In LifeScan Scotland, Ltd. V. Shasta Technologies, LLC, the Federal Circuit found that LifeScan’s distribution of its One-Touch Ultra glucose meters exhausted its patent rights such that it could not prevent Shasta from selling disposable test strips for use in the meters. In so doing, the court reversed the district court’s grant of a preliminary injunction that was based in part on the fact that LifeScan gave away at least 60% of its glucose meters and on its determination that the glucose meters likely did not embody the methods claimed in the patent at issue, which required both the meters and the test strips. Several aspects of this case are troubling, including the court’s emphasis on LifeScan’s failure to obtain a patent on its test strips when determining that the glucose meters alone substantially embody the claimed methods.
In Sanofi-Aventis v. Pfizer, Inc., the Federal Circuit affirmed the USPTO’s determination that Pfizer had proven an earlier date of invention of the DNA sequence at issue, even though it did not have the full, correct nucleotide sequence at the time. Because the subject matter at issue relates to cDNA, it remains patent-eligible under the Supreme Court’s Myriad decision. While the America Invents Act will phase out interference proceedings, new interferences still can arise between first-inventor-to-file patents and applications, and similar issues will remain relevant to questions of inventorship.
A unanimous panel of the Federal Circuit has found that yet another decision by the USPTO Patent Trial and Appeal Board (PTAB) improperly made a new ground of rejection in “affirming” the examiner’s rejections. The court’s decision in In re Biedermann follows similar rulings in Rambus, Stepham, and Leithem, and raises questions as to whether the USPTO’s focus on reducing the appeal and examination backlogs has caused it to lose regard for applicants’ due process rights.Continue reading this entry
In Keurig, Inc. v. Sturm Foods, Inc., the Federal Circuit upheld the district court’s decision that Keurig’s patent rights were exhausted by the sale of its machines, and so not infringed by the defendant’s sale of replacement coffee cartridges. Foley &Lardner LLP represented the appellee in this appeal, but this summary is based only on the public record, as reflected in the Federal Circuit decision.Continue reading this entry
In Intellect Wireless, Inc. v. HTC Corp., the Federal Circuit affirmed the district court decision holding Intellect’s patents unenforceable due to inequitable conduct. This is a rare case where the applicant was found to have submitted a false declaration, and did not cure that misrepresentation. Continue reading this entry
In Microsoft Corp. v. International Trade Commission, the Federal Circuit upheld the ITC’s determination that Microsoft had failed to establish that there was a “domestic industry” relating to three of four patents asserted to be infringed by Motorola Mobility LLC. This case underscores the additional requirement that must be proven when bringing an infringement action in the ITC under 19 USC § 1337.Continue reading this entry
In MeadWestVaco Corp. v. Rexam Beauty and Closures, Inc., the Federal Circuit upheld the admissibility of expert testimony that was not fully aligned with the district court’s claim construction. In so doing, the court explained that deviations from the claim construction might impact the infringement determination, but did not render the evidence irrelevant as a matter of law.Continue reading this entry
In Rambus, Inc. v. Rea, the Federal Circuit found several legal and procedural errors in the decision of the USPTO Patent Trial and Appeal Board (PTAB) that invalidated certain claims of the Rambus patent as obvious. While the technology at issue goes beyond the scope of PharmaPatentsBlog, the decision makes several important points of general interest.Continue reading this entry
In Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit reversed the district’s holding of no Lunesta® patent infringement that was based on a certification submitted to the court, and found infringement based on the product described in the Abbreviated New Drug Application (ANDA). In reaching its decision, the court upheld the district court’s construction of “consisting essentially of” that was based on arguments and evidence submitted during prosecution.Continue reading this entry
In Buckhorn Inc. v. Orbis Corp., the Federal Circuit reversed the district court’s refusal to enforce the fee-shifting terms of a licence and settlement agreement. The district court found that the terms did not apply because the new action was not brought to enforce the agreement, and also considered that the fee-shifting terms were unenforceable as unconscionable. The Federal Circuit disagreed on both points.
The Agreement At Issue
In 1992, predecessors-in-interest to the parties (Xytec and Ropak) settled patent infringement litigation with an agreement that included the following fee-shifting terms:
In any litigation based on a controversy or dispute arising out of or in connection with this Agreement or its interpretation, the prevailing party shall be entitled to recover all fees, costs, reasonable attorney’s fees, and other expenses attributable to the litigation.
The New Dispute
In 2000, Ropak transferred its entire materials handling business (including its rights under agreement) to Linpac Materials Handling, Inc. (“LMH”), which was acquired by Orbis in 2006.
In 2006, the successor-in-interest to Xytec licensed several patents to Myers Industries, Inc., including U.S. Patent 5,199,592, which was encompassed by the agreement. Under the license, Myers could commence infringement actions and transfer its rights to a subsidiary without notice .
In 2008, Buckhorn Inc., a wholly-owned subsidiary of Myers, brought the infringement action at issue against Orbis and others.
Orbis raised the Ropak-Xytec agreement as an affirmative defense, asserting that it was the successor-in-interest of Ropak’s rights under the agreement. After the district court granted Orbis’ motion for partial summary judgment on its affirmative license defense, Orbis moved for an award of fees under the fee-shifting terms of the agreement.
As summarized by the Federal Circuit:
The district court denied ORBIS’s motion, stating that this “case cannot be a litigation based on a controversy or dispute arising out of or in connection with the License when Plaintiffs clearly had no knowledge of the License at the time the litigation was initiated.” …. The district court also found that enforcing the fee-shifting provision would be unconscionable.
The Federal Circuit Decision
The Federal Circuit opinion was authored by Judge O’Malley and joined by Chief Judge Rader and Judge Reyna.
Reviewing the agreement under California state law (in accordance with its choice of law provision), the Federal Circuit found:
The district court erred by denying ORBIS’s motion for fees and costs based solely on the fact that the Buckhorn plaintiff was unaware of the Ropak-Xytec Agreement when it instituted the infringement action against ORBIS …. Apparently, the trial court believed that an action could only arise out of the license agreement if the action included an express attempt to enforce or rescind it.
In particular, the Federal Circuit found that the litigation was “based on a controversy or dispute … in connection with” the agreement because it “related to the very intellectual property rights addressed in [the agreement],” and because the existence of the agreement resolved the patent infringement issues in the litigation.
The Federal Circuit also rejected the district court’s concerns that the fee-shifting provision was “unconscionable.” The court summarized California law on this point as follows:
[A]n unconscionable contract ordinarily involves both a procedural and a substantive element:
(1) oppression or surprise due to unequal bargaining power, and
(2) overly harsh or one-sided results.
The Federal Circuit determined that the district court’s error stemmed from its frame of reference:
In denying fees and costs, the district court found that “[i]t would be unconscionable to require Plaintiffs to pay fees and costs under the License, as Plaintiffs were not even given a copy of the License until May 28, 2010, over 18 months after the case was filed.” …. It also stated that applying the fee provision “would be unconscionable given the timeline and facts of this case,” … based on Plaintiffs’ alleged lack of awareness of the Ropak-Xytec Agreement as of the filing of the lawsuit.
According to the Federal Circuit:
The district court erred by basing its finding of unconscionability on events taking place after Ropak and Xytec entered into their agreement rather than at the time they entered it. As a determination of unconscionability considers factors at the time the contract was made, the district court erred by considering subsequent events.
Thus, the Federal Circuit held that the district court could “not refuse to make an award given the unambiguous terms of the contract,” could consider any “dilatory conduct on the part of ORBIS during discovery” when assessing the reasonableness of any fee award.
While the district court relied on the Plaintiffs’ lack of knowledge of the agreement, the Federal Circuit makes the following point in footnote 3 of its opinion:
Schoeller does not contend it lacked knowledge of the Ropak-Xytec Agreement; it only denied being aware that the agreement covered the ’592 patent. In fact, Schoeller produced the Ropak-Xytec Agreement in its initial productions during discovery and produced documents and witnesses reflecting knowledge of the agreement prior to the litigation. ….
There is no further discussion of this issue, but it is interesting that the agreement included a license to U.S. Patent 4,967,927 and “any corresponding divisional, continuations, continuations-in-part, extensions, or reissues,” and the ’592 patent is a grandchild patent of the ’927 patent.
In St. Jude Medical, Inc. v. Access Closure, Inc., the Federal Circuit found that one of St. Jude’s patents was invalid under the doctrine of obviousness-type double patenting. This case highlights the potential difficulty of maintaining consonance with an original restriction requirement in a multi-generational patent family. Continue reading this entry
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.
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.
In University Of Utah V. Max-Planck-Gesellschaft, the Federal Circuit was faced with deciding whether a patent inventorship dispute between two different state universities is a “dispute between two states” that falls under the Supreme Court’s exclusive jurisdiction. A divided panel of the court determined that it is not.Continue reading this entry
In Hamilton Beach Brands, Inc. v. Sunbeam Products, Inc., the Federal Circuit affirmed the district court’s finding that the asserted claims were invalid under the on sale bar of 35 USC § 102(b) due to a purchase order between Hamilton Beach and it’s supplier. Judge Reyna’s dissenting opinion questions whether the transaction at issue was a “commercial” offer for sale. His concerns might be at least partially addressed by the America Invents Act, if new § 102(a)(1) embodies a “public availability” component as the USPTO has found. Continue reading this entry
In Leo Pharmaceutical Products, Lt. v. Rae, the Federal Circuit issued a rare decision reversing an obviousness determination by the USPTO Patent Trial and Appeal Board (PTAB). The patent at issue was a Taclonex® patent, and the court found both that the prior art did not render the claimed combination formulations obvious and that the PTAB had failed to give proper weight to the objective indicia of non-obviousness. This decision reinforces the principle that even under KSR more than general teachings are required to support an “obvious to try” rationale of obviousness.Continue reading this entry
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
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.
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.
In In Re Bimeda Research & Development Ltd., the Federal Circuit upheld the decision of the USPTO Patent Trial and Appeal Board (PTAB) that found that a claim that excluded the presence of a specific compound was not supported by a description that excluded a genus of compounds. This case illustrates the challenges of establishing written description for exclusion of specific embodiments.Continue reading this entry
In Novozymes A/S v. DuPont Nutrition Biosciences APS, the Federal Circuit determined that the Novozymes amylase patent at issue did not satisfy the written description requirement of 35 USC § 112, because the disclosure did not demonstrate possession of the claimed subject matter as a whole. While the opinion states that the decision is consistent with other Federal Circuit case law (such as University of Rochester v. G.D. Searle & Co. (Fed. Cir. 2004)), I find the court’s analysis to reflect an EPO-type analysis. Indeed, the majority states that Novozymes needed to have actually reduced the claimed subject matter to practice in order to satisfy the written description requirement.
In In re Adler, the Federal Circuit affirmed the decision of the Patent Trial and Appeal Board (PTAB) that upheld the Examiner’s determination that the claims at issue were obvious. In so doing, the court rejected Adler’s arguments that the PTAB decision was based on a new ground of rejection that would have entitled Adler to reopen prosecution or obtain a rehearing.Continue reading this entry
In Fresenius, USA Inc. v. Baxter International, Inc., the Federal Circuit interpreted the ex parte reexamination statutes (35 USC §§ 301-307) as providing that the final cancellation of claims in a reexamination proceeding is binding on concurrent litigation proceedings, as long as the litigation is still pending. This decision validates the use of ex parte reexamination to launch a collateral attack on patents in litigation. While many defendants hesitate to bring an ex parte reexamination because of the very limited role they would have in the proceedings, because ex parte reexamination is not limited by the timing requirements of inter partes review and post grant review proceedings, and does not carry the same litigation estoppel, it may be worthy of a second look under appropriate circumstances.
In Wyeth v. Abbott Laboratories, the Federal Circuit affirmed the district court’s decision that the claims at issue are invalid for failing to satisfy the enablement requirement of 35 USC § 112. The court took only 10 pages to explain why a specification that describes one specific compound did not enable claims encompassing tens of thousands of compounds.
In its third look at the Novo Nordisk A/S patent related to Prandin®, in Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories Ltd., the Federal Circuit affirmed the district court’s finding that claim 4 of U.S. Patent No. 6,677,358 is invalid as obvious, but reversed the district court’s finding that the patent is unenforceable due to inequitable conduct. This decision illustrates both the difficulty of sustaining a patent based on unexpected results and the difficulty of invalidating a patent based on inequitable conduct.Continue reading this entry