Orange Book Blog

FTC Seeks to Force Warner Chilcott to Keep Marketing Ovcon 35

Faced with Barr Labs' impending launch of a generic version of Warner Chilcott's oral contraceptive Ovcon 35, Warner Chilcott recently stopped shipping Ovcon 35 and tried to convert the market to its new product, Ovcon Chewable.  There are no generic versions of Ovcon Chewable, so if Warner Chilcott could convert the entire market to its new product, it wouldn't lose any market share when Barr launched its generic Ovcon 35.  Pharmacies cannot substitute generic Ovcon 35 for Ovcon Chewable because they're not rated as equivalent by the FDA.  Abbott Labs previously used a similar strategy with Hytrin (tablet to capsule switch) and Tricor (capsule to tablet switch) to preserve its market share.

In response to Warner Chilcott's formulation switch, the FTC filed a notice in the U.S. District Court for the District of Columbia (where it was already in litigation against Warner Chilcott over an authorized generic deal for Ovcon 35) that it intended to seek a preliminary injunction forcing Warner Chilcott to continue marketing Ovcon 35.  Unfortunately, the motion itself is not publicly available because the FTC filed it under seal.

Almost simultaneously with the FTC's filing of its motion for preliminary injunction, Warner Chilcott announced that it had canceled the exclusivity provisions of its Ovcon 35 authorized generic deal--a move intended to dispose of the litigation with the FTC.  In the FTC's complaint in that case, the FTC alleged that an authorized generic deal between Warner Chilcott and Barr for Ovcon 35 was anticompetitive, in violation of Section 5(a) of the FTC Act.

RELATED READING:

• 26-Sep-06 article in The Street
• 26-Sep-06 Barr Labs press release
• 7-Nov-05 FTC press release

NOTE:  thanks to a helpful reader for providing information about this case.

Pfizer Advises Supreme Court That Orange Book Listing/Justiciable Controversy Case is Moot

Via SCOTUSblog, Pfizer recently filed a supplemental brief in opposition to Apotex's petition for certiorari in Apotex v. Pfizer, suggesting that the case is moot.  In its cert petition, Apotex asked the Supreme Court decide whether the listing of patent information in the Orange Book creates a justiciable controversy sufficient to form the basis for a declaratory judgment action for noninfringement or invalidity.  Apotex does not agree that the case is moot, and therefore it has not withdrawn its petition.

According to Pfizer's brief, the case is moot for two reasons:  (1) Pfizer granted an unconditional covenant not to sue Apotex on the subject patent (U.S. Patent No. 5,248,699); and (2) Teva began marketing its generic Zoloft, thereby triggering the 180-day exclusivity period that Apotex sought to trigger with a hypothetical court judgment in its favor.  Pfizer's brief states that Apotex did not explain to Pfizer why there are still any issues for the Court to decide, though Apotex likely will provide that explanation soon, in a supplemental brief in support of its petition.

RELATED READING:

• 16-May-06 Orange Book Blog post

Takeda Wins Attorneys' Fees in ANDA Case Against Alphapharm and Mylan Relating to ACTOS

Takeda v. Mylan and Alphapharm, Nos. 03-8253, 04-1966 (S.D.N.Y. 2006)

Judge Denise L. Cote of the U.S. District Court for the Southern District of New York recently awarded attorneys' fees to Takeda Pharmaceutical Company in a case involving Takeda's blockbuster antidiabetic drug, ACTOS (pioglitazone hydrochloride).  Judge Cote previously found Takeda's U.S. Patent No. 4,687,777 valid, enforceable, and infringed by Alphapharm Pty. Ltd. and Mylan Laboratories, both of whom filed ANDAs for generic versions of ACTOS (click here for opinion).  Subsequently, Takeda moved for an award of its attorneys' fees, arguing that this was an exceptional case under 35 USC 285.

The court's ruling on attorneys' fees stated that Takeda showed by clear and convincing evidence that Alphapharm and Mylan filed baseless Paragraph IV certifications.  Specifically, the Court found that "Alphapharm’s certification, which asserted invalidity due to obviousness, was deeply flawed and Alphapharm revised its theory again and again in a futile effort to state a prima facie case of obviousness."  The Court further found that "Mylan completely abandoned its Paragraph IV theory of invalidity and proceeded to trial on a contorted claim that Takeda had engaged in inequitable conduct before the Patent and Trademark Office."  The Court stated that both Alphapharm and Mylan also engaged in other exceptional litigation misconduct.

Federal Circuit Denies Apotex's Request to Stay Preliminary Injunction on Generic Plavix Sales, and Sets Expedited Schedule for Appeal

Sanofi-Aventis and Bristol-Myers Squibb announced in a press release today that the Court of Appeals for the Federal Circuit has refused Apotex's motion to stay the preliminary injunction against Apotex's sales of its generic version of Plavix.  Additionally, the CAFC established an expedited schedule for Apotex's appeal of the preliminary injunction order, with oral argument set for October 31, 2006.

Here's a brief history of the case:

• July 11, 1989:  Sanofi is awarded U.S. Patent No. 4,847,265 on clopidrogel bisulfate, the active ingredient of Plavix;
• November, 1997:  FDA approves Plavix for the prevention of heart attack and stroke;
• November, 2001:  Apotex files ANDA for clopidrogel bisulfate, ten years before the '265 patent will expire;
• March 21, 2002:  S-A and BMS (Sanofi's marketing partner for Plavix in the U.S.) file a patent infringement suit against Apotex; Apotex counters that the '265 patent is invalid as anticipated and obvious, as well as unenforceable;
• January, 2006:  the parties reach a preliminary settlement of the patent litigation;
• January 20, 2006:  FDA approves Apotex's ANDA;
• July 28, 2006:  state attorneys general reject the final settlement agreement;
• August 8, 2006:  Apotex launches its generic Plavix product;
• August 15, 2006:  S-A and BMS file motion for preliminary injunction;
• August 31, 2006:  In a 58-page opinion, S.D.N.Y grants motion for preliminary injunction;
• September 1, 2006:  S.D.N.Y. denies Apotex's motion to stay preliminary injunction;
• September, 2006:  Apotex appeals to CAFC and files motion to stay preliminary injunction;
• September 20, 2006:  CAFC denies Apotex's motion to stay; sets expedited appeal schedule.

Plavix, which is taken daily by 48 million Americans, had annual global sales of nearly $6 billion before Apotex launched its generic version last month.  According to published reports, Apotex had sold wholesalers over a year's supply of its generic Plavix before its sales were halted by the preliminary injunction.  The wholesalers are allowed to sell the generic Plavix they already have in stock while Apotex's appeal is pending.

Rep. Waxman Announces Plan to Introduce Biogenerics Legislation; Governors Petition FDA on Biogenerics

Representative Henry Waxman (D-CA) announced plans to introduce legislation that would establish an FDA approval process for generic biologics.  He announced his plans in a speech to the Generic Pharmaceutical Association (GPhA) yesterday.

Rep. Waxman stated, "I intend to introduce legislation that will establish a clear pathway for generic biologics very shortly."  Moreover, the pathway should include evaluation of biological products on a "case-by-case approach" due to the "uniqueness of biological products."

Last month, the governors of four states filed a citizen petition asking the FDA to release guidance for industry that would explain the requirements for applications seeking approval to market generic insulin and human growth hormone.

RELATED READING:

• AP story on Rep. Waxman's speech
• Press releases from Gov. Doyle (WI) and Gov. Pawlenty (MN) regarding their citizen petition
• GPhA press release regarding the governors' citizen petition

NOTE:  Thanks to a helpful reader for providing a copy of Rep. Waxman's remarks to GPhA.

A Reverse Payments Case For the Supreme Court? Second Circuit Denies Request for Rehearing in Tamoxifen Citrate Antitrust Litigation

Barr Pharmaceuticals announced in a press release yesterday that the 2nd Circuit Court of Appeals has denied the plaintiffs' petitions for rehearing and rehearing en banc of its decision affirming the U.S. District Court for the Eastern District of New York's dismissal of this antitrust case.

The case involves a $21 million "reverse payment" from the NDA holder, Astra Zeneca, to the generic challenger, Barr Labs, to settle Hatch-Waxman patent litigation between the two companies.  In the 2nd Circuit's initial opinion in the case, decided by a 2-1 majority last November, the court held that the settlement agreement was not unlawful because, among other reasons, "the settlement agreement did not extend the patent monopoly by restraining the introduction or marketing of unrelated or non-infringing products."

Some experts believe that this case is a better candidate for Supreme Court review of "reverse payment" settlements than was the FTC v. Schering case.  In fact, even the FTC seemed to acknowledge that in its cert petition.  The Supreme Court denied certiorari in FTC v. Schering over the summer.  It should be interesting to follow this case and see whether it makes it to the Court.

Many interested parties had filed amicus briefs in support of or in opposition to the petitions for rehearing of the Tamoxifen case.  Several of the briefs are available in this June 19th Orange Book Blog post.

Alza Loses Appeal of Ditropan XL Case to Mylan

The Court of Appeals for the Federal Circuit recently affirmed a lower court's determination that Alza's patent on Ditropan XL, a controlled-release formulation of oxybutinin, is invalid due to obviousness.  Ditropan XL is a treatment for incontinence, with annual sales of $380 million.

In the opinion, written by Judge Gajarsa, a unanimous panel of the Federal Circuit concluded that the controlled-release formulation of oxybutinin claimed in Alza's U.S. Patent No. 6,124,355 would have been obvious.  Alza argued that one of ordinary skill in the art would not have believed that oxybutinin could be absorbed in the colon, and therefore would not have believed that a controlled-release formulation would have been effective, and therefore there was no motivation to make the claimed oxybutinin formulation.  The court rejected Alza's argument based on Mylan's expert testimony.

The Federal Circuit used this case, like it has used other recent cases, to defend its "teaching, suggestion, motivation" test of obviousness, which is under assault in the KSR v. Teleflex case currently pending before the Supreme Court.  The Federal Circuit stated:

As an initial matter, it is essential to recognize that, as we have explained above, under our non-rigid "motivation-suggesting-teaching" test, a suggestion to combine need not be found in the prior art.  . . .  Accordingly, where the testimony of an expert witness is relevant to determining the knowledge that a person of ordinary skill in the art would have possessed at a given time, this is one kind of evidence that is pertinent to our evaluation of a prima facie case of obviousness.

The district court decision, written by Judge Irene M. Keeley of the U.S. District Court for the Northern District of West Virginia, found that Alza's patent was both invalid and not infringed by Mylan.  Because the Federal Circuit affirmed the obviousness finding, it did not address the infringement issue.

RELATED READING:

• Mylan press release announcing the CAFC opinion
• extensive coverage of the KSR case on Patently-O

Pfizer's Patent on Norvasc Survives Challenge by Synthon

The U.S. District Court for the Middle District of North Carolina recently found Pfizer's patent on the active ingredient of Norvasc, amlodipine besylate, valid and infringed by Synthon's generic equivalent.  Norvasc, a treatment for hypertension, has annual sales of nearly $5 billion.

In the opinion, Judge James A. Beaty, Jr. concluded that Pfizer's U.S. Patent No. 4,879,303 was not invalid for obviousness, lack of written description, or double patenting.  According to Pfizer's press release announcing the court decision, in January the U.S. District Court for the Northern District of Illinois found the same patent valid and infringed by Apotex.

As reported in Orange Book Blog last month, the U.S. District Court for the Eastern District of Virginia recently found that Pfizer did not infringe Synthon's patent on a process for making amlipodine.

ABA Section of Antitrust Law Presents Discussion of Authorized Generics

The ABA Section of Antitrust Law presented a short, but very informative and interesting, teleconference on authorized generics today.  The speakers were Seth Silbert of Wilson Sonsini, Tim Gilbert of Gilbert's LLP, and Jerry Swindell of Johnson & Johnson.  Mr. Silbert presented an introduction to the topic, Mr. Gilbert presented the generic drug industry's perspective, and Mr. Swindell presented the perspective of the brand drug industry.  In case you missed it, the ABA should be making an audio file of the teleconference available here.  Additionally, links to the PowerPoint presentations are provided below.

LINKS:

• Seth Silbert presentation
• Tim Gilbert presentation
• Jerry Swindell presentation

Astra Zeneca Lists Device Patents In Orange Book

AstraZeneca recently filed a Request for Advisory Opinion with the FDA, asking for a determination "whether patents on drug delivery systems, such as inhalation devices, that do not recite the approved active ingredient or formation," should be listed in the Orange Book.  GlaxoSmithKline submitted a request to the FDA in January, 2005, asking the very same question, which AstraZeneca attached to its filing.

Interestingly, AstraZeneca reveals toward the end of its request, "Because AstraZeneca believes that such patents should be listed, AstraZeneca will continue to list them unless it receives guidance from  FDA that such listings are improper."  Of course, Orange Book listing is a predicate to a 30-month stay of FDA approval of any generic equivalents, as well as to 6-month marketing exclusivity after any successful generic patent challenge.

NOTE:  Thanks very much to Kurt Karst for bringing this FDA filing to my attention.