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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: derekb.lowe@gmail.com Twitter: Dereklowe

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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

« Sanofi-Aventis: It's $69/Share, And That's Where It Stays | Main | A New Way to Approve Drugs »

September 13, 2010

You May Not Be Interested In It - But It's Interested In You

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Posted by Derek

Like any blog owner, I check the traffic on my site. It follows the working day, with peaks during on weekday lunchtimes, in case you're wondering: I can see both the East and West coasts kicking back with sandwiches and some blog time. And I can see when some post has really revved up the readership, or brought in hordes of outside links. (Yep, "Things I Won't Work With" is the champion in that category). I can also see when a topic has failed to do either of the above.

Patent law is the champion there. That's both understandable and sort of a shame, because it is, of course, of huge importance to the drug industry. And it can also be quite interesting, once you get into it a bit. But there's no doubt that it can also make you wish that you'd listened to Momma and gone to truck-driving school like she always wanted. Many chemists just try to avoid dealing with patent questions, or rely on a few rules of thumb that they've picked up over the years, accurately or not.

Well, there's now a book that might do a lot of us a lot of good. I've been looking over The Chemist's Companion Guide to Patent Law, by Chris Miller and Mark Evans, and I think that the field has been needing something like this for a long time. It was published just last month, and one of the authors had Wiley send me a copy. I'm in the process of reading it cover to cover, and it's staying on my reference shelf.

The title is accurate; it's a top-to-bottom look at the major features of patent law as it applies to the business of chemistry. Freedom to operate, patentability (two very different concepts), claim structure, prior art, enablement, obviousness, inventorship, infringement - all the key concepts that, frankly, almost all working chemists turn out to be a bit hazy on when you get down to details. (And law, inevitably, always gets down to the details). It's illustrated with numerous examples from recent cases, structures and all, and with plenty of very realistic hypotheticals. For example:

Imagine that you are a chemist who has been laboring to find a compound that is capable of inhibiting a very important pathway in a human disease state. After many years of hard work and false leads, you find a compound - compound 4 in Figure 7.9 - that appears to possess all of the necessary attributes. However, your information scientist reports that there are prior art references that disclose a total of three different Markush structures, each of which encompasses your compound as shown in Figure 7.9. The prior art references that contain these three genera provide the general methods of making the compounds, and the preparation is enabled for one skilled in the art. A few specific examples have been made that fall within genus 1 (and hence genera 2 and 3 as well) of the prior art, but your exact compound has not been specifically disclosed. The question is now whether compound 4 is anticipated and rendered nonpatentable per se. . .

Sound familiar? For most experienced drug discovery chemists, it sure will. As the authors go on to say, a Markush that has so many variables that it can be expanded to eight wazillion compounds isn't something to really worry about - you're supposed to be able to "at once envisage" the later invention if it's going to wipe out patentability. On the other end, a direct claim of only one compound - yours - is clearly a direct hit. But what about that huge area in between? If you don't know what it means to reference the Petering case in this area, you should.

There's a lot of good stuff in this book. It's not always light reading, but it's the most readable treatment of some very complex patent issues that I've seen. Patent attorneys know everything in it (or they flippin' well should), but if you're a chemist, you probably don't. I've learned quite a few interesting things myself in the few days I've been looking it over. Every industrial chemistry department should have a copy.

Comments (25) + TrackBacks (0) | Category: Patents and IP


COMMENTS

1. Ed on September 13, 2010 8:10 AM writes...

Derek, the Look Inside feature doesn't seem to be fully working - does it cover patenting in the EU/ROW and how this is different?

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2. HelicalZz on September 13, 2010 9:01 AM writes...

Thank you for bringing this reference to our attention, and not letting the 'traffic numbers' influence your posting subjects. It is indeed a subject we need to pay more attention to, no matter how dry it can get.

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3. gyges on September 13, 2010 9:13 AM writes...

"And it can also be quite interesting, once you get into it a bit."

I find Synthon BV v. Smithkline Beecham plc [2005] UKHL 59 to be a cracking read.

It's packed with drama.

The missing IR spectrum - imagine what the chemist went through!

The things Baldwin said about Adlington. (All deserved, no doubt).

Adlington's recrystallisation but not in the proscribed manner.

The idea of enablementment.

The wasted manhours in every company I've worked in where people have tried to slavishly follow the exact procedure of a patent.

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4. ancor on September 13, 2010 9:26 AM writes...

With only few chemists left and the small molecule discovery at choke point, I wonder if buying is worth. Comments welcome.

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5. barry on September 13, 2010 10:18 AM writes...

Those chemists still plying the art in the U.S. look forward fervently to the day (may it be soon!) when the parts of this book on "first to invent" are rendered obsolete. When the U.S. joins the rest of the world on the "first to file" standard, electronic notebooks will finally come into their own.

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6. A Nonny Mouse on September 13, 2010 10:41 AM writes...

#5

If you really want to see a "first to invent" saga look up Rolabo v Medichem (Google) which is now the text book standard for notebook keeping (or not).

There should be some nice videotape of me giving evidence on this case back in 2001. I think the case may still be going on.

Ah.....Adlington with his brown lab coat and multiple expletives every sentence- fond memories of university days.

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7. John Spevacek on September 13, 2010 1:53 PM writes...

I learned early on to treat anything that I come up with as patentable, especially when it is obvious. If our lawyers say "No", fine, I'll let it go, but I want them making that call. I don't have the training to make it myself.

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8. Chrispy on September 13, 2010 2:37 PM writes...

Some of the most interesting legal stuff these days is coming out of large molecule therapeutics. All the companies are scrambling to patent the epitopes of their antibodies. The methodology is all over the place and is as yet untested in the courts (well, except for the $1.8B Centocor verdict against Abbott for anti-TNF currently on appeal...).

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9. Mike on September 13, 2010 4:05 PM writes...

@Ed:

Looks like this is mainly (in fact, probably exclusively) for United States patent concerns. Look Inside works fine for me (I'm running the latest version of firefox, if that helps), and I didn't see anything in the available bits that looked like they were related to the EU/ROW.

I could be wrong, though; I could only get the table of contents and the introduction.

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10. lori chem on September 13, 2010 5:11 PM writes...

I have this book and started reading it. It's detailed but fairly comprehendible - some difficult concepts are broken down fairly well. I flipped through it and there is a little bit of European and PCT stuff but it looks to be US focused for the most part. I like the fact that it has a lot of very specific examples with structures and problems. Whether I actually get through it all or not, let's see!

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11. Anonymous BMS Researcher on September 13, 2010 6:15 PM writes...

One fairly recent case to cite Petering was Sanofi-Synthelabo v. Apotex, Inc., 550 F.3D 1075, 1084 (Fed. Cir. 2008) which knowledgeable readers will know was of more than academic interest to those of us at BMS -- this was the fight over the Plavix patent.

By the way, I agree with Barry -- life will become easier for pharma researchers (and not only chemists) if and when the US adopts "first to file."

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12. Anonymous BMS Researcher on September 13, 2010 6:39 PM writes...

@3. gyges
Yes, this is an unusually interesting ruling. At one point in the ruling it says "...with great respect to Aldous LJ, who is an acknowledged master of patent law..."

Anybody who has more than a nodding familiarity with courts will know that appellate courts love to heap praise on judges whose rulings they are about to reverse.

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13. Morten G on September 13, 2010 9:48 PM writes...

? I was so sure that US had actually gone to first-to-file... dammit. Good thing the US legislative branch is so efficient. They'll have this fixed in no time.

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14. maddog on September 13, 2010 10:56 PM writes...


For the abridged version of Synthon BV vs Smithkline [2005] UKHL 59 mentioned by @gyges, try this link:

http://www.thefreelibrary.com/Case+Note%3A+Synthon+BV+v+SmithKline+Beecham+plc,+House+of+Lords-a0138674319

not as flowery, but succinct.

Permalink to Comment

15. DLIB on September 14, 2010 12:06 AM writes...

I am definitely NOT a fan of the first to file rules established by the rest of the world. I understand the homogenization has lots of attraction, and it would make life easier for bench scientists, but it would wreak havoc on the small inventors with little resources. Big multinationals with armies of lawyers would go nuts!! IBM probably has enough lawyers to stop up the works of the PTO for a good long time.

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16. Jose on September 14, 2010 12:55 AM writes...

My personal favorite is the Albany Molecular Allegra debacle: founder of a contact research company (while working on a contract scale-up project) re-designs the route, files a patent hours?days? ahead of the Hoechst M-R lawyers, and then licenses it back!

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17. A Nonny Mouse on September 14, 2010 3:27 AM writes...

#16

What was patented was "a more pure form"! I was also involved in research on this so I know it well.

It was licensed back as it gave HM-R an extra X years patent life on the product as the original patent on the metabolite had almost expired before launch.

The truth is (having seen T D'A's notebooks) that he was trying to analyse a separation of the 3 and 4 isomers by low resolution NMR rather than HPLC. I must admit that the HPLC separation was difficult, but even the idiot that I had working for me managed to repeat the patent process.

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18. likeitis on September 14, 2010 10:08 PM writes...

US pharma majors obviously could not possibly tolerate a first to file patent system, because they are not innovative enough.
They mostly only copy each other and/or steal ideas from the academic med chem literature when the authors are not watching.
US affiliates of EU pharma are more innovative - I wonder why that might be? Couldn't possibly be because of more enlightened management by savvy execs who actually earn their salaries???

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19. Hap on September 15, 2010 4:24 PM writes...

Um...do the letters "GSK" mean anything to you? I don't know that they're drastically more productive and inventive or less mismanaged than US pharma companies - they certainly don't look it.

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20. biotech investment paradigm on September 15, 2010 7:10 PM writes...

Derek,

I hope you got a commission from that link. You certainly tipped the popularity of that book in under a day. I ordered it Monday when it was in-stock at $80, and by Tuesday night it was shipping in "3-6 weeks" at $85.

Good recommendation though. I've just started into the book, and like it so far.

Permalink to Comment

21. likeitis on September 16, 2010 4:56 AM writes...

#19
Hap: Last time I looked, GSK is not an EU company......but after reading about the AZ CEO and his fat pension gaff, I'm outta here!

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22. Hap on September 16, 2010 8:44 AM writes...

I thought GSK was British (the SK wasn't, but the Glaxo was).

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23. likeitis on September 16, 2010 7:39 PM writes...

#22
*Was* is the key word.
If the shareholder *cohorts* determine the *nationality* of the company, in the case of GSK I believe the Brits are now in a minority.
Is the location of facilities, or even head office, the determining factor?
To illustrate: if Merck moved its R & D to Shanghai, would you consider it to have become a Chinese company?
There are still many distinctly European major pharmas, e.g. Novartis, San-Aven, Bayer.

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24. G2 on October 13, 2010 4:12 PM writes...

Hi Derek,
you was ahead in time, now a book review appeared in JMC:
DOI: 10.1021/jm101260w

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25. telecharger video youtube on May 29, 2013 2:47 PM writes...

I genuinely enjoy studying on this site, it contains wonderful articles . "I have a new philosophy. I'm only going to dread one day at a time." by Charles M. Schulz.

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