About this Author
DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

Chemistry and Drug Data: Drugbank
Chempedia Lab
Synthetic Pages
Organic Chemistry Portal
Not Voodoo

Chemistry and Pharma Blogs:
Org Prep Daily
The Haystack
A New Merck, Reviewed
Liberal Arts Chemistry
Electron Pusher
All Things Metathesis
C&E News Blogs
Chemiotics II
Chemical Space
Noel O'Blog
In Vivo Blog
Terra Sigilatta
BBSRC/Douglas Kell
Realizations in Biostatistics
ChemSpider Blog
Organic Chem - Education & Industry
Pharma Strategy Blog
No Name No Slogan
Practical Fragments
The Curious Wavefunction
Natural Product Man
Fragment Literature
Chemistry World Blog
Synthetic Nature
Chemistry Blog
Synthesizing Ideas
Eye on FDA
Chemical Forums
Symyx Blog
Sceptical Chymist
Lamentations on Chemistry
Computational Organic Chemistry
Mining Drugs
Henry Rzepa

Science Blogs and News:
Bad Science
The Loom
Uncertain Principles
Fierce Biotech
Blogs for Industry
Omics! Omics!
Young Female Scientist
Notional Slurry
Nobel Intent
SciTech Daily
Science Blog
Gene Expression (I)
Gene Expression (II)
Adventures in Ethics and Science
Transterrestrial Musings
Slashdot Science
Cosmic Variance
Biology News Net

Medical Blogs
DB's Medical Rants
Science-Based Medicine
Respectful Insolence
Diabetes Mine

Economics and Business
Marginal Revolution
The Volokh Conspiracy
Knowledge Problem

Politics / Current Events
Virginia Postrel
Belmont Club
Mickey Kaus

Belles Lettres
Uncouth Reflections
Arts and Letters Daily
In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

« Natural Product Fragments: Get Rid of the Ugly Ones Now | Main | Selective Inhibitor, The Catalog Says »

February 26, 2013

Standard of Care? Not So Fast, Not in the United Kingdom

Email This Entry

Posted by Derek

Did you know that in the UK, patent law says that using a competitor's compound as a comparison in a clinical trial is an infringement? I sure didn't. The government has realized that this rule is much stricter than most other countries, and is moving to change it in a bid to keep more clinical research in the country. Thanks to FierceBiotech for the heads-up on this.

Comments (11) + TrackBacks (0) | Category: Patents and IP


1. PP on February 26, 2013 12:15 PM writes...

I do not know how you do it in the USA but in Europe is extremely hard to get competitor's compounds to use in clinical trials.

Permalink to Comment

2. cynic on February 26, 2013 12:58 PM writes...

Can someone offer a bit more explanation of the logic to the original law? In many clinical trials, one set of patients is treated using a commercially available drug. Isn't that what hospitals do on a daily basis, treat these people with commercially available drugs and monitor their health? How does reporting patients' medical information infringe on the commercially available drug's patent? Does it also infringe upon patents for the food the patients ate and the smartphone they used during the treatment as well?

Permalink to Comment

3. ChristianKl on February 26, 2013 1:08 PM writes...

What are we talking about? Buying the drugs of a competitor on the open market and then using them in a clinical trial? Or are we talking about synthesing them in a lab and using them in a clinical trial?

Permalink to Comment

4. Anonymous on February 26, 2013 1:12 PM writes...

oooohhh, a smart move on the backwards islands. does that not contradict the UK policy of making science more difficult?

Permalink to Comment

5. Andy on February 26, 2013 1:14 PM writes...

I believe even preparing a competitor's compound in house and using it in your own assays is actually an infringement. How many people abide by this, I'm not sure.

Permalink to Comment

6. David Formerly Known as a Chemist on February 26, 2013 3:19 PM writes...

@5 Andy...this was actually settled pretty conclusively by a Supreme Court decision in 2005 (Merck KGaA v. Integra Life Sciences). The Court upheld experimental use of patented compounds for preclinical as well as clinical research.

"Justice Antonin Scalia delivered the Court's unanimous opinion that federal law allowed the use of patented compounds in preclinical studies, as long as there was a reasonable basis to believe the compound could be the subject of an FDA submission. The Court reasoned that federal law provided "a wide berth for the use of patented drugs in activities related to the federal regulatiory process" and that "this necessarily included preclinical studies." Because federal law required only a "reasonable relation" to FDA submission, information gathered on the patented invention (a compound in this case) did not necessarily need to be submitted to the FDA to be exempt from patent protection."

Permalink to Comment

7. DatamonitorMark on February 26, 2013 3:50 PM writes...

It’s more a case that there was a lack of certainty as to what situations constituted infringement, and this allegedly was putting people off even thinking about the UK as a location for certain trials.

For discussion see and

The IPO’s attempt at summarizing the situation is “Trials carried out to discover something unknown, to test a hypothesis, or to find out whether something will work in specific conditions can be regarded as an experiment, but trials carried out to demonstrate to a third party that a product works, or to amass information to satisfy a third party that it works as claimed, are not regarded as acts done for experimental purposes and are therefore not acts which are exempt from infringement.”

The two documents at the following IPO site provide background to the recent consultation and the responses they obtained.

Given all the griping about how this was hindering R&D in the UK, the response to the IPO’s consultation was perhaps underwhelming. Their conclusions are drawn from a mere 20 responses.

As the IPO notes: “Although a call for evidence was made, very little quantified evidence has been provided.”

Permalink to Comment

8. Wile E. Coyote, Genius on February 26, 2013 4:39 PM writes...

I once worked on a preclinical toxicology study where the US regulatory agency aksed that additional tox groups be included on the study to compare two other already marketed drugs. This was a couple years before the 2005 Supreme Court decision. I think the US court got it right, as it is can be a relevant question to ask, in the right circumstances.

Permalink to Comment

9. fat old man on February 26, 2013 10:34 PM writes...

I guess I must be slow I don't get why there would be a patent infringement if the drug product was prescribed by a physician and sourced on the open market, paying the market rate, as was the custom on all projects I was familiar. Sometimes there was a deal with the other product's company for a lower price, just in cases where the drug candidate would be marketed with the co-medication (a win-win for both in a successful trial). Does this have anything to do with importation from a different country for a UK-unapproved product? Or some weird complexity of their national health system?

Permalink to Comment

10. will on February 27, 2013 9:01 AM writes...

@ 8 and 2 - The issue is almost certainly a patent on the method of using the drug for a particular therapy. The situation was the same in the US prior to the enactment of the Hatch Waxman act in 1984.

Permalink to Comment

11. Anonymous on February 27, 2013 3:38 PM writes...

@10 - field of use is certainly part of the problem. Sometimes you would like to run your clinical trials while a FOU patent is in force - but by the time you have run the trials and got reg approval the patent will have lapsed. This change will enable this to happen though how often it is really a problem and how many litigations there have been I don't have any data on.

Also in a double blind trial you may wish to have your compound and comparitor look the same. Hence you would need to make it yourself and this would infringe. If you bought some 'little blue diamonds' as a comparitor for your ED trial I reckon everyone might guess which is which and this could affect your data...

@9 this has nothing to do with the NHS. It does have something to do with politicians tinkering with laws to make it look like they are doing something to 'save the life science industry in the UK'.

Permalink to Comment


Remember Me?


Email this entry to:

Your email address:

Message (optional):

The Last Post
The GSK Layoffs Continue, By Proxy
The Move is Nigh
Another Alzheimer's IPO
Cutbacks at C&E News
Sanofi Pays to Get Back Into Oncology
An Irresponsible Statement About Curing Cancer
Oliver Sacks on Turning Back to Chemistry