Biotechnology

As reported in previous posts, on petition for certiorari the Supreme Court vacated the Federal Circuit's 2011 decision in Association for Molecular Pathology v. US PTO and remanded the case for further consideration in light of its decision in Mayo v. Prometheus . Yesterday, the Federal Circuit issued its decision on remand. Of course, this might not be the end of the story, since the plaintiffs will presumably petition for rehearing by the en banc Federal Circuit and/or certiorari by the Supreme Court. Some believe that the Supreme Court is likely to grant certiorari, based on the diverging opinions of the three Federal Circuit judges, and the arguably short shrift given by the majority to the relevance of Mayo to the Myriad claims. Not surprisingly, the Mayo decision and the parties' subsequent re-briefing and re-arguing of the case did not alter the views of any of the three Federal Circuit judges deciding the case. As was the case in the first decision, the judges al...

GENEVA, Switzerland CNN The World Health Organization on Wednesday raised its pandemic alert to 5, its second-highest level, warning of widespread human infection from the swine flu outbreak that originated in Mexico. Dr. Margaret Chan, the U.N. agency's director-general, said the decision to raise the alert on the 6-point scale indicated that all countries should "immediately" activate pandemic preparedness plans. "This change to a higher phase of alert is a signal to governments, to ministries of health and other ministries, to the pharm industry and the business community that certain actions now should be taken with increased urgency and at an accelerated pace," Chan said. The announcement came as the number of confirmed cases increased rapidly across the world. The WHO and national governments have confirmed 148 cases in nine countries. Most of those cases are in the United States, where the Centers for Disease Control and Prevention has confirmed 91 cas...

There is an on going debate about the future of the current pandemic. This debate is portrayed superbly in the following articles by the BBC. The first was published on May the 1st and the second only five days later. It is important to understand that scientific knowledge cannot predict the evolution of the virus; this is why the global scientific community is monitoring the progress of the pandemic in such an intense manner. What scientists know about swine flu Emma Wilkinson Health reporter, BBC News 13:17 GMT, Friday, 1 May 2009 14:17 UK Preliminary analysis of the swine flu virus suggests it is a fairly mild strain, scientists say. It is believed that a further mutation would be needed in order for the H1N1 virus to cause the mass deaths that have been estimated by some. But at this point, it is impossible to predict with any accuracy how the virus will continue to evolve. UK experts at the National Institute for Medical Research outlined on Friday the work they are due to sta...

In the 1990s Centocor and Abbott both developed human antibodies specific for interleukin 12 ("IL-12", a cytokine), and filed patent applications broadly claiming isolated antibodies that bind IL-12. Abbott's work has resulted in a pharmaceutical composition (briakinumab )that is currently in late stage clinical trials, and two US patents, (6,914,128 and 7,504,485). Centocor's has resulted in the FDA approved drug Stelara. In 2007 an interference was declared between Abbott's ‘128 patent and a pending Centocor patent application, and in 2009 the BPAI decided the interference in favor of Abbott. Both companies’ antibody products bind to the P40 subunit of IL-12 (it was not clear to me from reading the decision whether the products bind to the same epitope, although I suspect they do not). The antibodies have substantially different amino acid sequences, and were developed independently using different methodologies. Abbott has sued Centocor, seeking a declarat...

Influenza A virus subtype H1N1 H1N1 is a subtype of the species Influenza A virus. The "H" refers to the Hemagglutinin protein, and the "N" refers to the Neuraminidase protein. H1N1 has mutated into various strains including the Spanish Flu strain (now extinct in the wild), mild human flu strains, endemic pig strains, and various strains found in birds. A variant of H1N1 was responsible for the Spanish flu pandemic that killed some 50 million to 100 million people worldwide from 1918 to 1919. A different variant exists in pig populations. Low pathogenic H1N1 strains still exist in the wild today, causing roughly half of all flu infections in 2006. When the 1918 virus was compared with human flu viruses in 2005, it was noticed that it had alterations in just 25 to 30 of the virus's 4,400 amino acids. These changes were enough to turn a bird virus into a version that was human-transmissible. In April 2009, an H1N1 outbreak killed over one hundred (100) in Mexico, ...

When I first read the Supreme Court's decision in Prometheus , I must admit I was somewhat taken aback. To my mind, the Federal Circuit had already drawn a reasonable and relatively well-defined line between patent eligible molecular diagnostic methods that entail a physical step of analyzing for the presence of molecular marker and/or treating a patient ( Prometheus ) and patent ineligible diagnostic methods that could potentially be infringed by the mere analysis of genetic information ( Myriad ). Prior to yesterday, I had been hopeful that a majority of the Justices on the Supreme Court would agree and that the Federals Circuit's decision in Prometheus would be affirmed. Instead, as most of my readers are no doubt already aware, the Supreme Court unanimously reversed the Federal Circuit’ decision, declaring all of Prometheus’ claims at issue in the case patent ineligible. With the benefit of 20/20 hindsight, the Supreme Court's decision does not strike me as surprisi...

In previous posts to this blog, I have discussed three important cases that pertain to the patent eligibility of inventions based on the discovery of medically useful correlations involving patient clinical data - Prometheus v. Mayo , Association for Molecular Pathology v. PTO (AMP) and Classen v. Biogen . Correlations of this type lie at the heart of diagnostics and personalized medicine, so the outcomes of these cases has important ramifications for the patent eligibility of these increasingly important technologies. Classen v. Biogen was decided on August 31, 2012, so now we have Federal Circuit decisions on all three cases. None of the three cases is necessarily “over” - the Supreme Court has granted certiorari in Prometheus, the parties are petitioning the Federal Circuit for a rehearing of AMP, and the parties in Classen will have the opportunity to do the same. Still, it seems like an appropriate time to step back and assess where we are in light of these three important p...