Patent Docs

Hatch-Waxman Boot Camp

April 20, 2012

American Conference Institute (ACI) will be holding the next session of its Hatch-Waxman Boot Camp conference on June 25-26, 2012 in San Diego, CA. ACI faculty will help attendees:

• Comprehend how recent biosimilars legislation is changing industry dynamics;
• Understand the interplay of between the PTO and FDA in the patenting of drugs and biologics;
• Learn about the essentials of the FDA approval process and its link to biopharmaceutical patents;
• Develop an in-depth and practical knowledge of Hatch-Waxman protocols, including Orange Book listings, bioequivalency, exclusivities, the 30-month stay, and the safe harbor;
• Navigate the intricacies of patent term adjustment and patent term extension; and
• Recognize how new pre-commercialization concerns relative to CMS approval and Medicare/Medicaid formulary selection are influencing the patenting and approval of drugs and biological products.

In particular, ACI's faculty will offer presentations on the following topics:

• Key agencies overview: Understanding the jurisdiction and interplay of the FDA and PTO in the patenting of drugs and biologics;
• Identifying and comprehending pre-commercialization concerns relative to small molecules and biologics;
• Exploring the link between the FDA approval process and the patenting of drugs and biologics;
• IP overview for drugs and biologics: Hatch-Waxman, BPCIA, trade dress, and more;
• Paragraph IV disputes and litigation: Federal Court, PTO proceedings & ITC actions;
• How the dynamics of biosimilars are changing the Hatch-Waxman landscape;
• Orange Book listings, de–listings, and related challenges;
• Bioequivalence and the "same active ingredient" vis-a-vis patentability;
• An in-depth look at 180-day exclusivity;
• Comprehending the intricacies of non-patent/regulatory exclusivity;
• Assessing patent protections afforded under the safe harbor; and
• Examining pharmaceutical patent extensions: Patent Term Adjustment and Patent Term Restoration.

A post-conference interactive biosimilars strategy session, entitled "Biosimilars: An In-Depth Look at the Law, Interpreting Regulations, and Anticipated Litigation," will be offered from 9:00 am to 12:00 pm on June 27, 2012. The workshop will provide an overview of the law governing biosimilars and will then delve into the preparations that should be made in anticipation of litigation.

A post-conference workshop, entitled "Patent Reform 101: Overview of the Fundamental Provisions in the America Invents Act and the Impact on Hatch-Waxman Litigation," will be offered from 1:00 pm to 4:00 pm on June 27, 2012. The workshop will provide a clear overview of the numerous sections in the America Invents Act, especially highlighting how it will tie into Hatch-Waxman and when implementation will begin.

The agenda for the Hatch-Waxman Boot Camp conference can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee for the conference is $2,295 (conference alone), $2,895 (conference and one workshop), or $3.295 (conference and both workshops). Those registering by April 27, 2012 will receive a $300 discount and those registering by May 25, 2012 will receive a $200 discount. Patent Docs readers who reference the discount code "PD 200" will receive $200 off the current price tier when registering. Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media partner of ACI's Hatch-Waxman Boot Camp conference.
GW Law Symposium on Intellectual Property

April 20, 2012

The George Washington University Law School (with Mayer Brown and Cornerstone Research) will be holding its annual GW Law Symposium on Intellectual Property on May 8, 2012 at The George Washington University Law School, 2000 H Street NW, Washington, DC. The Symposium will offer presentations on the following topics:

• Keynote Address — Janet Gongola, Patent Reform Coordinator, U.S. Patent and Trademark Office
• Damages in Patent Litigation Cases: The New Models
• Tips and Trends for Litigating Patent Cases in The Federal Courts
• Luncheon Address — Hon. Randall R. Rader, Chief Judge, U.S. Court of Appeals for the Federal Circuit
• A New Challenge: Navigating Inter Partes and Post Grant Review under The America Invents Act
• The In-House Counsel Perspective: Tips for Outside Counsel and Trends

Additional information about the Symposium, including a program, list of speakers, and directions can be found at the Symposium's website. A cocktail reception will take place following the Symposium.

The registration fee for the Symposium is $25 (GW IP Law Student) or $75 (all other registrations). Those interested in registering for the Symposium can do so here.
C5 Pharma Patent Lifecycles Conference

April 20, 2012

C5 (UK) will be holding its 11th International Forum on Pharma Patent Lifecycles on June 20-21, 2012 in London, England. The conference will provide practical and strategic guidance on patent lifecycle extensions, including:

• Recent SPC case law developments and their implications on the industry;
• Maximizing exclusivity for new medical products in light of regulatory and case law developments;
• How to get the most value out of pediatric exclusivity for your patent portfolio;
• Patent Office insights on key challenges in SPC regulation Europe-wide;
• Guidance from the European Commission on lifecycle extensions and anti-trust enforcement;
• Avoiding 'Abuse of Dominance' in your patent management strategies;
• Designing successful patent lifecycle plans for biosimilars following new regulatory guidelines in Europe and the U.S.;
• How U.S. patent reform and U.S. case law developments will impact your lifecycle management strategies; and
• Understanding the latest regulatory developments and IP reforms in Brazil.

In particular, C5 faculty will offer presentations on the following topics:

• EPO — An Update on the Latest Developments — to be presented by Dieter Tzschoppe, Director Pure and Applied Organic Chemistry, European Patent Office;
• PTO Panel: Addressing Key Challenges in SPC Regulation Europe-wide and Contrasting Different Interpretations — panel includes Martijn de Lange, Netherlands Patent Office; Dr. Hubertus Zink, Patent Examiner, DPMA (German Patent and Trademark Office); and Dr. Lawrence Cullen, Deputy Director (Biotechnology, Pharmaceuticals & Organic Chemistry) Patents Directorate, Intellectual Property Office (UK IPO);
• Defining "New Actives" in Light of the Latest Regulatory and Case Law Developments;
• Clarifying SPCs for Enantiomers;
• Utilising Paediatric Exclusivity to Maximise the Value of your Patent Portfolio;
• Big Pharma Panel: How to Adopt SPC Strategies to Overcome Challenges Based on Recent Court Decisions and Industry Trends;
• Developing Strategies for Biosimilar Products Following New Regulatory Guidelines;
• Generics Panel: Strategies for Overcoming IP Challenges for Generic Companies;
• European Commission Keynote: The Latest Guidance on Patent Lifecycle Extensions — to be presented by Lavinia Teodorescu, DG Competition Antitrust Pharma and Health Services, European Commission;
• Competition Law vs. Patent Law – Overcoming Potential Conflicts;
• Avoiding 'Abuse of Dominance' in Your Patent Management Strategies: Lessons to be Learnt From Recent Cases;
• Prior Art and Obviousness: Understanding this Complicated Legal Area;
• Maximising the Use of Your Existing IP through Patent Pooling;
• Identifying the Latest Amendments and Reforms in Brazilian Patent Law;
• How the Latest IP Trends and Case Law Developments Impact Your Patents in China;
• Discover the Latest on the FDA Guidelines for Biosimilars; and
• The Impact of the U.S. Patent Reform.

A pre-conference workshop, entitled "Designing an Effective and Up-to-date SPC Strategy" will be offered from 1:30 pm to 5:30 pm on June 19, 2012.

A complete brochure for this conference, including an agenda, list of speakers, detailed descriptions of conference sessions, and registration form can be downloaded here.

The registration fee is £2095 for the conference and workshop and £1595 for the conference alone. Those registering by May 22, 2012 will receive a £100 discount. Patent Docs readers who reference the discount code "PD 10" will receive 10% off the current price tier when registering. Those interested in registering for the conference can do so here, by calling +44 20 7878 6888, by faxing a registration form to +44 20 7878 6885, or by e-mailing registrations@C5-Online.com.

Patent Docs is a media partner of C5's Pharma Patent Lifecycles conference.
Kappos v. Hyatt (2012)

April 19, 2012

By Kevin E. Noonan —

That rarest of rara aves issued from the Supreme Court yesterday, an affirmance of a Federal Circuit opinion in Kappos v. Hyatt. Perhaps it is because, as in Stanford v. Roche one of the parties was the government (here, Director David Kappos representing the U.S. Patent and Trademark Office, perhaps the least likely administrative agency to receive Supreme Court deference). Or maybe it is because the Office's position appears to be contrary to the plain meaning of the statute under consideration, 35 U.S.C. § 145. But in an opinion by Justice Thomas (another 9-0 opinion at that), the Court firmly sided with applicant Hyatt regarding both the extent of new evidence that a dissatisfied applicant can produce during a § 145 proceeding and the standard of review to be applied by the district court to such evidence.

The case arose from a decision by the District Court to exclude evidence that applicant Hyatt could have presented in the first instance to the PTO, and to enter judgment against Hyatt based on a deferential review of the PTO record. This decision was affirmed by a merits panel in a 2-1 decision written by former Chief Judge Michel (joined by Judge Dyk), who asserted an equitable reason for the exclusion:

It is clear from the record that under our case law Hyatt had an affirmative and specific duty to disclose to the PTO the evidence excluded by the district court, and was so notified by the PTO, but willfully refused to cooperate in the examination process. On the facts of this case, we uphold the district court's exclusion of Hyatt's evidence. We therefore hold that the district court correctly granted summary judgment sustaining the Board decision because Hyatt offered no other evidence and the Board's decision was based on findings of fact and factual conclusions, all of which are supported by substantial evidence, and thus we affirm.

This decision was based on the majority's characterization of how district courts had treated such evidence:

In sum, it has been the general practice of federal courts for over eighty years in certain circumstances to exclude evidence which a party could and should have introduced before the Patent Office but did not despite an obligation to do so. Our own cases likewise have not adopted a de novo standard for trial. We have said that "[c]learly, the applicant does not start over to prosecute his application before the district court unfettered by what happened in the PTO." On the other hand, it is beyond question that in appropriate circumstances new evidence may be submitted to the district court in a § 145 action (subject, at least, to the Federal Rules of Evidence). See Gould v. Quigg, 822 F.2d 1074, 1079 (Fed. Cir. 1987) ("[A]dditional evidence is permitted in a civil action under section 145, allowing the district court to make de novo fact findings."); Newman v. Quigg, 877 F.2d 1575, 1579 (Fed. Cir. 1989) ("A district court action under 35 U.S.C. § 145 is a de novo determination of patentability. It is not limited to the record before the PTO.")

Judge Moore's dissent was based on her interpretation of the plain language of the statute:

The majority's decision to affirm the district court's exclusion of the inventor's own declaration in a § 145 civil action severely restricts the rights that Congress action contemplated and enacted by Congress. Moreover, by concluding that an inventor has an "affirmative duty" to submit his own declaration in response to a rejection by the PTO, lest he be prevented from admitting the material in any subsequent district court proceeding, the majority makes it impossible for inventors to ever testify in a § 145 action unless their testimony had first been proffered to the PTO. I cannot agree that this was what Congress contemplated when it enacted § 145, and therefore I dissent.

The Federal Circuit reconsidered this decision en banc, and arrived at Judge Moore's position (she wrote the 7-2 decision):

On its face, § 145 authorizes a civil action in district court by which an applicant can prove his entitlement to a patent. The statute provides no indication that this civil action is somehow different from a customary civil action. In particular, § 145 does not provide that unique rules of evidence, separate from or supplementary to the Federal Rules of Evidence that apply to all civil actions, control to limit an applicant's ability to introduce new evidence before the district court. Additionally, § 145 makes clear that the civil action is distinct from an appeal, in which the applicant would be limited to the record before the Patent Office. See 35 U.S.C. § 144. Pursuant to the plain language of § 145, this civil action does not merely afford judicial review of agency action. Rather, the statute directs that the district court may "adjudge that such applicant is entitled to receive a patent for his invention . . . as the facts in the case may appear."

The opinion cites in support earlier Supreme Court cases (Butterworth v. Hoe, 112 U.S. 50 (1884); Gandy v. Marble, 122 U.S. 432, 439 (1887); Hoover Co. v. Coe, 325 U.S. 79, 83 (1945)) that permitted applicants to adduce new evidence in support of suits brought at the district court under the legislative parent of § 145 (§ 4915 of the Patent Act of 1927), as well as Dickinson v. Zurko ("[Section 145] permits the disappointed applicant to present to the court evidence that the applicant did not present to the PTO. The presence of such new or different evidence makes a factfinder of the district judge"). Finally, the majority held that "new evidence is admissible in a civil action under 35 U.S.C. § 145, subject only to the Federal Rules of Evidence and Federal Rules of Civil Procedure." And the standard of review to be used by district courts was de novo for any evidence newly submitted in those proceedings (while the opinion concedes that a deferential standard of review for evidence considered by the Office was appropriate under the provisions of the Administrative Procedures Act, 5 U. S. C. § 701 et seq.).

Judge Dyk's dissent, joined by Judge Gajarsa, warned that "applicants will deliberately withhold evidence in their possession, in order to spring it on the district court under section 145," saying further that the majority's decision "reflects yet another misguided effort to craft special rules for patent cases that the Supreme Court in other cases has held to be impermissible," citing eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006), and MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007).

The Supreme Court specifically rejected these arguments in affirming the majority's decision. In an opinion written by Justice Thomas, the Court reviewed the history of § 145 and its predecessor statutes as well as its own jurisprudence regarding the questions of whether new evidence could be adduced and the standard of review to be applied by district courts. With regard to the first issue, the Court held that "there are no evidentiary restrictions beyond those already imposed by the Federal Rules of Evidence and the Federal Rules of Civil Procedure," echoing the Federal Circuit majority. As for the standard of review, the Court held that "the district court must make a de novo finding when new evidence is presented on a disputed question of fact."

The Court's reasoning on the first issue was based on the distinctions between review sought under 35 U.S.C. § 145 with direct review to the Federal Circuit under 35 U.S.C. § 141. Citing Zurko, the opinion states that one important distinction between these two statutory provisions is the ability for an applicant to "present new evidence to the district court that was not presented to the PTO," which is "significant" because the Office did not "generally" accept oral testimony. The opinion recognizes that it has not spoken on whether there were any limitations on the new evidence or the appropriate standard of review of such evidence, which it supplies in this decision.

A clue to the basis for this decision comes from one way the opinion characterizes the PTO position: "[b]oth of these arguments share the premise that §145 creates a special proceeding that is distinct from a typical civil suit filed in federal district court and that is thus governed by a different set of procedural rules" based on "background principles of administrative law and pre-existing practice under a patent statute that predated §145." But the Court finds these arguments unavailing, based on the plain meaning of the statutory language: "[b]y its terms, §145 neither imposes unique evidentiary limits in district court proceedings nor establishes a heightened standard of review for factual findings by the PTO."

In view of its finding that these arguments by the Director were unavailing, the Court then turned to the Director's appeal to those "traditional principles of administrative law" embodied in the APA, specifically 5 U.S.C. § 706 ("judicial review of an agency decision is typically limited to the administrative record"). The issue is that here, the statute itself contradicts this interpretation, because it expressly provides for the applicant to present new evidence, which requires the court to "act as a factfinder." It thus "makes little sense for the district court to apply a deferential standard of review to PTO factual findings that are contradicted by new evidence," reasoned the Court. Moreover, "[t]he PTO, no matter how great its authority or expertise, cannot account for evidence that it has never seen," making it necessary for the district court to "make its own findings de novo." As such, the district court is not a "reviewing court" under the APA. The opinion also rejects the Director's contention that the Federal Circuit's decision would violate the principle of "administrative exhaustion," i.e., that the agency should in the first instance make all such factual determinations in the exercise of its special expertise. But the Court finds that the reason for this principle, as enunciated in McKart v. United States, 395 U. S. 185, 193–94 (1969), was to avoid "premature interruption of the administrative process." Here, the opinion states, § 145 actions arise only after the administrative process is complete.

The opinion then turned to the historical evidence, tracing the right of review back to the 1836 Act, which provided for an applicant to bring a bill in equity for rejections based on whether grant of a patent would "interfere" with another patent, grounds which were expanded in 1839 to encompass any ground of rejection. This procedure was modified by the 1870 Act, which provided for intermediate levels of review in the Office (to a three-member panel of Examiners-in-Chief and the Director), followed by en banc consideration by the Supreme Court of the District of Columbia (a trial court that exercised appellate review when sitting en banc). Importantly, the 1870 Act preserved the right to bring a bill in equity upon denial by the Commissioner or the Supreme Court of D.C.

Finally, the opinion reviewed how it had interpreted the immediate predecessor to § 145, Revised Statute 4915 in two cases: Butterworth v. United States ex rel. Hoe, 112 U. S. 50 (1884), and Morgan v. Daniels, 153 U. S. 120 (1894). In the Butterworth case, the Court found that actions under R.S. 4915 were not an appeal, but rather an action "prepared and heard upon all competent evidence adduced and upon the whole merits." Morgan, on the other hand, used a deferential standard of review of the Patent Office record. While noting some tension between these cases, the Court here discerns that different circumstances (i.e., that no additional evidence was adduced in Morgan) explains the different standard of review applied by the Court.

In addition, the opinion notes that later decisions by the Court followed the "well-reasoned interpretation of R.S. 4815" in Butterworth (including Gandy v. Marble, 122 U.S. 432, 439 (1887), and Hoover Co. v. Coe, 325 U.S. 79, 83 (1945), cited by the Federal Circuit majority opinion). The Court states that the circumstances here mandate that the Butterworth precedent should be followed, finding that in a § 145 action, as in an action under R.S. 4915, a district court should consider "all competent evidence adduced" and "is not limited to considering only new evidence that could not have been presented to the PTO." And the opinion also agrees with the Federal Circuit majority that "where new evidence is presented to the district court on a disputed fact question, a de novo finding will be necessary to take such evidence into account together with the evidence before the board," citing Fregeau v. Mossinghoff, 776 F. 2d 1034, 1038 (1985), because "[a]s a logical matter," the district court must make its determinations de novo on new evidence ('it is the first tribunal to hear the evidence in question')."

The opinion addresses the question of how to balance the scope of new evidence the statute permits an applicant to adduce before the district court with the PTO record by agreeing that the district court "may, in its discretion, 'consider the proceedings before and findings of the Patent Office in deciding what weight to afford an applicant's newly-admitted evidence'" (emphasis added). In this way the district court can accommodate its own need to consider the new evidence presented with its duty to "accord respect to decisions of the PTO." In coming to this accommodation the opinion expressly rejected the possibility that an applicant could be motivated to "withhold evidence from the PTO intentionally with the goal of presenting that evidence for the first time to a nonexpert judge." This "scenario" is "unlikely," according to the Court because "[a]n applicant who pursues such a strategy would be intentionally undermining his claims before the PTO on the speculative chance that he will gain some advantage in the §145 proceeding by presenting new evidence to a district court judge."

Justice Sotomayor concurred, in an opinion joined by Justice Breyer that emphasized that the Court's opinion did not "foreclose a district court's authority, consistent with 'the ordinary course of equity practice and procedure,' to exclude evidence 'deliberately suppressed' from the PTO or otherwise withheld in bad faith" (citations omitted).

Kappos v. Hyatt (2012)
Opinion of the Court by Justice Thomas
Concurring opinion by Justice Sotomayor, joined by Justice Breyer
Court Report – Part III

April 19, 2012

By Sherri Oslick —

In an effort to catch up with recently filed biotech and pharma cases, Patent Docs presents this additional installment of Court Report.

AR Holding Co. Inc. v. Par Pharmaceutical Inc.
1:12-cv-00419; filed April 4, 2012 in the District Court of Delaware

Infringement of U.S Patent Nos. 7,619,004 ("Methods for Concomitant Administration of Colchicine and Macrolide Antibiotics," issued November 17, 2009), 7,601,758 ("Methods for Concomitant Administration of Colchicine and Macrolide Antibiotics in the Treatment of Gout Flares," issued October 13, 2009), 7,820,681 ("Methods for Concomitant Administration of Colchicine and a Second Active Agent," issued October 26, 2010), 7,915,269 (same title, issued March 29, 2011), 7,964,647 ("Colchicine Compositions and Methods," issued June 21, 2011), 7,964,648 ("Methods for Concomitant Administration of Colchicine and a Second Active Agent," issued June 21, 2011), 7,981,938 ("Colchicine Compositions and Methods," issued July 19, 2011), 8,093,296 ("Methods for Concomitant Administration of Colchicine and Macrolide Antibiotics," issued January 10, 2012), 8,093,297 ("Methods for Concomitant Administration of Colchicine and a Second Active Agent," issued January 10, 2012), and 8,097,655 ("Methods for Concomitant Administration of Colchicine and Macrolide Antibiotics," issued January 17, 2012) following Par's filing of an ANDA to manufacture a generic version of Mutual's Colcrys® (single-ingredient colchicine product, used to prevent and treat gout flares). View the complaint here.

Teva Pharmaceuticals USA, Inc. et al. v. Synthon Pharmaceuticals, Inc. et al.
5:12-cv-00179; filed April 4, 2012 in the Eastern District of North Carolina

• Plaintiffs: Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.; Teva Neuroscience, Inc.; Yeda Research and Development Co. Ltd.
• Defendants: Synthon Pharmaceuticals, Inc.; Synthon Holding B.V.; Synthon B.V.; Synthon s.r.o.

Infringement of U.S. Patent Nos. 7,199,098 ("Copolymer-1 Improvements in Compositions of Copolymers," issued April 3, 2007), 6,939,539 (same title, issued September 6, 2005), 6,054,430 (same title, issued April 25, 2000), 6,620,847 (same title, issued September 16, 2003), 5,981,589 (same title, issued November 9, 1999), 6,342,476 (same title, issued January 29, 2002), and 6,362,161 (same title, issued March 26, 2002), all licensed to Teva, following a Paragraph IV certification as part of Synthon's filing of an ANDA to manufacture a generic version of Teva's Copaxone® (glatiramer acetate injection, used for the reduction of frequency of relapses in patients with relapsing-remitting multiple sclerosis). View the complaint here.

Allergan Sales LLC v. Akorn Inc.
2:12-cv-00175; filed April 4, 2012 in the Eastern District of Texas

Allergan Sales, LLC v. Alcon Research, Ltd. et al.
2:12-cv-00177; filed April 4, 2012 in the Eastern District of Texas

• Plaintiff: Allergan Sales LLC
• Defendants: Alcon Research, Ltd.; Alcon Laboratories, Inc.; Alcon Pharmaceuticals Ltd.; Falcon Pharmaceuticals, LTD

Allergan Sales, LLC v. Apotex, Inc. et al.
2:12-cv-00178; filed April 4, 2012 in the Eastern District of Texas

• Plaintiff: Allergan Sales LLC
• Defendants: Apotex, Inc.; Apotex Corp.

The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 8,008,338 ("Ketorolac Tromethamine Compositions for Treating or Preventing Ocular Pain," issued August 30, 2011) based on defendants' manufacture, use, and sale of a generic version of Allergan's Acular LS® (ketorolac tromethamine ophthalmic solution, 0.4%, used for the reduction of ocular pain and burning/stinging following corneal refractive surgery). View the Akorn complaint here.

Precision BioSciences, Inc. v. Cellectis SA et al.
5:12-cv-00174; filed April 2, 2012 in the Eastern District of North Carolina

• Plaintiff: Precision BioSciences, Inc.
• Defendants: Cellectis SA; Cellectis bioresearch; Cellectis bioresearch Inc.

Infringement of U.S. Patent No. 8,148,098 ("Methods of Cleaving DNA with Rationally-Designed Meganucleases," issued April 3, 2012) based on Cellectis' manufacture, use, and sale of meganucleases targeting the HIV1 genome. View the complaint here.
Bayer Schering Pharma AG v. Lupin, Ltd. (Fed. Cir. 2012)

April 18, 2012

By Andrew Williams —

In a second case involving the Hatch-Waxman regulatory scheme decided by the Federal Circuit on Monday, the Court held in Bayer Schering Pharma AG v. Lupin, Ltd. that for an ANDA filing to infringe a method-of-use claim, the proposed label must indicate that the FDA has determined that the drug is safe and effective for the claimed method. Judge Newman dissented, however, because the District Court had made this determination on the pleadings but failed to conduct a standard infringement analysis. Instead, Judge Newman believed the question should have been whether the sale or use of the generic equivalent, in accordance with the representations in the ANDA, would infringe the claims of the patents, which should have at least proceeded past the pleading stage.

As background, when a pharmaceutical company files a New Drug Application (NDA) with the FDA seeking approval to market a new drug, it is required to identify every patent that claims the drug or use of the drug that could reasonably be asserted in an infringement action. For method-of-use claims, the FDA regulations provide that the patents must claim "indications or other conditions of use that are described in the pending or approved application" (21 C.F.R. § 314.53(b)). These patents are then listed in the Orange Book. Anyone wanting to market a generic version of the drug before the expiration of any method-of-use patents must either state that it is not seeking approval of the claimed method, i.e., that it created a carve-out, (a section viii statement), or they must certify that the claim is either invalid or not infringed (a Paragraph IV certification). The filing of an ANDA with a Paragraph IV certification is a statutory act of infringement, which can give rise to a "Hatch-Waxman" litigation.

The drug at issue in the present case was Yasmin, an oral contraceptive. Bayer's predecessor company received FDA approval in 2001, where the FDA "concluded that adequate information has been presented to demonstrate that the drug product is safe and effective for use as recommended in the agreed upon enclosed labeling text." The drug Yasmin or its use for contraception alone was not covered by a Bayer patent. Instead, Bayer had listed three patents in the Orange Book, one of which was U.S. Patent No. 5,569,652 ("the '652 patent"). All of the claims in this patent recite that the claimed method achieves three effects simultaneously: a contraceptive effect, an anti-androgenic effect (effective in treating conditions such as hirsutism or acne), and an anti-aldosterone effect (which can be used to reduce excess water retention). Claim 1 is representative:

1. A method of simultaneously achieving, during premenopause or menopause a gestagenic effect, antiandrogenic effect, and an antialdosterone effect in a female patient in need thereof comprising administering an amount of dihydrospirorenone to said female patient, wherein said amount of dihydrospirorenone is effective to simultaneously achieve a gestagenic effect, antiandrogenic effect and antialdosterone effect in said patient.

Watson and Sandoz filed an ANDA, followed shortly by Lupin, all with certifications that the ANDA products do not, among other things, infringe the '652 patent. In turn, Bayer filed complaints against all of the ANDA filers. Watson and Sandoz moved for judgment of non-infringement on the pleadings (pursuant to Rule 12(c)), arguing that Bayer could not succeed in its suit because the ANDAs that they filed only sought approval to market the generic form of Yasmin for oral contraception. Because the "Indications and Usage" section of the label was limited to the use for oral contraception, and not for the treatment of three conditions, the District Court granted the motion of non-infringement. In view of this ruling, Bayer and Lupin stipulated to final judgment in the other case, and both cases were considered together by the Federal Circuit.

Bayer's position was that the FDA did approve the use of all three effects simultaneously in menopausal and premenopausal women, and that the District Court erred because it only looked at the approved "Indications and Usage" section of the label. This section stated that "Yasmin is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive." Bayer pointed out, however, that the "Pharmacodynamics" subsection of the "Clinical Pharmacology" section of the label explains that one of the two active compounds in Yasmin had anti-mineralocorticoid activity, and in preclinical studies in animals had anti-androgenic activity. As such, the use of Yasmin to alleviate all three claimed conditions was described in the proposed labels. The majority, however, rejected this argument because that passage from the label did not provide any safety or efficacy information associated with the use of Yasmin to treat patients in need of these effects. The Court concluded that "[t]o practice the method claimed in the '652 patent, a physician must determine that all three effects are needed by a specific premenopausal or menopausal patient," and that "FDA approval of that method of use would require a showing that Yasmin was safe and effective for simultaneously obtaining those three effect in patients needing those effects." Because the label, taken in its entirety, failed to recommend or suggest this to a physician, the Court affirmed the District Court's ruling.

To support its opposition to the motion for judgment of non-infringement, Bayer submitted two declarations — one from Dr. Shulman, an obstetrician-gynecologist with experience in the clinical use of contraception, and Dr. Allan, a former FDA official who oversaw the approval of the Yasmin NDA. Dr. Shulman declared that prescribing Yasmin as an oral contraceptive with the intent to produce the other two pharmacological effects was "clearly stated and on-label." Similarly, Dr. Allan stated that the label indicates that the FDA approved Yasmin for all of the therapeutic effect of contraception, and the two pharmacological effects. She pointed out that the listing of those two effects on the label indicated that they were pertinent to the human use of the drug. However, the Court still found that because the label did not include that the drug was safe or effective in inducing the three claimed effects in patients with a specific need for those effects, the testimony of Dr. Shulman and Dr. Allan were unavailing.

Finally, Bayer argued that the FDA's own regulations regarding what patents should be submitted for inclusion in the Orange Book provided support for its position. As noted out above, the FDA requires submission not only of patents that claim "indications," but also patents that claim "other conditions of use." However, the Court pointed out that the FDA encourages broad disclosure of patents, and that just because a patent is listed doesn't mean that a generic product in an ANDA submission will necessarily infringe the patent. Moreover, as made clear by the recent Supreme Court decision in Caraco v. Novo Nordisk, the FDA does not police the correctness of information submitted for inclusion in the Orange Book.

Judge Newman took issue with the District Court's dismissal and judgment on the pleadings, and the Federal Circuit's affirmance, because they both ignored the fact that a plaintiff's non-conclusory factual allegations must be taken as true at this stage. Not only that, but the majority ignored the fact that Bayer also came forward with evidence, including Dr. Allan's testimony regarding the FDA approval process, stating that because the label included information regarding all three effects meant "that the FDA approved (a) the therapeutic effect (contraceptive) and (b) the two additional pharmacological effects (anti-androgenic and anti-mineralocorticoid) of Yasmin®." Judge Newman pointed out that it was error to only consider a portion of the FDA label in determining what a product's properties are, while failing to undertake a standard infringement analysis — to determine whether the patent would be infringed by the sale of use of the ANDA product. Instead, Judge Newman would have framed the infringement question as "whether sale or use of the generic equivalent of the Yasmin® product, in accordance with the representations in the ANDA with respect to FDA approval for the generic equivalent of Yasmin®, infringes the '652 patent." And, because this is a fact-intensive inquiry, she would have entitled Bayer the opportunity to present its infringement case at the district court level.

Bayer Schering Pharma AG v. Lupin, Ltd. (Fed. Cir. 2012)
Panel: Circuit Judges Newman, Plager, and Bryson
Opinion for the court by Circuit Judge Bryson; dissenting opinion by Circuit Judge Newman
Court Report – Part II

April 18, 2012

By Sherri Oslick —

In an effort to catch up with recently filed biotech and pharma cases, Patent Docs presents this additional installment of Court Report.

Allergan, Inc., et al. v. Watson Pharmaceuticals, Inc., et al.
1:12-cv-00321; filed March 30, 2012 in the Middle District of North Carolina

• Plaintiffs: Allergan, Inc.; Duke University
• Defendants: Watson Pharmaceuticals, Inc.; Watson Laboratories, Inc.; Watson Pharma, Inc.

Infringement of U.S. Patent Nos. 7,351,404 ("Method of Enhanced Hair Growth," issued April 1, 2008), 7,388,029 ("Compositions and Methods for Treating Hair Loss Using Non-Naturally Occurring Prostaglandins," issued June 17, 2008), 8,038,988 ("Method of Enhanced Hair Growth," issued October 18, 2011), 6,403,649 (""Non-Acidic Cyclopentane Heptanoic Acid,2-Cycloalkyl Or Arylalkyl Derivatives As Therapeutic Agents, issued June 11, 2002), and 8,017,655 ("Non-Acidic Cyclopentane Heptanoic Acid, 2-Cycloalkyl or Arylalkyl Derivatives as Therapeutic Agents," issued September 13, 2011) based on Watson's filing of an ANDA to manufacture a generic version of Allergan's Latisse® (bimatoprost topical solution/drops, 0.03%, used to treat inadequate or not enough eye lashes). View the complaint here.

Eagle Pharmaceuticals, Inc. v. Sandoz Inc.
3:12-cv-01938; filed March 30, 2012 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 7,589,106 ("Alcohol Free Formulation of Argatroban," issued September 15, 2009,) and 7,687,516 (same title, issued March 30, 2010) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Eagle's Argatroban in Sodium Chloride (argatroban 50 mg/ 50 mL, used for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia and also as an anticoagulant in adult patients with or at risk of heparin-induced thrombocytopenia undergoing percutaneous coronary intervention). View the complaint here.

Glaxosmithkline PLC et al. v. Hikma Pharmaceutical Co., Ltd. et al.
3:12-cv-01965; filed March 30, 2012 in the District Court of New Jersey

• Plaintiffs: Glaxosmithkline PLC; Pfizer, Inc.; Encysive Pharmaceuticals, Inc.; Mitsubishi Chemical Corp.; Mitsubishi Tanabe Pharma Corp.
• Defendants: Hikma Pharmaceutical Co., Ltd.; West-Ward Pharmaceutical Corp.

Infringement of U.S. Patent No. 5,214,052 ("Method for Dissolving Arginineamides and Pharmaceutical Compositions Containing Them," issued May 25, 1993) following a Paragraph IV certification as part of Hikma's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of GSK's Argatroban Injection (argatroban, used for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia and also as an anticoagulant in adult patients with or at risk of heparin-induced thrombocytopenia undergoing percutaneous coronary intervention). View the complaint here.

Otsuka Pharmaceutical Co., Ltd v. Kappos
1:12-cv-00357; filed March 30, 2012 in the Eastern District of Virginia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 8,030,312 ("5-HT1A Receptor Subtype Agonist," issued October 4, 2011). View the complaint here.
Marine Polymer Technologies, Inc. v. Hemcon, Inc. (Fed. Cir. 2012) (en banc)

April 17, 2012

By Kevin E. Noonan —

In a decision ripe for Supreme Court review (appropriately, this time), a fractured Federal Circuit delivered a plurality opinion in Marine Polymer Technologies, Inc. v. Hemcon, Inc. (Fed. Cir. 2012) (en banc). The case revealed a deep division between judges taking a strict constructionist view of the patent statute (in this case, 35 U.S.C. § 152 regarding intervening rights), and another cohort of judges who are apparently willing to adopt a more outcome-determinative view of the matter.

The case involved claims of U.S. Patent No. 6,864,245 directed to poly-N-acetyl glucosamine polymer used for treating trauma and other uses, purified from arthropods, fungi, and microalgae. The claims recited "biocompatible" preparations, based on four tests set forth in specification. A substance passes the test if the reaction is only mild or slight reactivity (<++), but some language in the specification indicated that truly biocompatible embodiments falling within the scope of the claim must be (< +), i.e., having "no detectable biological reactivity." The claims, on the other hand, recited biocompatible "generically," with no distinction based on degree (although some dependent claims recite values of 0).

During a Markman heating at the District Court, Marine Polymer argued that "biocompatible" p-GlcNAc should be construed to mean "biomedically pure [p-GlcNAc] that reproducibly exhibits acceptably low levels of adverse bioreactivity, as determined by biocompatibility tests." HemCon countered that "biocompatible" should be read as limiting the claims to p-GlcNAc that had been "harvested from plant microalgae," or in the alternative, should be interpreted broadly to mean "suited for biomedical applications." The District Court concluded that "biocompatible" p-GlcNAc, as claimed in the '245 patent, means p-GlcNAc "with low variability, high purity, and no detectable biological reactivity as determined by biocompatibility tests." The District Court granted summary judgment of infringement, and a jury entered a verdict of no invalidity and damages of ~$29M. In addition, the District Court granted Marine Polymer a permanent injunction.

While the District Court was pending, HemCon filed an ex parte request for re-examination, basing the "substantial new question of patentability" on District Court's claim construction. The examiner adopted a claim construction that differed from the District Court, concluding that "biocompatible" means "low variability, high purity, and little or no detectable reactivity" because (according to the examiner) independent claim 1 could not be construed to mean "no detectable bioreactivity" because there were dependent claims that recited low level of bioreactivity. Because this interpretation was broader than the District Court's claim construction, the examiner rejected all 22 claims on obviousness grounds. In response, the patentee canceled the dependent claims that recited little or no detectable reactivity, and argued that the District Court's construction should prevail. The examiner agreed and withdrew the rejections and issued the reexamination certificate.

A merits panel reversed the District Court on grounds that HemCon was entitled to intervening rights under Section 252. (Intervening rights apply to reexaminations under Sections 307(b) and 316(b).) In the Federal Circuit's en banc decision, written by Judge Lourie (joined by Chief Judge Rader and Judges Newman, Bryson and Prost in full, and Linn in part), with a dissent written by Judge Dyk (joined by Gajarsa, Reyna, and Wallach in full and Linn in part) (Judges O'Malley and Moore took no part in the decision), the Court "affirmed" (because the Federal Circuit was equally divided and hence there was no basis to reverse). The issue dividing the Court was whether a claim must be amended during reexamination (as opposed to merely changed in scope) for intervening rights to arise.

The "majority" opinion upheld the District Court's claim construction as being supported by intrinsic evidence (ignoring inconsistent portions of the specification), and determined that the claims did not define the term "biocompatible." Accordingly, the District Court was correct in interrogating the specification to ascertain the proper meaning of the term in the claim.

The opinion characterized the issue as "a conflict between teachings in the specification and the doctrine of claim differentiation," because the presence of dependent claims reciting the "little or no bioreactivity" limitation implied that the independent claim encompassed embodiments having a greater degree of bioreactivity). But the Court opined that the doctrine of claim differentiation was not controlling (not a "hard and fast rule") while claim construction based on the written description is, citing Seachange Int'l, Inc. v. C-Cor, Inc., 413 F.3d 1361, 1369 (Fed. Cir. 2005).

The issue of whether intervening rights arose as a consequence of the reexamination is where the Court split 5 to 5. HemCon's position was that cancellation of the dependent claims effectively changed the scope of the independent claim, and that this was enough to confer intervening rights. The majority rejected this contention, saying that the statute requires that the claims be "amended or new" to raise intervening rights, and here the independent claim was not amended. The opinion considered two types of intervening rights: absolute intervening rights and equitable intervening rights. Intervening rights do not accrue, according to the opinion, where the accused product or activity infringes a claim that existed in the original patent and remains "without substantive change" after reissue, citing Seattle Box Co. v. Indus. Crating & Packing, Inc., 731 F.2d 818, 827–28 (Fed. Cir. 1984). The opinion holds that the threshold inquiry is whether the claims were "amended or new"; only thereafter does the question become was there a substantive change. Accordingly, "HemCon ignores this threshold statutory requirement [that a claim be amended] and asks that we proceed directly to the subsidiary 'substantive change' analysis, which derives from § 252." While the plurality opinion recognizes that the amendments made during the reexamination changed claim scope, this is not the same as amending the claims, and HemCon's position that the equivalence of the effect should lead to an equivalent outcome (i.e., to raise intervening rights) "goes too far." Thus:

Section 307(a) identifies three categories of claims in a reexamined patent: (1) claims that existed in the original patent but have been cancelled as unpatentable, (2) claims that existed in the original patent and have been confirmed as patentable, and (3) amended or new claims that did not exist in the original patent but have been found to be patentable and will be incorporated into the patent by the PTO.

Intervening rights apply only to category #3 says the Court, if only because "[a]ny interpretation of 'amended' that includes disavowal or disclaimer by argument alone, as advocated by HemCon, would conflict with the rest of § 307, for it is difficult to envision how arguments about claim meaning could be 'incorporated into a patent' by the Director of the PTO."

The plurality addresses the concern raised by the dissent that their decision creates a "loophole" fraught with the potential for gamesmanship by patentees; the plurality does not believe the potential for a "loophole" is likely, because invalid claims will need amendment to be allowed. "Thus, the fear of gamesmanship does not persuade us to rule contrary to the plain meaning of the statute."

In sum, the plain directive of the governing statute before us does not permit HemCon to invoke intervening rights against claims that the PTO confirmed on reexamination to be patentable as originally issued. To be sure, patent applicants' actions and arguments during prosecution, including prosecution in a reexamination proceeding, can affect the proper interpretation and effective scope of their claims. But in rejecting HemCon's request for intervening rights, we are not here interpreting claims. Rather, we are interpreting a statute that provides for intervening rights following reexamination only as to "amended or new" claims. The asserted claims of the '245 patent are neither.

The dissent contends that the Court failed to address the issue except by dicta, and that the possible existence (or creation) of strategic advantages would only increase under the expanded post-grant review provisions of the Leahy-Smith America Invents Act (LS-AIA). For the dissenting judges, "[t]he starting point for an intervening rights determination is the meaning of the original claim language" as opposed to the plain meaning of the statute. These judges disagreed with District Court's claim construction, being more convinced by the claim differentiation argument that the meaning of the term "biocompatible" was broader than it was interpreted by the District Court's claim construction. It was also an important issue for these judges that whether the "product of nature" polymer was patent-eligible depends on the meaning of the term "biocompatible."

This case illustrates the continuing difficulties with the Federal Circuit's claim construction jurisprudence; the dissent says "[o]ne might at the outset be somewhat skeptical of this construction because it was not proposed by either party and was indeed contrary to the patentee's own proposed construction." This sentiment is in direct opposition to other pronouncements of the Federal Circuit, to the effect that a district court should not adopt either party's claim construction position but should instead come to an independent determination. (See, for example, Exxon Chemical Patents v. Lubrizol). Here, however, the dissenting judges think the District Court construction is contrary to the specification and prosecution history (and which is entitled to no deference), and also put more emphasis on the claim differentiation doctrine (saying it is ignored only if "compelled" by the intrinsic evidence). Thus:

Judge Lourie's new approach to claim construction would enable patentees to eliminate questions of validity by narrowing claims in accordance with a preferred embodiment or single example, while also allowing alleged infringers to narrow claims beyond their valid scope to avoid infringement. That approach cannot be correct.

The dissent also disagrees with the plurality's claim construction, relying on those portions of the specification that appear to indicate that "biocompatible" may be entitled to a broader interpretation that was given it by the District Court:

In other words, under the district court's incorrect claim construction, now binding on the parties as a result of the affirmance of the district court's judgment, the original and reexamined claims are identical in scope, and there is thus no issue of intervening rights and no need for the majority to offer "an alternative ground for decision."

The dissenting opinion equates "new or amended" = "substantially identical" ("clearly intended to have the same meaning"), relying on Laitram Corp. v. NEC Corp., 163 F.3d 1342, 1346 (Fed. Cir. 1998) ("Reexamined claims are "identical" to their original counterparts if they are 'without substantive change'") (this portion of the dissent is rebutted by the plurality on the grounds that the claims in Laitram were amended). Because "[t]he effect [of canceling claims] was to narrow the claims and protect them from a finding of invalidity," the dissenting judges believe that "[h]ere, although identical in language, the claims of the patent after reexamination were not identical in scope for purposes of intervening rights because they were "substantively changed" during reexamination." In perhaps their strongest argument, the dissenting judges note that the Supreme Court recognized that the scope of patents could be changed by an amendment to the specification where there is no formal amendment to the claim, citing Russell v. Dodge, 93 U.S. 460, 463 (1876) (noting that a specification might "be substantially changed, either by the addition of new matter or the omission of important particulars, so as to enlarge the scope of the invention as originally claimed").

Once again, this case illustrates one of the consequences of the difficulties inherent in applying the Federal Circuit's rubrics regarding whether the claims are being construed in light of the specification or the majority is importing limitations from the specification into the claims. The decision is also reminiscent of the differences on opinion that arose in Retractable Techs., Inc. v. Becton, Dickinson & Co., There, Judge Lourie wrote for the majority (reversing the District Court's construction) that:

There is a fine line between construing the claims in light of the specification and improperly importing a limitation from the specification into the claims. See Phillips, 415 F.3d at 1323. In reviewing the intrinsic record to construe the claims, we strive to capture the scope of the actual invention, rather than strictly limit the scope of claims to disclosed embodiments or allow the claim language to become divorced from what the specification conveys is the invention. Id. at 1323–24.

This sentiment was espoused even more strongly by Judge Plager, whoe wrote in a concurring opinion that: "the claims cannot go beyond the actual invention that entitles the inventor to a patent" and that "the [patentee's] obligation [was] to make full disclosure of what is actually invented, and to claim that and nothing more."

On the contrary, Chief Judge Rader, dissenting-in-part, argued the primacy of the claim language, and that it is impermissible to read limitations from the specification into the claims. He also joined in Judge Moore's dissenting opinion, which focused on a deficiency in the Court's application of the law: where to draw the "fine line" between "construing the claims in light of the specification and improperly importing a limitation from the specification into the claims." Relying principally on Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc), and the "bedrock principle" that "the claims of a patent define the invention to which the patentee is entitled the right to exclude," Judge Moore discounted the concerns voiced by the majority in Retractable Technologies, including that "the metes and bounds of what the inventor claims extend beyond what he has invented or disclosed in the specification." In that case, the question is one of validity rather than claim construction, she wrote, and it is not the role of the court to "tailor the claim language to the invention disclosed." Citing Phillips, Judge Moore's dissent relied once again on the mantra that the "plain meaning" of the clams controls (and the dissent voices surprise that this question was not resolved in Phillips). Judge Moore states her (stringent) standard for the relationship between the claims and the specification: "the specification cannot be used to narrow a claim term — to deviate from the plain and ordinary meaning — unless the inventor acted as his own lexicographer or intentionally disclaimed or disavowed claim scope," citing Phillips and Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1327 (Fed. Cir. 2002). Judge Moore identified the problem with the panel decision with particularlty:

The error in Retractable is the majority's attempt to rewrite the claims to better conform to what it discerns is the "invention" of the patent instead of construing the language of the claim. Indeed, the majority candidly explained that its construction, limiting "body" to a one-piece body, "is required to tether the claims to what the specifications indicate the inventor actually invented."

HemCon's position is supported by amici curiae Hewlett-Packard Co., Broadcom Corp., Cisco Systems, Inc., Dell, Inc., eBay, Inc., Facebook, Inc., Google Inc., and SAP America, Inc.; and GEICO Corp., FedEx Corp., and Macy's, Inc.

Marine Polymer's position is supported by amici curiae Jan K. Voda; Intellectual Ventures Management LLC; the Biotechnology Industry Association and Phar- maceutical Research and Manufacturers of America; Soverain Software LLC and Tessera, Inc.; and Sealy Corp.

Marine Polymer Technologies, Inc. v. Hemcon, Inc. (Fed. Cir. 2012) (en banc)
Panel: Chief Judge Rader and Circuit Judges Newman, Lourie, Bryson, Gajarsa, Linn, Dyk, Prost, Reyna, and Wallach
Opinion for the court by Circuit Judge Lourie, joined by Chief Judge Rader and Circuit Judges Newman, Bryson, and Prost in full, and by Circuit Judge Linn as to part II; dissenting opinion by Circuit Judge Dyk, joined by Circuit Judges Gajarsa, Reynam and Wallach in full, and by Circuit Judge Linn as to parts I-II.
Dey Pharma, LP v. Sunovion Pharmaceuticals Inc. (Fed. Cir. 2012)

April 16, 2012

By Andrew Williams —

On Monday, in Dey Pharma, LP v. Sunovion Pharmaceuticals Inc., the Federal Circuit affirmed a District Court's conclusion that it had subject-matter jurisdiction over a declaratory judgment action of a second ANDA filer, and as a result also affirmed the District Court's final judgment of non-infringement (based on a stipulation of the parties). This case follows the cases of Caraco Pharm. Labs. Ltd. v. Forest Labs, Inc., 527 F.3d 1278 (Fed. Cir. 2008), and Janssen Pharmaceutica, N.V. v. Apotex, Inc., 540 F.3d 1353 (Fed. Cir. 2008), in considering the scope of declaratory judgment jurisdiction for second ANDA filers in the context of Hatch-Waxman. Of specific concern in all of these cases was the ability of a first ANDA filer to "park" their 180-day exclusivity by not marketing their ANDA product, and the affect such an action would have on the ability of a subsequent ANDA filer to bring a declaratory judgment against the NDA holder.

As background, in the Hatch Waxman scheme, a first ANDA filer to challenge the validity of the Orange Book listed patents, or the ability of the NDA holder to assert infringement of the patents, is entitled to 180 days of generic marketing exclusivity. Under the present scheme, this exclusivity begins, or is triggered, when the first ANDA filer begins to market its generic product. If instead, the first ANDA filer "parks" its 180 day exclusivity by not launching its ANDA product, the exclusivity period is never triggered. And, without the trigger, no subsequently filed ANDAs can be approved by the FDA. In an attempt to address this problem, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ("MMA") modified the statute to provide for forfeiture of the first filer's exclusivity period if it did not, among other things, market the drug within 75 days of a final judgment that all of the Orange Book patents are invalid or not infringed, whether brought by itself or a subsequent ANDA filer. Congress contemplated that the NDA holder could chose not to sue a subsequent ANDA filer for infringement of any or all of the Orange Book listed patents, resulting in the forfeiture event from never occurring, and as a result, it specified in the statute that an ANDA filer could file a declaratory judgment action "to the extent consistent with the Constitution" (35 U.S.C. § 271(e)(5)). Such a situation presented itself in Dey. The Federal Court followed the Caraco case in finding that Dey, the second ANDA filer, properly brought a declaratory judgment action because subject-matter jurisdiction existed when the action was filed. The Court also held that such jurisdiction might be rendered moot when the first ANDA filer actually launched its product, thereby triggering the exclusivity period, but that regardless of how imminent the launch was, Sunovion had not met its burden of establishing that the subject-matter jurisdiction was now moot.

The brand-name drug at issue in this case was XOPENEX®, with levosalbutamol as its active ingredient, which is marketed to treat or prevent bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. The NDA-holder, Sunovion, listed three patents in the Orange Book related to this drug product: U.S. Patent No. 5,362,755 ("the '755 patent"), expiring on March 25, 2013; U.S. Patent No. 5,547,994 ("the '994 patent"), expiring on August 20, 2013; and U.S. Patent No. 6,451,289 ("the '289 patent"), expiring on March 21, 2021. Breath filed the first ANDA in June 2005, which contained Paragraph IV certifications to all three patents. Breath and Sunovion settled the subsequent litigation, with the parties agreeing that Breath could sell the generic product under its ANDA starting on August 20, 2012 (or earlier depending on a third-party commercial launch). In July 2005, Dey filed the second ANDA, which also contained Paragraph IV certifications to all three listed patents. However, Sunovion only asserted the '755 and '994 patents, causing Dey to bring a declaratory judgment action for the '289 patent. Sunovion then provided Dey with a covenant not to sue (which would not result in a forfeiture event), and moved to dismiss the declaratory judgment action for lack of subject matter jurisdiction. The District Court denied Sunovion's motion, and the parties stipulated to non-infringement. Sunovion only appealed the jurisdictional issue to the Federal Circuit.

This case has facts that are almost indistinguishable from Caraco. Caraco was decided based on the scheme that existed prior to the MMA, in which there were no forfeiture provisions, but the 180-day exclusivity period could also be trigged by a final judgment of invalidity and non-infringement, regardless of who obtained that judgment. Therefore, even though the schemes were different, the practical result was similar in both. In fact, the Court noted that this change in statutory trigger made no difference to the issues in this case. The only argument that Sunovion advanced to support its assertion that subject-matter jurisdiction did not exist when Dey brought its declaratory judgment action was that success in the DJ action was insufficient to redress Dey's injury — because Dey had to be successful in Sunovion's suit involving the '755 and '994 patents. In other words, Sunovion appears to have argued that it was necessary to consider the two litigations involving the three Orange Book patents sequentially, not concurrently, because if Dey was not successful in the first suit, the declaratory judgment action would be unnecessary. This argument has appeal when considering that while the parties were fighting over the jurisdiction of this case, the District Court entered a judgment in favor of Sunovion in the '755 and '994 litigation. Post-trial motions were still being considered in that case, but judicial resources would be saved if the declaratory judgment case was postponed until a final judgment was rendered. However, the analysis must begin by considering whether there was jurisdiction when the case was first filed. If so, then jurisdiction will not be lost just because a companion case is at a further stage. It is even more egregious in this case because it was Sunovion's actions in not asserting the '289 patent that gave rise to the multiple litigations. Of course, should the '755 and '994 litigation reach a final judgment against Dey, it is possible that the Court would entertain a motion to dismiss on the grounds that the DJ case would then be moot. However, those were not the facts before the Federal Circuit.

Sunovion also argued that even if jurisdiction existed when Dey filed the declaratory judgment action, it did not still exist when the case reached the Federal Circuit. The basis of this argument was that, according to the agreement between Breath and Sunovion, Breath was going to be able to market its ANDA product soon. In fact, there was insufficient time for even the '755 and '994 litigation to reach a final judgment before the August 20, 2012 launch date. The Court, however, pointed out the flaw in Sunovion's logic — Breath had not yet launched, and even though it appeared to have every incentive to launch in August, it is not certainty that it would. In fact, the Federal Circuit noted that because it was Sunovion's "heavy" burden to bring forward information to establish that the case was now moot, merely pointing out the approaching date of a potential launch was insufficient to meet that burden. The Federal Circuit all but guaranteed that situation would have resolved itself differently if Sunovion had brought the same motion after Breath actually went to market with its ANDA product. Nevertheless, because Breath had not yet launched, the Court affirmed the judgment of non-infringement.

Dey Pharma, LP v. Sunovion Pharmaceuticals Inc. (Fed. Cir. 2012)
Panel: Circuit Judges Bryson, Dyk, and Moore
Opinion by Circuit Judge Dyk
Court Report

April 15, 2012

By Sherri Oslick —

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.

Horizon Pharma Inc. et al. v. Par Pharmaceutical Companies Inc. et al.
1:12-cv-00393; filed March 28, 2012 in the District Court of Delaware

• Plaintiffs: Horizon Pharma Inc.; Horizon Pharma USA Inc.
• Defendants: Par Pharmaceutical Companies Inc.; Par Pharmaceutical Inc.

Infringement of U.S. Patent No. 8,067,033 ("Stable Compositions of Famotidine and Ibuprofen," issued November 29, 2011) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Horizon's Duexis ® (famotidine and ibuprofen, used for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers). View the complaint here.

Precision BioSciences, Inc. v. Cellectis SA et al.
5:12-cv-00160; filed March 27, 2012 in the Eastern District of North Carolina

• Plaintiff: Precision BioSciences, Inc.
• Defendants: Cellectis SA; Cellectis bioresearch; Cellectis bioresearch Inc.

Infringement of U.S. Patent No. 8,143,015 ("Methods of Cleaving DNA with Rationally-Designed Meganucleases," issued March 27, 2012) based on Cellectis' manufacture, use, and sale of meganucleases targeting the HPRT gene in Chinese Hamster Ovary cells, meganucleases targeting the GS gene in Chinese Hamster Ovary cells, meganuncleases targeting the human RAG1 gene, and meganucleases targeting the HIV1 genome. View the complaint here.

Precision BioSciences, Inc. v. Cellectis SA et al.
5:12-cv-00161; filed March 27, 2012 in the Eastern District of North Carolina

• Plaintiff: Precision BioSciences, Inc.
• Defendants: Cellectis SA; Cellectis bioresearch; Cellectis bioresearch Inc.

Infringement of U.S. Patent No. 8,143,016 ("Methods of Cleaving DNA with Rationally-Designed Meganucleases," issued March 27, 2012) based on Cellectis' manufacture, use, and sale of meganucleases targeting the HPRT gene in Chinese Hamster Ovary cells, meganucleases targeting the GS gene in Chinese Hamster Ovary cells, and meganucleases targeting the HIV1 genome. View the complaint here.

Allergan, Inc. v. Watson Laboratories, Inc. et al.
6:12-cv-00197; filed March 23, 2012 in the Eastern District of Texas

• Plaintiff: Allergan, Inc.
• Defendants: Watson Laboratories, Inc.; Watson Pharmaceuticals, Inc.; Watson Pharma, Inc.

Infringement of U.S. Patent Nos. 7,851,504 ("Enhanced Bimatoprost Ophthalmic Solution," issued December 14, 2010) and 5,688,819 ("Cyclopentane Heptanoic Acid, 2-Cycloalkyl or Arylalkyl Derivatives as Therapeutic Agents," issued November 18, 1997) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Allergan's Lumigan® (0.01% bimatoprost ophthalmic solution, used to treat lower intraocular eye pressure in people with open-angle glaucoma or ocular hypertension). View the complaint here.

Novartis Pharmaceuticals Corp. et al. v. Actavis Elizabeth LLC et al.
2:12-cv-01798; filed March 22, 2012 in the District Court of New Jersey

• Plaintiffs: Novartis Pharmaceuticals Corp.; Novartis Corp.; Novartis AG; Novartis Pharma AG
• Defendants: Actavis Elizabeth LLC; Actavis, Inc.; Actavis Group PTC EHF; Actavis Group HF

Novartis Pharmaceuticals Corporation et al. v. Actavis Group hf et al.
1:12-cv-00366; filed March 21, 2012 in the District Court of Delaware

• Plaintiffs: Novartis Pharmaceuticals Corp.; Novartis Corp.; Novartis AG; Novartis Pharma AG
• Defendants: Actavis Group hf; Actavis Group PTC ehf; Actavis Inc.; Actavis Elizabeth LLC

The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 6,465,504 ("Substituted 3,5-Diphenyl-1,2,4-Triazoles and Their Use as Pharmaceutical Metal Chelators," issued October 15, 2002) and 6,596,750 (same title, issued July 22, 2003) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Novartis' Exjade® (deferasirox, used for the treatment of chronic iron overload due to blood transfusions). View the Delaware complaint here.

Cubist Pharmaceuticals Inc. v. Hospira Inc.
1:12-cv-00367; filed March 21, 2012 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,468,967 ("Methods for Administration of Antibiotics," issued October 22, 2002), 6,852,689 (same title, issued February 8, 2009), RE39,071 ("Anhydro-and Isomer-A-21978C Cyclic Peptides, issued April 18, 2006), and 8,058,238 ("High Purity Lipopeptides," issued November 15, 2011) following a Paragraph IV certification as part of Hospira's filing of an ANDA to manufacture a generic version of Cubist's Cubicin® (daptomycin for injection, used for the treatment of skin infections caused by certain Gram-positive microorganisms). View the complaint here.

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