By Donald Zuhn —

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