Orange Book Blog

At the intersection of Patent and FDA Law

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  • Federal Circuit Affirms Dismissal of Prasco’s Declaratory Judgment Suit Against Medicis

    Prasco v. Medicis Pharm. Corp., No. 2007-1524 (Fed. Cir. 2008)

    Medicis markets a benzoyl peroxide cleansing product, Triaz.  Prasco sells a competing benzoyl peroxide cleansing product, Oscion.  Prasco filed a declaratory judgment complaint, requesting judgment that Oscion does not infringe four patents owned or licensed by Medicis.  Prasco alleged declaratory judgment jurisdiction based on three facts:  (1) Medicis marked its Triaz products with the numbers of the four patents-in-suit; (2) Medicis previously sued Prasco for infringement of an unrelated patent by a different cleanser product; and (3) Medicis refused to provide Prasco with a covenant not to sue on the four patents-in-suit.

    In an opinion released August 15th, the Federal Circuit affirmed the district court’s dismissal of Prasco’s complaint for lack of subject matter jurisdiction.  At the outset, the court noted that the “basic standard” for declaratory judgment jurisdiction, as set forth by the Supreme Court in MedImmune last year, is whether “the facts alleged, under all the circumstances, show that there is a substantial controversy, between the parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.”

    In this case, the Federal Circuit viewed the “immediacy and reality” inquiry “through the lens of standing.”  According to the Federal Circuit, standing is established when the plaintiff alleges “(1) an injury-in-fact, i.e., a harm that is concrete and actual or imminent, not conjectural or hypothetical, (2) that is fairly traceable to the defendant’s conduct, and (3) redressible by a favorable court decision.”  Prasco’s complaint was based on the threat of future injury by Medicis.  Thus, the court stated, “there can be no controversy without a showing that this threat was real, imminent, and traceable to defendants.”

    The court found that “none of the facts on which Prasco relies overcome the complete lack of evidence of a defined, preexisting dispute between the parties concerning Oscion.”  First, the court found that “Medicis’ decision to mark its products, prior to any knowledge of Prasco’s Oscion product, is irrelevant to the question of whether Medicis believes Oscion infringes the applicable patents.”  Second, while “prior litigious conduct is one circumstance to be considered,” “one prior suit concerning different products covered by unrelated patents is not the type of pattern of prior conduct that makes reasonable an assumption that Medicis will also take action against Prasco regarding its new product.”  And third, “a defendant’s failure to sign a covenant not to sue is one circumstance to consider . . . [but] it is not sufficient to create an actual controversy–some affirmative actions by the defendant will also generally be necessary.”  Here, the court noted that “a patentee has no obligation to spend the time and money to test a competitors’ product nor to make a definitive determination, at the time and place of the competitors’ choosing, that it will never bring an infringement suit.”

    Accordingly, the court found that under the totality of the circumstances, Prasco had failed to establish declaratory judgment jurisdiction.

  • Non-Patent Exclusivity and 180-Day Exclusivity Forfeiture Slides Posted

    Last week, I gave a talk about non-patent exclusivity at ACI's FDA Boot Camp conference in Boston.  The talk covered new chemical entity (5-year) exclusivity; new clinical trial (3-year) exclusivity; orphan drug exclusivity; pediatric exclusivity; and generic drug (180-day) exclusivity.  You can download a copy of my slides here.

    In June, I gave a talk about forfeiture of 180-day exclusivity at IIR's Generic Drugs Summit conference in Washington.  The talk included a discussion of the "failure to market" forfeiture provisions, particularly the FDA's Acarbose and Granisetron decisions.  You can download a copy of those slides here.

  • CBI “Paragraph IV Disputes” Conference, Philadelphia, October 15-16

    On October 15-16 in Philadelphia, the Center for Business Intelligence will hold a conference entitled "Pharmaceutical Congress on Paragraph IV Disputes:  Navigating Regulations and Enforcement Trends to Increase Preparedness and Optimize Paragraph IV Strategies."

    CBI provides its top five reasons to attend:

    • To hear the FTC's stance on antitrust and acceptable settlement strategies
    • To learn to optimize cost savings in e-discovery
    • To assess ANDA litigation after KSR
    • To understand the "earlier of" – "later of" maze in forfeiture provisions
    • To conduct an in-depth analysis of recent paragraph IV developments and their implications on industry

    The conference will begin with a workshop, "Assess Litigation Strategies to Proactively Plan for Paragraph IV Disputes," on October 15 from 8:30 am to noon.

    The main agenda then includes numerous talks that look interesting:

    • "Strategies to Optimize Patent Lifecycle from Drafting to Maturity"
    • "Preparing for Paragraph IV Challenges — Generic Pre-suit Strategies"
    • "Best Practices in E-Discovery — Overcoming Obstacles, Controlling Costs and Maximizing Benefits"
    • "The KSR Decision and ANDA Litigation"
    • "Implications of Recent Developments and Trends in Litigating Paragraph IV Disputes" (I'll be speaking on this topic as one of the panelists)
    • "Citizen Petitions and Their Impact on Generic Entry"
    • "Interpreting Forfeiture Provisions — An Analysis of Recent Cases to Increase Preparedness and Improve Product Strategy"
    • "The FTC, Antitrust Law and Settling Paragraph IV Litigation," presented by Markus Meier, Assistant Director, FTC

    For more information or to register, please visit the conference website.

    Orange Book Blog readers can save $400 by using registration code SAQ782.

  • ACI “Maximizing Pharmaceutical Patent Life Cycles” Conference, New York, October 15-16

    American Conference Institute is holding its ninth annual “Maximizing Pharmaceutical Patent Life Cycles” conference October 15-16 in New York.  According to ACI, this “definitive Hatch-Waxman event provides the crucial information for pharmaceutical patent counsel to cultivate, modify, and enhance a foundation for their life cycle strategies.”

    The agenda includes many topics covered on Orange Book Blog.  Selected talks include:

    • “Constructing, Adjusting, and Executing a Pharmaceutical Patent Life Cycle Management Plan”
    • “View from the FTC,” presented by Saralisa Brau, Health Care Services and Products Division, FTC
    • “Navigating the Complexity of Structuring Patent Settlement Options Between Brand Name and Generic Pharmaceutical Companies”
    • “Eye on the Bench:  Identifying Judicial Trends in Pharmaceutical Patent Cases”
    • “Mastering the Intricacies of the 180-Day Generic Market Exclusivity”
    • “Plotting a Course Into Safe Harbor for Branded Pharma”
    • “View from the FDA,” presented by Elizabeth Dickinson, Office of Chief Counsel, FDA
    • “Slicing Through the Complex Spectrum of Declaratory Judgment Actions in Pharmaceutical Patent Cases”
    • “Factoring the Role, Challenges, and Impact of Orange Book Listings and Delistings in Patent Portfolio Management”

    In addition, two optional post-conference workshops are offered on October 17th:  a brand name master class entitled “Overpowering the Challenges in Increasing the Pharmaceutical Patent Life Cycle Through Patent Extensions” and a generics master class entitled “Adding Value to Paragraph IV Certifications and Notice Letters.”

    For more information or to register, please visit the conference website.

    Orange Book Blog readers can save $200 by using registration code S.

  • ACI “FDA Boot Camp” Conference, Boston, September 22-23

    American Conference Institute will be holding another "FDA Boot Camp" in Boston, September 22-23.

    The conference is designed to give patent lawyers, product liability lawyers, and life sciences investment and securities experts a strong working knowledge of core FDA regulatory competencies.  The conference features FDA regulatory and patent law experts from pharmaceutical companies and outside law firms.

    Talks on the agenda include:

    • The Basics: Understanding and Working with the FDA — Jurisdiction, Functions, Organization, and Operations
    • The Nature of the Approval Process
    • Understanding the Clinical Trial Process for Drugs and Biologics
    • Patent and IP Overview: Hatch-Waxman, Trademark Protection, and More
    • Non-Patent Exclusivity (I'll be presenting this one)
    • Bioequivalence: What Lawyers Need to Know
    • Follow-On (Comparable or Biosimilar) Biologics

    For more information or to register, please visit the conference website.

    Orange Book Blog readers can save $200 on registration with code SP1.

  • Federal Circuit Narrows the Scope of the Section 271(e)(1) Research Exemption

    Proveris Scientific Corp. v. Innovasystems, No. 2007-1428 (Fed. Cir. 2008)

    35 U.S.C. § 271(e)(1) states:

    It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use or sale of drugs or veterinary biological products.

    This statute, passed as part of the Hatch-Waxman Act in 1984, provides a "safe harbor" from claims of patent infringement based on activities related to the pursuit of FDA approval of drug products.  For example, it exempts ANDA applicants from allegations of patent infringement based on R&D done for the purpose of establishing bioequivalence.

    Proveris Scientific owns U.S. Patent No. 6,785,400, which is directed to a system and apparatus for characterizing aerosol sprays used in drug delivery devices, such as nasal spray pumps and inhalers.  Innova makes and sells a device that, although not itself subject to FDA approval, is used in connection with FDA regulatory submissions.  Specifically, the device is used to measure the physical parameters of aerosol sprays used in nasal drug delivery devices.

    Proveris filed suit against Innova, alleging infringement of the '400 patent.  As part of its defense, Innova invoked the safe harbor provision of section 271(e)(1).  Innova argued that its allegedly infringing activities are immunized because its device is used by third parties solely for the development and submission of information to the FDA.  At trial, the district court ruled as a matter of law that Innova could not avail itself of section 271(e)(1).  In an opinion released yesterday, the Federal Circuit affirmed the district court.

    Innova argued on appeal that it is entitled to the benefit of section 271(e)(1) because it offered to sell its device only to pharmaceutical companies and the FDA, and that its device was used exclusively in relation to applications for FDA approval.  Proveris responded that the section 271(e)(1) safe harbor is applicable only to products that are subject to patent term extensions under 35 U.S.C. § 156(f)–namely, drug products, medical devices, food additives, and color additives.  According to Proveris, section 271(e)(1) does not immunize infringement of patents on laboratory or manufacturing equipment.

    The Federal Circuit framed the issue as this:  "whether section 271(e)(1) immunizes the manufacture, marketing, or sale of Innova's device, which is used in the development of FDA regulatory submissions, but is not itself subject to the FDA premarket approval process."

    The court concluded that section 271(e)(1) provides no such immunity, reasoning that Congress did not intend for section 271(e) to apply to parties like Innova, whose device is not subject to FDA premarket approval, and who therefore faces no regulatory barriers to market entry upon patent expiration.

    The Federal Circuit explained that its conclusion "achieves the same kind of fit, or symmetry" that the Supreme Court spoke of in the Eli Lilly v. Medtronic case, which also dealt with section 271(e)(1).  According to the court, "Because Proveris's patented product is not subject to a required FDCA approval process, it is not eligible for the benefit of the patent term extension afforded by 35 U.S.C. § 156(f).  At the same time, because Innova's device also is not subject to a required FDCA approval process, it does not need the safe harbor protection afforded by 35 U.S.C. § 271(e)(1)."

    RELATED READING:

  • District Court Denies Early Motion For Rule 11 Sanctions in Ritalin LA Case

    Celgene and Novartis v. KV Pharm., No. 07-4819 (D.N.J. 2008)

    KV Pharmaceutical filed an ANDA for a generic version of Ritalin LA (methylphenidate HCl extended-release capsules) with paragraph IV certifications to Celgene’s U.S. Patent Nos. 5,837,284 and 6,635,284.  Apparently KV made an offer of confidential access to its ANDA, but Celgene and Novartis (which markets Ritalin LA) declined it.  Last October, within 45 days of receiving notice of KV’s paragraph IV certifications, Celgene and Novartis sued KV for infringing the two patents.

    Earlier this year, KV filed a motion for sanctions under Rule 11 on grounds that Celgene and Novartis “failed to make a reasonable inquiry into their infringement claims before filing suit.”  KV sought dismissal of the suit, plus costs and attorney fees.  KV’s motion relied on Q-Pharma, Inc. v. Andrew Jergens Co., 360 F.3d 1295 (Fed. Cir. 2004), which states, “In the context of patent infringement actions, we have interpreted Rule 11 to require, at a minimum, that an attorney interpret the asserted patent claims and compare the accused device with those claims before filing a claim alleging infringement.”

    On July 22nd, the district court denied KV’s motion with prejudice.  According to the court, “The pre-filing requirements stated in Q-Pharma make sense only in the context of a typical patent infringement case, and not in the context of a Hatch-Waxman case.”  The court reasoned:  “In Q-Pharma, the act of infringement alleged in the complaint was the sale of the infringing product.  …  Here, in contrast, the act of infringement alleged in the complaint is the filing of an ANDA–not the manufacture or sale of the product.”

    The court further observed:

    If this Court were to grant KV’s motion, it would put pharmaceutical patent owners in an untenable position.  After receipt of notification of an ANDA application for a generic pharmaceutical, the patent owner would need to conduct what is likely to be a highly technical infringement analysis, make the decision to file suit, and then do so, all within 45 days, or face dismissal as a sanction under Rule 11.  This would be difficult for patent owners to accomplish and would have the effect of frustrating the purpose of the Hatch-Waxman scheme.

    In conclusion, the court explained its decision to deny KV’s motion with prejudice:  “Because KV’s motion is premised on an erroneous application of Federal Circuit law, and because this Court finds the record before it sufficient to determine that Celgene’s pre-filing investigation of the allegation that KV infringed Celgene’s patents by filing ANDA No. 79-004 was reasonable under the circumstances, it is appropriate not only to deny this motion prior to full briefing, but to deny it with prejudice.”

    More:

  • ACI “Biotech Patents” Conference, Boston, September 15-16

    ACI’s “Biotech Patents” conference will be held at the Royal Sonesta Hotel in Boston, September 15-16.  According to ACI, this is the “ONE place biotech patent practitioners come to learn and discuss the most recent and vital changes facing the industry today.”

    The agenda includes several talks that look interesting:

    • “Navigating the Board of Patent Appeals and Interferences in Light of the KSR Decision”
    • “They Are Coming:  Preparing Your Practice for the Inevitable Insurgence of Follow-On Biologics and Predicting the Future of the Biotech Industry”
    • “The International Perspective:  Changing Patent Practices in the EU and India:

    • “Practicing Biotechnology Arts:  Claim Drafting Strategies”

    • “Ex Parte Kubin:  A Case Study”

    • “Different But the Same:  The Unique Nature of Prosecuting Antibody Therapeutics Applications Under the Standard Patent Prosecution Process”

    There is also a post-conference master class, “Drafting Successful Patent Applications for Biotechnology-Related Inventions.”


    Orange Book Blog readers can save $200 off registration by using code SP1.


    For more information or to register, visit the conference website.

  • Federal Circuit Affirms Validity and Enforceability of Eisai’s Compound Patent on Aciphex

    Eisai v. Dr. Reddy’s and Teva, Nos. 2007-1397, -1398 (Fed. Cir. 2008)

    Patents on chemical compounds are holding up well to obviousness arguments in the Federal Circuit, even after KSR.  In an opinion released today, the Federal Circuit affirmed the nonobviousness of rabeprazole, the active ingredient in Aciphex.  This follows a decision last year affirming the nonobviousness of pioglitazone, the active ingredient in Actos.

    Eisai’s U.S. Patent No. 5,045,552 claims rabeprazole and its salts.  Rabeprazole is in a class of drugs known as proton pump inhibitors, which suppress gastric acid production in the stomach.  Aciphex (rabeprazole sodium) is indicated for the treatment of duodenal ulcers, heartburn, and associated disorders, and accounts for over $1 billion of Eisai’s annual sales.

    Dr. Reddy’s stipulated to the validity of the ‘552 patent (relying on inequitable conduct arguments instead), but Teva challenged its validity, arguing that a combination of three prior art references rendered the claims of the ‘552 patent obvious:  (1) European Patent No. 174,726, claiming lansoprazole; (2) U.S. Patent No. 4,255,431, claiming omeprazole; and (3) an article by Brandstrom et al., entitled “Structure Activity Relationships of Substituted Benzimidazoles”.

    The Federal Circuit began by summarizing its recent chemical obviousness jurisprudence:

    Where, as here, the patent at issue claims a chemical compound, the analysis of the third Graham factor (the differences between the claimed invention and the prior art) often turns on the structural similarities and differences between the claimed compound and the prior art compounds.  Obviousness based on structural similarity thus can be proved by identification of some motivation that would have led one of ordinary skill in the art to select and then modify a known compound (i.e., a lead compound) in a particular way to achieve the claimed compound.  In keeping with the flexible nature of the obviousness inquiry, the requisite motivation can come from any number of sources and need not necessarily be explicit in the art.  Rather, it is sufficient to show that the claimed and prior art compounds possess a sufficiently close relationship to create an expectation, in light of the totality of the prior art, that the new compound will have similar properties to the old.

    With respect to the prior art, the Federal Circuit made the following observations:  (1) Rabeprazole and lansoprazole are structurally similar–the two compounds differ only at the 4-position on the pyridine ring, where lansoprazole contains a fluorinated substituent; (2) “omeprazole is structurally farther afield from rabeprazole than is lansoprazole”; and (3) “rabeprazole, lansoprazole, and omeprazole are all Brandstrom core structure compounds,” a class of anti-ulcerative compounds.

    Thus, the Federal Circuit stated, “one of skill in this art may have considered [lansoprazole] a candidate for a lead compound in the search for anti-ulcer compounds.”  However, according to the court, “the EP ‘726 reference teaches at best that the fluorinated substituent of lansoprazole provides a special path to achieving lipophilicity, and the record “shows no discernible reason for a skilled artisan to begin with lansoprazole only to drop the very feature, the fluorinated substituent, that gave this advantageous property.”  The court concluded that one of skill in the art would not have considered such a modification to be “an identifiable, predictable solution.”

    Addressing Teva’s suggestion that another compound might have served as a lead compound, the Federal Circuit observed that “Teva alone selected lansoprazole as the anchor for its obviousness theory.”  Moreover, according to the court, “post-KSR, a prima facie case of obviousness for a chemical compound still, in general, begins with the reasoned identification of a lead compound.  Teva cannot create a genuine issue of material fact on obviousness through the unsupported assertion that compounds other than lansoprazole might have served as lead compounds.”

    In addition to affirming the validity of the ‘552 patent, the Federal Circuit affirmed its enforceability, rejecting arguments that Eisai committed inequitable conduct.

    Dr. Reddy’s and Teva alleged that Eisai misled the Patent Office in five ways:

    1. failing to disclose Eisai’s own co-pending ‘013 application, which claimed the “ethyl homolog” of rabeprazole;
    2. withholding rejections from the ‘013 application’s prosecution that also would have been applicable to the ‘552 patent’s prosecution;
    3. failing to disclose the prior art “Byk Gulden patent”;
    4. submitting a misleading declaration to the examiner of the ‘552 patent; and
    5. concealing lansoprazole from the examiner.

    The Federal Circuit affirmed the district court’s findings that the materiality of the ‘013 application was “low”; that there was insufficient evidence that Eisai intended to deceive the Patent Office by failing to disclose the rejections made during prosecution of the ‘013 application; that the Byk Gulden patent was cumulative with other references disclosed to the Patent Office; that Eisai did not intend to deceive the Patent Office by submitting the “misleading declaration” during prosecution of the ‘552 patent; and that lansoprazole was not material to the patentability of rabeprazole.

    Affirming the district court on all counts, the Federal Circuit concluded, “In a series of thoughtful, thorough opinions, the district court carefully explained its reasoning with respect to both obviousness and inequitable conduct.”

    RELATED READING:

  • OBB News Briefs

    • Teva announced Friday that it is acquiring Barr Pharmaceuticals for $7.5 billion plus $1.5 billion in debt.  For more:  AP; Reuters; WSJ.
    • Zentiva, the Czech generic drug maker, announced Friday that it rejected a takeover bid from Sanofi-Aventis.  Sanofi already owns 25% of the company.
    • Meanwhile, the WSJ Health Blog recently reported that the CEOs of GSK and Roche have no interest in getting into the generics business.
    • FDA Law Blog recently reported on two interesting USPTO decisions denying Patent Term Extension requests under 35 U.S.C. § 156.  In both cases, AstraZeneca was the applicant:  July 8 (Symbicort); July 16 (Prilosec OTC).
    • On July 16, Impax and Wyeth announced a settlement of their litigation over Impax's generic version of Effexor XR.  Under the agreement, Impax may launch its capsule formulation of Effexor XR on June 1, 2011, and possibly as early as January 1, 2011.
    • On July 11, Momenta Pharmaceuticals announced the filing of an ANDA with a paragraph IV certification for a generic version of Copaxone, Teva's $500 million multiple sclerosis drug.  According to Pharmalot, Teva's CEO is not concerned.
    • The Baltimore Sun recently reported that the brand-name pharmaceutical industry has been successfully pushing legislation at the state level requiring pharmacists to inform doctors or get their permission before substituting a generic drug for a brand-name drug.
    • The FDA announced on July 9 that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.  CDER will no longer issue "approvable" or "not approvable" letters.  For more:  Pharmalot; WSJ Health Blog.
    • The WSJ Health Blog had an interesting post recently about a report from the HHS Inspector General, finding that FDA typically takes longer than the 180 days allowed under law to review a generic drug application.
    • The Mircera case between Amgen and Roche is attracting a great deal of attention, particularly because of the "public interest" factor of the injunction analysis.  Pharmalot has more on the case.
    • Insmed recently announced that it has developed a biosimilar version of Amgen's Neupogen, a $1 billion drug for the treatment of Neutropenia.  Pharmalot has more.