To me, it’s a good idea to always carry two sacks of something when
you walk around. That way, if anybody says, “Hey, can you give me a
hand?” You can say, “Sorry, got these sacks.” ~Jack Handey
Chief Judge Rader, joined by Circuit Judge Newman, offered their own deep thoughts in a concurring opinion on Classen Immunotherapies, Inc. v. Biogen IDEC by pondering various ways that crafty patent drafters sneak ineligible patent subject matter into their claims. Particularly by the use of the Beauregard claim:
The patent eligibility doctrine has always had significant unintended implications because patent eligibility is a “coarse filter” that excludes entire areas of human inventiveness from the patent system on the basis of judge-created standards. For instance, eligibility restrictions usually engender a healthy dose of claim-drafting ingenuity. In almost every instance, patent claim drafters devise new claim forms and language that evade the subject matter exclusions. These evasions, however, add to the cost and complexity of the patent system and may cause technology research to shift to countries where protection is not so difficult or expensive.
The first unintended consequence, claim drafting evasion, has occurred several times in the past. After all, patents require a translation of technology into text, i.e., patent claims. Inevitably the subject matter exclusions of eligibility doctrines depend on the way that claims are drafted. Thus, careful 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.
Two well-known examples of claim drafting to circumvent eligibility restrictions are the Beauregard claim and the Swiss claim. The Beauregard claim was devised to draft around restrictions on software imposed in Gottschalk v. Benson, 409 U.S. 63 (1972). Benson denied eligibility to mathematical algorithms, a category broad enough to endanger computer software in general. The Beauregard claim form, however, was for “computer programs embodied in a tangible medium.” In re Beauregard, 53 F.3d 1583 (Fed. Cir. 1995). Claims were redrafted so that the intangible computer code in Benson instead became an encoded tangible medium in Beauregard. See id. at 1584 (PTO stating it will treat such claims as patent eligible subject matter); MPEP § 2106 (8th ed. Rev. 8, July 2010) (same).
The Swiss claim was devised to draft around restrictions on medical treatment methods imposed by the European Patent Convention (“EPC”). EPC, art. 52(4) prohibited patents on the use of a compound X for the treatment of disease Y. The Swiss claim form, however, was for the use of a compound X for the manufacture of a medicament for the treatment of disease Y. Claims were redrafted so that the focus became the manufacture of a product instead of the direct treatment using that product. The theory was that the claimed use was restricted to the patentable (initial) industrial use instead of the ineligible (ultimate) therapeutic use. See Eisai/Second Medical Indication, G05/83 O.J. (EPO Enlarged Bd. of Appeals 1984) (allowing Swiss claims); Preparatory Documents to Revision of EPC art. 54(5), CA/PL 4/00 (EPO Jan. 24, 2000) (revising the EPC to make clear that such subject matter is patent eligible so that Swiss claims are not needed).
When careful claim drafting or new claim formats avoid eligibility restrictions, the doctrine becomes very hollow. Excluding categories of subject matter from the patent system achieves no substantive improvement in the patent landscape. Yet, these language games impose high costs on patent prosecution and litigation. At the same time, the new games can cheat naïve inventors out of their inventions due to poor claim drafting. Moreover, our national innovation policy takes on characteristics of rewarding gamesmanship.
In addition to gamesmanship, eligibility restrictions increase the expense and difficulty in obtaining a patent. By creating obstacles to patent protection, the real-world impact is to frustrate innovation and drive research funding to more hospitable locations. To be direct, if one nation makes patent protection difficult, it will drive research to another, more accommodating, nation.
Once again, this unintended consequence is not theory but history. In the past, this cause-effect relationship of eligibility restrictions and stifling innovation favored our country in, for example, biotechnology. While Europe imposed eligibility restrictions, the United States embraced strong patent protection. Compare Diamond v. Chakrabarty, 447 U.S. 303 (1980) with EPC, art. 53 (1973) (exceptions to patentability) and Harvard/OncoMouse, T19/901 E.P.O.R. 501 (Technical Bd. of Appeal 3.3.21 1990) (eventually deciding against an outright ban but continuing to impose restrictions).
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. Nevertheless, the tide can turn against us, too. The effect of eligibility restrictions can send innovation investment elsewhere. Maybe an accommodating clinic in another country would be happy to take the additional funding and opportunity. In sum, judges should tread carefully when imposing new limits on the protection for categories of human innovation.
These public policy reasons are consistent with the broad language of § 101. As discussed in the majority opinion, section 101 is a general statement of subject matter eligibility. It is a threshold statement that explicitly directs attention to the “conditions and requirements of this title” to qualify for a patent. Thus, patentability, as opposed to subject matter eligibility, depends on the substantive conditions in the rest of the title. See 35 U.S.C. §§ 102, 103, 112. Many litigation-spawned applications of section 101 do not focus on categories of subject matter that deserve no patent protection but on the particularities of claim language, a question of patentability depending on prior art and adequate disclosure.