Patent Docs

Biotech/Pharma Docket

By James DeGiulio --

Pfizer Settles Lipitor Patent Suits with Aurobindo, Kremers

Pfizer has settled separate cases with Aurobindo and Kremers, ending its patent infringement actions over the generic companies' efforts to enter the market for the cholesterol drug Lipitor.  On June 27, 2011, Pfizer sued Aurobindo in response to the generic's filing of an ANDA for atorvastatin calcium, claiming infringement of U.S. Patent No. 5,969,156, issued in 1999, and its reexamination certificate, issued in 2006 (see "Court Report," July 4, 2011).  Aurobindo's May 17 letter informed Pfizer of its intent to seek FDA approval to sell 10 mg, 20 mg, and 80 mg dosages of generic Lipitor.  The '156 patent's expiration date is July 8, 2016, but the patent has been granted a further period of pediatric exclusivity running through January 8, 2017.

On November 7, Judge Leonard P. Stark signed off on a joint motion to dismiss filed by the parties under Federal Rule 41(a)(2).  The joint motion indicated that Pfizer and Aurobindo had entered into a settlement agreement on November 2, thus prompting their request for dismissal of all claims and counterclaims.  The dismissal is without prejudice and shall not act as an adjudication on the merits.

On November 18, in another Lipitor case pending since December 2009 (see "Court Report," December 7, 2009), Kremers Urban Pharmaceuticals Inc. also entered into a settlement agreement with Pfizer over 10 mg, 20 mg, 40 mg, and 80 mg dosages, known generically as atorvastatin calcium tablets.  The terms of this agreement are confidential, and the agreement remains subject to review by the U.S. Department of Justice and the Federal Trade Commission.

Mylan and Novartis Settle Patent Suit over Vivelle-Dot

Mylan has settled both of its patent litigations with Novartis related to the estrogen therapy drug Vivelle-Dot, opening the door to begin manufacturing a generic version of the estrogen replacement patch.  In February, Novartis filed two lawsuits against Mylan, one in the U.S. District Court for the District of Vermont and one in the U.S. District Court for the Southern District of New York.  The suits allege that Mylan's ANDA covering a generic Vivelle-Dot infringes U.S. Patent Nos. 5,656,286 and 6,024,976.  Mylan asserted that these patents were invalid or unenforceable, and would not be infringed by the generic estradiol transdermal system the company proposed.  Novartis requested a permanent injunction barring Mylan from manufacturing the drug and damages if the company produced its proposed generic before the two patents expired.

On November 23, New York District Judge Katherine B. Forrest issued a stipulation and order staying the case pending approval of the settlement by the U.S. Department of Justice and the Federal Trade Commission.  According to the agreement, Mylan will receive a patent license to begin selling generic versions of the product on December 16, 2013, or earlier under certain circumstances.  Additional details of the settlement are confidential.  The agreement allows Mylan to begin manufacturing a generic version of the estrogen replacement patch, and Mylan can enter the market first as the first ANDA filer.  Vivelle-Dot generated $240 million in U.S. sales over the past year.

Teva and Bayer Settle Dispute over Levitra Patents

Bayer reached a settlement with Teva over two patents directed to Levitra, and Teva agreed not to produce the generic drug until a settled date following a consent judgment for the plaintiffs.  Teva notified Bayer in May 2009 that it had filed an ANDA seeking to market generic vardenafil hydrochloride.  In response, Bayer filed five related but separate cases in 2009 and 2010, alleging infringement of U.S. Patent Nos. 6,362,178 and 7,696,206 based on Teva's ANDA (see "Court Report," April 19, 2010 and July 25, 2010).  Teva asserted that Bayer's patents were invalid and would not be infringed.  Bayer argued that Teva's Paragraph IV notice letter provided no valid basis for these assertions regarding the patents-in-suit.

On November 17, Judge Sleet signed off on a consent judgment and order, entering judgment in favor of Bayer and against Teva on Bayer's claims of infringement of the '178 and '206 patents.  Under the judgment, claims 1-5, 7, and 8 of the '178 patent and claims 1-6 of the '206 were deemed valid, the patents were declared enforceable, and Teva's ANDA was found to infringe the same claims.  Teva agreed not to make, offer for sale, or sell the products that are described in its ANDA prior to the date set forth in the Settlement Agreement.  The parties waived any right to appeal the judgment.

Biotech/Pharma Docket

By James DeGiulio --

Validity of Allergan Lumigan Patents Upheld

Allergan has successfully defended its patents covering the glaucoma drug Lumigan from an invalidity attack by alleged infringers Teva and Sandoz.  In May 2009, Allergan filed the suit in the District of Delaware against Teva and Barr Laboratories, alleging infringement of U.S. Patent Nos. 6,403,649 and 5,688,819 after Barr filed an ANDA for generic Lumigan (see "Court Report," May 17, 2009).  Allergan also filed a similar suit against Sandoz (see "Court Report," January 17, 2010), which was consolidated with the Teva suit in April 2010.  A bench trial on the issues of infringement and validity was held between January 31 and February 4, 2011.  At trial, defendants' defense focused mainly on the claim that the two patents were invalid for anticipation and obviousness.  The defendants did not dispute that their ANDA products infringe three claims of the '649 patent, and conceded that the generics infringed the other asserted patent after trial was completed.

On September 8, Judge Sue L. Robinson issued an opinion finding Allergan's patents valid and determiningb that the defendants had failed to prove otherwise.  Of key importance was Judge Robinson's finding that the credibility of the defendants' expert witness, Dr. Ashim K. Mitra, had been "eviscerated" on cross-examination.  Dr. Mitra had testified that the compound bimatoprost, the active ingredient in Lumigan, was anticipated by a patent that described a method for treating glaucoma with derivatives from a class of compounds known as prostaglandins.  The prior art patent did not explicitly name bimatoprost, but describes a compound that may result from the breakdown of bimatoprost and a compound that can be converted to bimatoprost.  However, the law on inherent anticipation requires convincing evidence that bimatoprost itself is necessarily present in the prior art, which the defendants did not prove.  Further, at trial, Allergan's attorneys discredited Dr. Mitra by establishing that he had incorrectly drawn the bimatoprost molecule during his deposition and disparaged the anticipatory prior art in a previous trial in 2008.  After trial, the defendants tried to raise a different theory of obviousness that did not rely on the prior art patent, but Judge Robinson prohibited the defendants from pursuing this new theory.

Sanofi Secures Injunction Blocking Sun from Marketing Generic Eloxatin

In settling its patent dispute with Sun Pharmaceuticals over the colon cancer drug Eloxtin, Sanofi has successfully secured a ruling that will keep generic versions of its drug off the U.S. market until August 2012.  In June 2007, Sanofi brought suit in the District of New Jersey against Sun and other generics makers, alleging infringement of U.S. Patent No. 5,338,874 (see "Court Report," July 30, 2007).  By June 2009, Sanofi and Sun had reached a settlement agreement that included a consent decree and license agreement in which Sun would not market its generic drug until August 2010, the date of patent expiry, but would be permitted to market the drug before that date if the other drugmakers launched their own generics at-risk.  Before the agreement was signed, the District Court granted summary judgment of noninfringement of the '874 patent that allowed the other generics makers to market their versions of Eloxatin, but the Federal Circuit vacated this order.  Sanofi then reached a settlement agreement with the other generics makers that enjoined them from selling their versions of Eloxatin as of June 30, 2010.  Sun began selling its generic version of Eloxatin at-risk in January 2010, and Sanofi submitted a revised consent decree expanding the injunction to cover Sun, which was granted over Sun's objections.  Sun then appealed to the Federal Circuit, which ruled that the District Court should conduct an evidentiary hearing on the new language of the agreement.

On September 15, Judge Joel A. Pisano issued an opinion reinstating the April 2010 consent decree that prevented Sun from selling its generic Eloxatin from June 30, 2010 through August 9, 2012.  Sun argued at the evidentiary hearing that the consent decree between Sanofi and the other generics makers did not qualify as an enjoining decision because it was merely entered by a judge, not decided by one.  However, Judge Pisano found that an enjoining decision should be interpreted broadly and is not limited to decisions on the merits.  Thus, his ruling is a judicial act that results in an injunction.  In his ruling, Judge Pisano noted that the new language of the agreement intended to provide a mechanism by which Sanofi could regain exclusivity after at-risk launches are enjoined.  According to the judge, interpreting the term "decision(s) enjoining" to require a decision on the merits would be inconsistent with the intent of the new language of the agreement.

Medicis Secures Permanent Injunction, Settling Solodyn Dispute with Aurobindo

Medicis successfully resolved its latest patent dispute over the acne drug Solodyn, when it reached an agreement with Aurobindo which permanently enjoins the generic drugmaker from entering the market absent a Medicis license.  In December 2010, Medicis filed suit in the District of Delaware, alleging that Aurobindo infringed U.S. Patent Nos. 5,908,838 and 7,790,705, which cover the anti-acne oral antibiotic (see "Court Report - Part II," December 13, 2010).  Aurobindo notified Medicis in an October 2010 notice letter that it was seeking approval from the FDA for a generic version of Solodyn before the patents covering it expired.  In addition to infringement, the suit alleged that the notice letter did not provide a detailed statement of the legal basis for the claims that Aurobindo's version would not infringe the patents.

On September 14, Judge Stark entered a consent judgment that, in the absence of a Medicis license, permanently enjoined Aurobindo from manufacturing, using, offering to sell, selling, importing, or distributing any current or future products having the same strength and dosage form as Medicis' Solodyn products.  Under the terms of a settlement and license agreement between the parties, Judge Stark dismissed all claims and counterclaims without prejudice, thus ending the suit.  Aurobindo acknowledged that the patents were valid and enforceable as part of the settlement.  Judge Stark noted that final settlement of the litigation will help Medicis and defendants avoid the substantial uncertainty and risks involved with prolonged litigation, save litigation costs, and conserve judicial resources.  Medicis has reached settlements with numerous generics over Solodyn, including Lupin, Teva, Mylan, Ranbaxy, Sandoz, and Impax.

Biotech/Pharma Docket

By James DeGiulio --

Teva's Patents Covering Copaxone Upheld in Infringement Suit

Mylan failed in its efforts to dismiss Teva's patent suit over the multiple-sclerosis drug Copaxone when the patents directed to the active pharmaceutical ingredient (API) in the drug, glatiramer acetate, were upheld as valid.  In September 2008, Teva brought suit in the Southern District of New York against Sandoz, and in 2009 against Mylan, after both companies filed Abbreviated New Drug Applications (ANDAs) for Copaxone (see "Court Report," September 7, 2008 and November 8, 2009).  Teva asserted four patents in its infringement suits:  U.S. Patent Nos. 7,199,098, 6,939,539, 6,054,430, and 6,620,847.  Among other defenses, Mylan and Sandoz argued that the patents were invalid.  The defendants argued during claim construction that the claims were indefinite because the molecular weight of the compound was not described sufficiently, and both defendants moved for summary judgment on this issue.  Sandoz' motion was denied, while Mylan's motion was pending.  In October 2010, Teva attempted to force the defendants to provide advance notice of their intent to launch the generic.  This attempt was not successful.  On July 5, the District Court again denied Teva's request for an order directing the generic drug makers to provide the Court and Teva with 10 days notice prior to the launch of their generic Copaxone products, ruling that the defendants "are under no legal obligation" to provide such notice.  The trial was scheduled to begin today.

On August 29, Judge Barbara S. Jones issued a Memorandum and Order denying Mylan's summary judgment motion that the patents are invalid under 35 U.S.C. § 112 for not explicitly defining the molecular weight of the glatiramer acetate.  Mylan's main objection was that the definition focused on how the chemical compound is made.  The defendants also argued that the term "molecular weight" as it is used in the asserted patents was merely a "random amino acid composition" because it was made up of molecules with average molecular weights.  Judge Jones rejected this definition, adopting Teva's claim that the "copolymer-1" that makes up the drug is a mixture of molecules, all with different molecular weights.  The parties also disputed the term "average molecular weight," which Sandoz and Mylan asserted as subject to several interpretations, thus rendering term invalid.  However, Judge Jones noted that Teva had successfully argued during the prosecution of the patent that a person of ordinary skill would understand its meaning.  This was found to produce a presumption that the description complies with the provisions of 35 U.S.C. § 112.

Mylan Found to Infringe One of Galderma's Oracea Patents

Mylan was found to infringe one of five patents asserted against it, but managed to invalidate two of the five patents, in Galderma's suit against the generic drug maker for infringement of patents directed to the rosacea drug Oracea.  On October 19, 2010, Galderma filed suit in the District of Delaware, asserting that Mylan's ANDA infringed U.S. Patent Nos. 5,789,395, 5,919,775, 7,211,267, 7,232,572, and 7,749,532, which are directed to a once-daily administration of doxycycline for the treatment of acne rosacea.  Galderma launched two suits, which were later consolidated.  Mylan answered by asserting that the patents were invalid and unenforceable, and that its product did not infringe any of the claims of the five patents.  Mylan's ANDA was approved in July 2010, and Galderma quickly secured a preliminary injunction against Mylan, blocking the company from entering the market with its generic Oracea product.

On August 26, Judge Leonard P. Stark, in a detailed Opinion, determined that Galderma had proved by a preponderance of the evidence that Mylan's proposed generic rosacea drug infringed all of the asserted claims of the '532 patent (the "Chang" patent), which is not set to expire until on December 19, 2027.  The Chang patent, which was upheld in the face of anticipation, obviousness, inventorship, and written description challenges, covers the formulation for Oracea.  Judge Stark also ruled that Galderma had failed to prove that Mylan had infringed any claims of the other four patents, and that Mylan successfully demonstrated that the '395 and '775 patents were invalid.  These patents were invalidated due to inherent anticipation, where the prior art disclosed the use of a high dose of tetracycline to treat periodontitis or rheumatoid arthritis, diseases with similar properties as rosacea.

Despite finding that Mylan's proposed product would infringe the Chang patent, Judge Stark declined to adopt the remedy suggested by Galderma, which was to convert the preliminary injunction in place into a permanent injunction.  Further, Galderma requested to change the effective date of FDA approval of Mylan's ANDA to a date no earlier than the expiration of the latest asserted, valid patent.  Judge Stark stated that while Galderma is entitled to some relief, neither party had prevailed in the entirety of its positions.  He also said it was noteable that the only patent Mylan was found to have infringed issued well after the company filed its ANDA.  As such, he said he would require the parties to submit briefs addressing the appropriate remedy and would leave the preliminary injunction in place for now.

Shire Avoids Dismissal in Patent Suit over Generic Intuniv

Impax and Watson were unsuccessful in their attempt to dismiss a patent infringement suit brought by Shire over a generic version of Shire's ADHD drug Intuniv.  On December 2, 2010, Shire and the inventors brought suit in the Northern District of California for patent infringement and a declaratory judgment against defendants Impax and Watson (see "Court Report," December 12, 2010).  Impax and Watson had both filed ANDAs for a generic form of guanfacine hydrochloride extended release tablets, and Shire asserted that this filing infringed U.S. Patent Nos. 5,854,290, 6,287,599, and 6,811,794.  Plaintiffs moved to dismiss all of defendants' counterclaims under Rule 12(b)(6) and to strike all their affirmative defenses under Rule 12(f).  Following Shire's motions, the defendants countered with a motion to dismiss the suit.  Impax and Watson argued that their answers to Shire's complaint are pleaded in the same fashion as the complaint itself.  Following this logic, defendants concluded that if the District Court dismissed their counterclaims and defenses, it should dismiss the complaint as well.

On August 29, in an Order Denying Motions to Dismiss, Judge Richard Seeborg denied both plaintiffs' and defendants' motions.  Judge Seeborg noted that there would be little benefit in requiring parties to replead their claims and counterclaims with additional factual allegations.  Shire has been aggressively litigating its patent rights to Intuniv over the past year, having also brought suit against Mylan and Sandoz in West Virginia and Colorado federal court, respectively.

Biotech/Pharma Docket

By James DeGiulio --

Allergan Secures Infringement Ruling Against Generics in Combigan Patent Suit

Allergan has successfully secured an infringement ruling against Sandoz, Alcon, Apotex, and Watson Laboratories in the consolidated patent suit over four patents covering the glaucoma medication Combigan.  Allergan has spent several years aggressively protecting its patents for Combigan, which is used to lower intraocular pressure in patients with glaucoma or ocular hypertension.  Four patents have been listed in the Orange Book for Combigan:  U.S. Patents Nos. 7,030,149, 7,320,976, 7,323,463, and 7,642,258.

In April 2009, Allergan brought suit in the U.S. District Court for the Eastern District of Texas against Sandoz in response to the ANDA Sandoz filed seeking approval to market a generic version Combigan (see "Court Report," April 12, 2009).  More generic drugmakers filed ANDAs over the glaucoma drug, which spurred Allergan suits against Hi-Tech and Alcon in 2009 (see "Court Report," June 14, 2009, November 15, 2009), and Apotex and Watson in 2010 (see "Court Report," June 20, 2010, September 12, 2010).  In June 2010, Allergan and Hi-Tech settled their case, resolving the infringement claims (see "Biotech/Pharma Docket," June 20, 2011).

On August 22, after a bench trial, Judge T. John Ward issued a Judgment and Injunction, ruling that Sandoz, Alcon, Apotex, and Watson infringed all four Allergan patents in their efforts to market generic versions of Combigan.  Judge Ward also confirmed that the four patents are valid and enforceable.  The generics were enjoined from gaining approval of their ANDAs and thus from entering the market with their own versions of brimonidine tartrate/timolol maleate ophthalmic solution until after the last of the '149, '976, '463, and '258 patents expires.

Novartis and Apotex Resolve Patent Dispute over Myfortic

Novartis has resolved an infringement suit against Apotex over the patents covering Myfortic.  Novartis' Myfortic is an immunosuppressant drug used to prevent patient's bodies from rejecting transplant organs.  These types of drugs have been successfully used to protect against transplant rejection, but have been criticized recently by the FDA for their potential associated side effects, including kidney disease.

On November 3, 2009, Novartis brought suit in the U.S. District Court for the District of New Jersey after Apotex submitted an ANDA in June 2009 seeking approval for delayed-release tablets in 180- and 360-milligram doses (see "Court Report," November 15, 2009).  Novartis accused Apotex of infringing U.S. Patent Nos. 6,025,391, 6,172,107, and 6,306,900, which Novartis listed as covering treatments using mycophenolate salts, the active ingredient in Myfortic.  Novartis sought to have the District Court permanently enjoin Apotex from marketing and selling its generic version of Myfortic, as well as an order that any approval of Apotex's ANDA would not be effective until after the patents expire in April 2017.  Apotex refuted the infringement allegation by challenging the validity of the patents, stating in its claim construction brief, filed in December 2010, that Novartis barely provided any evidence to support its position that its patent claims were valid.  Novartis also has a case pending against Teva in Delaware over a generic Myfortic (see "Court Report," May 8, 2011).

The District Court was first notified that the parties had reached a settlement on June 29.  On August 18, Judge Peter G. Sheridan granted Novartis' stipulation of dismissal, ending the litigation between the two parties.  The parties stipulated to dismissal under Federal Rules 41(a)(1)(A)(ii) and 41(c).  Terms of the agreement were not disclosed in the order.

Novartis Settles with Macleods in Famvir Patent Dispute

Novartis has agreed to settle a suit with Macleods Pharmaceutical, ending its infringement dispute with Macleods of its plan to market a generic version of the herpes treatment Famvir.  On April 1, 2010, Novartis filed suit in U.S. District Court for the District Of Columbia, alleging that Macleods infringed U.S. Patent No. 5,866,581 when it filed an ANDA seeking approval for a generic version of the herpes treatment (see "Court Report," April 11, 2010).  Novartis was also engaged in a Famvir infringement suit against Roxane Laboratories in the District of New Jersey (see "Court Report," May 18, 2008), but that case settled in June.  Novartis remains in litigation with Teva over its generic form of Famvir.

On August 22, Judge James E. Boasberg signed an order dismissing the case without prejudice after both parties filed a stipulation of dismissal under Federal Rules 41(a)(1) and 41(c), indicating that they would reach a settlement agreement.  Further details about the settlement were not immediately available.

Biotech/Pharma Docket

By James DeGiulio --

Medicis and Nycomed Settle Vanos Patent Dispute

Medicis and Nycomed have reached a licensing agreement to settle a patent dispute over a generic version of the psoriasis treatment Vanos.  In May 2010, Medicis filed the suit in the Southern District of New York in response to Nycomed's ANDA seeking approval from the FDA to make and sell 0.1% fluocinonide cream before the expiration of Medicis' U.S. Patent Nos. 6,765,001, 7,220,424, and 7,217,422 (see "Court Report," May 23, 2010).  Nycomed's ANDA included a Paragraph IV certification asserting that the three patents would not be infringed by its generic version of Vanos.  According to the complaint, Nycomed was required to amend its ANDA to provide certification relating to U.S. Patent No. 7,794,738, at issue in another Medicis-Nycomed dispute, but Medicis had yet to receive notification of any such amendment.

On August 16, U.S. District Judge Denise L. Cote signed off on a stipulation and order of dismissal dismissing the suit with prejudice after the two parties notified the Court that they had agreed on a licensing agreement.  Nycomed admitted that Medicis' patents covering Vanos were valid and enforceable, and that its ANDA for a generic version of Vanos would infringe Medicis' patents outside of the licensing agreement.  The Court noted the public interest in judicial economy in dismissing the suit, and both parties waived any right to appeal the stipulated order.  Medicis will grant Nycomed a license to make and sell generic versions of Vanos products beginning December 15, 2013.  In return, Nycomed will pay Medicis a royalty based on product sales.

Pfizer Successfully Defends Viagra Patent Against Teva

Pfizer has prevailed in its patent infringement action against Teva over a generic version of Viagra, securing a ruling that the Pfizer patent for the blockbuster drug remains valid and enforceable.  On March 24, 2010, Pfizer sued Teva in U.S. District Court for the Eastern District of Virginia, challenging the generic drug maker's contention that U.S. Patent No. 6,469,012 is invalid or would not be infringed by Teva's proposed generic (see "Court Report," April 4, 2010).  The '012 patent represents an important holding for Pfizer, as it does not expire until 2019.  During a 12-day bench trial in July, Teva conceded that its proposed generic drug would infringe the '012 patent.  However, Teva raised a series of challenges to Pfizer's patent, including the validity and enforceability of the patent, as well as Pfizer's standing to sue.

On August 15, U.S. District Judge Rebecca Beach Smith, in a lengthy opinion, found that the decision to try an orally administered version of the active ingredient, sildenafil, to treat erectile dysfunction was not obvious.  Judge Smith distinguished the standard of "obvious to try" with a mere "motivation to try."  She also ruled against Teva with respect to its claim of double patenting, finding the compound to be sufficiently different from a similar version protected by an earlier Pfizer patent, noting that even small changes in chemical structure could significantly affect how the drug worked in the body.

In a significant portion of the opinion, Judge Smith cited Therasense and chastised Teva for wasting judicial resources by trying to have the patent declared unenforceable by accusing Pfizer and one of its attorneys of engaging in inequitable conduct by not submitting information related to the Canadian version of the patent during prosecution.  Judge Smith found that the material was not relevant to the prosecution of the U.S. patent because the patent examiner had already asked the company not to submit further foreign references similar to what had already been provided.  Teva also lost a bid to amend its answer to flesh out inequitable conduct claims against the company and some of its attorneys.  Judge Smith ruled that not only did Teva unnecessarily delay in seeking to amend its counterclaims, but that Pfizer and the accused individuals would be prejudiced by such a late change.

The Court's decision prevents Teva from receiving approval for a generic form of Viagra until October 2019.  Litigation on the same patent remains pending against other generic companies, but no trials have been scheduled in those other cases.

Lilly and Hospira Settle Gemzar Patent Suit

Eli Lilly and Hospira have reached a settlement dismissing Hospira's declaratory judgment action over the patent covering the ovarian, breast, lung, and pancreatic cancer treatment Gemzar.  On September 30, 2010, Hospira filed suit against Lilly in the Northern District of Illinois, seeking a declaratory judgment that its plans to sell several versions of a generic version of Gemzar, also known as gemcitabine, would not infringe Lilly's U.S. Patent No. 5,606,048, which protects a "stereoselective glycosylation process for preparing" the drug (see "Court Report," October 3, 2010).  Hospira filed an ANDA seeking regulatory approval to sell three versions of the drug in late 2009, and was making preparations to sell the product immediately upon approval.  Hospira asserted non-infringement of the '048 patent, but claimed reasonable apprehension that Lilly would assert the '048 patent against Hospira to block the marketing and sale of Hospira's competing product.  Hospira contends that Lilly's foreign lawsuits over the drug in Denmark and the United Kingdom gave it a reasonable apprehension that Lilly intended to file a lawsuit to block a generic drug release in the U.S.

On August 10, U.S. District Judge Milton I. Shadur affirmed the parties' stipulation regarding dismissal with prejudice.  The settlement brings to an end the U.S. litigation over Gemzar, which has arisen between the two parties in five different countries.  Each side is to bear its own costs and attorneys' fees.  Additional terms of the settlement were not immediately available.

Biotech/Pharma Docket

By James DeGiulio --

Medicis and Lupin Settle Solodyn Infringement Dispute; Agree to Drug Development Collaboration

Medicis has entered into multiple agreements with Lupin over the acne drug Solodyn, allowing the generic drugmaker to enter the market prior to the expiration of Medicis' patents.  In a separate agreement, Medicis agreed to join Lupin in a drug development collaboration worth an initial $20 million to the generic company.

In November 2009, Medicis filed suit against Lupin, which had filed an ANDA intending to launch a generic version of Solodyn in three approved strengths (45, 90, and 135 mg).  Medicis later amended the complaint to cover all five approved dosages and to add an additional patent.  Medicis claimed Lupin infringed U.S. Patent Nos. 5,908,838 and 7,790,705 by seeking to manufacture a generic version of Solodyn before the patents expire.  The '838 patent covers a slow-dissolving form of tetracycline, a class of oral antibiotics commonly used to treat acne.  When tetracycline dissolves too rapidly after being swallowed, the incidence and severity of side effects such as vertigo, dizziness, and blurred vision can increase.  The '705 patent relates to methods of administering the dosages.

On July 21, Judge J. Frederick Motz signed off on a consent judgment that permanently enjoined Lupin from selling generic Solodyn except under the terms of a separate licensing agreement.  The licensing agreement allows Lupin to sell a generic version of Solodyn in various different doses prior to the expiration of the patents.  Under the agreement, Lupin can move ahead with 45-, 90-, and 135-milligram doses in November, the 65- and 115-milligram doses in February 2018, and the 55-, 80-, and 105-milligram doses in February 2019.  Under certain conditions that were not disclosed, Lupin could begin making the generic earlier.

In a separate agreement, Lupin announced it had agreed with Medicis to enter a collaborative partnership, where Lupin would use its proprietary formulation technology to develop new therapeutic compounds.  As part of the development collaboration, Medicis agreed to pay out a $20 million upfront payment in exchange for Lupin's technology.  The agreement gives Medicis exclusive rights to the developed products outside India, where Lupin is based.  Lupin is eligible for future milestone payments of up to $38 million for certain research, development, regulatory, and other targets, while Medicis is responsible for future commercialization of the licensed products.

Asahi Award Reduced in Fasudil Licensing Dispute with Actelion

A $577 million award secured by Asahi against Actelion has been cut by $70 million.  In its suit, Asahi claimed that Actelion bought CoTherix in order to undermine a licensing deal over the hypertension treatment Fasudil.

Asahi brought suit in 2008 in the Superior Court of the State of California, County of San Mateo, accusing Actelion of acquiring CoTherix and then interfering with the latter's deal with Asahi to develop Fasudil.  CoTherix terminated the licensing deal for Fasudil in 2007 after being acquired by Actelion.  Asahi alleged that Actelion's acquisition of CoTherix was an attempt to protect its monopoly in the market for treating pulmonary arterial hypertension.  Actelion maintained that there was no commitment between Asahi and CoTherix, noting that the licensing agreement explicitly stated that there was no partnership.  During a three-month trial, Asahi argued that Actelion expected a major loss in market share if competitive drugs were introduced, for Acetlion's drug Tracleer had caused 3,427 patient deaths that had gone unreported to the FDA.  Actelion argued that the decision not to develop Fasudil was made due to numerous safety concerns from doctors and medical authorities as to the drug's potential side effects on the kidney and the liver.  In May 2011, the jury found that Actelion and CoTherix had acted with malice in interfering with Asahi's 2006 agreement with CoTherix to develop and commercialize Fasudil, and awarded Asahi $550 million in damages for interrupting the licensing agreement.

Following the damage award verdict, Actelion asked Judge Marie S. Weiner to offset a $78.4 million arbitration payment CoTherix made in 2009 from the jury verdict.  Judge Weiner ordered a $70.4 million offset.  Actelion also contested part of the verdict, asking the judge for an election between lost profit and development costs.  The $577 million jury award consisted of $360 million in lost profits, $187 million in development costs, and $30 million in punitive damages.  Judge Weiner rejected the motion on procedural grounds, telling Actelion that it must wait until judgment before filing its motion.  Actelion has stated its intention to appeal the jury verdict in due course following entry of judgment, expected after August 8, and rulings on further post-trial motions.

Pfizer Settles Relpax Infringement Suit with Apotex

Pfizer could be wrapping up its infringement lawsuits over the migraine drug Relpax, as it reached a settlement agreement with Apotex, the deal with Apotex following a settlement Pfizwer reached with Teva earlier this month.  Pfizer filed suit against Apotex on July 9, 2010 in the District Court of the Southern District of New York, after Apotex filed an ANDA to manufacture a generic form of eletripian hydrobromide, which Pfizer markets as Relpax.  Pfizer claimed that Apotex's generic would infringe U.S. Patent No. 6,110,940.  Pfizer sought a judgment of infringement and a permanent injunction against Apotex, along with attorneys' fees and costs.  Apotex asserted that its generic version did not infringe the '940 patent because it uses a different form of eletripian hydrobromide.  In an answer and counterclaim filed in September, Apotex requested a declaratory judgment of invalidity and noninfringement of the '940 patent.

On July 26, Pfizer's attorneys filed a letter with Judge Lewis A. Kaplan, informing him that the companies had reached a settlement.  According to the letter, the parties sought to avoid further judicial involvement, and achieve the same result as with Teva.  Terms of Pfizer's settlement with Teva were not disclosed.  Pfizer also asked Judge Kaplan to extend discovery deadlines in the case, in order to provide adequate time for the parties to close on a final settlement agreement.

Biotech/Pharma Docket

By James DeGiulio --

Drug Wholesalers Secure Injunction Blocking Braintree from Terminating MiraLAX Supply

Direct purchasers of MiraLAX, who have brought a class action suit headed by Rochester Drug Cooperative ("RDC") against drugmaker Braintree Laboratories Inc., were successful in obtaining a preliminary injunction blocking Braintree from terminating its sales to the drug wholesaler plaintiffs.  In the original action, Braintree filed a patent infringement suit against Schwarz Pharma in 2003, after the company submitted an ANDA to manufacture a generic version of MiraLAX.  The suit and prior Paragraph IV filing, which concerned U.S. Patent No. 5,710,183, triggered a 30-month stay on the FDA's approval of Schwarz's ANDA.  Braintree eventually dismissed its claims against Schwarz Pharma, thus waiving the remainder of the 30-month stay, and the ANDA was approved in July 2004.

In March of 2007, RDC filed this putative class action suit on behalf of drug wholesalers who purchase MiraLAX directly.  RDC claimed that the original ANDA litigation was a ploy to extend Braintree's monopoly on MiraLAX because Braintree knew or should have known the patent it asserted against Schwarz Pharma was invalid.  The plaintiffs claim Braintree engaged in an anti-competitive scheme that allowed it to charge supracompetitive prices for MiraLAX, or polyethylene glycol 3350, and the delay of generic competition caused them to overpay for MiraLAX by millions of dollars.  In lieu of an answer, Braintree filed a motion to dismiss the action, which was denied.  In March 2011, Braintree sent letters to the plaintiffs, stating that they would no longer sell products to them due to their allegedly meritless antitrust litigation.  RDC then moved for a preliminary injunction to force Braintree to continue to supply MiraLAX to the plaintiffs.

On July 7, Judge Sue Robinson issued a memorandum opinion granting the request for a preliminary injunction from plaintiffs RDC, Louisiana Wholesale Drug Co., and Meijer Inc., forcing Braintree to stop its retaliatory action and resume its supplier relationships with the companies.  After Braintree cut off its supply, RDC said the move threatened the plaintiffs' ability to obtain and retain customers, and forced them to switch to other suppliers that charged them higher prices.  Judge Robinson analyzed the four eBay factors, and was persuaded by plaintiff's authority Bergen Drug Company Inc. v. Parke, Davis & Co., 307 F.2d 725 (3d Cir. 1962).  Judge Robinson agreed to issue the injunction, but she said the plaintiffs would have to agree to post a bond for the cost of the litigation.  The plaintiffs have shown only possible harm, not any specific harm, caused by Braintree's decision to terminate its business relationships with the plaintiffs.  This is because ultimate relief sought by the plaintiffs is to be reimbursed for the cost of Braintree's branded MiraLAX product.  Judge Robinson said the plaintiffs must bear the risk of costs going forward if the plaintiffs seek the extra relief of Braintree's continued business.

Takeda Agrees to Drop Mylan Inc. from Prevacid Patent Litigation, But Mylan Subsidiary Remains

Takeda Pharmaceutical Co. Ltd. has agreed to drop Mylan Inc. as a defendant in Takeda's lawsuit over Mylan's generic version of the acid reflux drug Prevacid, but subsidiary Mylan Pharmaceuticals Inc. remains in the suit to litigate the generic maker's position.  Takeda brought suit in May 2011, accusing Mylan of infringing its two patents covering Prevacid, U.S. Patent Nos. 6,328,994 and 5,464,632, by filing an ANDA for a generic version of the drug (see "Court Report - Part II," May 23, 2011).  Ethypharm SA, which owns the '632 patent and licenses it to Takeda, joined Takeda as a plaintiff.  According to the complaint, the plaintiffs claimed the generic's release would cause irreparable harm, and asked the District Court to block approval of Mylan's generic drug.  Takeda also requested that the case be declared exceptional so that Mylan would be forced to cover its attorneys' fees.  After Takeda filed its complaint, Mylan filed counterclaims seeking declaratory judgment that the two patents were invalid and that Mylan's drug did not infringe either patent.

On July 11, Judge Joel Pisano signed off on a stipulation dismissing Mylan Inc. as a defendant.  However, the dismissal may not have a significant impact, for Mylan Inc. subsidiary Mylan Pharmaceuticals Inc. remains in the suit.  In exchange for the dismissal, Mylan and Matrix Laboratories agreed to abide by the District Court's final judgment relating to any damages, as well as any court orders against it.  Mylan also agreed to make any documents or information relevant to the alleged infringement and validity of Takeda's patents available for discovery as if the generics maker were still party to the suit.

Astellas Settles Adenoscan Patent Suit with Sagent and Strides Arcolab

After just a few weeks, Astellas Pharma US Inc. has settled a lawsuit against Sagent Pharmaceuticals Inc. and Strides Arcolab Ltd., who were accused of infringing Astellas' patent covering the pharmacologic stress agent Adenoscan.  In June 2011, Astellas and Item Development AB brought suit against Sagent Strides, a joint venture between the two defendant companies, alleging infringement of U.S. Patent No. 5,731,296 (see "Court Report," June 26, 2011).  Astellas was notified in May that Sagent Strides had filed papers seeking FDA approval for an Adenoscan generic.  Sagent Strides asserted that the '296 patent was invalid and unenforceable.  Astellas has vigorously defended the '296 patent, which is set to expire in March 2015, bringing several suits against generic makers seeking to enter the market for its Adenonscan product.  However, Astellas entered into a settlement with Teva in 2007, which provides Teva with a license to market and sell its Adenoscan generic in September 2012.

On July 11, Judge Mary Cooper signed off on an order dismissing the case against Sagent Strides without prejudice.  The action can be reopened if there is no settlement within 60 days, and the District Court retains jurisdiction over the matter to enforce the terms of the settlement, which were not disclosed.  It is not clear whether the settlement included a provision that would allow Sagent Strides to market and sell its generic Adenoscan product before the expiration of the patent.

Biotech/Pharma Docket

By James DeGiulio --

Elan and Abbott Drop Tricor Patent Suit with Teva

Elan and exclusive licensee Abbott have agreed to dismiss their case with Teva over its intended marketing of a generic version of the cholesterol drug Tricor.  The dispute between the companies began in July 2010, when Abbott, subsidiary Fournier, and Elan brought suit against Teva in the U.S. District Court for the District of New Jersey (see "Court Report," July 25, 2010) after Teva announced its plans to make a generic version of Tricor and filed an ANDA in May 2010.  The plaintiffs accused Teva of infringing U.S. Patent Nos. 5,145,684, 7,276,249, and 7,320,802.  Abbott's Fournier unit developed the drug's active ingredient and is the exclusive licensee of the patents, while Elan has developed a system for controlling how the drug is absorbed by the body.

On June 30, Judge Garrett E. Brown signed off on the joint stipulation of dismissal between the parties.  Under the agreement, the complaint against Teva and all of the counterclaims were dismissed without prejudice.  According to the dismissal, no party admits liability and each will bear its own costs.  Elan and Abbott have steadily been wrapping up Tricor-related lawsuits in recent months, having settled with Biovail (now owned by Valeant), Lupin, and Ranbaxy.

Sanofi Settles with Actavis in Allegra Suit

Sanofi and Actavis have settled a patent infringement suit over Actavis' planned generic version of the allergy drug Allegra.  In May 2010, Sanofi brought suit against Actavis in the U.S. District Court for the District of New Jersey, alleging that Actavis' planned generic version of Allegra would infringe three patents:  U.S. Patent Nos. 6,399,632, 6,187,791, and 6,037,353 (see "Court Report," June 6, 2010).  Actavis had previously sent Sanofi its notice letter in April 2010 announcing that it had filed an ANDA, and claiming that the three Sanofi patents were invalid or would not be infringed by the proposed generic drug.  Sanofi responded that not only would the generic version infringe the patents-in-suit, but that the infringement would be willful.  The complaint further sought damages and an injunction barring Actavis from selling generic Allegra.  Sanofi has been aggressive in protecting its patents for the medication, suing several generic makers for their efforts to introduce generic versions of the allergy drug.  However, many of these cases are drawing to a close.  In March, Sanofi settled a similar suit over generic Allegra with Impax, Mylan, and Dr. Reddy's.  That case had been pending since 2002.

On June 30, Judge Garrett E. Brown signed off on an order of dismissal, which dismissed the action without prejudice, while retaining jurisdiction to enforce the terms of the settlement.  No costs were awarded to either side and the terms of the settlement were not disclosed.  The case can be reopened within 60 days if the settlement is not finalized.

Wyeth and Intellipharmaceutics Settle Effexor XR Patent Litigation

Wyeth has settled its lawsuit against Intellipharmaceutics, which was filed when Intellipharmaceutics applied for regulatory approval to produce a generic version of the antidepressant drug Effexor XR.  The dispute between Wyeth and Intellipharmaceutics began in July 2010, when Wyeth filed suit in the U.S. District Court for the Southern District of New York against Intellipharmaceutics after its submission of an ANDA for a generic extended release version of venlafaxine HCl (see "Court Report," July 5, 2010).  Wyeth asked the District Court to find that Intellipharmaceutics had infringed U.S. Patent Nos. 6,274,171, 6,403,120, and 6,419,958.  Intellipharmaceutics responded by asserting that that patents were invalid and unenforceable.  As of July 2011, Wyeth has filed at least seventeen suits over Effexor XR since the drug was approved in 2000, and has settled over half of these suits.

On June 20, Judge Laura Taylor Swain approved a stipulation of dismissal under Federal Rule 41 and a consent judgment.  According to the stipulation, all of the claims, counterclaims, and affirmative defenses are dismissed with prejudice.  No costs were awarded.  Although the companies' filings did not disclose the terms of the settlement, the judgment references a licensing agreement between the parties.  The judgment also stated that Intellipharmaceutics stipulated to the validity and enforceability of the three patents. 

Biotech/Pharma Docket

    By James DeGiulio --

Allergan and Hi-Tech Settle Combigan Patent Dispute

Allergan has resolved its dispute with Hi-Tech Pharmacal over the latter's bid to market a generic version of Allergan's glaucoma treatment Combigan.  In June 2009, Allergan sued Hi-Tech in the U.S. District Court for the Eastern District of Texas, claiming that Hi-Tech's ANDA filing infringed U.S. Patent Nos. 7,030,149; 7,320,976; 7,323,463; and 7,642,258 (see "Court Report," June 14, 2009).  Allergan sought injunctive relief as well as an order prohibiting approval of Hi-Tech's ANDA until the allegedly infringed patents expire.  Allergan has also brought similar infringement suits against generic-drug makers Sandoz, Apotex, and Watson, which are still pending.

On May 31, in accordance with a May 20 settlement, Judge T. John Ward signed off on an Order dismissing all claims in Allergan's suit against Hi-Tech.  The dismissal stipulated that all four Allergan patents related to Combigan were valid and infringed by the generic product described in Hi-Tech's ANDA.  According to the stipulation, Allergan's claims are dismissed with prejudice, and each party shall bear its own costs, expenses, and attorneys' fees.

Novartis and Sun Settle Focalin Patent Suit

Novartis Pharma has resolved a patent infringement suit with Sun Pharmaceutical Industries over Sun's proposed generic version of Novartis' attention deficit disorder drug Focalin.  In July 2010, licensee Novartis and patent owner Celgene brought suit in the U.S. District Court of New Jersey, claiming that Sun's ANDA for its proposed generic Focalin would infringe U.S. Patent Nos. 5,908,850; 6,355,656; and 6,528,530 (see "Court Report," July 11, 2010).  The plaintiffs asked to be given access to the ANDA, but Sun would not agree to provide it on reasonable terms, instead sending Novartis and Celgene a statement that acknowledged that the proposed generic version would infringe two of the three patents for Focalin.  With respect to the third patent, Sun stated that the generic would not infringe.  In March 2011, the parties notified the District Court that they had reached a settlement and requested a stay pending regulatory approval.

On June 10, after counsel for the parties notified the District Court that regulatory review of the settlement had been completed, Judge Susan D. Wigenton signed off on the agreement dismissing the case without prejudice.  The litigation over Focalin continues, however, as manufacturer Elan has brought suit against Intellipharmaceutics, Par Pharmaceuticals, and Teva over a planned generic Focalin.  All three of these cases remain pending.

Antitrust Sanctions Upheld Against Pfizer in Neurontin Case

Sanctions for a witness testimony violation were upheld on appeal in a case involving accusations that Pfizer used patent litigation to delay generic competition for the epilepsy drug Neurontin.  The plaintiffs, which include CVS Pharmacy, Rite Aid Corp., Louisiana Wholesale Drug Co., and Meijer, first brought suit in March 2002 alleging that Pfizer and Warner-Lambert engaged in an overarching anti-competitive scheme to acquire and maintain monopoly power in the market for gabapentin products in violation the Sherman Act.  The plaintiffs allege that Pfizer improperly listed two patents in the Orange Book, manipulated the patent approval process so a third patent could delay generic entry, initiated multiple sham suits over the patents, and engaged in fraudulent off-label promotion.  In October 2002, the case was stayed pending resolution of the infringement action.  In February 2008, following the remand by the Federal Circuit (see "In re Gabapentin Patent Litigation (Fed. Cir. 2007)"), the stay was lifted and the antitrust case continued.  Sanctions were imposed after Pfizer produced two witnesses who were not prepared to discuss why Pfizer had denied promoting Neurontin for off-label uses in the antitrust suit, despite having pled guilty to doing so in a separate criminal case in 2004.

On June 9, Judge Faith S. Hochberg issued an Opinion and Order rejecting Pfizer's appeal of the sanctions and affirmed the Order handed down by Magistrate Judge Shwartz.  The Order gave the plaintiffs an opportunity to redepose the witnesses, banned Skadden Arps Slate Meagher & Flom LLP from appearing at the new deposition, and struck all objections at the original deposition.  During the deposition that led to the sanctions, the witness who was brought in to testify after the District Court deemed Pfizer's first witness inadequate simply recited an outline of responses Skadden had prepared.  The judge ruled that this was equivalent to failure to appear.  The judge's Order also required Pfizer to pay all attorneys' fees and costs associated with the matter.

Biotech/Pharma Docket

By James DeGiulio --

Cephalon's Amrix Patents Infringed But Invalid in Suit against Mylan and Barr

Two of Cephalon's patents covering the muscle relaxant Amrix drug were found to be infringed by Mylan and Barr, but those same patents were also found to be invalid for obviousness.  Cephalon originally brought six cases against several generic manufacturers to block them from producing generic versions of the extended release drug Amrix after the generics filed Abberviated New Drug Applications (ANDAs).  These cases were consolidated in the U.S. District Court for the District of Delaware in December 2009, and a bench trial was held from September 29 through October 10, 2010.  At trial, Barr and Mylan challenged the validity of Cephalon's patents, arguing that cyclobenzaprine was well known in the art and anyone with ordinary skill could have made an extended release version with minimal effort.  They also asserted that the patents-in-suit, U.S. Patent Nos. 7,387,793 and 7,544,372, were unenforceable due to inequitable conduct.  After trial, Cephalon settled with Impax.  On October 29, Cephalon, Mylan, Barr, and Anchen stipulated that the generic drugmakers would not enter the Amrix market until April 17, 2011, or the date of issuance of an opinion on Cephalon's patents, whichever was earlier.  On April 8, Judge Sue L. Robinson blocked Mylan, Barr and Anchen from introducing their generic versions of Amrix until she issued her final ruling (see "Biotech/Pharma Docket," April 14, 2011).

In an opinion issued on May 12, Judge Robinson ruled that the '793 and '372 patents were invalid due to obviousness.  The key prior art includes a European patent application that discloses a controlled release micropellet, a U.S. patent that describes a multidose delivery mechanism for a drug similar to cyclobenzaprine, and two articles in the Journal of Clinical Pharmocology that describe scientific studies with cyclobenzaprine.  Judge Robinson said that a person of ordinary skill in the art would have been motivated to combine these references to create an extended release version of cyclobenzaprine, and would have had a reasonable expectation of success in doing so.  The defendants argued that cyclobenzaprine had been on the market for years and anyone with ordinary skill could have easily made an extended release version.  The plaintiffs argued against obviousness by pointing to several secondary considerations:  other leading drug companies had failed to create extended release cyclobenzaprine, that there was a long felt need fulfilled by Amrix, and that its commercial success proved the patents' validity.  Judge Robinson instead found that Amrix's success was due to an expansive marketing campaign, rather than its patented features, and that the patents were obvious.  In the judgment accompanying her opinion, Judge Robinson also determined that Anchen did not infringe the patents-in-suit.

Cephalon Drops Nuvigil Suit Against Teva

Last month, Teva acquired Cephalon for $6.8 billion.  Not surprisingly, Cephalon has now dropped Teva from its long list of alleged infringers in its patent suit over narcolepsy drug Nuvigil.  The Nuvigil litigation began in December 2009 against Actavis, and in December 2010, Cephalon's case against Teva was consolidated with several other infringement actions over Nuvigil.  Other defendants included Apotex, Teva, Mylan, Watson, Lupin, and Sandoz.  While Cephalon asserted U.S. Patent No. 7,132,570 in all seven of the consolidated suits, it also alleged that Sandoz and Apotex infringed U.S. Patent Nos. 7,297,346 and RE37,516.  Cephalon recently dropped its suit against Actavis in March (see "Biotech/Pharma Docket," March 24, 2011).  In April, Teva amended its patent certification to a Paragraph III in its bid for regulatory approval for generic Nuvigil.

On May 11, Judge Gregory M. Sleet signed off on a stipulation and order dismissing the case.  The stipulation and order does not act as an adjudication on the merits of any claim or counterclaim, and Teva agreed to cooperate in good faith to provide reasonable discovery for continuing use in Cephalon's litigation against the other defendants.

Breckenridge, Synthon Settle Actos Patent Suit with Takeda

Takeda has reached an agreement with Breckenridge and Synthon Pharmaceuticals, ending the patent dispute over the diabetes drug Actos.  In September 2010, Takeda brought suit in the Southern District of New York against Breckenridge and Synthon, claiming that defendants' ANDA infringed U.S. Patent Nos. 5,965,584; 6,329,404; 6,166,043; 6,172,090; 6,211,205; 6,271,243; and 6,303,640.  In 2009, Breckenridge and Synthon had signed a distribution and supply agreement on the generic drug product and have been working together, including the settlement of the Paragraph IV litigation.

On May 16, the suit was resolved following an agreement between the parties.  Under the terms of the agreement, Takeda granted Breckenridge and Synthon a non-exclusive, royalty-free license to the patents covering the drug, permitting launch of their generic-equivalent formulation of Actos after first-filers of ANDAs with Paragraph IV certifications exhaust their 180-day marketing exclusivity on February 13, 2013, or earlier under certain circumstances, pending regulatory approval.

Biotech/Pharma Docket

By James DeGiulio --

Seroquel Suit between AstraZeneca and Biovail Dismissed

AstraZeneca and Biovail have agreed to end their patent dispute over Seroquel XR after Biovail converted its Paragraph IV certification to a Paragraph III filing, thus agreeing not to market a generic version of Seroquel XR until after the expiration of the patents in the suit.  The dispute between the drug companies began in January 2009, when AstraZeneca brought suit in the U.S. District Court for the District of New Jersey against Biovail, alleging that Biovail's Abbreviated New Drug Application (ANDA) covering three doses of extended-release quetiapine fumarate infringed U.S. Patent Nos. 4,879,288 and 5,948,437 (see "Court Report," January 18, 2009).  In April 2009, Biovail countered that it did not infringe either patent, and that both patents were invalid.  Biovail also argued that one of the patents was unenforceable because AstraZeneca engaged in inequitable conduct during prosecution of the patent by withholding internal information about compounds that could be considered atypical anti-psychotics.

On April 29, AstraZeneca and Biovail filed a joint stipulation of dismissal after Biovail changed its regulatory certification to a Pararaph III filing, agreeing not to commercially sell its generic drug until after the expiration of the '288 and '437 patents.  The patents expire in 2011 and 2017, respectively.  Judge Joel Pisano granted the parties' stipulation on May 2, dismissing all the claims and counterclaims in the action without prejudice, and ordered the parties to cover their own costs and attorneys' fees.  The stipulation allows the AstraZeneca to retain some of Biovail's confidential information and other data for use in the related patent litigation against Handa, Torrent, and other generics.

Eli Lilly Successfully Blocks Release of Generic Cymbalta

Eli Lilly successfully secured an order that prohibits the defendants in the Cymbalta patent litigation from selling a generic version of duloxetine during the term of Eli Lilly's compound patent.  In November 2008, Eli Lilly filed suit in the U.S. District Court for the Southern District of Indiana against Wockhardt, claiming the generic manufacturers' duloxetine oral capsules infringed U.S. Patent No. 5,023,269 (see "Court Report," November 23, 2008).  Eli Lilly brought suit against several other generic companies, and these other suits were consolidated in February 2009 and stayed pending the outcome of Eli Lilly's case against Wockhardt.  All defendants had alleged in their ANDAs that Eli Lilly's patent was invalid.

On April 27, Judge Tanya Walton Pratt entered final judgment against the defendants, prohibiting the sale of a Cymbalta generics and requiring that the defendants convert their certifications to a Paragraph III filing.  The '269 patent provides protection for Cymbalta until at least June of 2013.  The defendants also must notify the FDA that the defendants are no longer seeking approval for an ANDA.  Eli Lilly argued that the group was bound by Judge Pratt's March approval of a settlement between the company and Wockhardt that favored the plaintiff.  The judge's order ends Eli Lilly's case against Impax, Cobalt, Anchen, Actavis, Aurobindo, Lupin, Sandoz, and Sun.

Pfizer and Eon Settle Neurontin Patent Dispute

Pfizer and Eon Labs have reached an agreement ending their patent infringement suit over a generic version of the epilepsy drug Neurontin.  In June 2000, Pfizer brought suit in the U.S. District Court for the District of New Jersey against Eon, after Eon filed an ANDA over gabapentin.  In 2002, the case was joined with Pfizer's suits against other generic-drug makers Purepac and Teva.  Despite the lawsuit, the defendants opted to begin selling their generic gabapentin products "at risk" before a court ruling on infringement liability had been issued.  Pfizer asserted infringement of U.S. Patent No. 6,054,482 stemming from the ANDA and the sales of generic gabapentin.  In August 2005, the District Court found no infringement because Pfizer failed to prove that the anions of the Neurontin generic drugs fall within the claims.  Pfizer appealed the New Jersey court's decision to the Federal Circuit and it was reversed (see "In re Gabapentin Patent Litigation (Fed. Cir. 2007)").

On April 28, Judge Faith S. Hochberg signed off on a stipulation dismissing Eon and Sandoz from the case, leaving Purepac, Teva, and their affiliates as the only remaining defendants in the long-running patent suit, which is scheduled for trial on May 16.  The companies stipulated that Eon's gabapentin capsules infringed Pfizer's patent and that all claims and counterclaims pending between the companies should be dismissed.  The remaining terms of the settlement are confidential.

Protective Orders Put at Risk by New Bill

By Kevin E. Noonan --

Lost in all the hubbub over the America Invents Act (S. 23 and H.R. 1249, collectively "the patent reform bill"), Congress is considering another pair of bills (one in each House) that could have an equally deleterious effect on enforcing valuable patents.  Identified as S. 623 (introduced by Senator Herb Kohl (D-WI), joined by Senators Lindsey Graham (R-SC) and Patrick Leahy (D-VT)) and H.R. 592 (introduced by Representative Gerald Nadler (D-NY)), the bills are called the "Sunshine in Litigation Act," and are intended to prevent courts from granting protective orders in certain cases.

Specifically, the bills require a ban on protective orders for any civil action "in which the pleadings state facts that are relevant to the protection of public health or safety," adding Section 1660 to Title 28, U.S. Code, Chapter 111.  The bills constitute a Congressional "thou shalt not" for an order "otherwise authorized under rule 26(c) of the Federal Rules of Civil Procedure restricting the disclosure of information obtained through discovery, an order approving a settlement agreement that would restrict the disclosure of such information, or an order restricting access to court records."  Such a protective order would be permitted only after a court makes "independent findings of fact" that "such [an] order would not restrict the disclosure of information which is relevant to the protection of public health or safety" or that "the public interest in the disclosure of past, present, or potential health or safety hazards is outweighed by a specific and substantial interest in maintaining the confidentiality of the information or records in question" and "the requested order is no broader than necessary to protect the confidentiality interest asserted."  In addition, the bills would prohibit any protective order (except for an order approving a settlement agreement) from continuing in place after final judgment is entered, unless the court "makes a separate finding of fact" at that time that the requirements of the statute balancing the private interest in secrecy with the public's "right to know" (based on the effect of the information on "public health or safety") continue to favor the protective order.  A party that is the "proponent" of the protective order would bear the burden of establishing the requirements of the statute.  Stipulation between the parties would not overcome the onus placed on the court for independent fact-finding (and the presumption against entering or maintaining a protective order) before such an order could be put into place.  The bills also provide that "[t]he provisions [thereof] . . .  shall not constitute grounds for the withholding of information in discovery that is otherwise discoverable" under the Federal Rules of Civil Procedure.

The bills contain similar provisions prohibiting a court from enforcing any provisions in a settlement agreement between private parties that would prohibit any party from disclosing "the fact that such a settlement was reached or its terms" (except the amount of money damages) or from "discussing a civil action, or evidence produced in the civil action, that involves matters relevant to the protection of public health or safety."  Unless, of course, the court makes the independent factual findings that the public's right to know is outweighed by the parties' private interest in that information remaining secret.  Moreover, the bills create a rebuttable presumption that a party's interest in "personally identifiable information" that relates to "financial, health or similar information of an individual outweighs the public interest in disclosure."

In a separate provision, each of the bills would prevent a court from giving effect to an order "to the extent that such provision or such order prohibits or otherwise restricts a party from disclosing any information relevant to such civil action to any Federal or State agency with authority to enforce laws regulating an activity relating to such information."  Information disclosed to such an agency could remain confidential "to the extent provided by law," there not being any intention to abrogate other statutory protections.

The motivation for introducing these bills is products liability litigation, specifically in instances where companies have imposed non-disclosure provisions in settlement agreements.  Senator Kohl (at left) made the case in these terms when he introduced the Senate version of the bill on March 17th.  In remarks entered into the Congressional Record, the Senator stated that the bill was intended to "curb the ongoing abuse of secrecy orders in Federal courts . . . [that] keep[s] important health and safety information hidden from the public."  He characterized his "bipartisan" bill as a "commonsense measure" that is "an important step to improving transparency in our courthouses by requiring judges to consider public health and safety before permitting secrecy agreements."  This problem "most often arises in product liability cases," the Senator said, citing "a long history" of "tobacco companies, automobile manufacturers, pharmaceutical companies, medical device manufacturers, and others," and enumerated several purported instances, including automobile accidents caused by defective Bridgestone/Firestone tires; Toyota's recall of over 8 million cars due to sudden unintended acceleration problems; clinical studies about the harmful side effects of AstraZeneca's antipsychotic drug, Seroquel; explosions of "side saddle" fuel tanks in General Motors pickup trucks; and even the possibility of secrecy orders in cases stemming from the BP oil spill in the Gulf of Mexico last year.  The Senator recounted as "typical" an individual plaintiff suing a large corporation and being coerced into agreeing to keep the corporation's culpability secret as a condition for a financial settlement necessary to compensate the individual for medical and other damages caused by a defective product.  While this outcome may be adequate for the individual plaintiff, it is "the American public [that] incurs the loss because they remain unaware of critical public health and safety information that could potentially save lives," the Senator said.  Similar sentiments can be found in press releases and on the websites of the other sponsors of the House and Senate bills.

Regardless of whether the protections of these bills are necessary or will be sufficient to achieve the sponsors' goals, one immediate consequence of these provisions will be to put pharmaceutical and biotechnology companies at risk in any litigation.  Frequently, protective orders are entered in cases involving these companies to prevent disclosure of trade secrets, including technical know-how and valuable business information regarding prospective new uses and avenues of research.  Biotech and pharma patentees have a legitimate interest in keeping such information secret, but the nature of their businesses could easily be characterized as involving "public health."  The bill contains no definitions limiting the application of its provisions to products liability lawsuits, regardless of its sponsors' protestations of their intent; the case law is replete with decisions invoking the principle that the intent of an individual Member of Congress, even a sponsor, in introducing litigation is not dispositive on the scope of the bill when enacted into law.  The bill also provides the opportunity for manipulation by litigants, insofar as the threat of litigation (and the disclosure mandated by the Federal Rules not trumped by the provisions of this proposed statute) could be used to obtain an advantage over patentee plaintiffs.  This makes the bill particularly dangerous for biotech and pharma companies, since the multiple interests (especially the interest in lower drug costs regardless of the actual costs of developing such drugs) make the ultimate decision fraught with political consequences that overshadow the disputes and issues between private party litigants that might otherwise limit the  extent of any public interest in disclosure of such private information.

The effective date of the statute is 30 days after enactment and will apply only to actions commenced thereafter and apply to protective orders or settlement agreements entered on or after that date.  The Senate bill is slated to be marked up on Thursday, May 5th by the Senate Judiciary Committee for passage to the floor for a vote.

Biotech/Pharma Docket

    By James DeGiulio --

Pozen Secures Injunction Blocking Par's Generic Treximet

Earlier this month, Pozen obtained a preliminary injunction blocking Par Pharmaceutical from marketing a generic version of Pozen's migraine drug Treximet until an infringement suit over the drug is resolved.  The dispute between the parties began in November 2008 when Pozen brought suit in the U.S. District Court for the Eastern District of Texas against Par and the generic drugmakers Alphapharm, Teva, and Dr. Reddy's (see "Court Report," November 23, 2008).  All four defendants had submitted ANDAs seeking to market generic versions of Treximet.  Pozen claimed that the generic drugmakers infringed U.S. Patent Nos. 6,060,499; 6,586,458; and 7,332,183.  In April 2010, Teva was dismissed without prejudice from the consolidated litigation.  The case against the other three defendants was tried on October 12-15, 2010, and a decision is still pending.  However, in early 2011, Par received approval from the FDA to market its generic version of Treximet, allowing Par to launch its product once Pozen's three years of regulatory exclusivity expires on April 15.  After Par refused to reveal whether it planned to launch at-risk, Pozen then asked the court for a preliminary injunction until the court issues a final decision.

In an April 14 opinion, Judge Leonard Davis granted a preliminary injunction ordering Par not to make, use, sell, offer to sell, or import into the United States a generic version of sumatriptan and naproxen sodium.  Judge Davis focused his analysis on two asserted claims of the '458 patent, finding that Pozen had sufficiently shown that it was likely to succeed against Par on the merits of its infringement claim.  The court also rejected Par's arguments that it raised a substantial question regarding the enforceability of the '458 patent.  The injunction will remain in effect until a final decision is issued in the pending patent litigation.

Wyeth and Orchid Enter Licensing Agreement in Effexor XR Suit

Wyeth has entered into a licensing deal with Orchid Chemicals & Pharmaceuticals, thereby ending the parties' patent infringement litigation over Effexor XR.  The dispute between Wyeth and Orchid began in July 2009, when Wyeth filed suit in the U.S. District Court for the District of New Jersey against Orchid after its submission of an ANDA for a generic extended release version of venlafaxine HCl (see "Court Report," July 12, 2009).  Wyeth asked the court to declare that Orchid had infringed U.S. Patent Nos. 6,274,171; 6,403,120; and 6,419,958 and enjoin the generic drugmaker from making or selling its proposed generic.  Orchid responded by asserting that that patents were invalid.  In October, Wyeth was ordered to produce its prior Effexor patent settlement and licensing agreements after the court decided the agreements might be relevant to Orchid's patent misuse defense.  Wyeth has filed at least sixteen suits over Effexor XR since the drug was approved, and has settled with eleven generic companies to date.

On April 14, Judge Freda L. Wolfson signed an order approving the settlement.  Under the settlement, Orchid agreed not to manufacture its generic product until the expiration of the three patents at issue, except as permitted by a confidential licensing agreement.  The settlement requires each party to bear its own court costs.  Further details of the agreement were not revealed.

Takeda Agrees to Dismiss One Actos Infringement Suit against Apotex

After filing its complaint just one month ago, Takeda Pharmaceutical has requested a voluntary dismissal of its patent infringement suit against Apotex, centered around Apotex's efforts to manufacture a generic version of the diabetes medication Actos.  On March 22, Takeda brought suit against Apotex in the U.S. District Court for the Southern District of Florida, claiming that Apotex's ANDA infringed U.S. Patent Nos. 5,965,584; 6,329,404; 6,166,043; 6,172,090; 6,211,205; 6,271,243; and 6,303,640 (see "Court Report," March 27, 2011)  Apotex sought approval for generic pioglitazone tablets to be used for both monotherapy and in combination with a diabetes drug.  Takeda also alleged willfull infringement and inducing infringement, claiming Apotex was likely to advertise the Actos name on its website, thus inviting customers to follow the Actos treatment systems but substitute the Apotex version of the drug.

On April 13, Judge Ursula Ungaro entered an order dismissing the case without prejudice, based on Takeda's request and notice of voluntary dismissal.  Takeda did not disclose its reasoning for requesting dismissal, but both parties are currently litigating a nearly identical infringement suit in the U.S. District Court for the Southern District of New York.

Biotech/Pharma Docket

By James DeGiulio --

Cordis Stent Found to Infringe Boston Scientific Patent

Boston Scientific Corp. secured a favorable ruling on summary judgment in its patent infringement suit against Cordis Corp. over one of its drug-eluting stents.  In 2003, Boston Scientific sued Cordis in the U.S. District Court for the District of Delaware for infringement of U.S. Patent No. 5,922,021, asserting that three sizes of Cordis' Cypher stent infringed the '021 patent.  In 2005, a jury agreed and returned a verdict in favor of Boston Scientific.  Cordis sought reexamination of the '021 patent in 2009.  Three claims of the '021 patent were rejected as obvious, but Boston Scientific was able to overcome this rejection.  Cordis filed a second request for reexamination in January 2011, which rejected one claim of the '021 patent as anticipated and obvious.  Following this rejection, Cordis asked the District Court to delay trial until the Patent Office finished its reexamination, while Boston Scientific moved for summary judgment of infringement.

On April 13, Judge Sue L. Robinson issued an opinion that denied Cordis' motion to delay the start of a trial, weighing the general factors for staying a trial.  Judge Robinson considered the stay improper, since discovery was complete, the trial for damages was set to start May 5, and the reexamination could take many months to complete.  Judge Robinson also granted Boston Scientific's motion for summary judgment, finding that the product at issue, Cordis' 2.25 mm Cypher stent, infringes the '012 patent since it has the same architecture as three other sizes of stent that were found to infringe the same claim of the patent in a previous case.  Judge Robinson also assigned a favorable date to Boston Scientific for damage calculation.  Finally, Judge Robinson denied Cordis' Daubert motion to exclude an expert in royalty calculations from testifying for Boston Scientific.  Cordis had previously challenged the expert's methodology, but the favorable damage calculation date assigned to Cordis significantly weakened its challenge.

Mylan, Barr and Anchen Blocked from Introducing Generic Amrix

Cephalon was able to extend an injunction ruling that generic drugmakers cannot release their own versions of Amrix until the Judge issues a ruling on the validity and enforceability of the patents.  Cephalon brought six cases against several generic manufacturers to block them from producing generic versions of the extended release drug Amrix after their ANDA filings.  These cases were consolidated in the U.S. District Court for the District of Delaware in December 2009.  A bench trial was held from September 29 through October 10, 2010, where Barr and Mylan challenged the validity of Cephalon's Amrix patents, arguing that cyclobenzaprine was well known in the art and anyone with ordinary skill could have made an extended release version with minimal effort.  They also asserted that the patents were unenforceable due to inequitable conduct.  After trial, Cephalon settled with Impax (see "Biotech/Pharma Docket," October 14, 2010).  On October 29, Cephalon, Mylan, Barr, and Anchen stipulated that the generic drugmakers would not enter the Amrix market until April 17, 2011, or the date of issuance of an opinion on Cephalon's patents, whichever is earlier.

On April 8, Judge Sue L. Robinson issued an order enjoining the generic manufacturers from launching their products until an opinion on the patents is issued in the case.  The 30-month automatic stay in this case is set to expire on April 17, and the generics have made it known that they intend to introduce their Amrix drugs to market on April 17, regardless of whether Judge Robinson issues her ruling, as per the stipulation.  While Judge Robinson intends to release her opinion on the patents soon, she did not guarantee that the opinion would come down before April 17.  Consequently, despite the parties' stipulation, the judge issued an injunction over all defendants in all the cases, keeping all generic Amrix off the market until she issues her ruling.

Galderma, Dermalogix Agree to End Clobex Suit with Paddock

As trial was set to begin, Galderma SA and Dermalogix Partners Inc. reached an agreement with Paddock Labs which ends their patent infringement suit over a generic version of the psoriasis spray Clobex.  In 2009, Galderma and Dermalogix brought suit in the U.S. District Court for the Northern District of Texas, alleging infringement of U.S. Patent No. 5,972,920 after Paddock submitted an ANDA seeking approval for a generic clobetasol propionate spray (see "Court Report," January 11, 2011).  Both parties moved for summary judgment, with the plaintiffs asking the District Court to rule that the proposed generic infringes the '920 patent and that the patent is not invalid.  The judge found that Paddock's proposed spray did infringe the '920 patent as a matter of law.  Paddock argued that the '920 patent was unenforceable due to inequitable conduct by the inventors and patent attorney.  However, the judge determined that there were genuine issues of material fact with respect to both infringement and inequitable conduct that must be established at trial, which was slated to start Monday.

Judge Terry R. Means signed off on the three companies' stipulation to dismiss the suit with prejudice, leaving each side to pay its own costs and attorneys' fees.  The stipulation was silent as to any settlement.

Biotech/Pharma Docket

By James DeGiulio --

Cephalon's Fentora Patent Found Valid, Infringed by Watson

Cephalon enjoyed a needed victory in its patent dispute with Watson over Fentora after one of the patents at issue in the case was upheld and Watson's proposed generic of Fentora was found to infringe that patent.  The dispute between the parties began in June 2008, when Cephalon filed suit against Watson in the U.S. District Court for the District of Delaware over Watson's ANDA filing covering a generic version of Fentora (see "Court Report," June 8, 2008).  Cephalon alleged infringement of U.S. Patent Nos. 6,200,604 and 6,974,590.  In September 2009, Cephalon brought suit for infringement of U.S. Patent No. 6,264,981 (see "Court Report," October 4, 2009).  The cases were consolidated for purposes of discovery and a bench trial, which was held between May 10 and 17, 2010.  In early March, 2011 Judge Robinson found that Watson had established that the asserted claims of the '604 and '590 patents were invalid for lack of enablement (see "Biotech/Pharma Docket," March 15, 2011).

In an opinion issued on March 24, Judge Sue L. Robinson effectively ended Watson's efforts to market a generic version of Fentora for the time being after determining that the proposed generic drug infringes four claims of the '981 patent.  Watson contended that its proposed fentanyl buccal tablets were not covered by the '981 patent because they contained an amorphous rather than a solid solution, but the District Court agreed with Cephalon's argument that fentanyl cannot be completely in amorphous form.  The Court also held that the proposed generic contained a buffer system and absorption mechanism protected by the '981 patent.  Judge Robinson subsequently denied Watson's motion to vacate a previously entered injunction preventing Watson from marketing its generic drug.

Abbott Laboratories and WARF Settle Zemplar Patent Suit with Anchen Pharmaceuticals

Abbott Laboratories and the Wisconsin Alumni Research Foundation (WARF) entered into an agreement with Anchen Pharmaceuticals, thus ending a patent infringement dispute over a generic version of the kidney disease treatment Zemplar.  In October 2010, Abbott and WARF sued Anchen in the U.S. District Court for the District of Delaware, alleging that Anchen infringed U.S. Patent No. 5,587,497 when it filed an ANDA seeking approval to market generic Zemplar (see "Court Report," October 31, 2010).  WARF owns the '497 patent and exclusively licenses the patent to Abbott.  In their complaint, Abbott and WARF asked the court to prohibit the approval of Anchen's ANDA, enjoin the generics maker from marketing or selling paricalcitol capsules, and award the plaintiffs costs and attorneys' fees.

In January, the parties notified the District Court that Anchen was engaged in talks with the plaintiffs about the possibility of a settlement.  The Court agreed to grant Anchen a few months extra time to respond to the complaint, so the defendant could allocate resources to negotiating a settlement.  On March 23, Judge Gregory M. Sleet approved a joint stipulation filed by the parties, which agreed to dismiss all claims, counterclaims, and affirmative defenses in the suit without prejudice.  The parties also indicated that each would cover its own costs and attorneys' fees.

Pronova Settles with Apotex in Lovaza Patent Dispute

Pronova and Apotex have reached an agreement settling their litigation over Lovaza, agreeing to allow Apotex to enter the market for the triglyceride-lowering drug beginning in 2015.  In April 2009, Pronova brought suit against Apotex in the U.S. District Court for the District of Delaware, alleging infringement of U.S. Patent Nos. 5,502,077 and 5,656,667 following Apotex's ANDA filing (see "Court Report," May 3, 2009).  Pronova filed an amended complaint adding infringement claims with respect to U.S. Patent Nos. 7,678,930 and 7,718,698.  In January, Pronova filed a new infringement suit in the District of Delaware over U.S. Patent No. 7,732,488 (see "Court Report," January 9, 2011).  These suits were combined with Pronova's similar suits against generic makers Teva Pharmaceuticals USA and Par Pharmaceutical.  The first trial against all three defendants with respect to the '077 and '667 patents was set for March 29.

On March 29, Pronova and Apotex agreed to voluntarily drop Pronova's two infringement suits that were scheduled to begin that same day, with each party bearing its own attorneys' fees and costs.  Judge Robinson signed off on the settlement that day, issuing a stipulated order, which did not contain details on market entry.  However, on March 30, Pronova and GlaxoSmithKline announced in separate press releases that the parties' settlement grants Apotex a license to enter the U.S. market with a generic version of Lovaza in the first quarter of 2015, or earlier depending on certain undisclosed circumstances.  The '077 patent expires in March 2013, while the '667 patent expires in April 2017.  Pronova's allegations against Teva and Par are still pending.

Biotech/Pharma Docket

By James DeGiulio --

Apotex's Generic Provigil Found Not to Infringe Cephalon Patent

Apotex received a favorable ruling on summary judgment in its dispute with Cephalon regarding the narcolepsy drug Provigil after the U.S. District Court for the Eastern District of Pennsylvania determined that Apotex's proposed generic does not infringe one of two Cephalon patents at issue in the case.  The conflict between Cephalon and Apotex arose out of an earlier dispute between Cephalon and four other generics.  That earlier litigation began when Barr, Mylan, Teva, and Ranbaxy filed ANDAs seeking FDA approval to market generic versions of Provigil on December 24, 2002.  In response, Cephalon filed suit against all four generic companies, alleging infringement of U.S. Patent Nos. 7,297,346 and RE37,516.  Cephalon, however, reached settlements with all four defendants, giving them 180-day exclusivity to market their generics since all four companies filed their ANDAs on the same day.

In 2006, Apotex filed against Cephalon seeking a judgment of non-infringement with respect to the '516 patent and alleging antitrust claims against Cephalon with respect to the settlements with Barr, Mylan, Teva, and Ranbaxy.  Apotex later sought a judgment of non-infringement with respect to the '346 patent as well.  Apotex, and other drug suppliers, alleged that Cephalon asserted patents that it knew were weak and then offered the generics payoffs to stay off the market.  The plaintiffs contended that Cephalon and the other generics companies all benefited from Cephalon's alleged payoff, which amounted to an conspiracy to suppress generic Provigil.

On March 15, Judge Mitchell S. Goldberg issued an Order granting Apotex's motion for summary judgment, ruling that its generic did not infringe the '346 patent.  Cephalon also moved for summary judgment, indicating that it had only asserted the RE'516 patent against Apotex's ANDA and thus that there was no controversy concerning the '346 patent.  However, that motion was denied, and Cephalon conceded that Apotex's product would not infringe the '346 patent.  Judge Goldberg reminded  Apotex that it needed a ruling of noninfringement on both patents in order to trigger the statutory 180-day exclusivity period.  The infringement trial pertaining to the '516 patent has yet to be held.

Cephalon Drops Patent Suit Against Actavis over Nuvigil Generic

Cephalon and Actavis have agreed to settle their infringement suit over the narcolepsy drug Nuvigil after Actavis made the decision not to market a generic version of armodafinil.  In December 2009, Cephalon filed suit against Actavis in the U.S. District Court for the District of Delaware, claiming infringement of U.S. Patent No. 7,132,570 (see "Court Report," December 13, 2009).  In December 2010, the case was consolidated with several other infringement actions over Nuvigil.  Other defendants include Apotex, Teva, Mylan, Watson, Lupin, and Sandoz.  While Cephalon asserted the '570 patent in all seven of the consolidated suits, it also alleged that Sandoz and Apotex infringe U.S. Patent Nos. 7,297,346 and RE37,516.

On March 16, Judge Gregory Sleet issued an Order approving the stipulation between the two parties, thus ending Cephalon's case against Actavis.  According to the agreement, Actavis will wait to market its generic Nuvigil product until the expiration of the '570 patent.  Actavis can also enter the market if a final, nonappealable judgment is entered finding the '570 patent invalid or unenforceable.

OSI, Genentech, and Pfizer Settle Tarceva Patent Litigation with Teva

Astellas and subsidiary OSI Pharmaceuticals, along with Roche, Genentech, and Pfizer, have ended a case against Teva covering patents for the lung cancer drug Tarceva.  The case began in March 2009, when OSI sued Teva in the U.S. District Court for the District of Delaware, accusing Teva of infringing U.S. Patent Nos. 6,900,221, 7,087,613, and 5,747,498 through its ANDA filing and plans to market generic erlotinib (see "Court Report," March 29, 2009).  OSI markets the drug with Genentech, and Pfizer co-owns the '498 patent with OSI.  In May 2009, the Teva suit was consolidated alongside the plaintiffs' claims against Mylan.  Mylan remains as the sole defendant in the litigation.  On March 15, one day after beginning trial, Judge Sue L. Robinson signed off on the parties' consent order of dismissal.  Details of the agreement remain confidential.

Biotech/Pharma Docket

By James DeGiulio --

Watson Invalidates Cephalon's Fentora Patents

Watson Pharmaceuticals won a substantial victory in its lawsuit with Cephalon over Fentora when the generic drugmaker successfully established that two of three asserted patents covering the drug are invalid.  The dispute between the parties began in June 2008, when Cephalon filed suit against Watson in the U.S. District Court for the District of Delaware over Watson's ANDA filing covering a generic version of Fentora (see "Court Report," June 8, 2008).  Cephalon alleged infringement of U.S. Patent Nos. 6,200,604 and 6,974,590.  In September 2009, Cephalon brought another suit against Watson, alleging that Watson also infringed U.S. Patent Number 6,264,981 (see "Court Report," October 4, 2009).  Cephalon has also brought suit against Mylan and Barr, and has reached a settlement with Barr granting Barr a nonexclusive, royalty-free license to market and sell a generic version of Fentora in the U.S. as of October 2018.

In an opinion issued on March 11, Judge Sue L. Robinson determined that Cephalon had failed to prove that Watson infringed the asserted claims of the '604 and '590 patents and that Watson had successfully proven the asserted claims to be invalid for lack of enablement.  In the first section of her opinion, Judge Robinson adopted Watson's proposed claim constructions for the '604 and '590 patents.  Turning to the issue of infringement, the Judge Robinson found that Cephalon had failed to show that a reaction in Watson's product produced an effect that was required to establish infringement.  Judge Robinson also held that bioequivalence was insufficient to establish infringement under the doctrine of equivalents.  Finally, in addressing Watson's invalidity counterclaims, Judge Robinson was persuaded by Watson's expert who indicated that a person of ordinary skill in the art would not be able to practice the invention of the two patents without undue experimentation.  The opinion and accompanying order did not issue a ruling on the '981 patent.

Sanofi Agrees to Judgment Barring Assertion of Taxotere Patents

After a ruling in a related case rendered Sanofi-Aventis' patents covering Taxotere invalid for obviousness and inequitable conduct, the company agreed to a judgment preventing it from asserting these patents against Sandoz.  In January 2011, Sanofi filed suit against Sandoz in the U.S. District Court for the District of Delaware, accusing Sandoz of infringing U.S. Patent Nos. 5,750,561 and 5,714,512 (see "Court Report," January 16, 2011), despite a previous ruling in a related case with Hospira and Apotex that found these two patents invalid (see "Biotech/Pharma Docket," September 30, 2010).  The suit against Sandoz was based on its NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) covering a docetaxel injection product.  Sanofi also has a suit pending with Accord Healthcare over its NDA and Paragraph IV certification.  Sanofi has appealed the invalidity ruling from the Hospira and Apotex case.

On March 11, Judge Gregory M. Sleet signed off on a consent order and judgment, which the parties signed to promote efficiency and economy for themselves and the District Court.  The judgment bars Sanofi from asserting the two patents until a decision from the Federal Circuit is issued in the related case.  Plaintiffs reserved all rights to appeal from this final judgment.  The future of the case depends on the action of the Federal Circuit in the related case.  If the Federal Circuit affirms the invalidity ruling in the Hospira and Apotex case, Sanofi waives its righ to appeal or seek modification of the current judgment.  However, if the Federal Circuit vacates or reverses the invalidity ruling, the plaintiffs could reinstate their infringement claims as to the two patents.

Teva Dismisses Mylan's Inequitable Conduct Defenses in Azilect Dispute

Mylan will have to press on without an inequitable conduct defense in its dispute with Teva over the Parkinson's drug Azilect, after Teva successfully moved to dismiss Mylan's defense.  Last October, Teva filed suit in U.S. District Court for the District of New Jersey, alleging that Mylan (and other generic makers) infringed U.S. Patent No. 5,453,446 by submitting ANDAs for generic Azilect (see "Court Report," October 10, 2010).  Mylan raised its inequitable conduct defense in a November 30 response to the complaint, alleging that the '466 patent was unenforceable because the applicants did not disclose to the examiner that both deprenyl and PAI are R-enantiomers.  Mylan alleged that by failing to disclose this information, Teva, which asserted that the invention was "surprising and unexpected," intentionally misled the patent examiner.

In an opinion issued on February 24, Judge Jose L. Linares granted Teva's motion to dismiss Mylan's counterclaims and affirmative defense alleging inequitable conduct.  Judge Linares found that Mylan had failed to plead the circumstances of inequitable conduct with the requisite particularity under Rule 9(b), which requires that a plaintiff make sufficient allegations of underlying facts from which a court can reasonably infer the requisite intent to deceive the USPTO.  Judge Linares, following Exergen Corp. v. Wal-Mart Stores, Inc., found that Mylan had not sufficiently identified the individuals involved or why the information withheld or misrepresented was material.  Judge Linares also granted Mylan an opportunity to amend its complaint to remedy the shortcomings of its pleadings.

Biotech/Pharma Docket

By James DeGiulio --

Abbott and Elan End TriCor Suit with Ranbaxy

After only a few months, Abbott Loaboratories and Elan Pharma International, along with Abbott subsidiary Fournier Laboratories, have dropped their patent suit against Ranbaxy Laboratories over the latter's generic version of the cholesterol drug TriCor.  The dispute between the companies began in June 2010, when Abbott, Fournier, and Elan brought two suits against Ranbaxy in the U.S. District Court for the District of New Jersey following Ranbaxy's ANDA filing in April for a generic fenofibrate drug (see "Court Report," June 13, 2010).  The plaintiffs accused Ranbaxy of infringing Fournier's U.S. Patent Nos. 6,277,405, 7,037,529, and 7,041,319, in one action, and Elan's and Fournier's 7,276,249 and 7,320,802 in the other action.  Abbott is the exclusive licensee of the patents, while Elan has developed a system for controlling how the drug is absorbed by the body.  The plaintiffs alleged that Ranbaxy acted without a reasonable basis or a good faith belief that it would not be liable for infringing the patents and asked for a preliminary injunction.  Ranbaxy filed counterclaims in August, asserting patent invalidity and noninfringement.

On February 17, Judge Garrett E. Brown Jr. signed off on the parties' joint stipulation of dismissal, dropping both the claims and counterclaims without prejudice and without admitting any liability.  Judge Brown's order can be found here.  On February 28, Elan subsequently dropped its claims against Ranbaxy, and the two sides also agreed to drop Ranbaxy's invalidity counterclaims.  The order for the latter dismissal can be found here.  The end of these suits could mean Ranbaxy can now enter the U.S. market.

Merck and Teva Settle Patent Dispute over Cancidas

Merck has dropped its patent suit against Teva over its planned marketing of a generic version of the anti-fungal drug Cancidas.  On November 25, 2009, Merck brought suit against Teva in the U.S. District Court for the District of New Jersey, alleging infringement of U.S. Patent Nos. 5,378,804, 5,514,650, and 5,952,300, which cover caspofungin acetate, the active ingredient in Cancidas (see "Court Report," December 7, 2009).  In May 2010, the District Court consolidated Merck's patent action against Teva with a similar lawsuit against Sandoz (see "Court Report," May 23, 2010).  Claim construction of the Merck patents at issue occurred in October through December 2010.

On February 23, Judge Stanley Chesler dismissed Merck's infringement action following its decision to settle the litigation.  Trial was set to begin in fall 2011.  All claims and counterclaims were dismissed, and each side will be responsible for its own costs and fees.  The rest of the settlement terms remain confidential.  Judge Chesler's order dismissing the case can be found here.

PDL BioPharma Settles Medimmune Synagis Litigation for $93M

After a key patent in PDL BioPharma's litigation with MedImmune was invalidated earlier this year, PDL has now settled the suit over the respiratory treatment Synagis and has agreed to pay MedImmune $92.5 million.  The relationship between the parties began in 1997, when PDL granted MedImmune a license to develop certain types of antibodies covered by five PDL patents.  In 1998, MedImmune received approval from the FDA to market the antibody drug Synagis, which is used to prevent lower respiratory tract disease in infants and children.  In December 2008, in a complaint filed in the U.S. District Court for the Northern District of California, MedImmune asked for a declaratory judgment that the five PDL patents covering the antibodies were invalid, and that it owed no payments to PDL under a patent license agreement reached by the companies (see "Court Report," December 21, 2008).  PDL argued that the patents were valid and that MedImmune's antibody treatments infringed those patents.  Leading up to the latest ruling in the case, only a single claim of one patent (U.S. Patent No. 6,180,370) remained at issue, which MedImmune claimed was invalid and which PDL claimed covered Synagis.  Recently, MedImmune moved for summary judgment of invalidity, and PDL moved for summary judgment with respect to MedImmune's restitution claim regarding the patent royalties paid.  In January, PDL was dealt a blow when a ruling came down invalidating the '370 patent at issue in the case (see "Biotech/Pharma Docket," January 20, 2011).

In the settlement, PDL agreed to pay $65 million immediately and pay another $27.5 million one year from now.  In return, MedImmune, a unit of AstraZeneca PLC, agreed to dismiss with prejudice its invalidity claims against PDL's patent.  The settlement resolves the last remaining claim of the long-standing patent dispute.  Details regarding the settlement can be found here.

Biotech/Pharma Docket

By James DeGiulio --

Medicis and Q-Med Settle Restylane Dispute with Genzyme

Genzyme has agreed to drop its infringement suit with Medicis regarding the cosmetic injection product Restylane in exchange for a lump sum payment from Q-Med.  In October 2010, Genzyme brought suit in the U.S. District Court for the District of Massachusetts against Medicis, who licenses the product from Q-Med (see "Court Report," October 25, 2010).  Genzyme claimed that importing and selling Restylane, Perlane, Restylane-L, and Perlane-L injection products infringed U.S. Patent No. 5,399,351.  Genzyme alleged that Medicis also actively induced the infringement of the patent by selling these products together with instructions that advised others to infringe the '351 patent.  Q-Med, as licensor, was not named as a defendant in the suit, but Q-Med elected to assume the defense of Genzyme's claim in accordance with its license agreement with Medicis.

On February 15, Q-Med announced in a press release that the parties had reached a settlement agreement, and that Genzyme agreed to dismiss the case and release Medicis and Q-Med from any liability related to the suit.  Q-Med did not disclose the exact sum paid to Genzyme.  However, Medicis is not required to make any payments under the terms of the settlement and none of the parties admit any liability related to the lawsuit's claims.

Sun Agrees to Briefly Stop Selling Generic Eloxatin

As Sun Pharma and Sanofi-Aventis continue to try to close their long-running battle over the cancer drug Eloxatin, Sun has agreed to temporarily halt its sales of oxaliplatin while the parties decide how to proceed with the infringement dispute that appeared to have been settled.  The case has a long history.  In 2007, the dispute between Sun and Sanofi-Aventis began, after Sanofi brought suit against Sun in response to Sun's ANDA filing, alleging infringement of U.S. Patent No. 5,338,874 (see "Court Report," July 30, 2007).  Sanofi also filed suit against other generic drug manufacturers who filed ANDAs for generic oxaliplatin.  In 2009, the parties entered into settlement negotiations, eventually agreeing to a license.  Two days after Sanofi and Sun reached a settlement agreement, the District Court denied summary judgment of invalidity and granted summary judgment of noninfringement of '874 patent.  A series of challenges to the original license agreement followed, eventually reaching the Federal Circuit, which vacated the settlement and remanded the case because the disputed language in the consent judgment was susceptible to two different interpretations (see "Sanofi-Aventis v. Sandoz, Inc. (Fed. Cir. 2010)").  The Federal Circuit denied Sanofi's request for reconsideration of this decision on February 7.

On February 9, Judge Joel A. Pisano of the U.S. District Court for the District of New Jersey approved the stipulation and proposed order requiring Sun to briefly refrain from selling, attempting to sell, or offering for sale any product containing oxaliplatin until February 17.  In exchange, Sanofi agreed not to seek injunctive relief against Sun or its affiliates until February 15, according to the order.  The agreement was sought to facilitate further negotiation in the action.  This latest agreement can be found here.

Novozymes' Biofuel Enzyme Patent Survives Danisco Invalidity Challenge

Novozymes' patent covering a modified enzyme for use in ethanol production survived an invalidity challenge in the company's patent dispute with Danisco following the denial of Danisco's motion for summary judgment ofr invalidity.  In May 2010, Novozymes sued Danisco in the U.S. District Court for the Western District of Wisconsin, claiming that Danisco and its U.S. affiliates infringed U.S. Patent No. 7,713,723, covering the modified alpha-amylase enzyme (see "Court Report," May 23, 2010).  Novozymes moved for a preliminary injunction in September, asking the District Court to stop Danisco and its subsidiaries from selling GC358 and the more recent GC980 enzymes.  However, that bid was denied.  The Court concluded that Novozymes had failed to demonstrate that it would be irreparably harmed without an injunction, and questioned whether the patent-in-suit was actually valid, criticizing its written description.  Following this ruling, Danisco moved for summary judgment of invalidity of the '723 patent.

On February 4, Judge Barbara B. Crabb denied Danisco's motion for summary judgment, rejecting the argument that the patent's written description does not convey to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.  Judge Crabb ruled that Danisco had not met its burden to prove invalidity by clear and convincing evidence.  However, she also stated in her opinion that lack of enablement might be a better argument for the defendants, hinting that the specification may require undue experimentation.  Judge Crabb's opinion can be found here.

Biotech/Pharma Docket

By James DeGiulio --

Abbott Fails to Stay Patent Dispute with Wyeth over Stents

Despite pending reexaminations over the patents-in-suit, Abbott Laboratories was unsuccessful in its attempt to stay litigation with Wyeth over patents for drug-coated stents.  On September 22, 2009, Wyeth filed suit against Abbott in the U.S. District Court for the District of New Jersey, accusing the defendants of infringement by selling certain drug-eluting coronary stents.  According to the complaint, Wyeth claimed that Abbott's Xience V stent infringed U.S. Patent No. 7,591,844, which issued that same day.  Boston Scientific, a licensee of Abbott's stent, is also accused of infringement.  The plaintiffs sought a permanent injunction, damages, and attorneys' fees.  On April 15, 2010, Boston Scientific requested an inter partes reexamination of all 24 claims of the '844 patent, alleging that the claims are invalid as obvious in light of a number of prior art references that had not been disclosed during prosecution.  In July, Wyeth amended the complaint by adding U.S. Patent No. 6,746,773 to the infringement counts.  Abbott then asked the USPTO for an inter partes reexamination of all remaining claims in the '733 patent.  Both requests for reexamination were granted, and Abbott moved to stay the case while the USPTO reexamined both patents at issue in the case.

On February 1st, Judge Joel A. Pisano denied the defendants' motion to stay proceedings in the suit.  Judge Pisano applied the three-part test for deciding whether to stay a case:  (1) whether a stay would unduly prejudice or present a clear tactical disadvantage to the non-moving party; (2) whether a stay will simplify the issues in question and trial of the case; and (3) whether discovery is complete and whether a trial date has been set.  The judge ruled that putting the litigation on hold for the six years the reexamination is likely to take will subject plaintiffs to continuing sales and market loss.  Although he acknowledged that reexaminations resulting in cancelled claims would simplify the issues in the case, Judge Pisano found that the case was moving along at an appropriate pace, noting that litigation has been pending for over a year, discovery is underway and claim construction proceedings will take place in the coming months.  Judge Pisano's opinion can be found here.

Roxane Sanctioned in Asacol Patent Dispute with Medeva

Roxane Laboratories was hit with sanctions when Medeva successfully argued that Roxane Laboratories concealed a batch of its generic drug in a patent suit over the colitis drug Asacol.  In October 2007, Medeva filed suit in the U.S. District Court for the District of New Jersey alleging that Roxane infringed U.S. Patent No. 5,541,170 by filing an ANDA for a generic version of Asacol (see "Court Report," November 4, 2007).  The infringement issue is whether Roxane's proposed generic product releases its entire dose of mesalamine to the right side of the colon as claimed in the '170 patent.  After discovery, Medeva filed a motion for sanctions, claiming that Roxane was responsible for spoliation of evidence by destroying highly relevant documents and manufacturing a "secret batch" of its generic product in November 2008 in order to conduct testing in humans.  The District Court heard oral argument on the motion on November 23, 2010.

On January 28, Magistrate Judge Tonianne Bongiovanni granted Medema's motion to impose sanctions for Roxane's impermissible concealment of a batch of its generic product, but denied the plaintiffs' motion to impose sanctions for Roxane's alleged destruction of documents.  Plaintiffs had requested information regarding all samples of Roxane's mesalamine product, but Roxane did not reference the concealed lot in its discovery responses and did not state it was withholding information based on the attorney-client privilege or the work product doctrine.  The judge thus found no justification for Roxane's failure to include information on this drug batch.  However, Judge Bongiovanni did not agree with the plaintiffs that Roxane's alleged destruction of documents warranted sanction, noting that Roxane had produced high-quality documents thus far in the litigation, and had adhered to a policy that required the company to retain technical information, such as laboratory notebooks, for a minimum of 20 years.  Judge Bongiovanni said Roxane must now pay Medeva's expert costs related to its expedited testing of the concealed batch, along with attorneys' fees incurred in arguing its motion over the batch.  Judge Bongiovanni's opinion can be found here.

Watson Settles with Promote Innovation in Androderm False Marking Suit

Watson Pharmaceuticals has settled with Promote Innovation over a false marking suit concerning its Androderm testosterone treatment, agreeing to stop using packaging for the product that was allegedly marked with expired patents.  Promote Innovation first brought suit in the U.S. District Court for the Eastern District of Texas in August 2010, arguing that Watson had been marking Androderm products with four expired patents:  U.S. Patent Nos. 4,849,224; 4,855,294; 4,863,970; and 4,983,395 (see "Court Report," August 23, 2010)  The complaint accused Watson of wrongfully and illegally advertising a patent monopoly, alleging that Watson's marketing materials give the false impression that the patents for Androderm are still in effect and not in the public domain.  Promote claimed that Watson benefited from this false marking by increasing its market power or commercial success, while consumers were harmed by preventing other companies from developing rival products.  Promote further claimed that Watson's actions harmed the U.S. government by stifling competition and violating the spirit of U.S. patent law.

On February 1st, Judge T. John Ward ratified a stipulated dismissal between Watson and Promote Innovation.  The order calls for Watson and any companies selling its Androderm products to stop using the labels, packaging, and other materials.  However, Watson is granted reasonable time to sell inventory that was manufactured on or before the date of the order.  Each company is to pay its own attorneys' fees and costs, but other terms of the settlement were not disclosed.  Judge Ward's order can be found here.