•     By Jason Derry —

    King Pharmaceuticals
    King Pharmaceuticals, Inc. has announced that it will purchase Alpharma Inc. for about $1.6 billion in cash.  King had been trying to convince Alpharma to accept an offer for the past couple of months (see "King Pharmaceuticals Extends Tender Offer to Acquire Alpharma").  Alpharma has two marketed pain killer products, KADIAN (an extended-release morphine painkiller) and FLECTOR (an NSAID patch product), as well as a line of products for animal health.  Alpharma also has an abuse-resistant morphine pill that is currently under FDA review.  These products and other product candidates complement King's portfolio of pain management therapeutics.

    Johnson & Johnson
    In addition, Johnson & Johnson has announced an agreement to buy Omrix Biopharmaceuticals, Inc. for about $438 million in cash.  Omrix will reportedly continue to operate as a stand-alone company.  Omrix is a biopharmaceutical company that focuses on research and development of products relating to protein-based biosurgery and immunotherapy.  Omrix has two marketed protein-based products that can be used during surgeries to control bleeding.

    Jason Derry, Ph.D., who graduated with honors from DePaul University
    College of Law, is a molecular biologist and founding author of Patent Docs.

  •     By Sherri Oslick

    Gavel_2About
    Court Report:  Each week we will report briefly on recently filed
    biotech and pharma cases, and a few interesting cases will be selected
    for periodic monitoring.


    Abbott Laboratories et al. v. Teva Pharmaceuticals USA, Inc. et al.

    1:08-cv-06659; filed November 20, 2008 in the Northern District of Illinois

    Infringement of U.S. Patent Nos. 5,246,925 ("19-nor-Vitamin D Compounds for Use in Treating Hyperparathyroidism," issued September 21, 1993) and 5,587,497 ("19-nor-Vitamin D Compounds," issued December 24, 1996) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Abbott's Zemplar® (paricalcitol, used to treat secondary hyperparathyroidism in patients with kidney failure).  View the complaint here.


    Eli Lilly and Company et al. v. Teva Parenteral Medicines Inc.

    1:08-cv-00860; filed November 19, 2008 in the District Court of Delaware

    Infringement of U.S. Patent No. 5,344,932 ("N-(pyrrolo(2,3-d)pyrimidin-3-ylacyl)-Glutamic Acid Derivatives," issued September 6, 1994), licensed to Eli Lilly, following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Lilly's Alimta® (pemetrexed for injection, used to treat malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer).  View the complaint here.  [NB:  As reported previously in Court Report, Eli Lilly filed suit against Teva earlier this year on this same patent based on an ANDA directed to a different dosage form.]


    Boehringer Ingelheim Pharma GMBH & Co., KG et al. v. Norbrook Laboratories Limited et al.

    4:08-cv-00870; filed November 18, 2008 in the Western District of Missouri

    Infringement of U.S. Patent No. 6,184,220 ("Oral Suspension of Pharmaceutical Substance," issued February 6, 2001) following the equivalent of a Paragraph IV certification as part of Norbrook's filing of its ANADA (Abbreviated New Animal Drug Application) to manufacture a generic version of Boehringer's Metacam® (meloxicam, used for the control of inflammation associated with osteoarthritis in dogs).  View the complaint here.


    Alpharma Inc. v. Purdue Pharma L.P.

    1:08-cv-00050; filed November 17, 2008 in the Western District of Virginia

    Declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. 6,277,384 ("Opioid Agonist/Antagonist Combinations," issued August 21, 2001), 6,375,957 ("Opioid Agonist/Opioid Antagonist/Acetaminophen Combinations," issued April 23, 2002), 6,475,494 ("Opioid Agonist/Antagonist Combinations," issued November 5, 2002), 6,696,066 (same title, issued February 24, 2004), 7,172,767 (same title, issued February 6, 2007), 7,419,686 (same title, issued September 2, 2008), 6,228,863 ("Method of Preventing Abuse of Opioid Dosage Forms," issued May 8, 2001), 6,627,635 (same title, issued September 30, 2003), and 6,696,088 ("Tamper Resistant Oral Opioid Agonist Formulations," issued February 24, 2004) in conjunction with Alpharma's filing of an NDA seeking approval of their ALO-01, an abuse-resistant formulation of extended release morphine and sequestered naltrexone.  View the complaint here.


    Eli Lilly and Company v. Wockhardt Limited et al.

    1:08-cv-01547; filed November 14, 2008 in the Southern District of Indiana

    Eli Lilly and Company v. Impax Laboratories, Inc.
    1:08-cv-01549; filed November 14, 2008 in the Southern District of Indiana

    Eli Lilly and Company v. Sandoz, Inc.
    1:08-cv-01548; filed November 14, 2008 in the Southern District of Indiana

    Eli Lilly and Company v. Cobalt Laboratories, Inc.
    1:08-cv-01550; filed November 14, 2008 in the Southern District of Indiana

    Eli Lilly and Company v. Actavis Elizabeth LLC
    1:08-cv-01559; filed November 14, 2008 in the Southern District of Indiana

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 5,023,269 ("3-Aryloxy-3-Substituted Propanamines," issued June 11, 1991) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Lilly's Cymbalta® (duloxetine hydrochloride, used to treat depression and generalized anxiety disorder and for the management of diabetic peripheral neuropathic pain and fibromyalgia).  View the Wockhardt complaint here.


    Schering Corp. v. Caraco Pharmaceutical Laboratories, Ltd. et al.

    3:08-cv-05623; filed November 14, 2008 in the District Court of New Jersey

    Infringement of U.S. Patent No. 7,405,223 ("Treating Allergic And Inflammatory Conditions," issued July 29, 2008) following a Paragraph IV certification as part of defendants' amendment of their ANDA to manufacture a generic version of Schering-Plough's Clarinex® (desloratidine, used to treat allergies) prior to the expiration of the '223 patent.  View the complaint here.


    Pozen Inc. v. Par Pharmaceutical, Inc.

    6:08-cv-00437; filed November 14, 2008 in the Eastern District of Texas

    Infringement of U.S. Patent Nos. 6,060,499 ("Anti-migraine Methods and Compositions Using 5-HT Agonists with Long-Acting NSAIDS," issued May 9, 2000), 6,586,458 ("Methods of Treating Headaches Using 5-HT Agonists in Combination with Long-Acting NSAIDS," issued July 1, 2003), and 7,332,183 ("Multilayer Dosage Forms Containing NSAIDS and Triptans," issued February 19, 2008), licensed to GlaxoSmithKline, following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of GSK's Treximet® (sumatriptan and naproxen sodium, used to treat migrane attacks).  View the complaint here.

  • CalendarDecember 1, 2008 – 19th Annual Conference on U.S. Patent and Trademark Office Law and Practice (PTO Day) (Intellectual Property Owners Association) – Washington, DC

    December 2, 2008 – Patent Interferences Rules & Practice (Intellectual Property Owners Association) – Washington, DC

    December 3, 3008 – Parallel Patent Reexamination and Litigation 2008: The Latest Developments and Their Impact (Practising Law Institute) – San Francisco, CA

    December 8-9, 2008 – Pharmaceutical and Biotech Patent Opinion Writing*** (American Conference Institute) – Atlanta, GA

    January 3-7, 2009 – 26th Annual National CLE Conference (Law Education Institute) – Vail, CO

    January 12-13, 2009 – Pharmaceutical and Biotech Patent Opinion Writing*** (American Conference Institute) – San Diego, CA

    January 20-21, 2009 – Bio/Pharmaceutical Summit on Legal and Regulatory Product Lifecycle
    Strategies
    *** (Center for Business Intelligence) – Baltimore, MD

    January 26-27, 2009 – Structuring and Negotiating Pharma & Biotech Collaborative Agreements (C5) – London, England

    January 27-28, 2009 – ITC Litigation (American Conference Institute)*** – Washington, DC

    January 28-29, 2009 – 6th National Conference on Pharma/Biotech IP Due Diligence (American Conference Institute) – New York, NY

    January 29-30, 2009 – Commercialization of Life Sciences Inventions (Law Seminars International) – Phoenix, AZ

    ***Patent Docs is a media partner of this conference or CLE

  •     By Donald Zuhn

    USPTO Seal
    Yesterday, the U.S. Patent and Trademark Office published a notice in the Federal Register (73 Fed. Reg. 70282) clarifying the new appeals rules scheduled to take effect on December 10, 2008.  The Patent Office also posted a statement regarding the clarification on its website.  As we reported last summer, the USPTO set forth amended rules of practice before the Board of Patent Appeals and Interferences (BPAI) in ex parte appeals that would take effect six months from their June 10, 2008 publication date (see "New Appeals Rules Published"). 

    The Office's clarification involves the format of appeal briefs submitted prior to the December 10 effective date.  In particular, the Office has indicated that it will accept appeal briefs that are submitted in the new format prior to the effective date of the new appeals rules.  The Office noted that it had discovered that a number of appeal briefs have been submitted in the new format, and that these briefs were being rejected as non-compliant.  The Office stated that the rejection of such briefs was unintended, and that it "will not hold an appeal brief as non-compliant solely for following the new format even though it is filed before the effective date."  Appellants who have received a notice of non-compliant brief under such circumstances may request withdrawal of the notice.

    The Office noted that information regarding the new appeals rules, including a list of Frequently Asked Questions about the new rules and checklists for ensuring that briefs comply with the new rules, can be found on a dedicated webpage the Office has set up for the new appeals rules.

    Office of Management & Budget - OMB
    The Office's clarification may be somewhat surprising in view of two other Federal Register notices the Office has published on the new appeals rules.  In the first notice (73 Fed. Reg. 32559), published on June 9, 2008, the Office requested that interested members of the public comment on the Office's estimates for any additional burdens imposed on applicants by the new appeals rules.  As we noted in July, in addition to publishing the notice for comment only one day before the final version of the new appeals rules were published, the Office curiously neglected to list the June 9 notice on its website — in contrast to the June 10 notice setting forth the final appeals rules which was posted on the Office's website (see "USPTO Rulemaking Practices Being Called into Question (Again)").  The Office published a second notice (73 Fed. Reg. 58943) on October 8, 2008, inviting public comments on paperwork burdens associated with the new appeals rules (see "Unhappy with the Ex parte Appeal Rule?  Read This Now").  The publication date of this notice was significant, since the Office of Management and Budget requires 60 days in which to review comments regarding the paperwork burdens of new rules (it does not appear that the OMB has completed its review of the new appeals rules; see ICR regarding new appeals rules).  Interested applicants and patent practitioners will now await the OMB's decision regarding the appeals rules.

    For additional information regarding this topic, please see:

    • "More on Ex parte Appeal Rule," October 10, 2008
    • "Unhappy with the Ex parte Appeal Rule?  Read This Now," October 8, 2008
    • "Patent Office Posts Comments on New Appeals Rules," September 11, 2008
    • "More on USPTO Rulemaking Practices,"July 21, 2008
    • "USPTO Rulemaking Practices Being Called into Question (Again)," July 20, 2008
    • "New Appeals Rules Published," June 10, 2008
    • "Patent Office to Publish New Appeals Rules on Tuesday," June 9, 2008

  •     By Donald Zuhn

    Brill, Alex
    On Tuesday, Alex Brill (at right), a principal at Matrix Global Advisors, LLC and former chief economist to the House Ways and Means Committee, released a white paper which asserts that a follow-on biologics regulatory pathway providing a data exclusivity period of seven years would be "sufficient for maintaining strong incentives to innovate while fostering a competitive marketplace."  The 12-page paper, entitled "Proper Duration of Data Exclusivity for Generic Biologics:  A Critique," was funded by Teva Pharmaceuticals (see Teva press release), which also funded a report on data exclusivity released last September (see "BU Economics Professor Releases Report on the Impact of Marketing Exclusivity on Biologics Innovation").

    In arriving at a seven year data exclusivity period, the Brill paper finds fault with some aspects of an earlier economic model described by Duke University economist Henry Grabowski in a paper published last May in Nature Reviews Drug Discovery (see "Follow-on biologics: data exclusivity and the balance between innovation and competition").  According to Mr. Brill, Professor Grabowski's model estimates that a biologic's "break-even" point (i.e., "the number of years required for an average portfolio of biologic drug investments to recoup all development and fixed production costs and to also reward the investors their expected (double-digit) rate of return") is between 12.9 and 16.2 years.  Mr. Brill finds that "with more plausible assumptions regarding the cost of capital and the contribution margin, the 'break-even' period is considerably shorter," and further, that "because innovator drugs can be expected to continue to earn economic profits in a market open to biogeneric competition, optimal data exclusivity will always be less than the 'break-even' point."  As a result, Mr. Brill proposes a break-even period of just under nine years, and then reduces this calculation to seven years to account for profits earned after the market is opened to generic competition.

    Brill Paper
    In concluding that Professor Grabowski's break-even was too high, Mr. Brill altered two "key" variables:  cost of capital and contribution margin.  Figure 2 (below) of Mr. Brill's paper presents a range of results based on additional simulations of Professor Grabowski's model using alternative assumptions.  According to Mr. Brill, the simulation based on the most plausible assumptions (i.e., a 10 percent discount rate and a 60 percent contribution margin) yields a break-even point at just under nine years (represented by the teal line on Figure 2).  Mr. Brill contends that this 9-year break-even point should not be equated with the optimal data exclusivity period because "the break-even duration will always be greater than the optimal duration of data exclusivity in a market such as biologic drugs, where it can be expected that the innovator drug will continue to earn economic profits following the entrance of biogeneric competition."  After further adjustment of the plot in Figure 2, Mr. Brill concludes that "seven years is a reasonable duration to balance incentives for innovators with the market benefits of competition" (Mr. Brill notes that a 7-year data exclusivity period raises the break-even point from nine to ten years, but that beyond ten years, the innovator continues to earn profits in excess of the required rate of return).

    Brill, Figure 2

    In Teva's announcement regarding the release of Mr. Brill's paper, the generic pharmaceutical company noted that the data exclusivity period calculated by Mr. Brill was only half "the 14 years currently supported by the Biotechnology Industry Organization (BIO)," which Teva contends "widely touted" Professor Grabowski's economic model in arriving at the 14-year period.

    For additional information regarding this and other related topics, please see:

    • "BU Economics Professor Releases Report on the Impact of Marketing Exclusivity on Biologics Innovation," September 18, 2008
    • "Congressional Fact-finding on Follow-on Biologics," August 13, 2008
    • "CBO Releases Report on Senate Follow-on Biologics Bill; BIO Calls for Congress to Pass Biologics Bill in 2008," July 1, 2008
    • "Follow-on Biologic Drugs and Patent Law: A Potential Disconnect?" March 25, 2008
    • "New Follow-on Biologics Bill Introduced in the House," March 18, 2008
    • "Dr. Robert Shapiro Discusses Follow-on Biologics Report," February 19, 2008
    • "BIO CEO Provides Update on Patent Reform and Follow-on Biologics Legislation – Part II," February 14, 2008
    • "Biologics Legislation Faces Unresolved Issues," December 28, 2007
    • "Senate Committee Passes Biologics Legislation" July 5, 2007

  •     By Jason Derry —

    Stem Cell Sciences
    Stem Cell Sciences plc has announced an agreement with Pfizer Ltd., under which Stem Cell Sciences (SCS) will provide services that will support Pfizer's new regenerative medicine unit.  The partnership provides Pfizer with access to SCS's research services, cell lines, media, and reagents.  SCS provides its stem cell technology to biotechnology and pharmaceutical companies for drug discovery and research relating to regenerative therapeutics.  Pfizer Ltd. is the UK operating unit of Pfizer, Inc.  Pfizer's new Regenerative Medicine research unit launched Pfizer
    earlier this week (see Medical News Today report), and is co-located in Cambridge, UK and Cambridge, MA.  Pfizer's new unit is focused on stem cell biology research, and the discovery and development of new regenerative medicines.

    Jason Derry, Ph.D., who graduated with honors from DePaul University
    College of Law, is a molecular biologist and founding author of Patent Docs.

  •     By Christopher P. Singer

    USPTO Seal
    In a Notice published in the Federal Register (73 Fed. Reg. 67750) on Monday, November 17, 2008, the U.S. Patent and Trademark Office announced a new rule that would institute an annual fee for all registered practitioners.  The fee will be required for practitioners to maintain active status to practice before the Office.  As other commentators have mentioned, and as the Notice informs, the rule change is based on a prior Notice published on December 12, 2003 which discussed proposed amendments to 37 C.F.R. § 11 that include an annual practitioner fee (see, e.g., Patently-O, "Patent Practice: Annual Practitioner Maintenance Fee").  The Office rationalizes the motivation for the rule change based on an interest in "maintaining a roster of registered practitioners, including affording practitioners due process, protecting the public, preserving the integrity of the Office, and maintaining high professional standards" as well as protecting the general public interest in having an up-to-date roster of registered patent attorneys and agents.  The fee is currently scheduled to be $118 per year, and as Hal Wegner, a partner at Foley & Lardner LLP and professor at George Washington University Law School, noted in a Monday newsletter to his e-mail subscribers "since the final rules are effective in the new fiscal year (in December) the payment is due September 30, 2009."

    Cash
    The rules describe the protocol the Office plans to implement regarding notifying registered practitioners when the fee is due, as well as consequences for non-payment (administrative suspension) and how practitioners who are suspended, if suspended in good faith, can be placed back on active status.  These fees, according to the Notice, are designed to recover the Office's estimated annual cost of maintaining the active practitioner roster, which includes additions and removals from the roster, updating contact information, conducting investigations regarding allegations of practitioner misconduct, and conducting disciplinary proceedings against practitioners.

    Perhaps what is most disturbing about this Notice is that it comes on the heels of the USPTO's recent announcement that the recent rule changes to Markush claims and IDS practice will not go into effect under the current administration (see "PTO Announces No IDS or Markush Rules During Bush Administration").  Hopefully, this action will prove to be the single exception to the current Administration's stated intention of not making any further changes to the patent rules and regulations.

  •     By Donald Zuhn

    USPTO Seal
    The U.S. Patent and Trademark Office released its FY 2008 Performance and Accountability Report yesterday and announced that the Office had for the first time "met 100 percent of its Government Performance and Results Act (GPRA) goals."  According to the Patent Office, the year-end numbers "demonstrate the agency’s commitment to sustaining high performance in the quality and timely examination of patent and trademark applications."

    The Performance and Accountability Report indicates that the Office examined 448,003 applications in 2008 — the highest number of applications the Office has ever examined in a year (the Office's previous high of 362,227 examined applications was set last year).  The report also notes that 72.1% of patent applications were filed electronically via the EFS-Web in 2008, which is up from about 50% last year and less than 2% in 2005.  Not surprisingly, the Office also received a record number of application filings via the EFS-Web in 2008 (332,617).  Despite the significant increase in the number of applications that the Office examined in 2008, the report states that the total number of applications awaiting action rose from 760,924 in 2007 to 771,529 in 2008, and the total number of applications under examination rose from 1,112,517 in 2007 to 1,208,076 in 2008.

    The report indicates that while the Office had more patent application disposals (396,228) in 2008 than in any of the four previous years, the Office allowed fewer applications (187,607) in 2008 than it did in 2007.  The percent of application disposals constituting allowances in 2008 was 47.3%, down from 54% in 2007, 56.1% in 2006, 61% in 2005, and 64.2% in 2004.  Last year, the Office indicated that the dropping allowance rate supported its assertion that patent quality was on the rise.  In the 2008 report, the Office instead focuses on its higher than expected allowance compliance rate of 96.3 percent when speaking of increased patent quality.  (The allowance compliance rate is the percentage of reviewed applications allowed by examiners that did not have any errors.)

    Turning from the (ever) dwindling allowance rate, Tech Center 1600 (biotechnology and organic chemistry) offered biotech and pharma applicants and practitioners some good news, as that Group was once again able to reduce the average pendency to a first Office Action.  The average pendency to a first Office Action dropped (for the second year in a row) from 22.7 months in 2007 to 19.9 months in 2008.  Unfortunately, the average total pendency in Tech Center 1600 rose slightly to 34.8 months from 34.4 months in 2007.  As a point of comparison, the average pendency to a first Office Action for all Tech Centers combined jumped from 25.3 months in 2007 to 25.6 months in 2008, and the overall average total pendency increased from 31.9 months in 2007 to 32.2 months in 2008.

    For additional information regarding this and other related topics, please see:
    • "USPTO Announces 'Record Breaking' 2007 Performance," November 15, 2007
    • "BIO Issues Statement Regarding USPTO Performance Report," December 6, 2007
    • "Patent Office Announces Record-Breaking Year," December 27, 2006

  •     By Christopher P. Singer

    USPTO Seal - background
    In a Notice published in the Federal Register (73 Fed. Reg. 47534) on Wednesday, November 12, 2008, the U.S. Patent and Trademark Office announced new fees for the transmittal and search for international applications filed under the Patent Cooperation Treaty (PCT).  The fees are designed to recover the estimated average cost to the Office of processing PCT international applications and preparing international search reports and written opinions for PCT international applications.  The new PCT transmittal fee will be $240 (adjusted from the current fee of $300), and the new search fee where the USPTO is acting as the International Searching Authority will be $2,080 (up from the current fee of WIPO
    $1,800).  The supplemental search fee for each examined additional invention, which applicants have the option of requesting will also increase to $2,080, from the current fee of $1,800.  The fees will apply to international applications having a receipt date that is on or after January 12, 2009.

  •     By Kwame Mensah

    King Pharmaceuticals
    Last month, King Pharmaceuticals, Inc. announced that it is extending its previously announced tender offer for all outstanding shares of Class A Common Stock of Alpharma Inc. (representing a total equity value of approximately $1.6 billion and an enterprise value of approximately $1.4 billion) until 5:00 pm, Eastern time, on November 21, 2008.  The offer however, could be further extended.  The tender offer was originally scheduled to expire on Friday, October 10, 2008.  All other terms and conditions of the tender offer remain unchanged.

    Alpharma
    Alpharma Inc., headquartered in Bridgewater, New Jersey, is a global specialty pharmaceutical company active in more than 80 countries worldwide with 2007 revenues of $722 million.  Its two top pharmaceutical products are KADIAN® capsules, an extended-release oral formulation of morphine sulfate, and the FLECTOR® Patch, a prescription topical treatment for acute (short-term) pain due to minor strains, sprains, and contusions (bruises).  It is also involved in the development, registration, manufacturing, and marketing of pharmaceutical products and technologies for food producing animals.

    King Pharmaceuticals, headquartered in Bristol, Tennessee, calls itself a vertically integrated branded pharmaceutical company.  Acquisition of Alpharma will enhance the company's focus in the markets of neuroscience and acute care.