RELATED READING:

• Barr press release
• Bloomberg article
• Motley Fool article

After Court Victory over FDA, Teva Receives Final Approval of Risperidone ANDA and Launches With 180-Day Exclusivity

Teva announced yesterday that the FDA granted final approval to its ANDA for generic Risperdal (risperidone) tablets, that it was awarded 180-day exclusivity as the first paragraph IV filer for risperidone, and that it immediately commenced a commercial launch.  FDA confirmed the final approval in a press release.  Risperdal is a schizophrenia drug marketed by Janssen, a unit of Johnson & Johnson, with annual U.S. sales of $2.8 billion.

FDA's decision to grant 180-day exclusivity to Teva follows an April 11, 2008, order of the U.S. District Court for the District of Columbia, granting Teva's request to require FDA to relist Janssen's U.S. Patent No. 5,158,952 in the Orange Book and enjoin FDA from approving any other risperidone ANDAs until Teva's 180-day exclusivity period expires.

Teva was the first ANDA applicant to file a paragraph IV certification on the '952 patent, but FDA delisted the patent in 2001, in response to a request from Janssen.  FDA argued to the district court that the '952 patent was delisted before Teva filed its ANDA.  Teva argued that the delisting "did not become effective until January 2002, when the official Orange Book reflected the delisting of that patent."

FDA has appealed the district court's decision to the U.S. Court of Appeals for the D.C. Circuit, and oral argument is scheduled for September 12, 2008.  Meanwhile, according to the FDA website, risperidone ANDAs filed by Mylan and Pliva (a subsidiary of Barr Labs) have tentative approval.  Thus, if the D.C. Circuit reverses the district court, Teva's 180-day exclusivity period would be cut short.

RELATED READING:

• Janssen press release, announcing launch of authorized generic
• Motley Fool article
• April 11 FDA Law Blog post
• January 17 OBB post

King Pharmaceuticals Files Citizen Petition Relating to New Patent on Altace (Ramipril)

King Pharmaceuticals markets Altace (ramipril), which is indicated for the treatment of high blood pressure.  Until last year, when the Federal Circuit invalidated King's compound patent on ramipril, King earned about $700 million annually from U.S. sales of Altace.

Although Lupin was the ANDA filer who prevailed against King in the patent litigation, Cobalt Labs, as the first ANDA filer, won the 180-day exclusivity rights.  In a letter dated January 29, 2008, to attorneys for Lupin, FDA explained that Cobalt's exclusivity was triggered on December 10, 2007, and will expire on June 7, 2008.

Recently, on May 16, 2008, King submitted a citizen petition requesting that FDA require ANDA applicants for generic ramipril to submit a paragraph III or IV certification to U.S. Patent No. 7,368,469, which issued May 6, 2008, prior to final approval.  The '469 patent claims methods "for reducing the risk of a cardiovascular event" by administering an ACE inhibitor such as ramipril.

According to the FDA website, at least seven ANDA filers have tentative approval for ramipril and thus appear to have planned on obtaining final approval on June 7, when Cobalt's 180-day exclusivity expires.  Those plans may now be in doubt, as it may take FDA some time to decide how to rule on King's petition.

RELATED READING:

• Sept. 11, 2007 OBB post on Fed. Cir. decision
• Oct. 8, 2007 OBB post on FDA request for comments re: 180-day exclusivity
• Nov. 6, 2007 OBB post on comments submitted to FDA
• Feb. 4, 2008 OBB post on FDA decision re: 180-day exclusivity