Orange Book Blog

Apotex Tries Again for DJ Jurisdiction Based on Patent Listing in Orange Book

Undeterred by the Supreme Court's denial of its cert petition in Apotex v. Pfizer last year, Apotex has filed yet another lawsuit asserting that listing a patent in the Orange Book establishes a justiciable controversy and therefore declaratory judgment jurisdiction.  This argument failed at least twice before, in Teva v. Pfizer (relating to generic Zoloft) and Apotex v. Pfizer (concerning generic Accupril).  This time around, Apotex is targeting GlaxoSmithKline and its antiulcer medication Zantac Syrup (ranitidine HCl).

Apotex's complaint against Glaxo alleges as follows:

• Glaxo submitted U.S. Patent No. 5,068,249, covering aqueous ranitidine formulations, for listing in the Orange Book.
• "As a consequence of such Orange Book listing, Glaxo maintains, and has affirmatively represented to the world, that the '249 patent claims the approved drug, Zantac Syrup, or a method of using that drug, and that a claim for patent infringement could reasonably be asserted against any generic ANDA applicant, including Apotex, attempting to market a generic ranitidine product before patent expiration."
• Glaxo already has successfully enforced the '249 patent against other companies seeking to market a generic ranitidine product prior to the expiration of the '249 patent.
• Apotex submitted a paragraph IV certification to the '249 patent.
• Apotex's approval to market generic ranitidine is delayed due to the '249 patent, Apotex "also faces potentially enormous infringement liability if it markets its generic product prior to expiration of the '249 patent," and "only a declaratory judgment from this Court can alleviate this harm and allow Apotex to obtain approval of its product."
• "Apotex is entitled by law to bring and maintain this action for declaratory judgment of patent non-infringement under the Declaratory Judgment Act and the MMA where, as here, Glaxo did not sue Apotex within 45 days of receipt of Apotex's notice of paragraph IV certification to the '249 patent, and Apotex has offered Glaxo an Offer of Confidential Access to Apotex's ANDA for generic ranitidine oral solution."

While Apotex acknowledges in its complaint that NDA applicants are required by statute to submit patent information in their NDAs, Apotex incredibly states, "Thus, the NDA-holder/patent owner necessarily puts all prospective generic ANDA applicants on notice that a suit for infringement can and will be asserted against any ANDA applicant that attempts to seek approval for and market a generic version of the NDA drug before patent expiration."  Of course, Apotex knows full well that Glaxo's submission of patent information for listing in the Orange Book does not obligate it to sue anyone on the patent.

It appears that Apotex's arguments in this case are no better than Teva's arguments were in its case against Pfizer, where the Federal Circuit concluded that Teva failed to satisfy the "reasonable apprehension of suit" test for declaratory judgment jurisdiction, and therefore did not meet the "actual case or controversy" requirement of Article III of the Constitution.  Glaxo will undoubtedly file a motion to dismiss.  Apotex filed this case in the Eastern District of Virginia (known for its "rocket docket") and may be hoping for a speedy path back to the Federal Circuit and, if necessary, the Supreme Court.

Appeal to the Supreme Court may not be necessary, however, depending on how the Federal Circuit interprets the Court's recent MedImmune decision.  As an alert reader pointed out, J. Scalia (writing for the majority) strongly criticized the Federal Circuit's "reasonable apprehension of suit" test in dicta, and even cited Teva v. Pfizer.  In footnote 11, J. Scalia suggested that the test is in conflict with no fewer than four Supreme Court cases regarding declaratory judgment jurisdiction.  Apotex may have had this in mind when it filed its recent DJ action against Glaxo.

Ranbaxy Appeals Lipitor Case to Supreme Court

Lipitor (atorvastatin calcium), indicated for the reduction of cholesterol, is the world's best-selling pharmaceutical.  Ranbaxy has applied to market a generic version of Lipitor and has challenged Pfizer's patents on Lipitor in many countries around the world--usually without success.  For instance, in August 2006 the Federal Circuit upheld the validity of Pfizer's U.S. Patent No. 4,681,893.  (In the same decision the Federal Circuit invalidated Pfizer's U.S. Patent No. 5,273,995, but Pfizer has vowed to correct the defect through a re-issue.)  Now, Ranbaxy has appealed the case to the Supreme Court, on somewhat unconventional grounds.

The Federal Circuit's August 2006 decision affirmed the district court's claim construction and found that Ranbaxy's generic Lipitor infringed the '893 patent claims.  In addition, the Federal Circuit upheld the validity of Pfizer's patent term extension on the '893 patent, rejecting (in just a couple paragraphs) Ranbaxy's argument that the extension was invalid due to Pfizer's failure to disclose material information to the patent office.  Ranbaxy is appealing only this latter finding to the Supreme Court.

According to Ranbaxy's cert petition:

This case presents an important federal question: In seeking a patent term extension under 35 U.S.C. 156 on the basis that the patent claims an approved drug, do the controlling statute and regulation require a pharmaceutical company to disclose (1) its own prior, inconsistent representations made before the United States Patent and Trademark Office that the patent does not cover the approved drug, (2) a patent office Board of Patent Appeals and Interferences decision adopting those representations, and (3) a later patent claiming the drug on which the patent term extension application is premised, or is this information per se irrelevant to the patent term extension proceedings?

Pfizer obtained a patent term extension of more than three years for the '893 patent, due to the lengthy FDA approval process for Lipitor.  Without the extension, the patent would have expired on May 30, 2006.  Ranbaxy unsuccessfully argued in the Federal Circuit that the extension is invalid.  Chances that the Supreme Court will take the case seem remote.

Thank you to a helpful reader for passing along a copy of Ranbaxy's cert petition.

RELATED READING:

• Jan. 26, 2007 Ranbaxy press release, announcing favorable Lipitor ruling in Canada
• Aug. 31, 2006 and Oct. 23, 2006 OBB posts on Lipitor cases

UPDATE:

• On April 2, 2007, the Supreme Court denied Ranbaxy's cert petition

Generic vs. Generic

Generic drug makers typically set their litigation sights on brand-name drug companies.  Their goal is to invalidate the brand companies' patents and earn the right to market their generic drugs before the patents expire.  Increasingly, however, generics are suing each other to protect or gain market share.

For instance, Teva Pharmaceuticals announced today that it recently sued several generic rivals who filed ANDAs for generic Zoloft (sertraline HCl), alleging that the companies infringe Teva's patents on processes for making sertraline HCl.  Teva's 180-day generic exclusivity period expires next month and these lawsuits are an attempt to stave of generic competition.  Teva filed suit against at least the following companies:  Cipla; Hetero Drugs; Zydus-Cadila Healthcare; Sandoz; Andrx; Genpharm; Invagen; Lupin; and Apotex.  Teva's complaint against Andrx, for example, alleges that if Andrx launches its generic Zoloft, it will infringe four Teva patents covering processes for making the form II and V polymorphs of sertraline HCl.

It was also recently reported that Lek D.D., a subsidiary of Sandoz, filed a complaint for patent infringement against Bristol-Myers Squibb and Watson Pharmaceuticals relating to BMS's Pravachol (pravastatin sodium).  Lek's patents cover certain polymorphs of pravastatin sodium.  Lek sells a generic version of Pravachol and Watson sells the authorized generic of Pravachol.  While several other companies also sell generic Pravachol--including Teva, Apotex, Dr. Reddy's, Cobalt, Genpharm, and Pliva (Barr)--it is unclear whether Lek intends to sue any of them.

Another case of aggressive competition between generic drug companies involves Zofran (ondansetron HCl).  As we reported Tuesday, Dr. Reddy's recently launched the first generic version of ondansetron HCl tablets.  Apotex had sought to launch its generic ondansetron HCl tablets at the same time as Dr. Reddy's, but the FDA denied Apotex's request and the courts upheld the FDA's decision.  Apotex argued unsuccessfully that Dr. Reddy's 180-day generic exclusivity period came and went years ago, before the FDA had even granted tentative approval to Dr. Reddy's ANDA.

The trend of generics suing other generics appears likely to continue in the future, as generic drug companies boost spending on R&D and competition becomes more fierce.  Investment in R&D will eventually lead to patents, which may wind up being asserted against other generic drug companies.

Ondansetron Update: Apotex Loses Emergency Appeal, Dr. Reddy's Launches Generic Zofran

We previously reported on Apotex's lawsuit against the FDA concerning generic Zofran (ondansetron HCl) tablets.  Apotex sought an injunction directing FDA to approve Apotex's ANDA for generic Zofran tablets when GlaxoSmithKline's pediatric exclusivity on Zofran expired on December 24, 2006.  Although Dr. Reddy's was the first to file an ANDA for generic Zofran tablets, Apotex argued that a May 2005 district court dismissal of GSK's lawsuit against Apotex triggered Dr. Reddy's 180-day exclusivity period, which then ran to completion in December 2005.

On December 7, 2006, Judge Rosemary M. Collyer of the U.S. District Court for the District of Columbia denied Apotex's motion for a preliminary injunction against the FDA, prompting Apotex to file an emergency motion to stay the district court's order pending appeal.  On December 22, the D.C. Circuit Court of Appeals denied Apotex's motion.  That cleared the way for FDA to grant final approval for ondansetron HCl tablets to Dr. Reddy's, which it did on December 27.  The same day, Dr. Reddy's announced that it would "commence the shipment of this product shortly."

Zofran, which is indicated for the prevention of nausea and vomiting associated with chemotherapy, is available in several different dosage forms and strengths.  Besides granting final approval to Dr. Reddy's, FDA announced in November that it granted final approval to Teva and SICOR for generic Zofran Injection and Zofran Injection Premixed.  Additionally, FDA announced in December that it granted final approval to Kali Laboratories' ANDA for generic Zofran ODT (ondansetron orally disintegrating tablets) and to Roxane Laboratories' ANDA for generic Zofran Oral Solution.  The various forms of Zofran accounted for well over $1 billion in sales last year for GSK.

Meanwhile, it appears that Apotex's lawsuit against the FDA is moving forward.  On January 18, the FDA and Dr. Reddy's answered Apotex's complaint.  Today, the court set a March date for the initial scheduling conference.  With Dr. Reddy's already on the market as the sole generic supplier of ondansetron HCl tablets, it is unclear what Apotex has to gain by pursuing the case.

Caraco Wins Appeal Over Ortho-McNeil in Generic Ultracet Case

Ortho-McNeil Pharma. v. Caraco Pharma. Labs., No. 06-1102 (Fed. Cir. 2007)

Last Friday the Federal Circuit affirmed a district court ruling that Caraco Pharmaceutical Laboratories' ANDA for a generic version of Ortho-McNeil's Ultracet does not infringe Ortho's U.S. Patent No. 5,336,691.  Ultracet, an analgesic combining tramadol and acetaminophen, generated sales of approximately $350 million last year for Ortho-McNeil.  Caraco is majority-owned by Sun Pharmaceutical, the fifth largest generic drug maker in India, while Ortho-McNeil is a wholly-owned subsidiary of Johnson & Johnson.  The Federal Circuit's opinion vindicated Caraco's decision to launch its generic version of Ultracet "at risk" in late December 2005, after the district court ruling.

Ortho filed suit in the district court after Caraco filed an ANDA for a generic version of Ultracet, which included a paragraph IV certification with respect to the '691 patent.  Caraco's ANDA requested approval for a formulation containing tramadol and acetaminophen with an average weight ratio of tramadol to acetaminophen of 1:8.67, and requiring a weight ratio of no less than 1:7.5.  Ortho alleged that Caraco's proposed formulation infringed claim 6 of the ’691 patent, which recites (when read in conjunction with the two claims on which it depends): "A pharmaceutical composition comprising a tramadol material and acetaminophen, wherein the ratio of the tramadol material to acetaminophen is a weight ratio of about 1:5."

The only issue in the case was the claim construction for "about," as the parties had previously stipulated to be bound by the patent validity and enforceability decisions in Ortho-McNeil's corresponding Ultracet ANDA litigations against Kali Laboratories, Inc. (a Par Pharmaceutical subsidiary), No. 02-CV-5707-JCL-MF (D. N.J.), and Teva Pharmaceutical Industries, Ltd., No. 04-CV-886-HAA-GDH (D. N.J).  (The Kali and Teva cases are still pending.)  Caraco argued that the proper construction of "about 1.5" was "approximately 1:5, subject perhaps to minor measuring errors of, say, 5 or 10%."  Ortho argued that the proper construction is "approximately 1:5, and . . . encompasses a range of ratios of at least 1:3.6 to 1:7.1."

On motion for summary judgment, the district court followed Ortho's claim construction and found that Caraco's ANDA formulation did not literally infringe the '691 patent, nor did it infringe under the doctrine of equivalents, based on the doctrine of claim vitiation.  The district court concluded that finding infringement by Caraco’s formulation with an average weight ratio of 1:8.67 would render meaningless the "about 1:5" limitation.

In reviewing the district court's claim construction de novo, the Federal Circuit found no error in the district court's construction of the claim term "about 1:5," and further found there could be no literal infringement because Caraco’s formulation must have a weight ratio of tramadol to acetaminophen of no less than 1:7.5.  Finally, the Federal Circuit found no error in the district court's doctrine of equivalents analysis, stating that the 1:5 parameter was critical to the invention.

RELATED READING:

• Jan. 19 Caraco press release
• Read more at Patent Docs

FTC Commissioner Blasts "Reverse Payment" Agreements in Senate Testimony

In testimony yesterday before the Senate Committee on the Judiciary, Federal Trade Commission Commissioner Jon Leibowitz voiced support for legislation to prohibit litigation settlement agreements between generic and pharmaceutical brand manufacturers that include both payments to the generic manufacturer and a delay in generic drug market entry ("reverse payment" agreements).  Leibowitz argued that such reverse payment agreements harm consumers by substantially delaying access to cheaper generic drugs and that the courts have taken an extremely lenient view on such settlements, necessitating legislative intervention.  The Commissioner further testified that, absent a legislative fix, such settlement agreements will inevitably increase, as any profit expected by a generic manufacturer upon generic market entry is substantially less than the profit the brand manufacturer stands to lose due to price differences between the brand and generic versions of the drug.

In support of the Commissioner's testimony, the FTC yesterday released its annual report on agreements filed in fiscal year 2006 under the reporting requirements of the 2003 Medicare Modernization Act (MMA).  According to the report, forty five agreements were filed in FY2006, more than double the number of agreements filed in each of the two previous years.  The report makes a special point of noting that all of the FY2006 agreements were received after the Schering Plough vs. FTC decision by the 11th Circuit Court of Appeals, reversing the FTC's decision that the relevant settlement agreements violated the FTC Act.  Twenty eight of the agreements were final settlements of patent litigation between a brand and a generic manufacturer, fourteen of which were found to impose both a restriction on generic market entry and include a reverse payment.  Eleven of the agreements involved an ANDA first filer, with nine of those imposing both a restriction on generic entry and a reverse payment to the generic drug maker.  In comparison, only 27% (3 of 11) of final settlement agreements in FY2005 included both a restriction on generic entry and a reverse payment, supporting the Commissioner's testimony regarding an upward trend in reverse payment agreements.

RELATED READING:

• Links to written testimony and comments submitted at the hearing
• David Balto's observations on the hearing
• Jan. 17 FTC press release
• Jan. 17 GPhA press release
• Jan. 17 AP story (via Forbes)

NOTE:  A live webcast of the hearing was available online yesterday.  You may obtain a video recording of the hearing by contacting any U.S. Senator's office.

Celgene's Day in Court With Barr Over Generic Thalidomide Coming Soon

In the '50s and '60s thousands of pregnant women all over the world took thalidomide to prevent morning sickness.  However, the drug was banned after many of these women gave birth to babies with severe birth defects.  Now that researchers have discovered new uses for thalidomide, it has become so widely prescribed that generic drug companies are pursuing thalidomide.

On Wednesday, December 13, 2006, Celgene Corp. announced that it had received notification from Barr Laboratories, Inc. that Barr had filed an ANDA for generic thalidomide, 200 mg tablets, sold by Celgene under the brand name Thalomid.  On December 26, 2006, Celgene announced that it had received notification of Barr's ANDA for the 50 and 100 mg strengths of Thalomid.  The ANDAs contained paragraph IV certifications that any applicable Celgene patents are invalid, unenforceable, and/or not infringed.

Thalomid was Celgene's top-selling drug last year, with sales of about $388 million.  Thalomid sales are expected to reach around $430 million this year and fall to around $265 million by 2010 as Celgene's other thalidomide drug, Revlimid, hits the market.

There are ten patents listed in the FDA's Orange Book as covering Thalomid.  Although Thalomid must be used with caution, when used properly it may be prescribed in combination with dexamethasone for the treatment of patients with newly diagnosed multiple myeloma, for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL), as well as for maintenance therapy for the prevention and suppression of cutaneous manifestations of ENL recurrence, according to the Orange Book use codes.

Assuming that Celgene received Barr's notice on December 13, 2006, for the 200 mg tablets, then Celgene would have until about Saturday, January 27, 2007, to file a patent infringement lawsuit against Barr for the 200 mg tablets pursuant to 21 U.S.C. 355(j)(5)(B)(iii).  Of course, if Celgene received Barr's notice earlier than December 13, 2006, then its statutory 45-day clock would expire earlier than January 27th.  Likewise, assuming that Celgene received Barr's notice for the 50 and 100 mg tablets on December 26, 2006, then Celgene would have until about Friday, February 6, 2007, to file its lawsuit against Barr for those dosages, or earlier if Barr's notice was received earlier.

If and when Celgene files suit against Barr, we will add the case to the Hatch-Waxman Tracker.

Senate Judiciary Committee Plans Hearing on Reverse Payment Settlements of Hatch-Waxman Cases

This Wednesday, January 17, at 10 am, the Senate Judiciary Committee will hold a hearing entitled "Paying Off Generics to Prevent Competition with Brand Name Drugs: Should it Be Prohibited?"  The hearing is intended to examine the effects of "reverse payment" settlements of Hatch-Waxman litigation, in which an innovator drug company makes a cash payment to a generic drug company, who in return agrees to delay the launch of its generic drug product.

According to the Notice of Full Committee Hearing, those called to testify include:

• Jon Leibowitz, Commissioner of the Federal Trade Commission;
• Billy Tauzin, CEO of PhRMA;
• Merril Hirsh, partner at Ross, Dixon, and Bell LLP;
• Bruce Downey, Chairman and CEO of Barr Pharmaceuticals; and
• Michael Wroblewski of Consumers Union, which publishes Consumer Reports.

Mr. Leibowitz will testify first and will be followed by a panel that includes the other four speakers.  In the past, the FTC and consumer groups have vigorously opposed reverse payment settlements.  Meanwhile, both innovator and generic drug companies have supported allowing such settlements, arguing they resolve costly litigation on terms acceptable to both sides.  The testimony provided at Wednesday's hearing is expected to be posted on the hearing webpage.

The Senate Special Committee on Aging, chaired by Sen. Kohl (D-WI), held a similar hearing last year.  Also last year, Senators Kohl, Leahy (D-VT), Grassley (R-IA), and Schumer (D-NY) introduced a bill called the "Preserve Access to Affordable Generics Act," which would have banned reverse payment settlements.  Sen. Kohl recently re-introduced that bill and several other bills concerning pharmaceuticals in the new Congress.

Ethyol Case Between MedImmune and Sun Pharma Heats Up

MedImmune Oncology v. Sun Pharm. Indus., No. 04-2612 (D. Md. 2007)

MedImmune earns about $100 million annually from sales of Ethyol (amifostine), an injectable drug approved for the relief of certain side effects of chemotherapy and radiation therapy.  Sun Pharmaceutical Industries filed an ANDA to market a generic version of Ethyol.  In what appears to have become the standard strategy to protect sales of a brand name drug against generic competition, MedImmune responded by filing both a patent infringement lawsuit in court and a citizen petition with the FDA.

Last week in its patent infringement suit, MedImmune lost one battle and won another.  Judge Marvin J. Garbis of the U.S. District Court for the District of Maryland granted Sun's motion for summary judgment of noninfringement as to MedImmune's U.S. Patent No. 5,424,471 and denied Sun's motion for summary judgment of nonfringement as to the other patent in suit, U.S. Patent No. 5,591,731.  Click here for the memorandum opinion and order.

MedImmune asserted the product-by-process claims of the '471 patent, arguing on the basis of the Federal Circuit's decision in Scripps v. Genentech, 927 F.2d 1565 (Fed. Cir. 1991), that the claimed product is not limited by the process steps.  The court, however, thought the better rule was set forth in Atlantic Thermoplastics v. Faytex, 970 F.2d 834 (Fed. Cir. 1991), which held that process steps of product-by-process claims do impart limitations.  Because MedImmune and Sun did not dispute the fact that Sun makes its amifostine without using the process steps recited in the '471 patent, the court granted Sun's motion for summary judgment of noninfringement.  (Interestingly, other district courts have opted to follow the Scripps rule.)

The asserted claims of the '731 patent are product claims, directed to "thermally-stable, sterile, crystalline amifostine trihydrate."  However, the parties disputed whether the claimed crystalline amifostine must be "vacuum dried."  Because the court found that both sides presented reasonable arguments as to the putative inclusion of a "vacuum dried" limitation, the court denied Sun's motion for summary judgment of noninfringment of the '731 patent.  The court has scheduled a Markman hearing for June 6, 2007, to make a final determination on claim construction.

MedImmune filed its citizen petition relating to Ethyol on October 10, 2006, asking the FDA "to refuse to approve any ANDA for an amifostine product with labeling that omits dosage, administration, and other information related to the consequences of using the drug to reduce the incidence of xerostomia ["dry mouth"] in head and neck cancer patients being treated with radiotherapy."  MedImmune's petition was clearly meant to block approval of Sun's ANDA.

Ethyol is approved for two indications: (1) the reduction of cumulative renal toxicity associated with the repeated administration of cisplatin in patients with advanced ovarian cancer; and (2) the reduction of moderate to severe xerostomia, or dry mouth, in patients undergoing post-operative radiation treatment for head and neck cancer.  According to MedImmune's citizen petition, Sun Pharma "carved out" the second indication from the proposed labeling in its ANDA (presumably because MedImmune has method of treatment patents covering that use) and seeks approval for only the first indication.  MedImmune asserts in its citizen petition that only 2% of patients taking Ethyol take it for the first indication, which requires a dose three times as high as that for the second indication.  MedImmune claims "it would be unsafe to approve a generic version of Ethyol, yet allow the product to contain instructions on a dose that is simply incorrect for most patients for whom the drug is indicated."

MedImmune filed the patent infringement suit in August, 2004, and therefore the 30-month stay on approval is set to expire next month.  It will be interesting to see whether the FDA decides MedImmune's citizen petition before then.

RELATED READING:

• Jan. 10 MedImmune press release

Biovail Continues to Fight FDA, Anchen, Impax, and Teva to Protect Wellbutrin XL

Last August, the U.S. District Court for the Central District of California granted summary judgment of noninfringment to Anchen Pharmaceuticals in its case against Biovail over generic Wellbutrin XL.  Biovail has appealed to the Federal Circuit, but in the meantime, on December 15, 2006, the FDA granted final approval to Anchen's ANDA for Wellbutrin XL (bupropion HCl), 150 mg and 300 mg.  Having obtained final approval, Anchen could have launched at risk, but it chose not to.  Instead, Anchen selectively waived its 180-day exclusivity period for the 300 mg product in favor of Impax, who, in partnership with Teva (being deep-pocketed and less risk-averse) launched its own generic Wellbutrin XL, 300 mg.  Wellbutrin XL is an extended release version of Wellbutrin, the popular antidepressant manufactured by Biovail for GlaxoSmithKline, and had over $1 billion in sales last year.

In response to the Impax approval and launch, on December 18, 2006, Biovail filed a complaint against the FDA in the U.S. District Court for the District of Maryland, asserting that it was entitled to a 30-month stay prior to FDA approval of Impax's ANDA.  At the same time, Biovail filed a motion for temporary relief.  The FDA opposed Biovail's motion, asserting that while Biovail timely filed an infringement action against Impax on Wellbutrin XL, 150 mg, Biovail failed to timely amend its complaint to include an infringement count with respect to the 300 mg dosage form.  Teva intevened, filing its own opposition brief.  On December 21, 2006, the court denied Biovail's motion, thereby allowing Teva/Impax to continue marketing its generic product.  Patent owners must file suit within 45 days of receiving notice of a paragraph IV certification, and it appears that Biovail's delay in this case may have been costly.

Biovail also has a suit pending against the FDA in the U.S. District Court for the District of Columbia.  In that case, on December 18, 2006, Biovail filed a motion seeking to enjoin the FDA from approving any ANDAs for generic Wellbutrin XL and to stay the effectiveness of prior approvals, focusing its attention on the Anchen approval and the December 14, 2006, FDA denial of a Biovail citizen petition concerning Wellbutrin XL.  The FDA has filed an opposition to Biovail's motion, as have Anchen and Teva/Impax (as intervenors), and Biovail has filed a reply.  Biovail's arguments center on its assertion that the FDA wrongfully approved generic Wellbutrin XL with a label that falsely and misleadingly implies that the generic product was tested for risk of seizures, while the FDA and intervenors assert that Biovail's motion is an attempt to inappropriately extend its monopoly on Wellbutrin XL.  The court has not yet decided Biovail's motion.

RELATED READING:

• Dec. 18 Impax press release
• Dec. 15 Anchen press release
• Aug. 24 OBB post on Biovail's citizen petition