In June 2005, it issued a nonprecedential affirmance of a trial court decision finding a patent not invalid. The court also noted that a strict protocol was followed and that any unused drugs should have been returned to Janssen. The alleged public use (which was admittedly the claimed invention) was a process used internally by Invitrogen to make cells used in other Invitrogen research, but which were not sold commercially.40 The court applied the Supreme Court's Pfaff decision, directed to Section 102(b)’s related on-sale bar, to that section's public use bar, holding that the public use bar arises where the invention is in public use and ready for patenting before the critical date.41 In doing so, the court noted that the experimental use exception may negate either the ready for patenting or the public use prong of the test, even though the experimental use negation was not at issue in Invitrogen.42 Interestingly, for purposes of interpreting the new AIA Section 102(a)(1) invalidity standard, Invitrogen stated that the proper test for the public use bar is whether the purported use was “accessible to the public” or commercially exploited.43With the inclusion of “or otherwise available to the public” in AIA Section 102(a)(1), arguments will be made that inaccessible commercial exploitation of inventions, particularly process inventions, will no longer qualify as prior art.
The court also noted that Janssen received no money (suggesting that the trial was not for a commercial purpose) and was very small, with only 28 people involved.38 Then, in October 2005, the Federal Circuit issued a decision written by Rader that reset the standard for considering public use invalidity. Invitrogen noted that to qualify as public, a use must occur without any “limitation or restriction, or injunction of secrecy,” citing Egbert v.
Under the experimental use doctrine, an otherwise public use or sale of the invention will not be considered invalidating if the public use or sale was conducted primarily for the purpose of experimentation and perfection of the invention being tested. Pavement Co.6 in support of its conclusion that so long as the invention is no longer the subject of any bona fide effort to bring the invention to perfection, the one-year bar should begin as soon as the invention is ready for patenting.7 Elizabeth held that the public use of a new type of roadway in the City of Boston was not a public use because the inventor came to visit it regularly to see how it was holding up.8Pfaff expressly confirmed that “an inventor who seeks to perfect his discovery may conduct extensive testing without losing his right to obtain a patent for his invention—even if such testing occurs in the public eye.”9 The court's discussion of the experimental use exception is particularly relevant in the public use context because the “ready-for-patenting” prong of the Pfaff test was later applied by the Federal Circuit to set a new standard for application of the public use bar, in Invitrogen Corp. Biocrest Manufacturing Inc.,10 which is addressed later in this article.
The Federal Circuit's first attempt to answer the question of when a clinical trial is an invalidating public use of an invention suggested that most clinical trials should be considered invalidating public uses.
A careful reading of the Federal Circuit and district court cases that have squarely addressed this question offer a short list of key issues that have led courts to determine when a clinical trial is, or is not, an invalidating public use. What constitutes an invalidating public use will be much more important when the AIA's prior art definition is applied. Section 102(b) of the Patent Act, which defines prior art, states simply that: “A person shall be entitled to a patent unless: … in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States.”4 The last time the Supreme Court addressed the “public use” or “on sale” terms in this section was in 1998, in Pfaff v.
Wells Electronics Inc.5 Pfaff set a new standard for application of the “on-sale” bar in Section 102(b), holding that the on-sale bar should apply when, before the one-year-prior critical date, the invention was (i) the subject of a commercial offer for sale and (ii) “ready for patenting.” The ready for patenting prong may be satisfied by either (a) “reduction to practice,” or (b) the preparation of drawings and descriptions sufficient to enable practice of the invention.
It is instructive, however, to examine the facts and reasoning of the district court and the Federal Circuit in connection with the circuit's first attempt, which reversed a district court's decision on summary judgment of no invalidity under the public use bar of Section 102(b).11 Interestingly, the district court's reasoning was largely adopted by the Federal Circuit in later cases.
The trials at issue in this case were classic Phase III trials of paroxetine hydrochloride hemihydrate, or “PHC hemihydrate,” to determine its safety and efficacy for treating depression.Eli Lilly affirmed the lower court's finding that the trials were not public, and also affirmed the lower court's experimental use finding, stating that “even a use that occurs in the open may not invoke a bar when undertaken to experiment on or with the claimed invention.”49 In contrast, in the vacated Smith Kline Beecham decision, the asserted claims were directed to the compound itself, and a Federal Circuit panel found that clinical trials to test the utility of the compound did not qualify for the experimental use exception because they were not directed expressly or inherently to a claimed aspect of the invention.50 In 2008, the Federal Circuit affirmed another trial court finding of no public use in In re Omeprazole Patent Litigation,51 this time in a decision written by Bryson and joined by Gajarsa and Judge Alan D. The court did not reach the lower court's finding that the trials at issue (a series of Phase III trials directed generally to the safety and efficacy of the claimed formulation in various populations) were sufficiently confidential and controlled so that they should not be considered a “public use.”52 Instead, the Federal Circuit in In re Omeprazole affirmed the lower court's finding of no public use on the basis that the trials at issue were necessary to show that the claimed invention had been reduced to practice (which the court equated with working for its intended purpose), and so the invention was not ready for patenting.53 These trials related only generally to the intended, but largely unclaimed, purposes of the invention, which was the long-term stability of the formulation and its efficacy in releasing active ingredient in the upper intestine rather than the stomach of patients.54 In Omeprazole, the Federal Circuit expressly disagreed with the district court's alternative finding that the experimental use exception prevented a finding of invalidating public use, because the district court's finding was not limited to the time before the invention had been reduced to practice.55 The Federal Circuit cited several of its own prior cases for the proposition that experimental use cannot negate a public use after the invention has been reduced to practice.56 The court did note, however, that this rule has been questioned as inconsistent with the Supreme Court's Pfaff decision in Judge Sharon Prost's concurring opinion in Atlanta Attachment Co. Leggett & Pratt Inc.57 In Atlanta Attachment, Prost, joined by Judge Timothy B.Dyk, argued that the Supreme Court's discussion of the experimental use exception in Pfaff suggested that the experimental use exception could apply beyond reduction to practice of the claimed invention, to permit continued experimentation on claimed features of an invention.58 Under the Federal Circuit's rule, as applied in In re Omeprazole, the experimental use exception can only apply in the time between when the invention is ready for patenting and when it is reduced to practice.Schall, the court affirmed the trial court's holding that the patent claims at issue were not invalid under Section 102(b) for public use.48 The clinical trial at issue was a Phase I trial conducted entirely in a restricted Lilly facility under strict security measures, although patients were allowed visitors.The claimed inventions were both the compound olanzapine and a method of using this drug to treat schizophrenia.They argued that a compound's utility is an intrinsic part of the claim.30 Other amici argued that the invention was really directed to solving problems other than treatment of depression, in particular problems relating to commercial scale manufacturing.31 These amici argued that the decision would not have a chilling effect on pharmaceutical investment because other provisions of the patent law would incentivize pharmaceutical investment, such as the five year regulatory exclusivity awarded to new chemical entities and provisions of the Hatch-Waxman law allowing the addition of up to five years of patent life to patents covering approved new drugs.32 The Federal Circuit granted rehearing en banc, vacated the panel opinions, and remanded to the same panel for reconsideration.33 The panel simultaneously issued new opinions holding the patent claim at issue invalid on different grounds, namely, inherency.34 Surprisingly, all discussion of the Section 102(b) “public use” issue was removed from the new panel and concurring opinions, leaving the application of public use law to clinical trials for another day. Eon Labs Manufacturing Inc.,35 the court affirmed with little discussion a trial court decision finding that a bioequivalency trial looking at fasted versus non-fasted blood levels was not a public use.36 The court did not rely on the experimental use exception.