By Donald Zuhn —

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