Biotech and Medtech - Inventions & Patents

For years the relationship between doctors and the pharmaceutical industry has been under scrutiny.  The same magnifying glass is gradually being applied to surgeons and the medical device industry.  Within the last twelve months this type of scrutiny has intensified on the orthopedic community. This culminated in five leading US orthopedic companies being investigated.  The investigation resulted in the orthopedic companies agreeing to a Deferred Prosecution Agreement in September 2007 (see my Sep 2007 blog).  Although not admitting any liability, they agreed to pay a huge sum money and also agreed to be subject to oversight for 18 months by a US federally appointed monitor, pertaining to past consulting arrangements with healthcare professionals.  Zimmer alone paid the government $170 million.  One of the best attended symposiums at the recent annual meeting of the American Academy of Orthopedic Surgeons is the symposium on doctor-industry relation.  Certainly the situation is changing and advocate groups are getting more insistent and the industry is trying their best to comply with government's initiative (see Associated Press' report). 

For the medical device industry where ideas, innovation and identifying unmet medical needs, traditionally comes from surgeons and doctors.  There is a need to balance reform with judicious management of physician's conflict of interest.  We need to be mindful not to throw out the baby with the bathe water.

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

There is a marked contrast between the US and Canadian health care systems.  Having worked in both systems, I have often compared them staying as in Days Inn as the only choice (for Canadians) as opposed to the US system where you have a choice of staying either at the Hilton and or the Budget Motel.  The freedom to choose comes at a price and some may say too much.  An opinion piece published in the prestigious New England Journal of Medicine on Feb 7, 2008 blaming the failure of market forces to deliver optimal health care is surely going raise this issue to the next level of debate in this election year.  This article is written by Robert Kuttner, a well known and well respected left-leaning liberal writer-commentator.  He is the co-founder and co-editor of The American Prospect,  "an authoritative magazine of liberal ideas," according to its mission statement.

He crafted very cogent arguments for his point of view against a backdrop of the US health care system being an outlier against international practices.  Medicare statistics indicate that the average cost of health care for every person in the United States is $7,000 and this amounts to over $2.1 trillion.  He offered an alternative interpretation how the US health care system ended in the current extreme state of failure.  He stated that the pervasive commercialization of health care not only did not create an efficient market but has unintended consequences contributing to the massive market failure.   Kuttner claims that market forces for cost containment are generally targeted at maximizing shareholder values and the burden has fallen on the primary care physicians with increased case load, relying on tests rather than hands on diagnostic skill and referring to specialists when none is necessary.

Read more...

We are currently working in stealth mode on a journal article management plus academic networking software.  This has been previewed by a limited and trusted audience.  The initial reaction was why are you doing another one when there is already Endnotes and now Zotero out there.  I needed justification and inspiration as to why we are doing this as I am funding this project myself.

I am sure Steve Job was confronted with the same type of skepticism when he worked on iTune, iPod and iPhone.  Then I began to do more research on this including viewing all the videos of Steve Jobs posted on Youtube.  It was an interesting journey of discovery including re-reading Steve Jobs' commencement address at Stanford which I read more than 2 years ago.   Here is the full text......

1. Determination of a genuine need for consultants.
2. Physicians to disclose their financial engagement to patients and hospitals.
3. Provide a list of names and amount paid of all consultants on their website in a prominent fashion.
   

In designing medical devices or developing new products in the biotech industry, patent review is part and parcel of the due diligence process prior to committing resources into a project. Increasingly the engineers or scientists either by themselves or in consultation with IP professionals, have to make some kind of freedom-to-operate determination. Often times such decisions are subjective. The recent ruling by the United States Court of Appeals for the Federal Circuit on "willful infringement" could make things a little easier for the engineers and scientists....