Justia Patents Opinion Summaries
Fresenius USA, Inc. v. Baxter Int’l, Inc.
In 2003, Fresenius, a manufacturer of hemodialysis machines sought declaratory judgments of invalidity and non-infringement with respect to Baxter’s 434 patent, covering a dialysis machine with an integrated touch screen interface. Baxter counterclaimed for infringement. The Federal Circuit affirmed a determination that the claims at issue were not invalid, but remanded for reconsideration of an injunction and post-verdict damages. While the appeal was pending, the United States Patent and Trademark Office completed reexamination of the patent and determined that all asserted claims were invalid. The Federal Circuit affirmed. Meanwhile the district court entered judgment against Fresenius in the infringement proceedings. The Federal Circuit vacated; in light of the cancellation of the asserted claims and the fact that the infringement suit remains pending, Baxter no longer has a cause of action. View "Fresenius USA, Inc. v. Baxter Int'l, Inc." on Justia Law
MDS (Canada) Inc., et al. v. Rad Source Technologies, Inc.
This case involved disputes over licensing agreements for, inter alia, the RS 3400 blood irradiation device. At issue was whether the Federal Circuit has exclusive jurisdiction to hear an appeal of a breach of contract claim that would require the resolution of a claim of patent infringement for the complainant to succeed. The court concluded that it did not have appellate jurisdiction and resolved dispositive issues in favor of Rad Source, leaving a single dispositive issue for certification: When a licensee enters into a contract to transfer all of its interests in a license agreement for an entire term of a license agreement, save one day, but remains liable to the licensor under the license agreement, is the contract an assignment of the license agreement, or is the contract a sublicense? View "MDS (Canada) Inc., et al. v. Rad Source Technologies, Inc." on Justia Law
Wyeth & Cordis Corp. v. Abbott Labs.
Wyeth’s patents relate to the use of rapamycin for treatment and prevention of restenosis, the renarrowing of an artery. To open a blocked artery, a doctor guides a balloon catheter to the site of accumulated plaque and inflates the balloon to crush the plaque. As the balloon inflates it may cause injury to the arterial wall that leads to restenosis. The claims recite a method of treating or preventing “restenosis ... which comprises administering an antirestenosis effective amount of rapamycin.” In general, “rapamycin” may refer to a class of compounds; the parties agree that the specification discloses only one rapamycin species, sirolimus. In Wyeth’s infringement action, the district court adopted Wyeth’s proposed construction of “rapamycin,” but entered summary judgment, finding the patents invalid for nonenablement. The Federal Circuit affirmed, finding that the specification does not enable one of ordinary skill to practice the asserted claims without undue experimentation. View "Wyeth & Cordis Corp. v. Abbott Labs." on Justia Law
Commil USA, LLC v. Cisco Sys., Inc.
In a wireless system, devices communicate with fixed “base stations” according to “protocols,” which are standardized procedures that govern how data exchanged between devices is formatted, ordered, maintained, and transmitted. Effective wireless communication requires that the transmitting device and the receiving device follow the same protocol. Commil’s 395 patent covers a method of providing faster and more reliable handoffs of mobile devices from one base station to another as a mobile device moves throughout a network area. Cisco is a major supplier of WiFi access points and controllers. A jury found that Cisco directly and indirectly infringed specified claims of the 395 patent; that the specified claims were not invalid as indefinite, for lack of enablement, or as lacking adequate written description; and that Cisco was liable for $63,791,153 in damages and pre-judgment interest and costs. The Federal Circuit reversed in part, holding that the district court gave the jury a legally erroneous instruction concerning indirect infringement and that Cisco’s evidence of a good-faith belief of invalidity may negate the requisite intent for induced infringement. The district court did not err in granting a partial new trial.
View "Commil USA, LLC v. Cisco Sys., Inc." on Justia Law
Ultramercial, Inc. v. Hulu, LLC
The 545 patent claims a method for distributing copyrighted products (songs, movies, books) over the Internet where the consumer receives a copyrighted product for free in exchange for viewing an advertisement, and the advertiser pays for the copyrighted content. The district court dismissed an infringement claim. The Federal Circuit reversed and remanded, holding that the patent claims a "process" within the meaning of 35 U.S.C. 101. The Supreme Court vacated. The Federal Circuit subsequently held, again, that the district court erred in holding that the subject matter of the 545 patent is not a “process” within the meaning of 35 U.S.C. 101. The claimed invention is a practical application of the general concept of advertising as currency and an improvement to prior art technology and is not “so manifestly abstract as to override the statutory language of section 101.” View "Ultramercial, Inc. v. Hulu, LLC" on Justia Law
Novo Nordisk A/S v. Caraco Pharma. Labs., Ltd.
In 1990 Novo began experimenting with the drug repaglinide in monotherapy treatement of Type II diabetes, conducted a study to determine whether repaglinide might be more effective in combination with metformin, and concluded that the combination obtained fasting plasma glucose levels more than eight times lower than typically achieved by metformin alone. Novo filed a provisional patent application for the combination in 1997. The examiner rejected the initial application as obvious. In its fifth response, Novo included the Sturis report, concluding that the combination has synergistic properties in type 2 diabetic human patients. The examiner withdrew her rejection, based solely upon the Sturis declarations and reconsideration of the synergistic effects. The 358 patent issued in 2004. In 2005, pursuant to the Hatch-Waxman Act, Caraco filed an Abbreviated New Drug Application requesting FDA approval to sell a generic version of repaglinide, and certifying that the 358 patent was invalid or would not be infringed. Novo responded with an infringement lawsuit. The district court held that claim 4 of the patent was invalid because of obviousness and that the patent was not enforceable because of inequitable conduct. The Federal Circuit affirmed with respect to obviousness but reversed with respect to inequitable conduct. View "Novo Nordisk A/S v. Caraco Pharma. Labs., Ltd." on Justia Law
Fed. Trade Comm’n v. Actavis, Inc.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act), 21 U.S.C. 355(j)(2)(A)(vii)(IV) established procedures for identifying and resolving patent disputes between brand-name and generic drug manufacturers. One procedure requires a prospective generic manufacturer to certify to the FDA that any listed, relevant patent is invalid or will not be infringed by the manufacture, use, or sale of the generic drug (paragraph IV). Generic manufacturers filed paragraph IV applications for generic drugs modeled after Solvay’s FDA-approved, patented drug AndroGel. Solvay claimed patent infringement, 35 U.S.C. 271(e)(2)(A). The FDA approved the generic product, but the generic companies entered into “reverse payment” settlements, agreeing not to bring the generic to market for a number of years and to promote AndroGel to doctors in exchange for millions of dollars. The FTC sued, alleging violation of section 5 of the Federal Trade Commission Act by agreeing to abandon patent challenges, to refrain from launching low-cost generic drugs, and to share in Solvay’s monopoly profits. The district court dismissed. The Eleventh Circuit affirmed. The Supreme Court reversed and remanded, calling for application of a “rule of reason” approach rather than a “quick look.” Although the anti-competitive effects of the reverse settlement might fall within the exclusionary potential of Solvay’s patent, the agreement is not immune from antitrust attack. It would be incongruous to determine antitrust legality by looking only at patent law policy, and not at antitrust policies. The Court noted the Hatch-Waxman Act’s general pro-competitive thrust, facilitating challenges to a patent’s validity and requiring parties to a paragraph IV dispute to report settlement terms to antitrust regulators. Payment for staying out of the market keeps prices at patentee-set levels and divides the benefit between the patentee and the challenger, while the consumer loses. That a large, unjustified reverse payment risks antitrust liability does not prevent parties from settling their lawsuits; they may settle in other ways, e.g., by allowing the generic to enter the market before the patent expires without payment to stay out prior to that point. View "Fed. Trade Comm'n v. Actavis, Inc." on Justia Law
Robert Bosch, LLC v. Pylon Mfg. Corp.
In 2008, Bosch sued Pylon for patent infringement. Pylon asserted patent infringement counterclaims against Bosch. Pylon moved to bifurcate the issues of liability and damages. The district court granted the motion and stayed discovery on damages issues including willfulness. After the district court entered judgment on the liability issues, both parties appealed. Bosch then moved to dismiss both its appeal and Pylon’s cross-appeal on the grounds that the appeals court lacked jurisdiction. On rehearing, en banc, the Federal Circuit held that 28 U.S.C. 1292(c)(2) does confer jurisdiction to entertain appeals from patent infringement liability determinations when a trial on damages has not yet occurred and when willfulness issues are outstanding and remain undecided. View "Robert Bosch, LLC v. Pylon Mfg. Corp." on Justia Law
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Patents, U.S. Federal Circuit Court of Appeals
Assoc. for Molecular Pathology v. Myriad Genetics, Inc.
Myriad obtained patents after discovering the precise location and sequence of the BRCA1 and BRCA2 genes, mutations of which can dramatically increase the risk of breast and ovarian cancer. The discovery enabled Myriad to develop medical tests for detecting mutations for assessing cancer risk. Myriad’s patents would give it the exclusive rights to isolate an individual’s BRCA1 and BRCA2 genes and to synthetically create BRCA composite DNA. The district court entered summary judgment, finding the patents invalid under 35 U.S.C. 101 because they covered products of nature. On remand following the Supreme Court’s decision, Mayo Collaborative Servs. v. Prometheus Labs, Inc., the Federal Circuit found both isolated DNA and composite DNA patent-eligible. The Supreme Court affirmed in part and reversed in part, noting that the case did not involve “method claims” for new applications of knowledge about the genes or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. A naturally-occurring DNA segment is not patent-eligible merely because it has been isolated, but composite DNA is patent-eligible because it is not naturally-occurring. Myriad did not create or alter the genetic information encoded in the genes or the genetic structure of the DNA. Even brilliant discovery does not alone satisfy the section 101 inquiry. Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs chemical bonds that bind gene molecules together. The claims are not expressed in terms of chemical composition, nor do they rely on the chemical changes resulting from the isolation of a particular DNA section. Composite DNA, however, is not a “product of nature;” a lab technician unquestionably creates something new when introns are removed from a DNA sequence to make composite DNA. View "Assoc. for Molecular Pathology v. Myriad Genetics, Inc." on Justia Law
Organic Seed Growers & Trade Assoc. v. Monsanto Co.
The patented technologies incorporate traits into agricultural crops, conferring resistance to the active ingredient in Monsanto’s herbicide, Roundup. Farmers using the seeds are able to eliminate weeds by spraying the herbicide over their crops, which would kill conventional seeds. Monsanto sells seed under a license for a single generation of genetically modified seeds. Between 1997 and 2010, Monsanto brought 144 infringement suits for unauthorized use of its seed; about 700 other cases settled without litigation. A coalition of farmers, seed sellers, and agricultural organizations that grow, use, or sell conventional seed, concerned that their product could become contaminated by modified seed and that they could be accused of patent infringement, sought declaratory judgments that the patents were invalid, unenforceable, and not infringed. Monsanto referred to its website, which states: It has never been, nor will it be Monsanto policy to exercise its patent rights where trace amounts of our patented seeds or traits are present in farmer’s fields as a result of inadvertent means. The district court dismissed for lack of jurisdiction. The Federal Circuit affirmed, stating that Monsanto has made binding assurances that it will not take action where crops inadvertently contain traces of Monsanto biotech genes; the plaintiffs did not allege circumstances placing them beyond the scope of those assurances. There is no justiciable case or controversy. View "Organic Seed Growers & Trade Assoc. v. Monsanto Co." on Justia Law