Classen Immunotherapies, Inc. v. Biogen IDEC (Fed. Cir. 2011) -- Additional Views from Chief Judge Rader

By Kevin E. Noonan --

Accompanying the Federal Circuit's majority decision in Classen Immunotherapies, Inc. v. Biogen IDEC is a separate explication of "additional views" by Chief Judge Rader (at right) joined by Judge Newman.  These views tend towards the policy and philosophical implications of patent eligibility challenges before the Court in several cases (In re Bilski, Prometheus Laboratories, Inc. v. Mayo Collaborative Services, Association for Molecular Pathology v. U.S. Patent & Trademark Office, and the instant case), and it is clear that the Chief Judge does not believe § 101 is the proper vehicle for challenging the validity of these patents.

The opinion begins by recalling that the language of Section 101 is very broad, and that challengers of patent-eligibility typically urge the Court to impose limits on scope not supported by statutory language.  The opinion likens this to "substantive due process" in other contexts, something the opinion suggests has more "historical and contextual" support because patent law has other provisions that protect against "vague" claims.  "[I]t is difficult to 'invent' any category of subject matter that does not fit within the four classes [recited in] the statute:  process, machine, [article of] manufacture or composition of matter," in Chief Judge Rader's view, and the Court should "decline to accept invitations to restrict subject matter eligibility," for "public policy" reasons.

The opinion likens patent eligibility to a "'coarse filter' that excludes entire areas of human inventiveness" on "judge-created standards."  The result, according to Chief Judge Rader, is what he terms a "healthy dose of claim-drafting ingenuity" whereby claim drafters "devise new claim forms and language that evade the subject matter exclusions" created by judges.  The consequence is an increase in the "cost and complexity" of the patent system, which is bad enough, but "may cause technology research to shift to countries where protection is not so difficult or expensive."

The opinion then illustrates these general principles with two specific examples.  The first are so-called "Beauregard" claims, which the opinion characterizes as being developed to circumvent limitations on claiming software caused by the Supreme Court's opinion in Gottschalk v. Benson, 409 U.S. 63 (1972).  This claim type substitutes language directed to "intangible [patent-ineligible] computer code" from Benson with language that recites "a[ patent-eligible] encoded tangible medium."  The implication is that the "invention" has not changed, just the claim language used to describe it.  The second example is the "Swiss-type" claim, devised to overcome restrictions in medical treatment claims created by the European Patent Convention.  These claims take the form of "use of a compound X for the manufacture of a medicament for the treatment of disease Y" instead of "a method of treating disease Y using compound X."  Such a reaction to judge-imposed limitations on patent eligibility is to be expected, according to the opinion, because patents by their nature "translate technology into text, i.e. patent claims," giving rise to the opportunity for "careful claim drafting or new claim forms" to be created to avoid restrictions on patent-eligible subject matter.  The opinion characterizes this situation as "a game where lawyers learn ingenuous ways to recast technology in terms that satisfy eligibility concerns."  The product of this exercise, termed "hollow" in the opinion, does not result in any "substantive improvement in the patent landscape" while causing "high costs on patent prosecution and litigation" and raising the possibility that patent protection will depend on (and reward) "gamesmanship."

In addition, the opinion asserts that there is a "real-world [negative] impact" of such judge-made restrictions on innovation that could "drive research to more hospitable locations."  The opinion calls such a possibility "not theory but history," recounting as an example the difference in response to biotechnology patenting between the U.S. and Europe.  Europe "imposed [patent-]eligibility restrictions" on biotechnology inventions while the U.S. (principally as a result of the Supreme Court's Diamond v. Chakrabarty decision) "embraced strong patent protection" for biotechnology inventions.  (It cannot have escaped the Chief Judge's notice that one specific example of this difference involved patenting isolated DNA molecules.)  Such restrictions on patent eligibility had the following impact on innovation:

Europe became known for subjecting such inventions to delays in the patent office, challenges in litigation, increases in cost, and uncertainties in the legal landscape.  With those difficulties as a primary contributing factor, investors, corporations, and clinics shifted their research from Europe to the United States.  See Opinion of European Union Economic and Social Committee, COM (1995) 661 final (July 11, 1996), (recognizing that "Europe is lagging further and further behind the USA," as evidenced by the stark contrast in number of biotech patents, firms, and products; proposing strong patent protection as in the United States to solve "Europe's backwardness"); Council Directive 98/44, 1998 O.J. (L 213) (EC) (finally providing some protection for biotech inventions to counter the trend of companies preferring to patent in the United States).  Thus, with some considerable blame on its eligibility doctrines, Europe lost innovation investment to the United States.  Our country became the world leader in biotechnology innovation.

But "the tide can turn against us, too" the opinion cautions.  Thus, "judges should tread carefully when imposing new limits on the protection for categories of human innovation."  The correct approach, the Chief Judge counsels in his conclusion, is to use the "substantive conditions" of the patent statute, including "particularities of claim language" and "questions of prior art and adequate disclosure" to prevent overly-expansive claims rather than "litigation-spawned applications of section 101."

Classen Immunotherapies, Inc. v. Biogen IDEC (Fed. Cir. 2011)
Panel:  Chief Judge Rader and Circuit Judges Newman and Moore
Opinion for the court by Circuit Judge Newman; additional views by Chief Judge Rader; dissenting opinion by Circuit Judge Moore

Comments

[The Big Lebowski]

An American judge who looks beyond the borders of the U.S.A.? Are you kidding me?

[EG]

"[I]t is clear that the Chief Judge does not believe such challenges are the proper vehicle for challenging the validity of these patents."

Kevin,

I think that's a proper take on Chief Judge Rader's "additional views." Some may misconture Rader's comments about "claim drafting avoidance" and "gamemanship" for the opposite view. But I believe these comments by Rader are actually a lament that we've reduced the "coarse filter" of patent-eligibility to such nonsense.

[6]

"I think that's a proper take on Chief Judge Rader's "additional views." Some may misconture Rader's comments about "claim drafting avoidance" and "gamemanship" for the opposite view. "

Oh no, I doubt if anyone doesn't understand Rader's defeatist attitude here. Apparently he thinks that since some attorneys will try to game the system and some people in prosecution will be asleep at the 101 wheel (as they are now actually) we should all just give it up.

[EG]

Once again, dream on 6, dream on.