Friday, December 19, 2008

Classen v. Biogen: The Federal Circuit Applies Bilski to the Life Sciences

In a non-precedential opinion, a panel of the Federal Circuit affirmed a lower court’s decision in Classen v. Biogen to invalidate Dr. Classen’s process claims for encompassing patent-ineligible subject matter. I have previously discussed the district court decision in posts to this blog and Patently-O. The claims are directed to methods for determining an optimal immunization schedule based on comparing the observed incidence of immune-mediated disorders in treatment groups subjected to different vaccination schedules.

The decision, in its entirety, states as follows: “In light of our decision in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc), we affirm the district court’s grant of summary judgment that these claims are invalid under 35 U.S.C. § 101. Dr. Classen’s claims are neither “tied to a particular machine or apparatus” nor do they ‘transform[] a particular article into a different state or thing.’ Bilski, 545 F.3d at 954. Therefore we affirm.”

The opinion ducks important issues. Contrary to the holding, the claims do in fact involve a transformation, e.g., claim 1 of 5,723,283 recites a ‘method . . . which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens . . ..” The immunization of a mammal clearly effects a transformation of a particular article [a mammal] into a different state [a state of induced immunity]. It is inconceivable that this does not constitute a transformation; if that were the case, it would logically follow that all method of treatment claims are patent-ineligible. Rather, the court implicitly must have determined that, in the context of the claims at issue, immunization of a mammal constitutes an “insubstantial extra-solution activity.” In Bilski, the court held that an otherwise patent-ineligible process is not rendered patentable by tagging on an insubstantial additional step. The court could have provided some needed guidance by explaining its basis for determining that the immunization step is insubstantial, but instead the court decided to punt on the issue.

The lower courts decision was less than fully coherent on the basis for its determination that claims are patent-ineligible, at times asserting that the claims are invalid for claiming a mental process, while at other times complaining that that the claims encompass a natural phenomenon. The district court concluded that “[c]learly, the correlation between vaccination schedules and the incidence of immune mediated disorders that Dr. Classen claims to have discovered is a natural phenomenon.” The court provided absolutely no reasoning to support this conclusion. To my mind, it is not at all clear that it can be so blithely assumed that vaccination is a natural phenomenon. That would depend upon how vaccination is defined, but clearly immunization using human-generated vaccines is not something that occurs absent human intervention.

As I discussed in my previous post to Patently-O, to my mind the Bilski machine-transformation test is inappropriate in some cases involving natural phenomena. For example, a claim encompassing photosynthesis in a plant involves a transformation of a particular article [carbon dioxide and water] into a different thing [sugar and oxygen], so it passes the Bilski test. But it cannot be patentable under Supreme Court precedent, since it encompasses a natural phenomenon. I think the Federal Circuit needs to be careful in blinding applying the Bilski test to a claim arguably directed to a natural phenomenon.

A similar case is currently pending before the Federal Circuit, Prometheus v. Mayo, discussed in my earlier posts. The district court in Prometheus also found that the claims at issue encompass an unpatentable natural phenomenon, i.e., the correlation between the amount of a drug metabolite in a patient’s body with the optimal dosage of the drug. Unlike vaccination, which arguably encompasses the natural introduction of an immunogen into a patient’s body, the correlation at issue in Prometheus is entirely the results of the introduction of a non-naturally occurring drug into the patient. While the vaccination in Classen arguably can be interpreted so as to encompass a natural phenomenon, the correlation in Prometheus is not what I would consider to be a natural phenomenon. To hold otherwise would establish dangerous precedent, but the Federal Circuit might never even address the issue if it proceeds to simply apply the Bilski test in a reflexive manner, as appears to have to been the case in Classen.

I would also point out that the Classen decision does not bode well for a host of issued patent claims, particularly genetic diagnostic method claims which purport to broadly encompass any method of identifying a mutation.


Anonymous said...

I got a grant from the federal government for $12,000 in financial aid, see how you can get one also at

Tf said...

Professor Holman,

Thanks for your analysis. Do you think that the result of the claim (the comparing and determining the better immunization schedule) does not transform a thing explain the ruling, even though the descriptions of the claims do involve a transforming step? Additionally, since the claims are about comparison, thus the immunization step actually does not transform a "particular" article? Thanks for your insight.

Anonymous said...

We are counsel to Classen Immunotherapies in the recent 12-19-08 CAFC decision on section 101 post Bilski. We filed our Petition for rehearing yesterday and are seeking amicus briefing. We are only seeking to reverse that part of the opinion that states that immunization is not a transformation.
We would appreciate if you would be willing to file an amicus brief in support of rehearing.
If possible, could you send out this call for amicus briefs.
contact me at:

Anonymous said...

"Contrary to the holding, the claims do in fact involve a transformation[.]"

Well, An element of the claim cites a transformation, but not the claim as a whole.

The claim itself claims a "determining" method, i.e., "[a] method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals[.]"

web design company said...

nice post

Unknown said...

Top website designing company in India, Nashik provding world class website design and solutions.
Nashik Website Designing, Nasik Webpage Design, Nashik Website Design, Nashik website company, SEO Company Nashik, Nashik Website Development Services

Software Development India said...

Soniktechnologies is a website designing and Web development company, implementing IT-projects of any discipline and to any complexity. We have the experience in providing successful website development, back end website programming, E Commerce software development services and maintenance of sophisticated Internet applications for different industries with affordable costs.
Software Development India

Penny Auction Script said...

Thanks for providing such a beautiful analysis about the decision taken and you have provided also a criticism relate to the decision.

AuctionWebsiteScript, a leader of Penny Auction Script provider, are promised to do our best and offer our clients the most advance tools and scripts of auction management, statistical information gathering, and site promotion.

Mobile Game Development said...

Thanks for the nice information. I am sure, I will tweet this to my twitter account. This will help a lot of users. Windows Phone 7 Application Development Custom Software Development Mobile App Development iPhone Application Development iPhone Game Development

Anonymous said...

thank for bring up

Counter Depth French Door Refrigerator
How to Get Into Acting
Breville Smart Oven
How to Impress Woman
Picking Lottery Numbers
Canon Powershot A800
Adidas Barricade
Adidas Barricade 6.0
Cuisinart TOB-195
Acne Conglobata
Acer 11.6 Netbook
500 payday loan
acne inversa
checkmate payday loans
Pengurusan Masa

muebles vizcaya said...

This can't have effect in reality, that's what I think.

SITL said...

I have been meaning to read this and just never got a chance. Its an issue that Im very interested in, I just started reading and Im glad I did. Youre a wonderful blogger, 1 of the most effective that Ive seen. This weblog undoubtedly has some facts on topic that I just wasnt aware of. Thanks for bringing this stuff to light.

Indian exporters,canada exporters,b2b trade leads,suppliers directory,indian trade portal,Indian buyers,Indian tenders,trade fairs,indian distributer

Ranchi Hotels said...

This is awesome – thank you for all
this valuable information.
Best Hotel in Ranchi,Budget hotels in Ranchi,Cheap Hotel Rooms in Ranchi ,Economy hotels in Ranchi,Luxury Hotels in Ranchi ,Restaurant in Ranchi,Bar in Ranchi,Best Banquet in Ranchi

Ranchi Hotels said...

This is awesome – thank you for all
this valuable information.
Best Hotel in Ranchi,Budget hotels in Ranchi,Cheap Hotel Rooms in Ranchi ,Economy hotels in Ranchi,Luxury Hotels in Ranchi ,Restaurant in Ranchi,Bar in Ranchi,Best Banquet in Ranchi

Organic Search Engine Optimization services said...

Amazing Classen v. Biogen: The Federal Circuit Applies Bilski to the Life Sciences. thanks

singapore hotel deals said...

interesting! although I have no expert, but I want have to know more and more, on your blog just interesting and useful information. Keep it up!singapore hotel deals

phppennyauction said...

Great post....thanks for sharing useful info.

PHP Penny Auction

Cheap Essay Writing said...

Hello, This is really great information found here, I really like your blog. Thanks very much for the share. Keep posting.

Pakistani Models said...

great post, i agree, I found a lot of interesting information in your blog. Good job! keep it up, hope to read your other updates.

Hire a ASP.NET Developer said...

Тhіs pοѕt poѕted аt thіs sitе is reallу nісе.

Write My Essay said...

I'm still learning from you, but I'm trying to achieve my goals. I certainly enjoy reading all that is posted on your blog.Keep the information coming. I loved it!

Umrah Packages said...

Nice site! I enjoy a couple of from the articles which have been written, and particularly the comments posted! I will definitely be visiting again!

Wholesale Towels said...

Awesome post. I love to read your post. Because your posts are very informative.

Used Police Cars said...

I hope you have a nice day! Very good article, well written and very thought out. I am looking forward to reading more of your posts in the future.

male underwear online shopping in pakistan said...

Nice blog really good webpage and effort laid down suggestion are pretty good keep up the good work.

Unknown said...

This blog Is very informative, I am really pleased to post my comment on this blog. It helped me with ocean of knowledge so I really belive you will do much better in the future. Good job
Airport Taxi

Toronto Pearson Airport Taxi said...

Today's I found your blog to be very interesting. Thanks for such a great post.

Toronto Pearson Airport Taxi
Toronto Airport Taxi
Pearson Airport Taxi

Toronto Airport Taxi said...

Thanks for nice info. It’s useful for me. Can you give me some more information with details. I will wait for your next post Thanks a lot
Toronto Airport Taxi
Mississauga Airport Taxi
Airport Taxi Toronto

Cereb said...

It's great to see a blog of this quality. I learned a lot of new things and I'm looking forward to see more like this.

Cereb said...

It's a great post for the some concern company which are those do it that work

Unknown said...

i found these websites informative hk out these links.
Umrah Packages 2014
Special Umrah Packages 2014 USA CANADA
Guide To Mindfulness
Latest News Malala Imran Khan PTI
Simplify Your Life
8 Spiritual Thoughts To Never Let Go In Life\

Edward said...
This comment has been removed by the author.
Edward said...
This comment has been removed by the author.
Unknown said...

Imgtech website design company in Delhi Affordable web Design services offering best web design and Development Services in Delhi / NCR.

Unknown said...

With thanks for sharing your fantastic websites
levitra 20mg tablets price

CGIFlythrough said...

Nice post

alaa omran said...

شركة نقل اثاث بجدة
شركة نقل عفش بالرياض
شركة نقل عفش بالمدينة المنورة
شركة نقل عفش بالدمام
شركة نقل عفش بالدمام

alaa omran said...

شركة تنظيف خزانات بالمدينة المنورة
شركات تنظيف بمكة
شركة مكافحة حشرات
شركة تنظيف بالدمام
شركة تنظيف بالمدينة
شركة تنظيف بالطائف

alaa omran said...

شركة نقل عفش بالخرج
شركة نقل اثاث بالخرج
شركة نقل عفش بمكة
شركة نقل عفش بمكة
نقل عفش بمكة
نقل عفش بالخرج

Mobile App Development Services said...

Thanks for the nice information. I am sure, I will tweet this to my twitter account. This will help a lot of users

Thomas Armstrong said...

Good thought my fren..U really made the best points regarding ur decision and ideaolgy.

best regards
Mobile App Development Company in USA Provider

Islamic Society said...
This comment has been removed by the author.
Islamic Society said...

Very nice and informative article. Really want to take my family for Hajj & Umrah as it is obligatory for every Muslim once in their lifetime, provided they are physically fit and financially capable to perform Umrah and Hajj.
20 Days 4 Star Non Shifting Hajj Package

brisk logic said...

a fantastic article Thank you for sharing. Everyone seeking a software agency should read this post.
Brisk logic is a Mohali-based software design, app development, and web design firm.

mobile app development

Vyaparinfo said...

Really Nice Information It's Very Helpful Thanks for sharing such an informative post.