Related to Preliminary Thoughts on the Implications of Prometheus v. Mayo for Biotechnology

• Jumping On Genetic Testing—The War of the SNPs
  Molecular diagnostics still have a long way to go before they can properly deliver on all their promises.
  
• New Uncertainty Regarding Disclosure of Adverse Effects
  Recent Matrixx Initiatives decision muddies requirements set forth in Carter-Wallace over a decade ago.
  
• 2009 in Review: Headline-Making Stories in the Biotech Industry
  Even though last year was marred by the economic crash, the life science sector showed significant progress.
  
• Court’s Halt of Federally Backed ESC Research May Impact Economic Growth
  If the injunction sticks, U.S. firms will likely send ESC research jobs abroad.
  
• Getting Personal: Multigene Testing for Individual Cancer Evaluation
  Scientists find comfort in numbers, using molecular patterns as prognostic markers.
  
• Beckman Coulter on the Chopping Block?
  Some analysts believe it is not a question of who will buy the firm but if the firm will be bought.
  
• Tumor Cells Back in Circulation for Monitoring Cancer
  With one test on the market, researchers are developing tools that leverage CTCs as biomarkers.
  
• Opinion: Watson, Come Here … You're Needed at the PTO
  Without a transformation of the information technology supporting patent examiners, patent reform would be like rearranging the deck chairs on the Titanic.
  
• Patent Reform Likely to Benefit Industry Giants More Than Start-Ups
  Points of concern in the America Invents Act include provisions for first-to-file and inequitable conduct.
  
• Legal Challenges to Healthcare Reform Threaten Biopharmaceutical Legislation
  Initiatives detailed in the Act, like those to boost personalized medicine and comparative effectiveness research, could be lost.
  
• Supreme Court’s Decision in Matrixx v. Siracusano Calls for More Disclosure of Adverse Events to Investors
  Side effects that are not statistically significant must also be divulged.
  
• IP Rules for Synthetic Bio Generate More Questions Than Answers
  Among unresolved issues are gene patentability, patent protection vs. open access, and the effect of patent reform.
  
• Patent Uncertainty and Political Flux Keeping hESC Investors from Seeing Returns
  Researchers are exploring other avenues in light of various unknowns.
  
• House Version of Patent Reform Poses Challenges for Biotech Inventors
  Issuing on a first-to-file basis could hurt smaller firms, and restrictions on USPTO revenue could hinder review process.
  
• Diagnostic Market Stakeholders Take Aim at FDA’s RUO/IUO Draft Guidance
  Among potential changes is that manufacturers will have to anticipate customers’ intended use of their IVD products.
  
• Language in Bill and Capitol Hill Politics Create Cloudy Outlook for Sunshine in Litigation Act
  Where product liability suits are concerned, the status quo is most likely to prevail.
  
• USPTO Effort for Small Businesses Seeking Overseas Patents Draws Interest from Bioindustry
  A study assessing what role, if any, the federal government should play will be submitted mid-January.
  
• USPTO Tasked with Evaluating Impact of Gene Patents on Second-Opinion Testing
  Diagnostic firms argue IP protection is key to innovation, while their opponents say it hurts medical practice.
  
• Supreme Court Grapples with What Makes Processes Patentable in Prometheus v. Mayo
  Justices will consider whether Prometheus' claims cover laws of nature or applications of laws of nature.
  
• Standardization Key to Taking Next-Generation Sequencing to the Next Level
  As NGS technology makes steady progress with faster and cheaper machines, regulation will have to keep up.