Tuesday, February 26, 2008

Another setback for the Cabilly patent

Genentech the owner of the Cabilly patent announced on Monday February 25, 2008 that it has received notification from USPTO that the patentability of the claims in the Cabilly patent has been rejected.  This is a high stake game with millions of royalty payment at stake.

As discussed in my previous blogs, the Cabilly patent (also known as the Cabilly II patent for this particular case) covers the method of making monoclonal antibodies and antibody fragments.  Genentech in addition to using the technology to make it own drugs (Avastin, Herceptin and Rituxan) also license the technology to other companies.  Many billion dollar drugs such as Humira and Remicade for rheumatoid arthritis (Abbot and J&J) and Erbitux for colorectal cancer (Imclone) need the Cabilly patent for their manufacture.

This notification is in the form of a Final Office Action does not mean the end of the Cabilly patent.  Because of the huge amount of royalty is affected, Genentech will no doubt appeal the decision to the Board of Appeals of USPTO.  In the meantime the patent is deemed to be still valid pending the Appeal and this may take up to 2 to 3 years and Genentech can continue to enforce the patent and collect royalties.

Read my previous posts on Cabilly Patents
Cabilly I
Cabilly II

Posted by at 22:18:43 | Permanent Link | Comments (0) |

Sunday, February 17, 2008

Impending Changes on the Promotion of Off-Label Use

FDA is an agency within the United States Department of Health and Human Services and is mandated to regulate through its subdivisions Center for Devices and Radiological Health (CDHR) for medical devices and Center for Drug Evaluation and Research (CDER) for drugs with respect to safety and efficacy.  In addition to safety and efficacy, FDA regulates almost every facet of prescription drugs and use of medical devices, including testing, manufacturing, labeling, advertising and marketing.   The intent is to protect the public against fraudulent claims and to ensure safety of the consumers.  The intent of FDA is not to regulate the practice of medicine.  Within this context, a drug or medical device that has been approved by FDA for a specific use can at the discretion of the physician be legally used for conditions other than those approved by FDA.  Such practice is called the off-label use of an FDA approved product and the rules of the game are changing, at least for the companies. 
Posted by at 14:48:27 | Permanent Link | Comments (0) |

Sunday, December 23, 2007

Time Magazine's Best Inventions of the Year

Each year Time Magazine in conjunction with CNN come up with a list of best inventions for various categories.  Because of the large number of categories and each invention is listed on separate page (I guess for more advertising opportunities), it is cumbersome to go through all of them.  I have condensed the best inventions on the Health category into a single page.  The best invention in my opinion for the health category is....
Posted by at 23:30:58 | Permanent Link | Comments (0) |

Sunday, June 17, 2007

Renaissance Man

Jim Larrick, MD PhD runs a private research institute called Panorama Research in Mountain View, California (a stone throw from Google headquarter).  This private research institute competes on equal terms with academic institutions for research grants from NIH and other federal agencies including SBIR grants.  Jim has founded 14 biotech companies out of Panorama Research of which 4 have gone IPO (some through mergers).  This is not a bad record for a private research institute.  Many universities would have love such a track record.

Jim is first and foremost a maverick; not the type that will fit well in an academic institution.  He is not only an entrepreneur but also a consummate scientist with a solid track record of having published over 240 peer review journal articles.  He published one of the first books on oncogene with Ed Liu, currently the Executive Director of the Genome Institute of Singapore.

He was recently in Africa with the Sanofa Center for African Dance & Culture.  The purpose of this trip was to promote AIDS awareness through the medium of dance.  Jim's production company, Slick Production (no kidding), produced a moving documentary in HDTV format about this trip.  You can view a sample of the documentary from here and a new trailer from here.

Posted by at 12:31:35 | Permanent Link | Comments (0) |

Monday, March 26, 2007

Two Points

I have procrastinated for three months before I finally decided to re-visit my previous blog on RNAi. I want to use this Blog to illustrate two points. Firstly how fundamental research can lead to patentable platform technology which Christensen called "disruptive technology". Secondly, I would like to use this case as an illustration on how to look up information related to an issued patent that would not be apparent in the patent itself. Shortly after my blog on RNAi in September 2006, it was announced in October 2006 that Andrew Fire and Craig Mello were the recipient of the Nobel Prize in Physiology or Medicine for their work on RNAi. Their discovery that double-stranded RNA when injected into worms would silence the gene with the complimentary sequence was published in Nature in 1998. Underscoring the importance of this discovery is the fact that the Nobel Prize was awarded only eight years later after the initial discovery.
Posted by at 23:21:39 | Permanent Link | Comments (0) |

Friday, December 22, 2006

Best Inventions 2006

  

This year Time Magazine's Best Inventions 2006 has selected an invention which I felt is very relevant to the holiday season.  TruTouch technology has come up with a really bright idea (pardon the pun) of using near infrared spectroscopy to detect alcohol level transcutaneously.  This non-invasive method reportedly will detect alcohol level in 60 seconds flat.   

Posted by at 23:21:20 | Permanent Link | Comments (0) |

Saturday, September 30, 2006

Do you have to pay royalty during clinical trials?

Whether you are doing clinical trials for drug or medical device you need to be aware of a safe harbor provision in the US patent.  This exemption from infringement is known as Section 271(e)(1) and is especially important for the pharmaceutical industry.  This issue is made famous by the Merck vs. Integra case. The Supreme Court reviewed a decision of the court of Appeals for the Federal Circuit and held that Merck was not guilty of patent infringement for using Integra’s patents for clinical research.   

Posted by at 19:25:27 | Permanent Link | Comments (1) |

Monday, September 18, 2006

RNAi - A no-brainer that did not turn out to be so.

Why did a technology that was hailed as the “Breakthrough of the Year” in 2002 by the journal Science did not succeed commercially, at least not yet?  There was high hope that RNAi maybe the next class of miracle drug.  So much so that in February 2004, MIT’s Technology Review listed it as one of the “10 Emerging Technologies That Will Change Your World”.  It was believed that modern ailments such as heart disease, hepatitis, diabetes, Alzheimer’s disease, cancer and AIDS that are triggered by “errant genes”, could be arrested or cured by turning off the genes by using RNAi.  

Posted by at 19:57:11 | Permanent Link | Comments (0) |

Sunday, September 03, 2006

The Cabilly Controversy

In 1989, Genentech was issued the first ‘Cabilly’ patent (named after the inventor Shmuel Cabilly and others). The Cabilly patent (US 4,816,567) claims methods for making monoclonal antibodies using recombinant DNA technology. In the same year Celltech was issued a similar ‘Boss’ patent (named after the inventor Michael Boss and others). The Cabilly patent claims also included the claims in the Boss patent ( US 4,816,397). As a result the two companies entered into a lengthly interference dispute that was resolved in 2001.

 

Posted by at 22:42:31 | Permanent Link | Comments (0) |