Professor Peter Lee has commented that “the foreseeability inquiry is highly factually intensive.”291 But, several rules can still be drawn from those Federal Circuit cases. Though, the Federal Circuit in Festo 2003 accepted various sources of evidence showing unforeseeability. Ironically, the Federal Circuit has relied on prior art documents, expert testimony, defendant’s activities, and the patentee’s admission or arguments to determine that an alleged equivalent was foreseeable at the time of claim amendment. The standard for
280 See id. (citing Schwarz Pharma, Inc. v. Paddock Labs., Inc., 504 F.3d 1371, 1377 (Fed. Cir. 2007)).
281 Id. at 1380–81 (alteration in original) (citing Schwarz Pharma, 504 F.3d at 1377).
282 Id. at 1381.
283 Id.
284 See id.
285 Id.
286 Id.
287 Id.
288 Id.
289 Id.
290 See id.
291 Peter Lee, Patent Law and the Two Cultures, 120 Yale L.J. 2, 50 (2010).
the “unforeseeable” exception makes the exception more like “foreseeability”
estoppel, which may completely bar the application of DOE.
Because the Federal Circuit case law has not found any scenario where a patentee may successfully argue the “unforeseeable” exception, a complete bar of DOE may be revived.292 The Federal Circuit imposes an even higher bar on the patentee’s side. The higher bar is premised on an assumption that an applicant is free to add any substitute or equivalent of the disputed element at the time of amendment. That is not the case.
An applicant may have to wait for about nineteen months for a first office action.293 During that period, an alleged equivalent that was not considered as a substitute on the filing date may become a possible substitute at the time of amendment.294 While the applicant may be aware of the alleged equivalent, she cannot add it into the claim because of the new matter issue. As the Fed-eral Circuit stated in Smithkline Beecham Corp., “[t]he new matter doctrine prevents an applicant from adding new subject matter to the claims unless the specification shows that the inventor had support for the addition at the time of the original filing.”295 Because the specification does not disclose the alleged equivalent, the applicant is barred from adding the alleged equivalent into the claim. Consequently, PHE will definitely apply to the alleged equivalent.
The enablement requirement, as codified in 35 U.S.C. § 112, may also fore-close the inclusion of an alleged equivalent. As the statute is interpreted, “the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.”296 The determination of “undue experimentation” is based on the Wands factors including:
(1) the quantity of experimentation necessary, (2) the amount of direction or guid-ance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.297
292 Before the Supreme Court issued Festo 2002, some commentators had promoted the foreseeability bar, which is similar to the “unforeseeability” exception. See Matthew J. Coni-gliaro, Andrew C. Greenberg & Mark A. Lemley, Foreseeability in Patent Law, 16 Berkeley Tech. L.J. 1045, 1064–73 (2001).
293 See Jonathan T. McMichael, Comment, Producing Valuable Patents: The USPTO’s Missed Opportunity in Biotechnology, 54 Jurimetrics J. 179, 182 (2014).
294 See Smithkline Beecham Corp. v. Excel Pharms., Inc, 356 F.3d 1357, 1364 (Fed. Cir.
2004).
295 Id.
296 ALZA Corp. v. Andrx Pharms., LLC, 603 F.3d 935, 940 (Fed. Cir. 2010) (internal quotation marks omitted).
297 Id. at 938 n.5 (quoting In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988)).
This complex standard makes the enablement requirement uncertain for some technology.
Let’s alter the facts in Smithkline Beecham Corp., where the alleged equiva-lent (“PVA”) to the claimed HPMC was found foreseeable. Assume that in addition to HPMC, the original specification included the alleged equivalent (“PVA”) as an ingredient of the claimed drug formulation but without provid-ing the release rate data of PVA. It is possible that the applicant would have to remove PVA from the claims, if the examiner found that PVA could not enable the claimed controlled release rate. Because a human body is complex, the controlled release rate of a drug formulation cannot be predicted if no human experiment has been done. The applicant must test a drug formula-tion with the use of PVA and its controlled release rate inside a human body, so that she can present the evidence of enablement. Without doing so, the applicant may not overcome the rejection under the enablement requirement.
Maybe the applicant should be responsible for her mistake. But, if the use of PVA cannot enable an ordinary skilled person in the art to make a drug formulation of the claimed release rate, such person may not consider PVA as an equivalent to achieve the claimed release rate. Therefore, it is not rea-sonable to require the applicant to foresee PVA as an equivalent at the time of amendment.
The new matter doctrine and enablement requirement limit an applicant’s capability to add an alleged equivalent into the claim. The foreseeability standard developed by the Federal Circuit may be too flexible to go beyond what an applicant may expect at the time of amendment in the context of the issues related to new matter or enablement. As a result, once a claim is amended, any equivalent will be held foreseeable.
Conclusion
Claim amendment triggers PHE if the amended claim is more narrow than the original one. The result of PHE is that a patentee is presumed to surrender the protective range between the original claim and the amended claim. However, the Supreme Court has confirmed that a patentee is allowed to rebut the presumption by proving any of three exceptions. Under the
“unforeseeable” exception, a patentee may show that the alleged equivalent was unforeseeable at the time of amendment. Unfortunately, the Federal Circuit has taken a limited approach to the “unforeseeable” exception. This Article found that the development of the Federal Circuit case law may show a higher bar. Although the Federal Circuit allows a patentee to use extrinsic evidence to prove unforeseeability, a variety of evidence increases the likeli-hood that the Federal Circuit may support the finding of foreseeability. An alleged equivalent will easily be found foreseeable at the time of amendment under a broad range of circumstances. The only way for a patentee to be saved from PHE may be to include in the original specification as many equivalents
as possible. Therefore, when amendment is required during prosecution, a patentee may amend the claim while including more equivalents. The effect of PHE, then, may be eliminated.