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  • Enviro Tech Chemical Services, Inc. v. Safe Foods Corp. (Fed. Cir. 2026)
  • Hikma v. Amarin: The Amici Speak – Part III
  • Hikma v. Amarin: The Amici Speak – Part II
  • Hikma v. Amarin: The Amici Speak – Part I
  • Hikma v. Amarin at the Supreme Court: The Parties’ Opening Briefs – Part II

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  • Conference & CLE Calendar

    January 6, 2008

    Calendar_36
    January 9, 2008 – Patent Claim Construction (Law Seminars International) – San Francisco, CA

    January 14-15, 2008 – Patent Law Institute (Practising Law Institute) – New York, NY

    January 25-26, 2008 – Buying, Selling and Licensing Patents: New Case Law, Rules, Legislation and Markets (Law Seminars International) – San Francisco, CA

    January 28-29, 2008 – Patent Law Institute (Practising Law Institute) – San Francisco, CA

    January 30-February 1, 2008 – Pharma/Biotech IP Due Diligence (American Conference Institute) – New York, NY***

    February 15, 2008 – Patent Claim Construction (Law Seminars International) – Chicago, IL

    February 25-26, 2008 – Pharma/Biotech Patent Claim Drafting and Prosecution (American Conference Institute) – New York, NY***

    February 25-26, 2008 – Strategic Intellectual Property Planning (American Conference Institute) – Scottsdale, AZ

    March 30-April 1, 2008 – Advanced Courses (Patent Resources Group) – Bonita Springs, FL

    April 3-5, 2008 – Advanced Courses (Patent Resources Group) – Bonita Springs, FL

    June 17-20, 2008 – BIO International Convention (Biotechnology Industry Organization) – San Diego, CA

    ***Patent Docs is a media sponsor of this conference or CLE.

  • IPAuctions, Inc. Announces Bioscience Technology Auction

    January 4, 2008

        By Christopher P. Singer —

    Ipauctions_logo
    IpAuctions, Inc. has announced that it will be holding a ten day auction of intellectual property relating to bioscience and medical technologies from February 26 to March 5, 2008.  The online auction firm is targeting general IP and patents particularly in the fields of cancer therapeutics and diagnostics, medical devices, drug delivery, wellness, and nutraceuticals.  Anyone interested in learning more about the auction and how to register intellectual property for auction can contact IpAuctions by e-mail at info@ipauctions.com, telephone at 866-826-1300, or facsimile at 775-826-1322.  All items for sale must be posted by February 8, 2008.  More information about IpAuctions can be found here.

  • Patent Profile: stART Licensing Announces Issuance of Patents for Cloning Ungulates

    January 3, 2008

        By Donald Zuhn —

    Dolly
    Last month, stART Licensing, Inc. announced that it had been granted U.S. Patent Nos. 7,304,204 and 7,307,198.  stART Licensing, Inc., an Austin, Texas-based joint venture between Geron Corp. and Exeter Life Sciences, Inc., manages and licenses a portfolio of patent rights related to animal reproductive technologies (including patents encompassing technology originally developed by the Roslin Institute for the cloning of Dolly the sheep (at right)).

    The ‘204 and ‘198 patents, which are assigned to the Roslin Institute, relate to methods of cloning ungulate animals (hoofed mammals), fetuses, and embryos using differentiated cells.  The patents — the eighth and ninth U.S. patents to be awarded to the Roslin Institute — are part of a portfolio of patents and applications that the Roslin Institute has exclusively licensed to stART for non-human animal cloning applications.

    According to stART’s statement, the Roslin Institute also expects to secure two additional patents from related U.S. Application Nos. 09/650,194 and 09/989,126, for which the U.S. Patent and Trademark Office recently issued notices of allowance.  stART noted that the allowance of the ‘194 and ‘126 applications was the result of successful interference proceedings between those applications and U.S. Patent Nos. 5,945,577 and 6,235,970, which are assigned to the University of Massachusetts and exclusively licensed to Advanced Cell Technology.  stART Chairman Jonathan Thatcher stated that "[t]he technology covered by the Roslin patents and patent applications has been widely adopted," and "has been used to clone a broad range of species including cattle, sheep, pigs, goats, horses, mice, rats, rabbits, cats and dogs."

    The ‘204 and ‘198 patents issued from U.S. Application Nos. 09/989,125 and 09/989,128, respectively, both of which claim the benefit of U.S. Application Nos. 09/650,285 and 08/803,165 (the latter of which issued as U.S. Patent No. 6,252,133), International Application No. PCT/GB96/02098, and British application GB 9517779.6.  Representative independent claims 1 and 12 of the ‘204 patent recite:

    1.  A method of cloning an ungulate by nuclear transfer comprising:
        (i) inserting a nucleus of an ungulate differentiated somatic cell, which has passed start in the mitotic cell cycle and is in the G1 phase of the cell cycle, into an unactivated, metaphase II-arrested, ungulate enucleated oocyte of the same species to reconstruct an embryo;
        (ii) maintaining the reconstructed embryo without activation for a sufficient time to allow the reconstructed embryo to become capable of developing to term;
        (iii) activating the resultant reconstructed embryo;
        (iv) culturing said activated, reconstructed embryo; and
        (v) transferring said cultured, reconstructed embryo to a host ungulate of the same species such that the reconstructed embryo develops to term.

    12.  A method of cloning an ungulate fetus by nuclear transfer comprising:
        (i) inserting a nucleus of an ungulate differentiated somatic cell, which has passed start in the mitotic cell cycle and is in the G1 phase of the cell cycle, into an unactivated, metaphase II-arrested, ungulate enucleated oocyte of the same species to reconstruct an embryo;
        (ii) maintaining the reconstructed embryo without activation for a sufficient time to allow the reconstructed embryo to become capable of developing to term;
        (iii) activating the resultant reconstructed embryo;
        (iv) culturing said activated, reconstructed embryo; and
        (v) transferring said cultured, reconstructed embryo to a host ungulate of the same species such that the reconstructed embryo develops into a fetus.

    Representative independent claims 1, 14, and 17 of the ‘198 patent recite:

    1.  A method of cloning a pig, comprising:
        (i) inserting a nucleus of a differentiated pig cell, which is in the G1 phase of the cell cycle, into an unactivated, enucleated, metaphase II-arrested, pig oocyte, to reconstruct an embryo;
        (ii) maintaining the reconstructed embryo without activation for a sufficient time to allow the reconstructed embryo to become capable of developing to term;
        (iii) activating the resultant reconstructed embryo; and
        (iv) transferring said reconstructed embryo to a host pig such that the reconstructed embryo develops into a fetus,
        wherein the fetus is capable of developing to term.

    14.  A method of cloning a pig, comprising:
        (i) inserting a nucleus of a cultured, differentiated pig embryonic disc cell, which is in the G1 phase of the cell cycle, into an unactivated, enucleated, metaphase II-arrested, pig oocyte, to reconstruct an embryo;
        (ii) maintaining the reconstructed embryo without activation for a sufficient time to allow the reconstructed embryo to become capable of developing to term;
        (iii) activating the resultant reconstructed embryo; and
    (iv) transferring said reconstructed embryo to a host pig such that the reconstructed embryo develops into a fetus,
        wherein the fetus is capable of developing to term.

    17.  A method of producing an ungulate embryo by nuclear transfer comprising:
        (i) transfer of a nucleus of an ungulate cell, which has passed start in the mitotic cell cycle and is in the G1 phase of the cell cycle, into an unactivated, enucleated, metaphase II-arrested ungulate oocyte of the same species;
        (ii) activation of the recipient oocyte containing the donor cell nucleus; and
        (iii) incubation of the activated oocyte to provide an embryo;
        wherein the donor cell nucleus is from an ungulate differentiated cell.

  • USPTO to Reexamine Affymetrix Patents Asserted against Illumina

    January 2, 2008

        By Donald Zuhn —

    Illumina_2
    On December 21, 2007, Illumina, Inc. announced that the U.S. Patent and Trademark Office had ordered the reexamination of U.S. Patent Nos. 6,355,432; 6,646,243; 5,545,531; and 5,795,716.  The patents ordered into reexamination constitute four of the five patents that Affymetrix, Inc. asserted against Illumina in an infringement action filed on July 26, 2004 in the U.S. District Court for the District of Delaware.  Illumina indicated in its statements regarding the reexaminations that it has also filed a request for reexamination of the fifth patent (U.S. Patent No. 6,399,365) asserted by Affymetrix.

    Affymetrix
    The USPTO has assigned reexamination serial nos. 90/008,885; 90/008,889; 90/008,888; and 90/008,886 to the reexaminations of the ‘432, ‘243, ‘531, and ‘716 patents, respectively.  All four of the reexaminations were ordered following requests for ex parte reexamination filed by Illumina on October 19, 2007.

    For additional information regarding this topic, please see:

    • Illumina press release concerning the ‘432 and ‘243 patents
    • Illumina press release concerning the ‘531 and ‘716 patents
  • Top Stories of 2007: #5 to #1

    January 1, 2008

        By Donald Zuhn —

    Fireworks_2
    Yesterday, we counted down stories #10 to #6 of the top stories covered at Patent Docs in 2007, and on Sunday, we listed stories #11 to #15.  Today, we conclude the series by counting down the top five stories.  In case you missed the articles the first time around or wish to go back and review them at your convenience, links to our coverage of these stories (as well as a few links to articles on related topics) have been provided.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with our ranking, please let us know.

    #5 – USPTO Issues Obviousness Guidelines

    It took the U.S. Patent and Trademark Office only three days following the Supreme Court’s decision in KSR International Co. v. Teleflex Inc. to issue a “statement” regarding the decision (in the form of a memo from Margaret Focarino, Deputy Commissioner for Patent Operations, to PTO Technology Center Directors) and less than six months for the Office to issue full guidelines for making obviousness determinations.  As with the utility examination guidelines promulgated in January 2001, however, it will take some time for patent practitioners to discover the extent to which the new obviousness guidelines will impact patent prosecution.  For information regarding this topic, please see:

    • “DNA Non-obviousness under Ex parte Kubin (It Gets Worse),” October 18, 2007
    • “Patent Office Issues Examination Guidelines Regarding Obviousness after KSR,” October 10, 2007
    • “Patent Office Sends KSR Training Guidelines to OMB,” July 25, 2007
    • “Tidbits from the USPTO: KSR and More,” May 14, 2007
    • “The Patent Office Reacts to KSR: A First Look,” May 3, 2007

    #4 – Supreme Court Issues Decision in KSR Case

    If the Patent Office’s issuance of new obviousness guidelines takes the fifth spot on our list of top stories, it makes sense that the Supreme Court decision prompting the new guidelines would grab one of the top four spots.  The Supreme Court’s decision in KSR International Co. v. Teleflex Inc. on April 30, 2007 was easily one of the most eagerly awaited patent law-related decisions in recent memory.  In reversing the Federal Circuit’s determination of validity, the Supreme Court dealt a blow to the CAFC’s “teaching, suggestion, or motivation” (TSM) test for analyzing obviousness by rejecting a “rigid” application of the TSM test.  Not unexpectedly, the Supreme Court pointed to its 1966 decision in Graham v. John Deere Co. as providing the proper analytical framework.  For information regarding this and other related topics, please see:

    • “IPLAC Panel Discussion of KSR v. Teleflex,” May 18, 2007
    • “Trying to Understand What’s Not Obvious about What’s ‘Obvious to Try,’” May 16, 2007
    • “Like a Penny Saved for a Rainy Day (Albeit, Unintentionally): The Renewed Relevance of 35 U.S.C. § 103(b),” May 13, 2007
    • “BIO’s Reaction to KSR v. Teleflex,” May 8, 2007
    • “Implications of the Supreme Court’s KSR v. Teleflex Decision for Biotechnology,” May 4, 2007
    • “KSR Int’l Co. v. Teleflex Inc. (2007),” April 30, 2007
    • “The Federal Circuit Backpedals on Obviousness,” March 27, 2007

    #3 – USPTO Promulgates New Continuation and Claims Rules

    What could knock an important patent law-related Supreme Court decision out of our top three?  How about the most substantial revision to the patent rules that patent practitioners have seen in quite some time?  By now, patent practitioners are certainly well acquainted with the new continuation and claims rules and the impact these rules could have (if allowed to go into force by the Court or Congress) on the number of continuation applications, RCEs, and claims an applicant could file.  However, it is yet to be determined whether any (and if so, which) of the new rules will survive a recent court challenge.  For information regarding this and other related topics, please see:

    • “A Call to Arms,” October 22, 2007
    • “Will Compliance with the New Rules Be Enforced by the Patent Office through the Office of Enrollment and Discipline?” October 17, 2007
    • “USPTO News Briefs,” October 18, 2007
    • “PTO ‘Flagging’ Pending Applications that Exceed 5/25 Claim Limits,” October 17, 2007
    • “‘Impact’ of New Continuation and Claims Rules,” October 8, 2007
    • “Is the Patent Office Starting to Blink,” October 5, 2007
    • “Breaking A Very Long Silence,” October 1, 2007
    • “It Ain’t Necessarily So,” September 28, 2007
    • “Commissioner Doll Addresses ACI Biotech Patents Conference,” September 26, 2007
    • “NAPP Opposes New Continuation and Claims Rules,” September 7, 2007
    • “Patent Office Provides Recorded Web-Based Discussion of New Rules,” August 30, 2007
    • “New PTO Continuation Rules: Unfair to Biotech?” August 29, 2007
    • “Proposed Agenda for September 12, 2007 Biotechnology/ Chemical/Pharmaceutical Art Group Meeting,” August 24, 2007
    • “The ‘Word’ on the New Continuation Rules (from the USPTO Webcast) – Part II,” August 24, 2007
    • “The ‘Word’ on the New Continuation Rules (from the USPTO Webcast) – Part I,” August 23, 2007
    • “New Continuation and Claims Rules Published,” August 22, 2007
    • “More on M.P.E.P. § 710.06,” August 20, 2007
    • “Patent Office to Hold Webcast on New Claim and Continuation Rules on August 23, 2007,” August 20, 2007
    • “Patent Office Announces that New Continuation and Claims Rules Will Be Published . . . Tomorrow,” August 20, 2007
    • “Procuring Patent Protection from the Present USPTO,” August 15, 2007
    • “New Continuation and Claims Rules to Be Published in Late Summer,” July 25, 2007
    • “Lies, Damn Lies, and Statistics,” July 10, 2007
    • “They Just Don’t Get It – ‘Patent Reform’ at the USPTO,” April 11, 2007

    #2 – USPTO “Clarifies” New Continuation and Claims Rules

    We placed this story ahead of the publication of the new continuation and claims rules because it suggests that the Patent Office perhaps did not gauge the impact of the new rules as carefully as it would have liked us to believe.  No “clarification” provides a better example of this than the one that finally laid to rest the “divisional dilemma” we discussed here.  When a simple question about the impact of filing a Demand in an International application stumps the Commissioner of Patents, that should be a hint that the new continuation and claims rules require a little more work.  For information regarding this topic, please see:

    • “Changes to New Rules to Be Published in Early November,” October 11, 2007
    • “USPTO Issues Notice to “Clarify” Certain Provisions of the New Rules,” October 10, 2007

    #1 – District Court Enjoins New Continuation and Claims Rules

    Topping our list of top stories for 2007 is the court challenge to the new continuation and claims rules brought initially by Dr. Triantafyllos Tafas, which was then consolidated with the action filed by GlaxoSmithKline.  On Halloween, the Eastern District of Virginia granted a preliminary injunction in the consolidated actions, preventing the USPTO from implementing the new rules.  This case is likely to crack the top five again in 2008, however, since the Court will be determining whether to permanently enjoin the new rules in February.  For information regarding this and other related topics, please see:

    • “New Briefing Deadline Set In PTO Rules Case,” December 18, 2007
    • “Court Sets Summary Judgment Schedule in New Rules Case,” December 3, 2007
    • “No Discovery in New Rules Case,” November 27, 2007
    • “Tafas v. Dudas; SmithKline Beecham Corp. v. Dudas (E.D. Va. 2007),” October 31, 2007
    • “USPTO Late to Its Own Party,” October 31, 2007
    • “GSK Secures Injunction,” October 31, 2007 (includes links to Court’s Order and Opinion)
    • “Senator Schumer Sends a Signal,” October 30, 2007
    • “GSK TRO/Preliminary Injunction Hearing,” October 29, 2007
    • “AIPLA Supports GSK’s Lawsuit Against the Patent Office’s New Rules,” October 25, 2007
    • “GSK Brings Out the Big Guns Opposing the New Continuation and Claims Rules,” October 24, 2007
    • “Hooray! – (Finally) the Big Dogs Have Joined the Hunt,” October 11, 2007
    • “Rules Challenger Amends Complaint and Withdraws PI Motion,” September 11, 2007
    • “Inventor Sues PTO to Prevent New Continuation and Claims Rules from Taking Effect,” August 30, 2007
  • Top Stories of 2007: #10 to #6

    December 31, 2007

        By Donald Zuhn —

    Fireworks
    Yesterday, we counted down the first third of the top fifteen stories that were covered on Patent Docs in 2007 (see "Top Stories of 2007: #15 to #11").  Today, we count down stories #10 to #6, and tomorrow, we will count down the top five stories.  In case you missed the articles the first time around or wish to go back and review them at your convenience, we have also provided links to our coverage of these stories (as well as a few links to articles on related topics).  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with our ranking, please let us know.

    #10 – Drug Pricing and Compulsory Drug Licensing in the Developing World

    Developing countries have begun to deal with the high price of patented drugs by using — or threatening to use — tools provided by international agreements such as GATT, TRIPS, and the Doha Declaration (e.g., compulsory licensing and parallel importing).  However, in 2007, the developing world started to apply these tools to more than just patented anti-AIDS drugs, drawing criticism from and raising the concern of Western drug companies.  For information regarding this and other related topics, please see:

    • "Neocolonialism in the Current Global Drug Pricing Regime?" August 19, 2007
    • "More on the Global Drug Patenting Crisis," August 14, 2007
    • "EU Trade Commissioner Sends Warning Letter to Thailand," August 13, 2007
    • "Trying to Find a Solution to the Global Drug Pricing Crisis," July 16, 2007
    • "Pharma Sanity Lacks Global Reach," July 13, 2007
    • "Brasil Prevails in Dispute with Abbott over AIDS Drug Pricing," July 9, 2007
    • "Africa (Still) Depending on the Kindness of Strangers in Anti-AIDS Drug Pricing," May 29, 2007
    • "U.S. Trade Policy Becoming Less Pharma-Friendly," May 18, 2007
    • "The "Unfairness" of World Intellectual Property Protection According to The New Yorker," May 17, 2007
    • "Worldwide Drug Pricing Regime in Chaos," May 9, 2007
    • "Not Getting It about Patented Drug Prices at The Wall Street Journal," May 6, 2007
    • "A Modest Proposal Regarding Drug Pricing in Developing Countries," May 2, 2007
    • "The Law of Unintended Consequences Arises in Applying TRIPS to Patented Drug Protection in Developing Countries," May 1, 2007
    • "Abbott Agrees to Offer AIDS Drug at Reduced Price," April 12, 2007
    • "No New Abbott Medicines for Thailand," March 14, 2007
    • "More Compulsory Licensing in Thailand," February 1, 2007

    #9 – Regulation of Foreign Drugs Found to be Lacking

    The past year saw reports of the appearance of contaminated excipients obtained from overseas manufacturers in a variety of pharmaceutical products.  In addition, the FDA’s role in this story — through its less than adequate inspection of overseas generic drug manufacturers — came to light.  For information regarding this topic, please see:

    • "The Effect of Foreign Generics on the U.S. Drug Supply – Part III," July 17, 2007
    • "The Effect of Foreign Generics on the U.S. Drug Supply – Part II," June 20, 2007
    • "The Effect of Foreign Generics on the U.S. Drug Supply – Part I," June 19, 2007

    #8 – Senate Passes Biologics Bill

    In July, the U.S. Senate Committee on Health, Education, Labor & Pensions passed the Biologics Price Competition and Innovation Act, which would provide an FDA approval pathway for biosimilars (interchangeable biological products) that relies in part on the prior approval of the corresponding brand product.  Congress is expected to take up biologics legislation again in 2008.  For information regarding this and other related topics, please see:

    • "Biologics Legislation Faces Unresolved Issues," December 28, 2007
    • "BIO CEO Provides Briefing on Follow-On Biologics and Patent Reform," September 18, 2007
    • "Biotechs Facing New Challenges," August 13, 2007
    • "Three New Biosimilars Pass EMEA Test," July 26, 2007
    • "European Medicines Agency Releases Paper on Biosmiliar Medicines," July 23, 2007
    • "Senate Committee Passes Biologics Legislation," July 5, 2007

    #7 – OMB Approves New IDS Rules Despite Criticism

    In July 2006, the USPTO published new Information Disclosure Statement (IDS) rules for comment.  Last July, the Patent Office submitted the new IDS rules to the OMB for approval.  Not wanting to see a repeat of what happened with the new continuation and claims rules, two groups sent letters to the OMB taking the Office to task for its "analysis" regarding the effects of the new IDS rules on applicants.  Earlier this month, the OMB announced — despite harsh criticism and evidence to the contrary — that there would be no significant economic impact from the new IDS rules.  While the Patent Office has indicated that the new IDS rules will take effect in early 2008, the Office has not indicated to what extent the new IDS rules have changed since they were first published (even the new continuation and claims rules were modified between initial publication and promulgation).  Considering the comprehensive analysis provided in the two letters sent to the OMB, the Patent Office could soon be facing another court challenge of a new rules package.  For information regarding this topic, please see:

    • "The OMB Isn’t Listening, Either", December 11, 2007
    • "More on Second Letter to OMB Criticizing the IDS Rule," October 24, 2007
    • "OMB Receives Second Letter Criticizing Proposed IDS Rule," October 23, 2007
    • "Cantor Fitzgerald VP Criticizes IDS Rule in Letter to OMB," October 18, 2007

    #6 – Congress Working on Patent Reform

    In September, the House of Representatives passed its own version of patent reform legislation.  Senator Patrick Leahy, the Chairman of the Senate Judiciary Committee, recently indicated that the Senate’s own patent reform bill would continue to be refined and that the Senate would act on the bill "as early as the floor schedule permits" in 2008.  Thus, patent reform will continue to be a major story in the coming year.  For information regarding this and other related topics, please see:

    • "Patent Reform Discussed on Senate Floor," December 21, 2007
    • "Enjoined New Rules and Patent Reform Finally Appearing on Biotech Industry’s Radar," December 20, 2007
    • "Chinese IP Judge Discusses Implications of U.S. Patent Reform Bill and Two Congressmen Heed Warning," December 17, 2007
    • "IPO President Seeks Deletion of Patent Reform Provision," December 12, 2007
    • "Senate May Act on Patent ‘Reform’ Bill in the New Year," December 2, 2007
    • "The Wall Street Journal Gets It Half Right," November 5, 2007
    • "BIO CEO Provides Briefing on Follow-On Biologics and Patent Reform," September 18, 2007
    • "Patent ‘Reform’ Bill Passes House of Representatives," September 9, 2007
    • "Reversal in Microsoft Case Weakens Patent Reform Argument," August 7, 2007
    • "San Francisco Chronicle Opines on Patent Reform," August 6, 2007
    • "Patent Reform Bill to Be Delayed?" June 12, 2007
    • "Senate Judiciary Committee Holds Hearing on Patent Reform," June 10, 2007
    • "Could Creating a U.S. ‘Utility Model’ Patent Fulfill the ‘Need’ for Patent Law Reform?" May 21, 2007
  • Top Stories of 2007: #15 to #11

    December 30, 2007

        By Donald Zuhn —

    Fireworks_2
    It is natural at this time of year to reflect upon the events of the past twelve months in the hope that such a review might provide some indication of what to expect in the coming year.  In order to help focus on possible developments in biotech and pharma patent law in 2008, over the next three days, we will count down the top fifteen stories that we covered at Patent Docs in 2007.  In addition, we will provide links to our coverage of these stories (as well as a few links to articles on related topics) in case you missed the articles the first time around or wish to go back and have another look during the New Year’s holiday.  Today, we count down stories #15 to #11.  Tomorrow, we will count down stories #10 to #6, and on New Year’s Day, we will count down the top five stories.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with our ranking, please let us know.

    #15 – Genentech’s Avastin®/Lucentis® Controversy

    Genentech makes two drugs that can be used to treat neovascular or "wet" age-related macular degeneration (AMD):  Avastin®, which costs $20-60 per dose, and Lucentis®, which costs $2,000 per dose.  Unfortunately, the use of Avastin® to treat AMD is an off-label use.  In the fall, Genentech actively tried to prevent such off-label use, relenting (somewhat) only days ago.  For information regarding this topic, please see:

    • "Compromise Resolves Avastin® Dispute," December 26, 2007
    • "Genentech Beset with Avastin® Woes," December 6, 2007
    • "Age-related Macular Degeneration Patients Get a (Limited) Reprieve," November 7, 2007
    • "Genentech Acts to Halt Off-label Use of Avastin® for Age-related Macular Degeneration," October 21, 2007
    • "Genentech CEO Defends Differential Cost for Avastin®/Lucentis® Treatment of Macular Degeneration," June 6, 2007
    • "Retinal Specialist on the Avastin®/Lucentis® Controversy," February 23, 2007
    • "Lower Doses of Genentech’s Avastin® Effective in Treating Lung Cancer," February 23, 2007

    #14 – Venter Tries to Create First Synthetic Organism

    In an attempt to identify a minimal gene set for the purpose of creating the first synthetic organism, a group of researchers led by Dr. J. Craig Venter has been working to define a core set of essential genes in the Mycoplasma genitalium genome.  For information regarding this and other related topics, please see:

    • "Playing the Bioterror Card in the Synthetic Biology Debate," December 19, 2007
    • "The Synthetic Biology Sky Is Not Falling," December 16, 2007
    • "Patenting Life (Part II)," June 29, 2007
    • "Patenting Life (Really)," June 11, 2007

    #13 – WARF Stem Cell Patents under Re-examination

    Stem cell patents owned by the Wisconsin Alumni Research Foundation (WARF), which have been involved in re-examination proceedings in the U.S. Patent and Trademark Office, have come under attack from a number of groups that may have "hidden" motives for trying to knock out these patents.  For information regarding this and other related topics, please see:

    • "It’s Time to Stop the Hypocrisy over Stem Cell Patents – Part III," July 4, 2007
    • "WARF Responds to the Patent Office on Its Re-examined Stem Cell Patents," June 26, 2007
    • "The Potential Usefulness of Adult Stem Cells Reaffirmed," June 25, 2007
    • "Can Fibroblasts Solve The Problems with Human Embryonic Stem Cells?" June 15, 2007
    • "Massachusetts to Invest $1 Billion on Medical and Science Research," May 10, 2007
    • "It’s Time to Stop the Hypocrisy over Stem Cell Patents – Part II," April 26, 2007
    • "It’s Time to Stop the Hypocrisy over Stem Cell Patents – Part I," April 17, 2007
    • "WARF Stem Cell Patent Claims Rejected in Re-examination," April 3, 2007
    • "NIH Chief Dissents on Federal Stem Cell Funding Ban," March 20, 2007
    • "Stem Cells a Go! in California," February 28, 2007
    • "Limitations on the Usefulness of Adult Stem Cells," February, 28, 2007

    #12 – Gene Patenting Debate

    Following a year-long attack on gene patents by a number of individuals and groups, the House Subcommittee on Courts, the Internet and Intellectual Property held a hearing entitled "Stifling or Stimulating – The Role of Gene Patents in Research and Genetic Testing."  Will this hearing result in a bill to eliminate gene patents?  We will have to wait until 2008 to see.  For information regarding this and other related topics, please see:

    • "House Subcommittee Schedules DNA Patenting Hearing," October 26, 2007
    • "The Continuing Threat to Human Gene Patenting," October 16, 2007
    • "The Anti-Patent Beat Goes on at The New York Times," July 1, 2007
    • "The Future of DNA Patenting," February 20, 2007
    • "A DNA Patenting Thought Experiment," February 16, 2007
    • "Science Fiction in The New York Times," February 13, 2007
    • "The Continuing Value of Biotech Patenting," February 4, 2007
    • "Anti-Patent (Sullivan?) Malice by The New York Times," January 29, 2007

    #11 – District Court Dismisses Suit Challenging USPTO Deputy Director’s Appointment

    If the Patent Office had to win something, most patent practitioners would probably agree to let the Office have this suit.  Nevertheless, the appointment of Margaret Peterlin, a former Capitol Hill staffer having no "professional background and experience in patent or trademark law," did nothing to lessen the outcry of the Office’s critics.  For information regarding this topic, please see:

    • "Margaret Peterlin Gets to Keep Her Job," December 10, 2007
  • Biologics Legislation Faces Unresolved Issues

    December 28, 2007

        By Baltazar Gomez —

    We previously reported on the passage by the U.S. Senate Committee on Health, Education, Labor & pensions of bill S.1695, entitled "The Biologics Price Competition and Innovation Act of 2007."  The bill’s sponsors stated that the bill reflects a balanced approach that enables patients to have safe and effective biological drugs, while giving incentives to generic companies to bring low-cost versions to market.  The bill seeks to provide regulatory routes necessary to establish an approval process for generic biologics comprising the creation of a scientifically rigorous, efficient, and FDA-driven pathway, as well as a mechanism for timely resolution of patent disputes.

    800pxchicago_tribune_logosvg
    An article in the Chicago Tribune by staff reporter Bruce Japsen, however, paints a less glowing picture (see "Path May Clear for Biotech Generics").  Although cheaper biogenerics would be good news for consumers and for companies producing the biogenerics, innovator companies would see painful revenue reduction.  As the article points out, many innovator companies are already facing revenue reduction from expiring patents, and if the House approves a similar bill, innovator companies could face additional revenue reduction.  Presently, there is no regulatory pathway within the FDA to bring biogenerics to market.

    Generic_pharmaceutical_association_
    As beneficial as the bill seems for biogeneric companies, the generic industry cites critical issues that undercut the cost benefit to consumers.  For instance, Teva, a generic maker and significant patent holder, has stated that it would prefer a shorter exclusivity period closer to that provided by the Hatch Waxman Act than the unprecedented twelve years of market exclusivity the bill would provide to an innovator company.  And according to Kathleen Jaeger, president of the Generic Pharmaceutical Association, the bill would also allow innovator companies to make a minor change to a biologic drug and receive an additional twelve years of exclusivity (see "Victory of Sorts as ‘Biogenerics’ Bill Passed in US Senate").  Jaeger further argues that such practice would essentially prevent low-cost biogenerics from ever reaching patients.

    At the same time, any biogeneric legislation must ensure that innovator companies have sufficient incentive and patent protection to create and develop new biologics in addition to provide safe biogenerics.  Congress faced similar problems in the chemical drugs industry during the passage of the Hatch-Waxman Act in 1984.  But the Hatch-Waxman Act does not apply to biologics, which inherently differ from chemical drugs.  For example, biologics are made in living systems, such as micro-organisms, plants, or animal cells.  Biologics are usually produced by recombinant DNA technology and comprise very large and complex molecules.  Thus, biologics are extremely difficult to replicate and will require a separate set of regulatory rules.

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

    • "BIO CEO Provides Briefing on Follow-On Biologics and Patent Reform," September 18, 2007
    • "Three New Biosimilars Pass EMEA Test," July 26, 2007
    • "European Medicines Agency Releases Paper on Biosmiliar Medicines," July 23, 2007
    • "Senate Committee Passes Biologics Legislation," July 5, 2007
  • Biotech Auction in Progress

    December 28, 2007

        By Robert Dailey —

    Activbiotics_logo
    ActivBiotics announced last week that it is auctioning
    off substantially all of its assets following the failed clinical trial of its
    cardiovascular drug Rifalazil.

    Rifalazil, a bactericidal anti-chlamidial agent, had been
    placed on the FDA’s Fast Track just one year ago.  The drug had shown initial promise as a
    potential treatment for peripheral arterial disease (PAD).  While other treatments for PAD exist, none
    treat the underlying cause of the disease, the Chlamydia pneumoniae
    infection.  But in clinical trials, the
    drug showed no greater effectiveness in treating PAD than placebo.

    65663540display_3

    The assets for sale include intellectual property related
    to the following:

    • Rifalazil and related anti-bacterial compounds;
    • A superoxide dismutase (SOD) program focused on
      developing drugs for the treatment of inflammatory diseases; and
    • A library of novel anti-bacterial agents.

    Bids are due by February 1, 2008.

    ActivBiotics was founded in 1996 as Merlin Technologies,
    based in Lexington, Mass.  Following its
    IPO in 2006 and the news of rifalazil’s acceptance into Fast Track, the small
    biotech company seemed to be on the verge of making a big splash.

    The mid-1990s witnessed the founding of hundreds, if not
    thousands, of such biotech start-up companies.  For a number of years, these companies rode the wave of easy-to-get
    venture capital.  Now that a decade has
    passed, a lot of these start-up companies find themselves with little money and
    few promising compounds.  Are we seeing
    the beginning of a bursting biotech bubble?

    For years, Big Pharma has told us that drug development
    is an arduous process marked by extensive failure.  In the 90s, many investors doubted that
    warning, and believed that nimble start-ups would serve as the future
    incubators of blockbuster drugs.  Perhaps
    Big Pharma was right all along.

  • USPTO News: USPTO to Halt Weekly Paper Publication of USPTO Practice and Procedure Notices

    December 27, 2007

        By Christopher P. Singer —

    Uspto_seal
    In the December 26, 2007 Federal Register, the USPTO
    announced that
    it will discontinue publishing the paper form of the Official Gazette, after
    the December 25, 2007 publication.  The
    weekly USTPO notices will be published in the electronic Official Gazette (the
    eOG:P) and will display the notices with the volume/page numbers, and the last
    weekly eOG:P of each calendar year will include the annual publication of the
    consolidated notices pertaining to USPTO practices and procedures.  The prior versions of the eOG:P did not
    include the volume/page numbers, which were present in the separate paper
    publication.  The eOG:P, which will
    display the weekly notices (with volume/page numbers), can be found here beginning on Tuesday, January 1, 2008.  The first consolidated annual publication of
    the eOG:P will be published at the end of 2008 (i.e., the notices from 2007
    will not be indexed in a consolidated eOG:P with volume/page numbers).

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