By Kevin E. Noonan —
The Biotechnology Industry Organization (BIO) sent a letter today to Attorney General Eric H. Holder, Jr. and Acting Solicitor General Neal K. Kaytal regarding the Supreme Court's request for the government's views on the questions presented by petitioners in Microsoft v. i4i (the Court granted Microsoft's petition for writ of certiorari on November 29, 2010). BIO and the letter's 171 signatories write to voice their concerns over the government being unduly influenced by industries (most notably the information technology and computer industries) that have spent the past decade attempting to limit patent rights and the ability of patent holders to challenge (in some cases alleged) infringement by companies in that industry.
The letter expresses "great[] concern" over the prospect of the Court reversing the decisions below affirming that Microsoft failed to prove that the patent-in-suit (U.S. Patent No. 5,787,449, having survived reexamination under Control No. 90/010,347) was invalid. Such an outcome "could seriously weaken the presumption of validity that attaches to millions of [U.S.] patents." This would "undermin[e] longstanding investment-backed reliance interests . . . critical for domestic job creation and economic growth" considerations that should resonate in view of the lingering downturn in the economy. The letter expresses the opinion (supported by empirical evidence for the pharmaceutical and biotechnology industries even acknowledged by the most diehard patenting opponents) that patents promote innovation by "facilitating . . . investment necessary for small businesses to form and grow," as well as permitting "more established businesses to continue [to] compet[e] and thriv[e] in an increasingly competitive global environment." The public reaps the benefits of such innovation by promoting job creation and opportunities for growth "in every state and every sector of our economy," according to BIO's letter.
These benefits only exist, BIO asserts, if businesses can "rely on the strength and presumed validity of issued patents," which is necessary for "product development, partnering and licensing decisions." Because patent applications are examined and patents granted by an agency (the U.S. Patent and Trademark Office) but validity challenges thereto are heard by a "lay jury or generalist judge," "since long before enactment of the 1952 Patent Act . . . those that seek to challenge a patent . . . must carry a heightened burden of proof," namely "clear and convincing evidence." Should the Court permit validity challenges to be won under a lower evidentiary standard (such as a preponderance, as petitioners argue) this "could thus frustrate decades of settled expectations under which large investments [have been] made in reliance on patents . . . believed to carry a strong presumption of validity." Such a result could "profoundly change the behavior of patent applicants and litigants" as well as affecting (negatively) investment and product development decisions regarding these (most) innovative businesses, as well as affecting (negatively) "public-private technology transfer" such as commercialization of university scientific research under the Bayh-Dole Act.
BIO and its signatories favor none of these outcomes, and warn that the issue is "of critical importance for domestic innovation, job creation and the Nation's [international] technological leadership." Accordingly, BIO requests ("respectfully") not only that the government "carefully consider these implications" but also "seek input from a wade range of stakeholders" both inside and outside the administration before deciding to take a position on this issue (an entreaty made more poignant in view of the recent amicus brief filed by the Department of Justice in AMP v. ACLU (the Myriad case; see "DOJ Tries to Be All Things to All Constituencies in Myriad Amicus Brief").
The issue (as alluded to in BIO's letter) stems from a decision by the District Court and affirmed by the Federal Circuit that Microsoft did not establish, by clear and convincing evidence, that i4i's patent-in-suit was invalid under the statutory bar contained in 35 U.S.C. § 102(b), failure to file an application within one year of the date that the patented invention was "on-sale." While this is a basis for invalidation unlikely to come before the Patent Office, the District Court and the Federal Circuit required, under prevailing and long-standing precedent, that Microsoft establish the factual basis for invalidating i4i's patents by clear and convincing evidence. The stakes are high: the damages assessed against Microsoft amounted to $240 million, and the Federal Circuit affirmed a permanent injunction against Microsoft over its Word program (causing the company to disable certain features (involving XML editing) in order to stay on the market). Etan Chatlynne has recently published on Patently-O the results of a study showing that in 119 recent Federal Circuit decisions the lower standard would not have changed the outcome in 88 cases (74%) but could have made a difference in the remaining 30 cases.
BIO's letter was signed by 171 companies, including biotechnology companies (Amgen, Genentech, Gen-Probe, Genzyme, Human Genome Sciences, Life Technologies, Tessera), pharmaceutical companies (Eli Lilly & Co., GlaxoSmithKline, Hoffman-La Roche, Johnson & Johnson, Merck, Pfizer, Sanofi-Aventis), bio-agricultural companies (Bayer CropScience, Cargill, Monsanto, Pioneer Hi-Bred) and universities and technology transfer organizations (Regents of the University of California, Research Corporation Technologies, University of Kentucky, WARF), as well as several perhaps unexpected firms, such as 3M Company, BASF, BP America, Dolby Labs, Illinois Tool Works, Proctor & Gamble, and Uniloc, illustrating the range of corporate concern over the potential for the Supreme Court to (once again) "upset settled expectations" should it foray once more into patent law's waters.

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