Orange Book Blog

Federal Circuit Revives Mutual's Antitrust Counterclaims Arising From Temazepam ANDA Litigation

Tyco Healthcare et al. v. Mutual Pharm. et al., No. 2013-1386 (Fed. Cir.)

    by Aaron F. Barkoff

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:

1. That Tyco's section 271(e)(2) infringement claim constituted sham litigation that subjected Tyco to antitrust liability for using illegitimate means to keep Mutual's product off the market.
2. That no reasonable litigant could have expected Tyco's patent to withstand a validity challenge.
3. That Tyco's citizen petition was a sham.
4. That Tyco's infringement suit was the product of fraud under Walker Process.

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."

Supreme Court Decides That "Reverse Payment" Settlements Shall be Subjected to "Rule of Reason" Antitrust Analysis

Federal Trade Comm'n v. Actavis, Inc., 570 U.S. ____ (2013)

    by Aaron F. Barkoff

The U.S. Supreme Court, in a 5-3 opinion, decided today that "reverse payment" settlements of ANDA litigation shall be analyzed according to the "rule of reason."  Thus, the Court compromised between the positions urged by the parties: that such settlements are presumptively illegal (FTC) or that they are virtually immune from antitrust scrutiny (Actavis).

The case arose from ANDA litigation between Solvay and Actavis over a generic version of Solvay's AndroGel product.  The parties settled the case in 2006, agreeing that Solvay would pay Actavis $19-30 million annually until 2015, when Actavis would be permitted to market its generic product (5+ years before Solvay's patent expired).  In addition, Actavis agreed to promote AndroGel to urologists.

The FTC sued the parties in 2009, alleging that they unlawfully agreed "to share in Solvay's monopoly profits, abandon their patent challenges, and refrain from launching their low-cost generic products to compete with AndroGel for nine years."  The U.S. District Court for the Northern District of Georgia dismissed the FTC's complaint, holding that the allegations did not set forth an antitrust violation.  The 11th Circuit affirmed the dismissal, writing that "absent sham litigation or fraud in obtaining the patent, a reverse payment settlement is immune from antitrust attack so long as its anticompetitive effects fall within the scope of the exclusionary potential of the patent."

In affirming the dismissal of the FTC's complaint, the 11th Circuit applied the so-called "scope of the patent test," which looks primarily at whether the agreed-upon generic entry date is later than the expiration date of the patent.  Under this test, according to critics, reverse payment settlements are virtually immune to the antitrust laws.  Other circuits applying the "scope of the patent" test include the Federal Circuit (Ciprofloxacin) and 2nd Circuit (Tamoxifen).  The 3rd Circuit, on the other hand, held in the K-Dur case last year that the appropriate test is the "quick look," under which reverse payment settlements are presumptively illegal.  The Supreme Court took this case to resolve the circuit split.

Writing for the majority, Justice Breyer summarized the Court's opinion as follows:

In sum, a reverse payment, where large and unjustified, can bring with it the risk of significant anticompetitive effects; one who makes such a payment may be unable to explain and to justify it; such a firm or individual may well possess market power derived from the patent; a court, by examining the size of the payment, may well be able to assess its likely anticompetitive effects along with its potential justifications without litigating the validity of the patent; and parties may well find ways to settle patent disputes without the use of reverse payments.  In our view, these considerations, taken together, outweigh the single strong consideration--the desirability of settlements--that led the Eleventh Circuit to provide near-automatic antitrust immunity to reverse payment settlements.

The Court's opinion suggests a few ways in which ANDA litigants can settle their cases without raising antitrust concerns.  First, as the FTC has stated, the parties can settle simply by compromising on a generic entry date that is somewhat earlier than the patent expiration date--without any payment.  But the Court also suggested that even certain settlements including a payment will survive a rule of reason analysis:

Where a reverse payment reflects traditional settlement considerations, such as avoided litigation costs or fair value for services, there is not the same concern that a patentee is using its monopoly profits to avoid the risk of patent invalidation or a finding of noninfringement.  In such cases, the parties may have provided for a reverse payment without having sought or brought about the anticompetitive consequences we mentioned above.  But that possibility does not justify dismissing the FTC's complaint.  An antitrust defendant may show in the antitrust proceeding that legitimate justifications are present, thereby explaining the presence of the challenged term and showing the lawfulness of that term under the rule of reason.

Chief Justice Roberts, joined by Justices Scalia and Thomas, would have affirmed the 11th Circuit and upheld the "scope of the patent" test.  In dissent, he wrote:

The majority points to no case where a patent settlement was subject to antitrust scrutiny merely because the validity of the patent was uncertain.  Not one.  It is remarkable, and surely worth something, that in the 123 years since the Sherman Act was passed, we have never let antitrust law cross that Rubicon.

Also today, the Court scheduled a June 20 conference to discuss the cert petition in K-Dur.  Presumably, the Court will issue a "GVR," granting the petition, vacating the 3rd Circuit opinion, and remanding the case to the 3rd Circuit for analysis under the rule of reason.

RELATED READING:

• Actavis press release
• FTC statement
• GPhA statement
• New York Times
• PhRMA statement
• SCOTUSblog

Product Hopping -- The FTC Weighs In

    by Alex Menchaca

"Product hopping" is the practice of changing the formulation of an approved Reference Listed Drug to stay one step ahead of the generics seeking to compete with the RLD.

In July, Mylan Pharmaceuticals filed an antitrust complaint accusing Warner Chilcott of engaging in product hopping in connection with its Doryx product, which is prescribed for the treatment of severe acne and other bacterial infections.  Other plaintiffs include Meijer and Rochester Drug Co-Operative.  The case is Mylan Pharms. et al. v. Waner Chilcott Co. et al., No. 12-cv-3824-PD (E.D. Pa.).

The complaint alleges an interesting tale of how Warner Chilcott made a number of changes to its Doryx product in order to "manipulate the FDA regulatory processes to delay and/or prevent generic competition to Doryx, thereby foreclosing Mylan from the Relevant Markets."

Warner Chilcott, the complaint alleges, first obtained FDA approval for a Doryx capsule.  When generic competitors were on the verge of attaining FDA approval for the capsule product, Warner Chilcott converted the marketplace from capsules to tablets.  This move, Mylan alleges, rendered its proposed generic version of the capsules obsolete as a capsule cannot serve as a substitute for a tablet RLD.  The complaint continues its tale reciting two more examples where Warner Chilcott "pulled the rug out from under the generics by switching the market" to new formulations.  As the generics neared FDA approval for a formulation, that imminent approval would be rendered obsolete.  This conduct, Mylan asserts, constitutes anti-competitive behavior in violation of the Sherman Act, 15 U.S.C. §§ 1 and 2.

Applesauce Study.  The complaint also explains how applesauce can be used as part of a greater plan to violate the Antitrust Laws:

In 2006, Defendants released a study for the administration of Doryx with applesauce and sought a corresponding labeling change that required generic manufacturers to develop tablets that could be administered by breaking the tablets into pieces and sprinkling the pieces over applesauce.  This scheme delayed Mylan's development of its generic Doryx tablets anywhere from 6 to 12 months.

Motion to Dismiss.  Warner Chilcott filed a motion to dismiss commenting, in part, that the changes to its product were "nothing more than innovation [] and the marketing of those innovations once government approvals were obtained."  For example, Warner Chilcott reports that "dissolution storage stability" provided the motivation for one of the formulation changes.

In its brief, Warner Chilcott argues that "[a]ntitrust law does not impose a duty on anyone to slow down innovation, roll out new products at a certain pace, keep older versions on the market, or do anything else to help competitors compete."  Warner Chilcott cites to two cases for the proposition that "competitive loss from alleged 'product switching' is not antitrust injury."

Enter the FTC.  On November 21, 2012, the FTC filed a motion for leave to file an amicus brief.  In its amicus brief, the FTC asserts that "pharmaceutical product redesigns can constitute exclusionary conduct."  The FTC explains product hopping as follows:

Product hopping can work in the following way:  first, the brand manufacturer makes minor non-therapeutic changes to the brand product, such as a dosage or form change.  Next, prior to generic entry, it removes the original product from the marketplace, or accomplishes this indirectly, such as by recalling supply of the original product or raising the price of the original product by a meaningful amount above the reformulated one.  Such conduct can push patients and physicians to abandon the original product.  In this way, a brand manufacturer can convert existing market demand for the original product to its reformulated product – not because physicians and patients prefer it, but simply because the original product is no longer as available or is more costly.  Once the original version of the brand product is less available or more expensive, physicians will stop writing prescriptions for it.  Because the prescription must contain, among other things, the same dosage and form as the generic for a pharmacist to substitute it for the brand, a product switch will effectively eliminate substitution at the pharmacy counter and thus meaningful generic competition.  As the author of the leading antitrust treatise put it:  "Product-hopping seems clearly to be an effort to game the rather intricate FDA rules . . . .  The patentee is making a product change with no technological benefit solely in order to delay competition."

This past Monday, December 3rd, the court granted the FTC's motion and accepted its brief.

Warner Chilcott reports that "[t]hree courts have considered claims that new pharmaceutical products constituted illegal 'product switching' in violation of the antitrust laws."  Two courts have dismissed the complaint and one permitted the case to proceed (this latter case reportedly settled for $250 million after one day of trial).

We will keep our eyes on this case to see which way the court goes.

Third Circuit Issues Landmark Decision in Reverse Payment Case, Setting Up Supreme Court Review

In Re: K-Dur Antitrust Litigation, No. 10-2077 (3d Cir.)

In what antitrust experts are calling a "landmark" decision, the Third Circuit Court of Appeals on Monday held that so-called "pay-for-delay" or "reverse payment" settlement agreements are presumptively anticompetitive and illegal.  In 2005, the Eleventh Circuit Court of Appeals, analyzing the same settlement agreements at issue here, but applying a different test, reached essentially the opposite result.  Because of the circuit split, many observers believe that with this case, the Supreme Court will finally address the legality of reverse payment settlements.

The two settlement agreements at issue in the case involve Schering's blood pressure drug K-Dur 20.  In 1997, Schering and Upsher-Smith settled their paragraph IV case on terms that included a $60 million payment from Schering to Upsher and an agreement by Upsher not to market its generic version of K-Dur until 2001.  At about the same time, Schering and ESI Lederle settled their paragraph IV case on terms that included a $10 million payment from Schering to ESI and an agreement by ESI not to market its generic K-Dur until 2004.

The Third Circuit's opinion provides a concise history of court decisions examining reverse payment settlements under the antitrust laws.  Since 2001, five other circuit courts have addressed the legality of reverse payment settlements.  The D.C. Circuit in 2001 and the Sixth Circuit in 2003 both concluded that such agreements should be subject to strict antitrust scrutiny, at least where the parties attempted to "park" the first ANDA filer's 180-day exclusivity period in order to block subsequent ANDA filers.  The Eleventh Circuit in 2003 and 2005, the Second Circuit in 2006, and the Federal Circuit in 2008 each applied the "scope of the patent" test, under which "the essence of the inquiry is whether the agreements restrict competition beyond the exclusionary zone of the patent."  More specifically, under the scope-of-the-patent test, "reverse payments are permitted so long as (1) the exclusion does not exceed the patent's scope, (2) the patent holder's claim of infringement was not objectively baseless, and (3) the patent was not procured by fraud on the PTO."

The Third Circuit rejected the scope-of-the-patent test here, stating:  "As a practical matter, the scope of the patent test does not subject reverse payment agreements to any antitrust scrutiny.  As the antitrust defendants concede, no court applying the scope of the patent test has ever permitted a reverse payment antitrust case to go to trial."  According to the court, the "test improperly restricts the application of antitrust law and is contrary to the policies underlying the Hatch-Waxman Act and a long line of Supreme Court precedent on patent litigation and competition."

The court further explained:

In rejecting the scope of the patent test, we are cognizant that such a test encourages settlement, an objective our decisions generally support.  However, the judicial preference for settlement, while generally laudable, should not displace countervailing policy objectives or, in this case, Congress's determination--which is evident from the structure of the Hatch-Waxman Act and the statements in the legislative record--that litigated patent challenges are necessary to protect consumers from unjustified monopolies by name brand drug manufacturers.  We also emphasize that nothing in the rule of reason test we adopt here limits the ability of the parties to reach settlements based on a negotiated entry date for marketing of the generic drug: the only settlements subject to antitrust scrutiny are those involving a reverse payment from the name brand manufacturer to the generic challenger.

The Third Circuit thus remanded the case to the district court with the following instructions:

to apply a "quick look" rule of reason analysis based on the economic realities of the reverse payment settlement rather than the labels applied by the settling parties.  Specifically, the finder of fact must treat any payment from a patent holder to a generic patent challenger who agrees to delay entry into the market as prima facie evidence of an unreasonable restraint of trade, which could be rebutted by showing that the payment (1) was for a purpose other than delayed entry or (2) offers some pro-competitive benefit.

Consistent with the Third Circuit's decision, the FTC has often stated that it is not concerned with settlements in which the brand and generic companies compromise on a generic entry date that is prior to patent expiration but later than would occur if the patent-in-suit were invalidated in court--so long as nothing of value is provided from the brand to the generic as part of the agreement.  The FTC has also publicly stated that besides cash payments, it considers an agreement by the brand company not to launch an authorized generic drug at the time of generic entry to be "something of value" that should make the agreement presumptively anticompetitive.

RELATED READING:

• GPhA press release
• Statement by FTC Chairman Jon Leibowitz
• Thomson Reuters News & Insight
• Washington Post article
• WSJ Law Blog

Federal Trade Commission Issues Final Report on Authorized Generic Drugs

The Federal Trade Commission announced earlier today that it has completed its study into the competitive effects of authorized generic drugs.  The FTC's final report, entitled "Authorized Generic Drugs -- Short-Term Effects and Long-Term Impact," was unanimously approved by the five-member commission and follows up on a 2009 interim report.  The study was commenced upon requests in 2005 by Senators Grassley (R-IA), Leahy (D-VT) and Rockefeller (D-WV), and Representative Waxman (D-CA).

The final report contains four main findings:

1. Competition from authorized generics during the 180-day marketing exclusivity period has led to lower retail and wholesale drug prices.  Specifically, authorized generics are associated with retail prices that are 4-8% lower and wholesale prices that are 7-14% lower.
2. Authorized generics have a substantial effect on the revenues of competiting generic firms.  For instance, an authorized generic reduces the first filer's revenues by 40-52% during the 180-day exclusivity period and by 53-62% over the following 30 months.
3. Lower expected profits could affect a generic company's decision to challenge patents on products with low sales.  However, the reduced revenues resulting from authorized generic competition during the 180-day exclusivity period have not substantially reduced the number of challenges to branded drug patents by generic firms.
4. There is strong evidence that agreements not to compete using authorized generics have become a way that some branded firms compensate generic firms.  For example, in FY 2010, fifteen drug patent settlements combined an explicit agreement by the brand manufacturer not to launch an authorized generic competitor and a commitment by the first-filing generic to defer entry.

The report is 270 pages long, it contains dozens of tables and figures, and it includes a great deal of data about specific pharmaceutical companies.

The report concludes:

During the 180-day exclusivity period, competition from authorized generics lowers prices for consumers and lowers revenues for the independent generic competitor.  Over the longer term, lower expected profits could affect a generic company's decision to challenge a patent on products with low sales, and one company provided a few examples where it claimed the expectation of an authorized generic led it to reject or delay such a challenge.  Overall, however, patent challenges, even on drugs with low sales, remain robust and, by most measures, have increased despite the prevalence of authorized generic competition.  Moreover, as a consequence of an authorized generic's significant negative impact on a generic's revenues, some brand-name companies have used agreements not to launch an authorized generic as a way to compensate an independent generic in exchange for the generic's agreement to delay its entry.  The frequency of this practice and its profitability may make it an attractive way to structure a pay-for-delay settlement, a practice that causes substantial consumer harm.

FURTHER READING:

• GPhA statement
• PhRMA statement
• New York Times
• FDA Law Blog
• The Hill
• Pharmalot
• PharmPro

FTC Posts Friendly Reminder to Please Send Them Your ANDA Litigation Settlement Agreements

In a press release today, the Federal Trade Commission announced that it "has notified Sanofi-Aventis U.S. LLC, Watson Pharmaceuticals, Inc., and Synthon Holding B.V., that it believes the companies violated federal law by failing to inform antitrust authorities about drug patent agreements involving Sanofi's insomnia drug Ambien CR."  According to the release, "the FTC staff told the companies that it decided not to recommend enforcement action for several reasons, including its finding that the violation does not appear to have harmed consumers or competition, nor benefitted the companies."  Instead, the FTC apparently decided this is a "teachable moment," and published advisory letters that it mailed to Sanofi, Watson and Synthon.

The press release quotes FTC Bureau of Competition Director Richard Feinstein as stating, "The Bureau of Competition recognizes the importance of clear guidance concerning the types of agreements that are subject to the MMA filing requirement.  We expect that these companies, and the pharmaceutical industry more broadly, will closely consider the contents of these advisory letters in connection with future agreements that may be subject to the MMA."

According to the advisory letters, Section 1112(a)(2) of the Medicare Modernization Act requires an agreement to be filed if it concerns:

(A) the manufacture, marketing, or sale of the brand name drug that is the listed drug in the ANDA involved;

(B) the manufacture, marketing, or sale of the generic drug for which the ANDA was submitted; or

(C) the Hatch-Waxman 180-day exclusivity period as it applies to an ANDA based on the same brand name drug.

In addition, "companies must also file the text or a written description of any agreements between them that are contingent upon, provide a contingent condition for, or are otherwise related to an agreement that is required to be filed under the provisions set forth above."  The letters further state that "the only exclusion from the Act's filing requirement is an exception for agreements that solely concern: (A) purchase orders for raw material supplies; (B) equipment and facility contracts; (C) employment or consulting contracts; or (D) packaging and labeling contracts."

It appears that the FTC is monitoring activity in specific ANDA litigations--either in the press or perhaps through PACER--as the Ambien CR agreements were publicly available.  The FTC reminds industry that "in case of doubt about whether filing [of a specific agreement] is required, companies can contact Commission staff for guidance."

FTC Releases Report on Paragraph IV Litigation Settlements for FY 2010

On Tuesday, the Federal Trade Commission released its report on Paragraph IV litigation settlements filed in Fiscal Year 2010 (Oct. 2009 through Sept. 2010).  The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) requires pharmaceutical companies to file certain agreements, including settlements of Paragraph IV litigation, with the FTC and Department of Justice.  Each year, the FTC releases a report on the settlement agreements filed in the previous fiscal year.

The FTC's report for FY 2010 states that the FTC "received 113 final resolutions of patent disputes between a brand and a generic" during the year, 31 of which "contain both compensation to the generic manufacturer and a restriction on the generic manufacturer's ability to market its product."  The FTC refers to such agreements as "pay-for-delay" settlements.  In a press release announcing the report, the FTC noted that these 31 agreements represent a 60 percent increase in pay-for-delay settlements over FY 2009.  On a percentage basis, however, the number of such settlements remained the same in 2010 as it was in 2009.

I returned yesterday from the ACI Paragraph IV Disputes conference in New York, where Michael Kades of the FTC gave a presentation on pay-for-delay settlements.  Mr. Kades noted that the increasing prevalence of such agreements since 2003,
when the 6th Circuit declared a pay-for-delay settlement to be illegal in In re Cardizem, corresponds with the approval of such agreements by the 11th Circuit in 2005 (FTC v. Schering-Plough); the 2nd Circuit in 2006 (In re Tamoxifen); and the Federal Circuit in 2008 (In re Ciprofloxacin).  Mr. Kades further indicated that the FTC continues to vigorously pursue antitrust cases against pay-for-delay settlements in other circuit courts, and hopes that ultimately the Supreme Court will resolve the issue or Congress will outlaw such settlements.

RELATED READING:

• GPhA Press Release
• Pharmalot

OBB News Briefs

• The Federal Trade Commission announced the release of its FY 2007 Summary of Pharmaceutical Company Settlement Agreements.  For commentary, see FDA Law Blog, Pharmalot.
• Wyeth sued Sandoz over a generic version of Protonix I.V.  The WSJ Health Blog recapped all the Protonix ANDA litigation.
• India's drugmakers recently threatened to stop production of 33 bulk drugs, Pharmalot reports.
• The Washington Legal Foundation announced that it filed an amicus brief urging the Federal Circuit to rehear the Caraco v. Forest Labs case.

OBB News Briefs

• As reported by FDA Law Blog, FDA determined on May 7 that Cobalt forfeited its 180-day exclusivity on acarbose and Cobalt sued FDA on May 8 for injunctive relief.  Last Friday, for some reason, Cobalt voluntarily dismissed its suit against FDA.
• Also last Friday, FDA appealed the D.C. district court's decision requiring relisting of Janssen's patent on Risperdal (risperidone).
• Ivax recently filed a declaratory judgment complaint against AstraZeneca, reportedly seeking to trigger Ranbaxy's 180-day exclusivity on esomeprazole.  AstraZeneca and Ranbaxy settled their esomeprazole litigation last month.
• The district court in Washington, D.C. recently transfered the FTC v. Cephalon "reverse payment" antitrust case to the Eastern District of Pennsylvania, Reuters reported, possibly throwing a wrench into the FTC's plans to get a "reverse payment" case before the Supreme Court.
• Pharmalot had an interesting post last week on the coming wave of generic drugs from Chinese generic drug companies.

OBB News Briefs

• Earlier this week, FDA Law Blog provided an update on Teva's suit against the FDA, seeking relisting of Janssen's patent on Risperdal (risperidone) and confirmation of Teva's 180-day exclusivity on a generic version of the drug.
• Last week, FDA Law Blog reported on a recent FDA determination that Watson Labs forfeited its 180-day exclusivity on generic Camptosar (irinotecan HCl) because it failed to obtain tentative approval of its ANDA within 30 months of filing, as required by the MMA.
• Pharmalot and the WSJ Health Blog recently ran posts on a series of articles in the Los Angeles Times examining whether generic drugs are as good as brand-name drugs.
• Eighteen states recently sued Abbott Labs for antitrust violations, alleging that Abbott made trivial changes to the formulation of its TriCor cholesterol drug, thereby delaying generic competition.  Statements were released by the Attorneys General from Florida and Iowa.
• William Kovacic was appointed the new Chairman of the Federal Trade Commission this week, succeeding Deborah Platt Majoris.  The Wall St. Journal reported that Mr. Kovacic has been a strong proponent of FTC action against "reverse payment" settlements.