Immunization Methods are Patent Eligible

In December 2008, a Federal Circuit panel rejected claims concerning methods of immunization and determining an immunization schedule as not being directed to patentable subject matter.  The 70 word opinion authored by Judge Moore left many questions as to why the claim was so rejected.  After issuing its decision in Bilski v. Kappos, the Supreme Court issued a GVR order where it directed the Federal Circuit to reconsider its earlier opinion in light of Bilski.  The newly constituted panel included Chief Judge Rader and Judges Newman and Moore.

Today, the Federal Circuit issued a 57 page set of opinions to replace the original 70 word opinion.  This time, the court held that at least some of the claims are indeed directed to patentable subject matter.  Classen Immunotherapies, Inc. v. Biogen IDEC.

The case concerned 3 patents, the ‘139, ‘739, and ‘283 patents.  Claim 1 of the ‘283 patent states:

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, which comprises:

immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and

comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

Claim 1 of the ‘739 is said to be representative of both the ‘139 and ‘739 patent.  It states:

A method of immunizing a mammalian subject which comprises:

(I) screening a plurality of immunization schedules, by

(a) identifying a first group of mammals and at least a second group of mammals, said mammals being of the same species, the first group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a first screened immunization schedule, and the second group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a second screened immunization schedule, each group of mammals having been immunized according to a different immunization schedule, and

(b) comparing the effectiveness of said first and second screened immunization schedules in protecting against or inducing a chronic immune-mediated disorder in said first and second groups, as a result of which one of said screened immunization schedules may be identified as a lower risk screened immunization schedule and the other of said screened schedules as a higher risk screened immunization schedule with regard to the risk of developing said chronic immune mediated disorder(s),

(II) immunizing said subject according to a subject immunization schedule, according to which at least one of said infectious disease-causing organism-associated immunogens of said lower risk schedule is administered in accordance with said lower risk screened immunization schedule, which administration is associated with a lower risk of development of said chronic immune-mediated disorder(s) than when said immunogen was administered according to said higher risk screened immunization schedule.

Majority Opinion

The court determined that the claims of the ‘739 and ‘139 patents are directed to patentable subject matter, while affirming the district court’s invalidity ruling regarding the claims of the ‘283 patent.

In the opinion, Judge Newman was quick to note that issues regarding whether the claims meet the novelty, non-obviousness, or § 112 issues were not before the court, that is, the claims may still be invalid under another section of the Patent Act.

With respect to the patent-eligible claims, the district court held that the claims include mental steps.  The majority of the Federal Circuit held, however,  that the presence of a mental step is not fatal to patent eligibility.  Clearly, the immunization step cannot be performed within the mind.  These claims are directed to a specific, tangible application, and are thus patent eligible.

We conclude that the immunization step moves the ’139 and ’739 claims through the coarse filter of §101, while the abstraction of the ’283 claim is unrelieved by any movement from principle to application.

The court distinguished the ‘283 patent claims from those at issue in Prometheus relating to methods of calibrating drug dosages.  The court found those claims to be patent eligible due to the transformation of the drugs within the body.  The ‘283 claims, however, does not include such a transformation.

Judge Rader’s Additional Views

Chief Judge Rader provided an opinion styled “Additional Views” on patentable subject matter that were joined by Judge Newman.  He argued that the court should decline to limit the broad scope of patent eligibility.  He provides a great deal of guidance for patent attorneys and applicants on claim drafting and patent eligibility.

Indeed it is difficult to “invent” any category of subject matter that does not fit within the four classes acknowledged by Title 35: process, machine, [article of] manufacture, or composition of matter.
[C]areful claim drafting or new claim forms can often avoid eligibility restrictions. Eligibility then becomes a game where lawyers learn ingenious ways to recast technology in terms that satisfy eligibility concerns.

Judge Rader cited Beauregard and Swiss style claims as examples of the type of claims that would be patent eligible.  As for Beauregard claims, perhaps he hasn’t read Cybersource?

In some countries, such as the European Union, claims directed to methods of treatment are not patent eligible.  Applicants use Swiss style claims to get around this prohibition.  Swiss style claims recite the use of a compound for the manufacture of a medicament for the treatment of a condition, rather than a method of treating the condition itself.  The claim scope is generally very similar, but by using the Swiss style format, applicants can avoid prohibitions on patenting methods of treatment.

Judge Rader calls these types of claim drafting techniques “gamesmanship” that do nothing but add to the cost of patent prosecution and litigation.  Further, many applicants have poorly drafted claims that do not meet the requirements of these “games” and are thus excluded from obtaining a patent.

As an example of how this affects real word innovation, Judge Rader cited the field of biotechnology.  The US provides relatively strong protection to advances in biotechnology, while Europe imposes significant restrictions.  As a result, most biotechnology innovation takes place here and not in Europe.

The effect of eligibility restrictions can send innovation investment elsewhere.


Judge Moore, the original opinion author, dissented, arguing that none of the claims of any of the patents are directed to patent eligible subject matter.  The claims instead relate to a fundamental scientific principle so basic and abstract as to be unpatentable subject matter.  She further argued that she sees no difference in the scope of the claims between the ‘283 patent and the ‘139 and ‘739 patents.   Classen instead claims the scientific method itself as applied to the field of immunization. 

Because the claims contain no limitation on the type of drug to immunize with, the schedules that should be used for the immunization, the type of chronic immune disorder to look for, or any limitation in the control group. the claims are way too broad to be patent eligible.

Classen’s whole ’739 patent claim is to compare any two schedules for any drug and choose the one with fewer incidence of any chronic immune disease and then immunize.

She considers the immunization step in the claim to be post-solution activity that does not affect patent eligibility.  Judge Moore cites extensively to the Supreme Court’s unfortunate LabCorp. dissent.  Oh, how it still plagues us.

Finally, Judge Moore criticizes Judge Rader’s Additional Views as improper.  Rather than gamesmanship, she believes the court’s subtle distinctions lead to more careful claim drafting and better notice to the public of a claim’s scope.  Policy decision regarding patent eligibility should be left to Congress.  The court must take the facts of the cases that come to it, and apply existing statutes and precedent to the facts to reach as decision.

The Debate Continues

The Supreme Court has already agreed to review Prometheus in the October 2011 Term.  This case could also very well be headed back to the Supreme Court, which explains Judge Moore’s extensive dissent and Chief Judge Rader’s “Additional Views.”

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2 Responses to “Immunization Methods are Patent Eligible”

  1. Pharma & Biotech Global Week in Review 7 Sept 2011 from IP Think Tank Says:

    […] CAFC: Immunisation methods are patent eligible: Classen Immunotherapies, Inc v Biogen IDEC et al (Inventive Step) (Orange Book Blog) (Patently-O) (Patent Docs) (Patent Docs) (IPBiz) (Patent Law Practice Center) […]

  2. Patentable Subject Matter at the Supreme Court « INVENTIVE STEP Says:

    […] its earlier opinion.  The court that included a largely reconstituted panel changed its position, holding that the claims are patent eligible.  Judge Newman and Chief Judge Rader held the claims to be patent eligible, while Judge Moore […]

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