Scott Gottlieb, MD, in a Forbes opinion, opines the Food and Drug Administration’s increasingly cautious approach to the approval of new medicines. Previously, the FDA rejected the testosterone patch Intrinsa and recommended against over-the-counter status for the cholesterol-lowering drug Mevacor. Now, the FDA’s Oncology Drug Advisory Committee (ODAC) may delay approval of new drugs.

Apparently, the chair of the FDA’s cancer drug advisory committee rejected the idea that cancer drugs should be allowed onto the market if they are reasonably safe and have some degree of effectiveness ("efficacy") with the understanding that oncologists will determine their value through routine use of the drug, as is now customary.

This doesn’t bode well for biotech companies working on cancer drugs, most of whom are already suffering from a high burn rate. Currently, the approval process can take as long as ten years and cost nearly half a billion dollars

This begs the question:  Shouldn’t patients who are dying have some say on the cost:benefit ratio they are willing to accept?  As Dr. Gottlieb states, "A fresh crop of caution inside the FDA may keep the agency out of the news, but it won’t keep my cancer patients from dying."

  Print This Post Print This Post  

Mergen Limited announced it has resolved its patent infringement litigation case with Oxford Gene Technology.  Under the terms of the settlement, Mergen has obtained a license from OGT for its expression chips in the U.S., Europe and Japan.  This license allows Mergen to manufacture and sell microarrays, e.g., Mergen’s ExpressChip(TM) DNA microarray system for high-throughput, high-sensitivity gene expression profiling.   See the Press Release.

  Print This Post Print This Post  

Details behind the European Patent Office’s (EPO) decision in May 2004 to revoke Myriad Genetic’s 2001 BRCA1 gene patent have been made public. The main claim related to a method of diagnosing a predisposition to human breast/ovarian cancer by analysing mutations in the BRCA1 gene. The gene was defined broadly by reference to a specific amino-acid sequence and variant sequences "with at least 95% identity to that sequence". The Opposition Division of the EPO rejected the claims of the granted patent on the grounds that there was inadequate basis in the application as originally filed for inserting the feature "with at least 95% identity" into claim 1 of the granted patent. Several sets of amended claims filed by Myriad were then considered in turn by the EPO.

Myriad first tried to avoid the limitation of the claims to a specific BRCA1 sequence by removing the sequence from the claims, arguing that the term ‘BRCA1 gene’ was clear in itself and that the sequence of the gene was not necessary to carry out the invention. This was rejected by the EPO on the grounds that the sequence was an essential technical feature of the claim and also that its removal would illegally extend the scope of the patent. Myriad then tried to amend the claims to refer to the specific BRCA1 gene sequence and also to several specific mutations that are characteristic of breast and ovarian cancers.

The priority date of the claims then became a key issue, because a sequence of the BRCA1 gene and details of all three mutations claimed by Myriad were published in the interval between the filing of Myriad’s earliest US priority application and their European patent application.   Myriad’s original patent filing in 1994 contained several errors in the DNA sequence of the BRCA1 gene. In 1995, the company had submitted a revised sequence, correcting the errors but it turned out that the new sequences had already been published.  Myriad has until 21 January 2005 to file an appeal.

This shows the strict approach that the EPO takes regarding claim amendments and priority for gene sequences.   It’s just an example of the need to be incredibly stringent in filing gene applicaitons.

  Print This Post Print This Post  

France is considering a biotech tax cut believing that tax reform will boost innovation, but I’m not so sure that companies decide on starting or relocating to one country over another based on some tax cuts.

The proposal is for special tax status for “young listed companies” (“jeunes entreprises cotees”) that would help companies after initial public offering (IPO), expanding on a program that now helps companies before IPO. The plan would give investors and shareholders in companies with less than ?150 million (USD $195.4 million) in annual revenues and with fewer than 2000 employees breaks from capital gains taxes, inheritance taxes, wealth taxes, retirement, and other “social” costs 8 years after a company goes public.

Like the Midwest, I think France needs more aggressive researchers and venture capitalists specialized in biotech before they need tax cuts. It’s interesting to see how various governmental agencies all wring their hands at trying to develop a plan to be the Silicon-valley for biotech whenever that boat’s sailed.

See more at:

J. Burgermeister, “French scientists plan protest,” The Scientist, January 10, 2005.

S. Pincock, “Life sciences centers compared,” The Scientist, June 11, 2004.

  Print This Post Print This Post  

J. Craig Williams, on his blog May It Please the Court, after noting that "blogging as a phenomenon is reaching epic proportions, asks the question: Are blogs advertising?  Williams believes yes.  He thinks that "it would be difficult to identify a purely altruistic blog" and thinks that, in the broadest sense of the word, all legal blogging is advertising.  He then asks, if blogging is advertising, is the ad "just restricted to that rectangle at the top of this page?"

Post your thoughts on his blog here.

For the opposing view that blogs are not ads, see the post by David Giacalone of f/k/a ethicalEsq here.

I think that a blog, even in your field, doesn’t always constitute an advertisement.  If this were so, then any activity undertaken by a lawyer would be an ad.  If I’m coaching my son’s Little Leage game, should I be required to wear a jersey that states "This is an Advertisement" since I might bump into someone who might want some legal advice?   Now for the argument of what the definision of ad is.  Let me know your thoughts.

  Print This Post Print This Post  

According to a new survey, US universities increased the number of licenses and options executed by over 20% between fiscal years (FY) 2001 and 2003. However, the number of startups created from such licenses dropped 17%. The Association of University Technology Managers (AUTM), released its latest annual licensing survey, which covers FY2003. AUTM sent questionnaires to the licensing offices and 236 institutions responded.

The survey showed that the number of startups created in FY2003 was only 374, much less that the 424 two years earlier. The shift of licenses to more established businesses is is seen by the decrease in number of licenses to startups and small firms, which decreased from 69% in FY2002 to 65.5% in FY2003, while those to large companies increased from 31% to 34.5%.

Much of this would seem to be due to the overall drop in technology investing in early-stage companies and parallel drop in the stock market.  We’ve  seen a gradual increase in interest by investors in starting up companies and a more aggressive approach by big-pharma and bio companies to look to universities and start-ups for products to fill their pipeline.

  Print This Post Print This Post  

Jon Gowshall of Forrester Ketley & Co. sent us a note on changes to UK patent law starting on 1 January 2005.  The changes are to bring UK law into line with the WIPO Patent Law Treaty (PLT) signed in Geneva in June 2000, and into line with the European Patent Convention as prospectively amended in 2000 (but not yet in force).  These changes make the UK patent system much more applicant friendly, allowing rights to be safeguarded in situations where, previously, they would have been lost.

Some changes include:

1. Restoration of priority – If the twelve-month Convention deadline is missed, the new law allows a late application claiming priority to be filed, providing that it is filed within 2 months of the Convention deadline, and provided that the Comptroller of Patents is satisfied that the applicant always intended to file the application within the 12 month period.

2. Rush filing – The date of filing an application for a patent shall be taken to be the earliest date on which documents filed at the Patent Office to initiate the application satisfy the following conditions –

(i) the documents indicate that a patent is sought;

(ii) the documents identify the person applying for a patent or contain information sufficient to enable that person to be contacted by the Patent Office; and

(iii) the documents contain either: (a) something which is or appears to be a description of the invention for which a patent is sought; or (b) a reference, complying with the relevant requirements, to an earlier relevant application made by the applicant or a predecessor in title of his.

3. Extensions of time for reinstatement – available once, by a period of two months as of right. Extension must be requested in writing within two months of the expiry of the period in question.

4. Restoration of Lapsed Patents – restoration will be granted if the applicant can simply prove that his failure to pay the fee was unintentional.

5. Medical Use Claims – can now claim "Swiss-style" claims as ?Substance Y for use in treatment of disease X?.

I will be interested in seeing how the rush filing provisions are handled in practice.  These type of provisions are already available in Scandinavia, for example.  I’m always in favor in having some leeway in terms of getting a filing date.  If only the Patent Office could just know what I meant to file…

  Print This Post Print This Post  

The partners of Boston firm Testa, Hurwitz & Thibeault, LLP voted to wind up the business of the Firm and dissolve it.  In early December, 10 partners decided to leave the Firm and the remaining partners decided to dissolve the partnership.  The Firm had one of the largest patent and intellectual property practices in New England.

Read more here.

  Print This Post Print This Post