Source: https://patentlyo.com/patent/claim-construction
Timestamp: 2019-04-25 06:37:42+00:00

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One of the longstanding myths about the Federal Circuit is that it is formalist. This is usually levied by academics as a criticism, but no one does more than the Federal Circuit itself to spread the myth. For judges, being labeled as a jurisprudential machine is a badge of honor. Thus, even where their true motivation is clearly policy-based, judges invariably couch their opinions in legalistic terms.
The recent dissents from en banc rehearing in Retractable Technologies, Inc. v. Becton, Dickinson & Co. provide perfect examples. The issue in Retractable is an old one: should the Federal Circuit give deference to district judges on claim construction? Judge Moore (joined by CJ Rader) and Judge O’Malley both argued the court should. Their dissents each begin with the assertion that the Supreme Court in Markman held that claim construction is a “mongrel practice” with both legal and factual components, and this counsels for deference to trial judges.
Let me start by debunking this legalistic argument. The Supreme Court in Markman did not hold that claim construction is a “mongrel practice.” It started off by observing that claim construction is intrinsically a mongrel practice, and then held that the Court would adopt a legal fiction that claim construction was a pure question of law.
Why do I say this? If it is correct that Markman held that claim construction has a factual component, then the result under traditional common law principles is not that trial judges get to decide the factual component. Trial judges do not decide facts; juries do. Some well-known exceptions are for suits in equity, for jurisdictional facts, and for procedural facts. But nobody contends that these exceptions apply. The claim-construction-is-factual line of reasoning is a legalistic and logical dead end.
Rather, the case for deference to district judges on claim construction must succeed, if at all, entirely based on policy-based concerns. Trial judges have better access to evidence than appellate judges, and yet they are more experienced at dealing with legal documents like patents than juries. This is a perfectly plausible policy-based argument, and is almost certainly the true reason for Judges Moore and O’Malley to seek deference for trial judges. Too bad they feel the need to couch the argument in formalist terms.
It may come as no surprise that the law on whether claim preambles can serve as limitations is unclear. The Federal Circuit is aware of this issue, and at least one judge suggests that it may be time for the court to address this issue en banc.
The patent in this case, No. 6,986,764, relates to technology for vaporizing tissue using laser radiation. The invention can be used to treat Benign Prostatic Hyperplasia, a condition in which growth of the prostate gland restricts the passage of urine out of the bladder and through the urethra. By vaporizing or ablating some tissue, the size of the prostate is reduced, thus reducing bladder outlet obstructions. Although laser radiation was known in the art, various problems were associated with its use.
The inventors of the '764 patent determined that by using high "volumetric power density" (a high amount of energy delivered to a given volume of tissue) they could produce increased vaporization efficiency while minimizing one of the problems associated with the procedure, residual coagulation. The patent is directed to various methods and devices for achieving this high volumetric power density by manipulating variables such as wavelength, output power, beam quality, irrigant composition, and distance between the optical fiber and the tissue.
delivering laser radiation to a treatment area on the tissue, the laser radiation having a wavelength and having irradiance in the treatment area sufficient to cause vaporization of a substantially greater volume of tissue than a volume of residual coagulated tissue caused by the laser radiation, wherein the delivered laser radiation has an average irradiance in the treatment area greater than 10 kiloWatts/cm2 in a spot size at least 0.05 mm2.
During claim construction, the district court determined that the preamble phrase "photoselective vaporization" was a "fundamental characteristic" of the invention, and construed the term to mean "using a wavelength that is highly absorptive in the tissue, while being absorbed only to a negligible degree by water or other irrigant." Based on this construction, the court granted summary judgment in favor of the accused infringer.
Instead, the term “photoselective vaporization” is simply a descriptive name for the invention that is fully set forth in the bodies of the claims….The bodies of the asserted apparatus claims (claims 63-64) describe a structurally complete device, including a laser adapted to deliver “radiation at a wavelength and irradiance . . . sufficient to cause [tissue] vaporization[.]” The bodies of those claims identify the covered wavelengths by function (“sufficient to cause vaporization”), and nothing in the claim language suggests that the term “photoselective” further limits those wavelengths.
Slip Op. at 10 (internal citations omitted).
It seems to me that a rule recognizing that all preambles are limiting would make better sense and would better serve the interests of all concerned. There is, after all, little to be said in favor of allowing an applicant, in the claim drafting process, to include material in the claims that is not binding. If patentees are allowed to include material in the claim definitions that is not bind-ing, patentees can suggest or imply one position before the U.S. Patent & Trademark Office (“PTO”) to secure allowance of the patent on the theory that the preamble is limiting and another, inconsistent position in infringe-ment litigation on the theory that it is not limiting. Principles of fairness thus dictate that the patentee should be required to clearly define the claimed inven-tion’s scope. By creating a uniform rule that all pream-bles are limiting, we would ensure the patentee has the burden of drafting a patent that avoids confusion as to the scope of the claims….Neither the Supreme Court nor our court sitting en banc has ever addressed the preamble limitation issue. I think the time may have come for us to eliminate this vague and confusing rule.
Dissent at 3-4. He then turned to the issue of whether the preamble phrase in this case limited the scope of the patent, and concluded that it did based on the prosecution history and what he viewed as a definition of the term in the Summary of the Invention. He also disagreed with the majority that the district court's construction would be inconsistent with the specification.
Adams holds patent number 5,372,252, which covers an extended release formulation containing guaifenesin (an expectorant used to thin, loosen, and help expel mucus that causes congestion). Perigo sought FDA approval for a generic version of Adams' product, Mucinex®. After construing the claims, the district court granted summary judgment of noninfringement. Adams appealed that decision.
The claim terms in dispute related to pharmacokinetic parameters. These parameters are used to characterize the rate and extent of absorption of the active pharmaceutical ingredient ("API"). The primary term at issue, Cmax, indicates the maximum concentration of the API following dosing.
The parties' main dispute was over the meaning of the term "equivalent" in the context of "provides a Cmax in a human subject equivalent to the Cmax obtained when the first of three doses of a standard immediate release formulation having one third the amount of guaifenesin is dosed." For purposes of FDA approval, a formulation is considered to be bioequivalent if, among other things, its Cmax is within 80% to 125% of the value with which it is being compared at a 90% confidence interval. The district court agreed with Perrigo that "equivalent" should be construed to mean equivalent under the FDA bioequivalence guidelines.
On appeal, Adams challenged the requirement of a 90% confidence interval, arguing that it makes sense when seeking FDA approval, but not when proving infringement.
Requiring a 90% confidence interval would inappropriately raise the bar for establishing infringement. Adams must show that it is more likely than not that Perrigo's ANDA product will have a Cmax within the 980-125% range. Adams is not required to show that Perrigo's product will meet this requirement 9 times out of 10.
Comment: This interpretation opens up a box of statistical worms, and I suspect that down the line the court may regret its venture into probability theory. For the time being, however, it gives parties useful language to quote when attempting to prove infringement (and perhaps invalidity) via clinical results.
Adams also appealed the district court's ruling that it impermissibly compared the accused product to Mucinex. Adams' argument was that because the accused product was bioequivalent to Mucinex, and Mucinex was bioequivalent to a standard immediate release ("IR") product, then the accused product had a Cmax equivalent to the IR product.
The Federal Circuit agreed that, under the circumstances of this case, Adams' argument was sufficient to preclude summary judgment of noninfringement. The court cautioned, however, that "[i]f Adams had relied on the mere fact of bioequivalence of the two sets of products (and no PK data or Cmax values, that would not be enough to survive summary judgment." Slip Op. at 11. Here, however, Adams presented actual PK data and Cmax values, which a fact-finder could look at when assessing equivalence between the accused product and an IR product.
The court also addressed the meaning of the term "bioavailable" in the context of the '252 patent. The dispute hinged on whether the phrase "fully bioavailable in the subject's stomach" meant "both release and availability in the stomach for absorption, wherever that absorption might occur."
Perrigo argued that because "bioavailable" is commonly understood to mean absorption, thus requiring the guaifenesin to be absorbed in the stomach. Because guaifenesin is primarily absorbed in the small intestine, this construction would preclude a finding of infringement.
The court rejected the proposed construction as inconsistent with the specification: "Although the specification never expressly defines bioavailable, it uses the term when describing the availability of the drug for absorption, not the actual absorption." Slip Op. at 14. The court further noted that Perrigo's construction would exclude the preferred embodiment, which "is rarely, if ever, correct and would require highly persuasive evidentiary support."
Finally, Adams argued that the district court erroneously precluded it from relying on the doctrine of equivalents with respect to a dependant claim requiring that the total amount of guaifenesin released in to the patient be at least 3500 hr*ng/mL. The panel concluded that the use of a numerical limit did not preclude Adams from arguing that an amount of 3494.38 hr*ng/mL was equivalent to 3500 hr*ng/mL.
Double-patenting issues arise when two commonly owned applications cover the same or similar inventions. The issues in this appeal revolved around an earlier patent claiming a composition of matter and describing a method for using that composition, and a later patent claiming that method of use.
Both of the patents in this case, Patent No. 4,808,614 (the '614 patent) and Patent No. 5,464,826 (the '826 patent) relate to gemcitabine, the active ingredient of Lilly's Gemzar® product. The '614 patent claims both gemcitabine itself, as well as a method of using it to treat viral infections. In addition, the '614 patent's specification discloses using gemcitabine to treat cancer. The '826 patent claims a method of treating cancer comprising administering a therapeutically effective amount of gemcitabine. The difference was important: the '614 patent expired on May 15, 2010, while the '826 patent does not expire until November 7, 2012.
Note: The applications leading to both the '614 and '826 patents were filed on the same day, December 4, 1984. The '614 was a continuation-in-part of application No. 473,883 ("the '883 application"), which did not disclose using gemcitabine to treat cancer. That information was added as part of the continuation-in-part.
After filing an Abbreviated New Drug Application ("ANDA") for a generic version of Gemzar®, Sun Pharmaceuticals, sought a declaratory ruling that the '826 patent was invalid and not infringed. Lilly counterclaimed for infringement of the '826 and '614 patents. The '614 patent was not at issue in this appeal.
Applicants are barred from obtaining multiple patents covering the same invention by the doctrine of double patenting. There are two types of double patenting: statutory double patenting, which prohibits a later patent from covering the identical invention, and obviousness-type double patenting, which prevents a later patent from covering a slight variation of an earlier patented invention.
On appeal, the panel agreed with the district court and Sun that the latter type of double patenting occurred here, thus invalidating the asserted claims of the '826. The basis for the court's decision were two prior opinions, Geneva v. GlaxoSmithKline, 349 F.3d 1373, and Pfizer v. Teva, 518 F.3d 1353. In Geneva, the earlier patent claimed a compound and the specification disclosed its effectiveness for inhibiting beta-lactamase. The later patent claimed a method of using the compound to affect beta-lactamase inhibition. Similarly, in Pfizer, the earlier patent claimed several compounds and the specification disclosed their use in treating inflamation; the later patent claimed a method of using these compounds for treating inflammation. In both cases, the court ruled that the claims were not "patentably distinct," and thus the latter claims were invalid for obviousness-type double patenting.
While Lilly argued that Geneva and Pfizer did not apply because "the specification of the earlier patent disclosed a single use for the claimed compound, which was an essential part of the patented invention and thus necessary to patentability," Slip Op. at 8, the court rejected that argument for two reasons. First, the court disagreed that the specification in Pfizer disclosed more than one utility for the claimed compound. In addition, the court read the rule of Pfizer as simply that "obviousness-type double patenting encompasses any use for a compound that is disclosed in the specification of an earlier patent claiming the compound and is later claimed as a method of using that compound. Pfizer never implies that its reasoning depends in any way on the number of uses disclosed in the specification of the earlier patent." Slip Op. at 10.
The court also rejected Lilly's argument that the specification of an earlier application should have been consulted, as opposed to the specification of the '614 patent. Drawing upon its claim construction precedent, the court noted that the specification is relevant to determining the coverage of the claims, which is at the heart of the obviousness-type double patenting analysis. The court further noted that "consulting the specification of the issued patent, as opposed to an earlier version, is consistent with the policy behind double patenting," which rests "on the fact that a patent has been issued and later issuances of a second patent will continue protection, beyond the date of expiration of the first patent of the same invention or an obvious variation thereof." Slip Op. at 14-15.
On appeal, the Federal Circuit reversed the infringement decision based on claim construction — holding that as a matter of English-language-logic, the claims require a spring and hinged arm that are structurally distinct.
The unequivocal language of the asserted claims . . . requires a spring means that is separate from the hinged arm. . . . Where a claim lists elements separately, “the clear implication of the claim language” is that those elements are “distinct component[s]” of the patented invention. (Quoting Gaus v. Conair Corp., 363 F.3d 1284, 1288 (Fed. Cir. 2004)). . . There is nothing in the asserted claims to suggest that the hinged arm and the spring means can be the same structure.
Because the hinged arm of the Tyco needles performed the spring function themselves (as opposed to having a separate spring), the court ruled that those needles could not infringe.
The majority avoids the critical issue upon which this decision turns; i.e., whether 35 U.S.C. § 112, ¶ 6 governs the claim construction of the “spring means” limitation. In a brief footnote, the majority sweeps and brushes aside the means-plus-function analysis as unnecessary in light of the “plain language of the claims.” Without having analyzed the scope of the claims, the majority somehow concludes that the claim language covers only devices having separate “spring means” and “hinged arm” structures. Then applying this simplistic claim construction to analyze the sufficiency of the evidence, the majority improperly overturns the jury’s verdict finding infringement.
Yesterday raised a valuable discussion on claim construction with many excellent comments on the Cotropia-Bey article. The issue is obviously important since claim construction disputes arise in virtually every attempt to enforce a patent. One problem with claim construction in litigation is that the district court follows a completely different process of claim construction than do PTO examiners. The rules suggest that the two claim construction scopes should form concentric circles with the PTO’s broad construction and the Court’s narrower construction. The reality is that it is hard to form these concentric circles — especially with complex claims. And, it is virtually impossible to form concentric circles of construction using such distinct construction processes. Instead of nested constructions, in many cases the outcome of the district court tends to diverge from that suggested during prosecution.
It seems odd that the patent prosecution process does not focus on determining the correct meaning of the claims. The better approach may well be to allow the original examination to determine the correct meaning of claims in a way that can be followed by courts down the line. I suspect that this approach would actually lead to more valid patents — especially if examiners applied a stronger hand on issues of indefiniteness.
Joel Miller’s 2006 JPTOS article in the Broadest Reasonable Interpretation standard is available here.
Chris Cotropia (Richmond Law) and Dawn-Marie Bey (King & Spalding) have an interesting draft article out on the PTO’s “broadest reasonable interpretation” standard for interpreting claims during patent prosecution. The article notes that the increase in post-grant reviews (reexaminations) running concurrently with infringement litigation raises the stakes of the PTO’s standard.
Although there has been much commentary on patent claim interpretation methodology in general, very little has been written about the unique interpretation approach the Patent Office employs. The courts, starting with the Court of Customs and Patent Appeals and continuing with the Federal Circuit, instruct the Patent Office to give every applied-for claim its ‘broadest reasonable interpretation’ (BRI) during patent examination. This Article explores this special standard and concludes that not only are the previously articulated rationales behind the BRI standard severely lacking, the standard is also contrary to both the patent statutes and the concept of a unitary patent system. The BRI standard additionally allows patent examiners to avoid difficult claim interpretation issues, leads to improper and uncorrectable denials of patent protection, and is incurably ambiguous.

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