Orange Book Blog

Federal Circuit Allows Declaratory Judgment Jurisdiction for Generic Drug Patent Challenges

Teva Pharms. USA v. Novartis Pharms. et al., No. 06-1181 (Fed. Cir. 2007)

For the second time in as many days, the Federal Circuit has decided a case with broad implications for innovator and generic drug companies.  The decision today, in Teva v. Novartis, opens the door to many more lawsuits by generic drug companies seeking declarations of patent invalidity or noninfringement.

The Federal Circuit held as follows:

A justiciable declaratory judgment controversy arises for an ANDA filer when a patentee lists patents in the Orange Book, the ANDA applicant files its ANDA certifying the listed patents under paragraph IV, and the patentee brings an action against the submitted ANDA on one or more of the patents.  The combination of these three circumstances is dispositive in establishing an actual declaratory judgment controversy as to all the paragraph IV certified patents, whether the patentee has sued on all or only some of the paragraph IV certified patents.

In the case, Teva filed an ANDA to market a generic version of Famvir, an antiviral medication.  Novartis then sued Teva for infringing U.S. Patent No. 5,246,937, which covers the active ingredient in Famvir, famciclovir.  Novartis chose not to sue Teva on any of its other four Orange Book-listed patents for Famvir, each of which covers methods of use.  Teva then brought a declaratory judgment action on the four remaining method patents under a provision of the 2003 Medicare Modernization Act entitled "civil action to obtain patent certainty."  The district court dismissed Teva's complaint, and the Federal Circuit has now reversed the dismissal.

The district court dismissed the case pursuant to the Federal Circuit's application of its "reasonable apprehension of suit" test in Teva v. Pfizer.  The Supreme Court's recent decision in MedImmune, however, has forced the Federal Circuit to revisit that test.  Indeed, in today's opinion the Federal Circuit expressly acknowledged that MedImmune overruled the test.

Today's decision eliminates a powerful weapon innovator drug companies had in their ongoing battle against generics: the uncertainty and risk that generics face when considering whether to launch their drug products before patent expiration.  Now, generics in Teva's position will be able to file a declaratory judgment action and obtain a court decision on the validity or infringement of Orange Book-listed patents before deciding whether to launch.

In fact, the court's opinion today suggests that unless an innovator grants a covenant not to sue, the mere listing of a patent in the Orange Book coupled with a paragraph IV certification may be sufficient to establish declaratory judgment jurisdiction.  In other words, generic drug companies may be able to pursue declaratory judgment actions even if the innovator declines to file suit on any of its Orange Book-listed patents.

If that turns out to be true, it would go a long way toward solving a "bottleneck problem," where delay by a 180-day generic exclusivity holder prevents subsequent ANDA filers from launching their generic drugs.

RELATED READING:

• Patently-O; Patent Baristas; Patent Docs
• Feb. 26 OBB post on this case
• Jan. 31 OBB post on a similar DJ case recently filed by Apotex

UPDATES:

• The holding of this case does not bode well for Forest Labs' March 13 motion to dismiss Caraco's DJ complaint in the Lexapro case.

Merck Prevails in Patent Term Extension Case at Federal Circuit

Merck & Co. v. Hi-Tech Pharmacal, No. 06-1401 (Fed. Cir. 2007)

The U.S. Court of Appeals for the Federal Circuit held today that a patent term extension under 35 USC 156 may be applied to a patent that is subject to a terminal disclaimer under 35 USC 253, handing a victory to Merck in its battle with Hi-Tech Pharmacal over generic Trusopt (dorzolamide HCl opthalmic solution).  Hi-Tech had argued that Merck's patent on Trusopt expired in 2004 because a patent term extension on the patent was invalid.

As we reported last month, a loss for Merck in this case would have had drastic effects on pharmaceutical companies and patent owners, since the Patent Office has routinely granted patent term extensions on patents that are subject to a terminal disclaimer.  Brand-name drug companies would have lost years of patent protection on some of their best-selling drugs if the Federal Circuit had decided that a terminal disclaimer precludes a patent term extension.

Section 156 was enacted as part of the Hatch-Waxman Act in 1984 to allow restoration of part of a pharmaceutical patent's term "lost" due to lengthy FDA review of a new drug application.  Section 253, on the other hand, applies to all kinds of patent applications--not only those relating to pharmaceuticals--and allows the filing of a terminal disclaimer to overcome "obviousness-type double patenting" rejections made by the Patent Office.

In reaching its decision today, the Federal Circuit properly recognized that "the language of Section 156 is unambiguous and fulfills a purpose unrelated to and not in conflict with that of Section 253."  The court observed: (1) according to Section 156, a patent term "shall be extended" if five enumerated conditions, none of which concern terminal disclaimers, are met; (2) the legislative history is consistent with the mandatory language of the statute; and (3) Section 154 excludes patents in which a terminal disclaimer has been filed from the benefit of a term adjustment for PTO delays, but Section 156 contains no such exclusion for patents eligible for term extensions for FDA delays, which further supports the court's interpretation of Section 156.

Additionally, the court explained why Section 156 and Section 253 are compatible:

The purpose of the terminal disclaimer--to prevent extension of patent term for subject matter that would have been obvious over an earlier filed patent--remains fulfilled by virtue of the fact that the date from which any Hatch-Waxman extension is computed is the terminally disclaimed date.  At the same time, the purpose of the patent term extension--to restore some of the patent term lost due to regulatory review--is also satisfied.

Hi-Tech will now have to wait until at least April 28, 2008, when Merck's patent expires, before it can launch its generic version of Trusopt.

RELATED READING:

• Patently-O; Patent Baristas
  
• MarketWatch.com
• Wall St. Journal (subscription)

OBB News Briefs

• Adams Respiratory and Mutual Pharma settle guaifenesin patent litigation: press release
• FTC subpoenas Cephalon over Provigil patent litigation settlements: AP; Phil. Bus. J.
• Glenmark first to file Zetia ANDA with paragraph IV certification: Bloomberg
• Senate holds hearing on pediatric exclusivity: Reuters
• Takeda awarded $16.8 million in fees in pioglitazone patent case: NY Law J.; Reuters

Mylan Obtains Injunction Preventing FDA from Approving Any Other Generic Norvasc Until April 13

Mylan Laboratories announced this morning that the U.S. District Court for the District of Columbia has enjoined the FDA from approving any other ANDAs for generic Norvasc (amlodipine besylate) until at least April 13, 2007.  Mylan launched its generic Norvasc last week and, with the exception of Pfizer's authorized generic, currently has the only generic on the market.

Mylan was the first generic drug maker to file an ANDA for generic Norvasc, and is therefore entitled to a 180-day generic exclusivity period.  However, FDA's policy for pre-Medicare Modernization Act ("MMA") ANDAs (like Mylan's) is that the 180-day exclusivity period cannot extend beyond patent expiration.  Pfizer's patent on Norvasc expired on Sunday, and therefore without the injunction Mylan's 180-day exclusivity period might have been cut short.  (The MMA introduced numerous 180-day exclusivity "forfeiture provisions," one of which is that 180-day exclusivity ends upon patent expiration.  Since Mylan's ANDA was filed before December 8, 2003, however, the MMA does not apply.)

Mylan filed its Complaint against the FDA and Emergency Application for a Temporary Restraining Order and/or Preliminary Injunction yesterday, and the district court ruled on it the same day.  According to the district court's Order, the "FDA will now solicit the views of other interested parties on this matter by April 4, 2007 and will render an agency decision on April 11, 2007."  The FDA is to notify the court of its decision no later than April 11 and is enjoined from taking final agency action "until April 13, 2007 at 5:00 pm to enable the court to rule formally on the plaintiff's application for a TRO."

Presumably, such interested parties include Apotex, Dr. Reddy's, Gedeon Richter USA, Kali Labs, Matrix, Roxane, Teva, and Watson, each of which has been granted tentative approval to market generic Norvasc and is awaiting only resolution of the exclusivity issues.

The other party with a huge stake in this case is Pfizer--the innovator who developed Norvasc and whose patent the Federal Circuit declared invalid last Thursday.  Pfizer has 6 months of pediatric exclusivity on Norvasc and indicated last week that it will "pursue all available legal remedies" to protect that exclusivity.

This case is far from over.  We'll post additional briefs and submissions as they become available.

RELATED READING:

• Reuters
• TheStreet.com

UPDATES:

• FDA Law Blog reports that Mylan filed a citizen petition with the FDA on Monday to enforce its 180-day exclusivity period.

ACI "Paragraph IV Disputes" Conference, April 23-24, New York City

American Conference Institute has announced that its first ever conference devoted entirely to Hatch-Waxman litigation will take place April 23-24, 2007, at the Sheraton New York Hotel and Towers in New York City.

The conference promises "expert insights on Hatch-Waxman litigation strategies for brand names and generics."  Speakers will include leading patent litigators who specialize in Paragraph IV litigation.  Additionally, an optional half-day Master Class, "Settling Paragraph IV Disputes: Brand Name and Generic Perspectives," is offered on April 25.

The following presentations sound especially interesting:

• Pre-Suit Due Diligence: Anticipating the Paragraph IV Challenge
• Assessing the ANDA Applicant's Pre-Litigation Strategy and Initial Obligations
• Litigating with Multiple ANDA Filers: Brand Name and Generic Perspectives
• Exploring 180-Day Exclusivity Dilemmas Relative to Paragraph IV Litigation
• Injunctions and At-Risk Launches: Considerations and Options During Litigation and Appeal
• Settling a Paragraph IV Action

The co-chairs for the conference are Brian P. Murphy of Morgan Lewis & Bockius LLP and Barry S. White of Frommer, Lawrence & Haug LLP.  Additional details and registration information are available at the conference website.

Orange Book Blog is a media partner of this conference.

House Oversight Committee to Hold Hearing on Follow-on Biologics

On March 8, the Senate held a hearing on follow-on biologics.  Now it's the House's turn.  Tomorrow morning, the House Oversight Committee, chaired by Rep. Henry A. Waxman (D-CA), will hold a hearing entitled "Safe and Affordable Biotech Drugs--The Need for a Generic Pathway."

Rep. Waxman is the sponsor of the "Access to Life-Saving Medicine Act" (H.R. 1038) in the House.  A nearly identical bill (S. 623) has been introduced in the Senate.  If passed, the bill would establish an abbreviated pathway for FDA approval of follow-on biologics.  Democrats in both chambers have indicated that passage of the bill is a top priority for the new Congress.

Witnesses called to testify tomorrow include Dr. Janet Woodcock, Deputy FDA Commissioner, representatives from the pharmaceutical industry and third-party payors, and consumer advocates.

UPDATES:

• The hearing web page includes a video recording of the hearing and links to all of the prepared testimony.
• More at On Pharma
• March 26 AP article on the hearing
• March 26 Bloomberg report on the hearing
• March 26 BIO press release

Mylan Launches Generic Norvasc; Other Generics to Follow Soon?

Mylan announced in a press release today that it has launched its generic Norvasc (amlodipine besylate).  Mylan's generic launch follows the Federal Circuit's decision yesterday, invalidating Pfizer's patent on Norvasc.  The case presents some very interesting issues involving the interaction between patent rights, pediatric exclusivity, and 180-day exclusivity.

Last month, Mylan lost its patent challenge when Judge Terrence F. McVerry of the U.S. District Court for the Western District of Pennsylvania found that Pfizer's patent is valid, enforceable and infringed by Mylan.  At the time, the district court enjoined Mylan from marketing its generic Norvasc "until after the expiration of Pfizer's '303 patent term, as extended by the pediatric exclusivity period."  Pfizer's patent expires this Sunday, March 25; Pfizer's pediatric exclusivity expires six months later, on September 25.  Since then, Pfizer and Mylan have been busy filing motions to amend the district court's injunction and Mylan has appealed the decision to the Federal Circuit.

On March 8, Pfizer asked the district court to modify its injunction to include a "section 271(e)(4)(A) order" stating that the effective date of approval of Mylan's ANDA shall not be earlier "than the date of expiration of the '303 patent (March 25, 2007, with attached six months of pediatric exclusivity ending on September 25, 2007, to which Pfizer is entitled)."  The FDA had already granted final approval to Mylan's ANDA and, according to Pfizer, "in a telephone conversation on March 7, 2007, the FDA advised Pfizer that the FDA will not reset Mylan's effective approval date without a judgment including a section 271(e)(4)(A) order."

Mylan opposed Pfizer's motion and filed its own motion to amend the district court's order, asking the district court to enjoin Mylan only until Pfizer's patent expires on March 25.  According to Mylan's motion:

Pediatric exclusivity does not grant a drug maker a six month patent extension, but acts [only] to prohibit FDA from granting final approval.  Here Mylan has already received final approval and is the only ANDA filer with final approval.  In effect, then, the pediatric exclusivity period applies to all generic competitors except Mylan, thus giving Mylan a six-month head start over generic competitors.

In response, Pfizer filed a combined opposition and reply.  Pfizer argued that its proposed amended judgment was "purely formal, incorporating the precise words of the statue.  Mylan's proposed amended judgment, on the other hand, seeks to . . . deny Pfizer its right of pediatric exclusivity without any basis whatsoever."

On March 16, the district court reached a sort of compromise, ordering that Mylan's ANDA shall not be approved until Pfizer's patent expires and enjoining Mylan until then.  Mylan then filed an emergency motion to stay the court's new order, arguing that "there is a real danger that the Court's order will prompt the FDA to revoke [Mylan's] approval, keeping Mylan off the market even after the patent has expired."  Mylan worried that it would lose its 180-day exclusivity rights if the FDA revoked its approval.  Three days later, Pfizer opposed the motion.  Later that same day, the court denied it.

Yesterday, of course, the big news hit: the Federal Circuit invalidated Pfizer's patent in a separate case against Apotex, who had filed its own ANDA to market generic Norvasc (albeit later than Mylan).  Mylan's lawyers immediately picked up the phone, called Judge McVerry, and made "an emergency oral telephonic motion for a stay of the injunctive relief."  Recognizing that Mylan's lawyers presented the same emergency motion to the Federal Circuit, Judge McVerry denied Mylan's motion.

At the same time, Mylan filed this complaint against the FDA today in the District of Columbia district court, asking the court to enjoin FDA from taking any action that would "disturb the final approval granted to Mylan's ANDA."  Mylan indicated that in a phone call with Mylan's counsel, "FDA counsel stated that FDA would revoke Mylan's final approval and convert it to a tentative approval," if the Federal Circuit did not stay the March 16 order "by mid-day on March 23, 2007."  Mylan also filed this emergency TRO motion.

Apparently the Federal Circuit granted Mylan's motion for a stay of the March 16 order--otherwise Mylan could not have launched its generic Norvasc.  The Federal Circuit's action seems to moot the lawsuit Mylan filed today in the D.C. district court.

Now that Mylan has launched, the interesting question is whether the FDA will approve any other generics when Pfizer's patent expires on Sunday.  In its press release today, Mylan states that its generic launch triggered its 180-day exclusivity period, precluding the FDA from approving any other generics.  This AP story published today, however, suggests that Apotex has a different understanding, and expects to launch its own generic Norvasc "in the very near future."

Meanwhile, Pfizer announced late today that in response to Mylan's generic launch, it has launched an authorized generic Norvasc through its Greenstone subsidiary.  Pfizer added that it "will continue to pursue all available legal remedies to protect the market for Norvasc through a six-month pediatric exclusivity period that expires in September, 2007."

Stay tuned . . . this story is developing quickly.

RELATED READING:

• March 23 Bloomberg article

UPDATES:

• Mylan brief in support of its motion for a stay, pending appeal, of the district court's March 16 Order
• Pfizer brief in support of its motion to lift the Federal Circuit's temporary stay of the March 16 Order
• Fed. Cir. March 26 Order granting Mylan's motion and denying Pfizer's

Federal Circuit Invalidates Pfizer's Norvasc Patent; Mylan's Generic Expected to Launch Soon

Pfizer v. Apotex, No. 2006-1261 (Fed. Cir. 2007)

The U.S. Court of Appeals for the Federal Circuit invalidated Pfizer's patent on Norvasc today, clearing a major hurdle for Mylan in its bid to launch a generic version of Norvasc.  The FDA has already granted final approval to Mylan's ANDA for generic Norvasc and Mylan, as the first ANDA filer, holds the 180-day exclusivity rights.  Norvasc (amlodipine besylate) is Pfizer's blockbuster treatment for high blood pressure, with annual U.S. sales of $2.5 billion.

Three different U.S. district courts had previously upheld the validity of Pfizer's Norvasc patent (U.S. Patent No. 4,879,303), making today's appeals court decision somewhat of a surprise.  In January 2006, the Northern District of Illinois upheld the patent in Pfizer's case against Apotex; in August 2006, the Middle District of North Carolina upheld the patent in Pfizer's case against Synthon; and last month, the Western District of Pennsylvania upheld the patent in Pfizer's case against Mylan.  All three district court decisions were appealed.  Today's Federal Circuit decision came in the case against Apotex, though the invalidity ruling affects all three cases.

In the Federal Circuit opinion released today, a unanimous three-judge panel determined that claims 1-3 of the '353 patent, directed to amlodipine besylate and pharmaceutical and tablet formulations thereof, are invalid as obvious.  More specifically, the court concluded that amlodipine besylate would have been obvious in light of Pfizer's own U.S. Patent No. 4,572,909, which discloses amlodipine and related compounds, together with various articles describing besylate salts of different compounds.

Generic Norvasc was not expected to hit the market until September, when Pfizer's pediatric exclusivity expires.  Now, some analysts are predicting that Mylan will launch its generic Norvasc as early as next week.  If that happens, Mylan should probably send a thank you card to Apotex for achieving the invalidity decision in the Federal Circuit.

Before Mylan can launch its generic Norvasc, however, a court will need to lift the injunction that was entered when Pfizer defeated Mylan in the district court last month.  Pfizer, for its part, announced in a press release today that it is considering all options, including filing a request with the Federal Circuit for reconsideration of today's decision.

RELATED READING:

• Patent Prospector
• Patently-O

Pfizer Defeats Teva in Celebrex Case

Pfizer et al. v. Teva Pharms. USA, No. 04-754 (D.N.J. 2007)

In a 201-page opinion released today, Judge John C. Lifland of the U.S. District Court for the District of New Jersey found all three of Pfizer's patents on Celebrex (celecoxib) valid, enforceable, and infringed by Teva, who had sought to market a generic version of Celebrex before the patents expire in 2015.  Celebrex is Pfizer's blockbuster treatment for arthritis.

The patents in suit are U.S. Patent Nos. 5,466,823, 5,563,165, and 5,760,068.  They cover celecoxib (the active ingredient in Celebrex), a broad genus of compounds that includes celecoxib, pharmaceutical compositions including the compounds, and methods of using the compounds.  Teva challenged the validity of the patents on grounds of obviousness, best mode, and obviousness-type double patenting, and the enforceability of the patents on grounds of inequitable conduct.  Teva will likely appeal the decision to the Federal Circuit Court of Appeals.

RELATED READING:

• March 20 Pfizer press release
• March 21 Teva press release, announcing Teva plans to appeal

News From PhRMA Annual Meeting

PhRMA held its annual meeting today and yesterday in Washington.  So far, there seems to be relatively little news coming out of the meeting--at least compared to GPhA's annual meeting earlier this month.  Links to a few stories are provided below; I'll add more as I find them:

• March 16 article in the Star-Ledger of New Jersey
• March 15 AP story (via Washington Post)
• Biologic Drug Report: FDA Commissioner tells PhRMA that follow-on biologics will not be substitutable
• PhRMA press release on Board Chairman Election
• PhRMA press release on Discoverer's Award

Incidentally, the Business and Media Institute recently sent me this report on media bias against the pharmaceutical industry.