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Category Archives: Claim Construction

Federal Circuit Holds Patentee To Functional Claim Language

Posted in Claim Construction; Federal Circuit Decisions

In Bayer Cropscience AG v. Dow AgroSciences LLC, the Federal Circuit upheld the district court’s claim construction that interpreted “2,4-D monooxygenase” in accordance with its  established scientific meaning, even though the exemplified embodiment was shown not to be a “monooxygenase.” This case illustrates the risks of functional claim language, particularly if the recited function is proven to be inapplicable, but also if the specification does not provide adequate written description for the breadth of embodiments encompassed by the functional language.

The Patent At Issue 

The patent at issue was Bayer’s U.S. Patent 6,153,401, which relates to constructs and methods for “genetically modifying plants in order to confer resistance to a commonly used herbicide called 2,4-dichlorophenoxyacetic acid, or ’2,4-D’ for short.” The methods involve genetically modifying plants to express an enzyme that catalyzes a reaction that breaks the herbicide down “into something harmless to plants.” Claim 1 recites:

A recombinant gene, comprising a DNA sequence encoding a polypeptide having the biological activity of 2,4-D monooxygenase which is capable of being expressed in a plant, operably linked to a heterologous promoter capable of promoting the expression in a plant of a structural gene operably linked thereto.

Dependent claim 4 recites embodiments of claim 1 “wherein the DNA sequence is the structural gene sequence of FIG. 10.”

The “Monooxygenase” Issue

As summarized by the Federal Circuit, at the time the patent was filed it was known that “certain bacteria found in soil could grow on 2,4-D,” and that “those bacteria first convert 2,4-D into a substance called 2,4-dichlorophenol, or ’2,4-DCP,’ which the bacteria … use as a ‘source[] of carbon and energy.’” Thus, scientists were trying to identify the genes that encoded enzymes that catalyzed that reaction. According to the Federal Circuit decision, “[t]he inventors of the ’401 patent were the first ‘to isolate, to clone, and to characterize’ a gene that had that property, a gene from the soil bacterium strain Alcaligenes eutrophus JMP134.” The nucleotide sequence of that gene is set forth in Figure 10 of the patent, and is the only gene identified in the ’patent.

According to the Federal Circuit, although the inventors had identified an enzyme of interest, “they did not fully understand the enzymatic reaction that they were studying.” For example, while “the reaction requires the presence of the oxygen molecule, O2, … the inventors did not know where one of the two oxygen atoms wound up.” At the time the patent was filed, they and others in “the scientific community” believed that it “was incorporated into water.” In accordance with this understanding, the patent refers to the enzymes of interest as “monooxygenases.” Importantly, the record “established beyond dispute”  that the term “monooxygenases” refers to “enzymes catalyzing a reaction in which one oxygen atom ends up in water and the second is incorporated into a product other than water.”

While the ’401 patent still was pending, it was determined that the enzyme it described was not a “monooxygenase” because the second oxygen atom does not end up in water, but rather is “incorporated into products other than water.”   As such, the enzyme is properly characterized as a “dioxygenase.”

[D]espite the announcement of this discovery in the very title of the article, and Bayer’s knowledge of the article, Bayer did not alter the claims of its application—which did not mature into a patent until seven years after the 1993 discovery.

The Accused Products

The accused products relate to Dow AgroSciences’ genetically modified seeds that are resistant to 2,4-D and other herbicides. Dow’s genes are dioxygenases that catalyze a reaction in which 2,4-D converts to 2,4-DCP.

The District Court Decision 

Bayer asserted that its claims encompass “any enzyme that triggers cleaving of the side chain of 2,4-D to produce 2,4-DCP, even if it is a dioxygenase and even if it does not share other biological activities of the particular enzyme whose gene Bayer sequenced.” The district court rejected Bayer’s arguments, and construed the “monooxygenase” claim language in accordance with its ordinary eaning, i.e., as reciting enzymes that catalyze reactions in which one oxygen atom ends up in a water molecule.  Since Dow’s enzymes are dioxygenases, Dow does not infringe under that claim construction.

The Federal Circuit Decision 

The Federal Circuit conducted a two-part analysis of Bayer’s claim construction arguments.

First, the court found that the intrinsic record did not support the broad claim construction.

The conclusion we draw is that there is no clear message that the patent gives Bayer’s broad meaning to “2,4-D monooxygenase” in place of the term’s accepted scientific meaning, which describes a particular mechanism of action. ….

In short, as the district court explained, the claim language has a strong accepted scientific meaning. Bayer’s alternative construction strips the monooxygenase half of the claim phrase of its accepted descriptive meaning and then asserts a specification “definition” of the biological-activity half. We do not find enough in the specification or prosecution history to justify those steps.

Second, the court noted if the claims were construed as broadly as Bayer urged, they likely would be invalid under 35 USC § 112.

Bayer’s proposed construction broadly covers a class of enzymes defined by their function of causing cleaving of the side chain of 2,4-D, while its written description structurally identifies just one gene sequence and the enzyme it encodes. We have not articulated a comprehensive and precise formulation for identifying when such a combination runs afoul of Section 112(a)’s written description requirement; indeed, we have counseled against “bright-line rules” in this area. … But we have indicated the primacy of structural identification for inventions in certain areas like the one at issue here, and when we have adverted to the possibility of other means of identification, we have focused on whether such alternative means sufficiently correlate with structure….

The coverage of claim 1 that Bayer proposes would leave the ’401 patent far from providing even an indirect structural identification of all that would be within the claim’s scope. The enzymatic function—under Bayer’s construction, causing the cleaving of the side chain of 2,4-D—would be broad, yet the patent provides the DNA sequence (and hence amino-acid sequence) of just one embodiment. As the district court explained, … neither the patent nor the knowledge in the art showed that what Bayer offered in place of a description of the shared structure—the growth test—correlated closely with an enzyme’s structure. The patent provided what was “[a]t best . . . a roadmap [that would] ‘leav[e] it to the . . . industry to complete [the] unfinished invention.’”

Thus, the Federal Circuit affirmed the district court’s claim construction and the summary judgment of non-infringement.

Caveat Patentee

The Federal Circuit noted that the district court decision referenced precedential “decisions about the potentially unwelcome consequences of a patentee’s chosen claim language.” Further, the Federal Circuit remarked several times that the patentee was aware of the discovery that its enzyme was not a monooxygenase, but “did not change its claim language.” What is not clear from the Federal Circuit decision is who at Bayer was aware of the discovery and whether they were actively involved in prosecuting the patents.

 

Federal Circuit Remands Sequenom Down Syndrome Test Platform Patent For Consideration Under Myriad

Posted in 101; Claim Construction; Federal Circuit Decisions; Personalized Medicine; Prometheus

In Aria Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit vacated and remanded the district court’s decision denying Sequenom’s motion for a preliminary injunction relating to a patent covering the non-invasive Sequenom Down Syndrome test. The Federal Circuit found that the district court had “incorrectly interpreted the asserted claims and improperly balanced factors regarding issuance of a preliminary injunction.” The Federal Circuit also directed the district court to reexamine the patent eligibility issues in view of the Myriad Supreme Court decision, but I do not understand how the claims at issue could be invalid under 35 USC § 101.Continue reading this entry

Federal Circuit Finds “Molecular Weight” To Be Insolubly Ambiguous

Posted in Claim Construction; Federal Circuit Decisions

Please welcome Daniel Shelton, an associate in the Chemical, Biotechnology and Pharmaceutical Practice of Foley & Lardner LLP, as a new author for PharmaPatentsBlog.

In Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., the Federal Circuit invalidated a number of claims directed to a polymer defined by its “molecular weight” because the term was ambiguous, and Applicants’ conflicting statements during prosecution as to the meaning of “molecular weight” made the term insolubly ambiguous. On the other hand, the court found that similar statements regarding “molecular weight” did not give rise to prosecution disclaimer with respect to other claims that were not invalidated. The court agreed that those claims were infringed, thus making it likely that Teva will be able to keep generic versions of Copaxone® off the market until its patents expire in May of 2014.

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Claim Construction Not Illuminated By Ambiguous Restriction Requirement

Posted in Claim Construction; Federal Circuit Decisions

In Plantronics, Inc. v. Alph, Inc., the Federal Circuit rejected arguments that the election made in response to the Restriction Requirement limited the scope of the claims in a manner that was not reflected in the claim language, specification, or prosecution history. Although the patent holder prevailed on this issue, this case serves as a reminder that every stage of prosecution can give rise to prosecution history estoppel.

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A Quick Look At The First Patent Trial And Appeal Board Decision In a Covered Business Method Patent Proceeding, SAP America, Inc. v. Versata Development Group, Inc.

Posted in Claim Construction; Patent Trials; USPTO Board Decisions

On June 11, 2013, the USPTO Patent Trial and Appeal Board (PTAB) issued its first final decision in a covered business method patent (CBM) proceeding, in SAP America, Inc. v. Versata Development Group, Inc. (CBM2012-00001). Although this case is not in the field of pharmaceuticals or biotechnology, a few aspects of this decision will be of interest to stakeholders across all industries. 

The Patent At Issue

The patent at issue was Versata’s U.S. Patent 6,553,350, directed to methods of pricing products for different purchasers.

Versata sued SAP for patent infringement in 2007. After a jury trial, SAP was found liable for infringement, but the court ordered a second jury trial on damages. Both parties appealed to the Federal Circuit in 2011, and the court affirmed the finding of infringement in a decision issued in 2013, after the PTAB proceeding was commenced. Of note to this review, “SAP did not appeal the district court’s claim construction, and the validity of the ’350 patent was not an issue on appeal.”

The CBM Proceedings

CBM proceedings became available on September 16, 2012, the effective date of Section 18 of the America Invents Act (AIA). A party who has been sued for or charged with infringement of a covered business method patent can petition for Post Grant Review of the patent to challenge the validity of the patent “on any ground that could be raised under paragraph (2) or (3) of section 282(b) (relating to invalidity of the patent or any claim).”

SAP filed its petition for CBM review of the ’350 patent on September 16, 2012, asserting that certain claims were invalid under 35 USC §§ 101, 102, and 112. The PTAB granted the petition with regard to §§ 101 and 102, and SAP agreed to proceed only with relation to § 101 to obtain expedited review.

Points Of Interest

At least the following aspects of the PTAB decision will be of interest to stakeholders across all industries.

  • The CBM proceeding was brought after two jury trials that found SAP liable for infringement, and while an appeal was pending at the Federal Circuit.

 Did Congress intend CBM proceedings to permit a collateral attack on a patent already found to be infringed in a district court proceeding?

The estoppel provisions of the statute provide that a petitioner in a CBM proceeding “may not assert, either in a civil action … or in a proceeding before the International Trade Commission … that the claim is invalid on any ground that the petitioner raised during [the CBM] proceeding.” However, estoppel may run only one way, from a CBM proceeding to a district court/ITC proceeding, and not from a pending district court/ITC proceeding to a CBM proceeding. A similar issue just was addressed by the Federal Circuit in Fresenius USA, Inc. v. Baxter International, Inc. (July 2, 2013), where the court found that estoppel did not arise from a district court proceeding that still was pending.

  •  The PTAB construed the claims according to its “broadest reasonable interpretation” (BRI) paradigm, even though its claim construction was different from that of the district court.

Did Congress intend the PTAB to apply a BRI claim construction? Even when a district court already has construed the claims? Even when the parties did not appeal the district court’s claim construction?

At least Congressman Goodlatte (R-Va.) thinks otherwise.  The “discussion draft“ of patent reform legislation he released in May would amend the Post Grant Review and Inter Partes Review statutes to require the USPTO to construe a claim in such a proceeding as it “has been or would be in a civil action to invalidate a patent under section 282, including construing each claim of the patent in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art, the prosecution history pertaining to the patent, and prior judicial determinations and stipulations relating to the patent.”

 

In Uship Federal Circuit Finds Prosecution History Disclaimer In Arguments Against Restriction Requirement

Posted in Claim Construction; Federal Circuit Decisions

In Uship Intellectual Properties, LLC v. United States, the Federal Circuit upheld the claim construction applied by the Court of Federal Claims when it held that the United States and IBM Corporation did not infringe the claims at issue. Coming on the heels of the Biogen case, this decision provides another warning that any statements made during prosecution can give rise to prosecution history disclaimer.

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Federal Circuit Finds Prosecution History Disclaimer In Enablement Arguments

Posted in Claim Construction; Federal Circuit Decisions

In Biogen Idec, Inc. v. GlaxoSmithKline LLC, the Federal Circuit upheld a narrow claim interpretation based on prosecution history disclaimer. The court held that the applicants’ arguments against an enablement rejection served to disclaim the broader claim scope sought in the infringement action. This case highlights the risk that any statement made during prosecution can be used to construe the scope of the claims.

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Federal Circuit To Reconsider De Novo Review Of Claim Construction

Posted in Claim Construction; Federal Circuit Decisions

In a nonprecedential order issued March 15, 2013, the Federal Circuit granted rehearing en banc in Lighting Ballast Control, LLC v. Philips Electronics North America Corp., to consider the following questions:

  1. Should this court overrule Cybor Corp. v. FAS Technologies, Inc., 138 F.3d 1448 (Fed. Cir. 1998)?
  2. Should this court afford deference to any aspect of a district court’s claim construction?
  3. If so, which aspects should be afforded deference?

The order expressly invites amicus briefs:

The court invites the views of the United States Patent and Trademark Office as amicus curiae. Other briefs of amici curiae will be entertained, and any such amicus briefs may be filed without consent and leave of court but otherwise must comply with Federal Rule of Appellate Procedure 29 and Federal Circuit Rule 29.

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Federal Circuit Uses Dependent Claims To Construe “Therapeutically Effective Amount”

Posted in 103; Claim Construction; Federal Circuit Decisions

In Alcon Research, Ltd. v. Apotex Inc., the Federal Circuit held that most claims of Alcon’s patent were obvious in view of prior art that suggested the use of the recited active agent to treat the recited condition, but not by the recited mechanism of action, because the prior art used a concentration of active agent that overlapped with the concentration recited in several dependent claims. Two claims that recited a specific concentration outside the range disclosed in the prior art and used in Alcon’s commercial product were upheld, due in part to the evidence of commercial success.

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Federal Circuit Finds District Court Strayed Too Far When Construing Claims

Posted in Claim Construction; Federal Circuit Decisions

In Advanced Fiber Technologies Trust v. J & L Fiber Services, Inc., the Federal Circuit reversed the district court’s claim construction that relied on extrinsic evidence and was inconsistent with the specification. Although the patent holder ultimately may prevail, a different claim strategy might have avoided the problematic claim construction.Continue reading this entry

Federal Circuit Splits Over Claim Construction

Posted in Claim Construction; Federal Circuit Decisions

In Retractable Technologies, Inc. v. Becton, Dickinson and Company, the Federal Circuit affirmed-in-part and reversed-in-part the district court’s finding that two of Becton, Dickinson’s retractable syringes infringed Retractable’s patents. The Federal Circuit found that one, but not both, of Becton, Dickinson’s syringes infringed the patents. For many, the conflicting approaches to claim construction espoused by Judge Lourie and Judge Plager on one hand and Judge Rader on the other will be more interesting than the conflict between Retractable and Becton, Dickinson.

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Claim Differentiation: The Weakest Link?

Posted in Claim Construction; Federal Circuit Decisions

The recent Federal Circuit decision in ERBE Elektromedizin GMBH v. Canady Technology LLC serves as a reminder that the doctrine of claim differentiation generally will not be useful to support a claim interpretation that is contradicted by other claim construction tools.

The Claims At Issue

The technology at issue in ERBE relates to medical devices for argon gas-enhanced electrosurgery. Patent owner ERBE challenged the district court’s construction of independent claims 1 and 35 of U.S. 5,720,745, arguing that the court’s interpretation violated the doctrine of claim differentiation.

These claims recite, in relevant part:

1. An electrosurgical unit for achieving coagulation of tissue, comprising:
an endoscope . . .
a flexible, hollow tube . . . positioned within the endoscope . . . such that a gas stream exits from the opening at the distal end of the tube in order to establish an inert gas atmosphere between the distal end of the tube and the region of the tissue to be coagulated, and
an electrode for ionizing the inert gas . . .
a source of pressurized ionizable, inert gas . . . such that a stream of gas flows from the source, through the tube and exits through the opening at the distal end of the tube at a low flow rate of less than about 1 liter/minute . . . .

35. A method for coagulating tissue during endoscopic surgery comprising the following steps:
providing a surgical endoscope . . . having a flexible, hollow tube . . . connected to a source of ionizable, inert gas . . . and an electrode . . .
supplying the inert gas . . . with such a low flow rate, that gas exiting through said distal end opening is a not directed, non laminar stream but forms an inert gas atmosphere between the distal end of the tube and the region of the tissue to be coagulated . . .
ionizing said inert gas atmosphere . . . and
supplying an electric . . . and coagulating an area of the tissue . . . while the ionized gas is being supplied through the distal end opening of the tube as a not directed, non laminar stream with a low flow rate

Dependent claim 38 depends from claim 35 and recites:

38. The method as claimed in claim 35, whereby the stream of gas exits through said distal end opening with a flow rate of less than about one liter per minute

The District Court’s Claim Construction

The district court construed “low flow rate” to mean

a rate of flow less than about 1 liter/minute and producing flow velocities less than 19 km/hour such that the gas exiting through the distal end opening forms a non-laminar inert gas temperature.

It based this interpretation largely on prosecution history, and arguments that were used to overcome prior art rejections.

The Claim Differentiation Argument

ERBE challenged the district court’s claim construction on several grounds, including claim differentiation. In particular, ERBE argued that the district court’s interpretation of claim 35 rendered claim 38 redundant, "in violation of the canon of claim differentiation."

The Federal Circuit’s Analysis

The Federal Circuit approached claim construction as it usually does, considering the claim language, specification and prosecution history.

With regard to the specification, the Federal Circuit noted:

The specification explains that directed gas flow could injure the patient. The invention sought to overcome this problem by disclosing and claiming low argon gas flows that produce a low, not directed, non-laminar stream of gas exiting the tube. The specification further provides an exemplary flow rate of about less than 1 liter per minute.

With regard to the prosecution history, the Federal Circuit noted:

The inventors distinguished its low flow rate from the Canady ’675 patent prior art reference in order to obtain its invention. . . .

Applicants explained that the claimed flow rate avoids the production of laminar jets to prevent patient injuries. . . . Specifically, they stated:

This flow rate avoids the production of laminar jets of ionized gas directed with high impact onto the tissue. The problems of laminar jets are to be avoided, since the ionized gas can enter the blood-stream and have toxic effects on the patient. According to Canady [the ’675 patent], column 4 lines 3-5, a flow rate of 1 to 12 litres per minute is foreseen there. . . . A flow rate of 1 litre per minute leads to a flow velocity of 19 m/h. Taking the higher value of 12 litres per minute gives an outlet gas speed of 229 km/h. Such velocities in Canady would certainly be classified as laminar jets and would likely lead to the above problems.

The Federal Circuit also pointed out that after these arguments were submitted, "the examiner issued its notice of allowance." 

The Federal Circuit concluded that "the prosecution history clearly and unambiguously demonstrates that the applicants unequivocally disclaimed flow rates from 1 to 12 liters per minute that lead to ‘such velocities’ of 19 through 229 km/h disclosed in the ‘675 patent prior art reference, referred to by applicants as laminar jets." 

With regard to the doctrine of claim differentiation, the Federal Circuit generally agreed that “[a]ll the limitations of a claim must be considered meaningful,” but cautioned:

Claim differentiation may be helpful in some cases, but it is just one of many tools used by courts in the analysis of claim terms.

(This is not a quote you want to see in a decision if you advocated application of the doctrine to support a broad claim interpretation!)

In the case before it, the unambiguous disclaimer in the prosecution history trumped any general principles that might have supported a broader claim construction. Thus, the Federal Circuit agreed with the district court’s interpretation.

When Can Claims Differentiate?

There are Federal Circuit decisions that cite the doctrine of claim differentiation to support a claim broad interpretation. So, when does this doctrine apply?

Without undertaking a comprehensive review of case law on this issue, I think the following factors may be pertinent:

  • does the specification indicate that the limitation at issue is an optional feature, a possible variation, or one example among many?
  • does the specification disclose embodiments outside the scope of the narrower claim? 
  • does another claim recite embodiments outside the scope of the narrower claim? 
     
  • does the specification describe the invention in terms that suggest that the limitation is an essential feature of the invention?
  • does the prosecution history include any arguments or evidence that suggest that the limitation is an essential feature of the invention?
  • does the prosecution history include arguments that rely on the limitation at issue to distinguish prior art or satisfy the enablement requirement?  

(These factors are not exhaustive and may not apply in all cases.)

Whether you want to use the doctrine of claim differentiation to support a broad interpretation or are reviewing claims and considering whether the doctrine applies, you should keep in mind that the doctrine is usually treated as the "weakest link" among claim construction tools. As illustrated by ERBE, claim differentiation usually will not support an interpretation that is at odds with the plain meaning of the claims, any express definitions included in the specification, or any disclaimers made during prosecution.