The Federal Circuit held that a patentee’s listing of a patent in the FDA Orange Book does not, by itself, create the reasonable apprehension of suit necessary for a generic drug maker to maintain a Hatch-Waxman declaratory judgment action challenging the patent’s validity or non-infringement.
The Supreme Court held that a defendant asserting classic fair use in a trademark case bears no burden to negate likelihood of confusion, and some degree of consumer confusion may coexist with a lawful fair use.
The Federal Circuit affirmed that farmers who saved and replanted seeds from Monsanto’s patented Roundup Ready soybeans infringed Monsanto’s plant patents — holding that patent exhaustion did not apply to second-generation seeds and that Monsanto’s technology use agreements validly prohibited seed saving, reinforcing the enforceability of biotech seed patents.
In an en banc decision, the Federal Circuit eliminated the rule that a patent infringer who invokes attorney-client privilege faces an adverse inference of willful infringement, substantially reshaping the willfulness landscape.
The Federal Circuit held that the DMCA’s anti-circumvention provision does not create a new property right and requires proof that access was unauthorized; because Chamberlain implicitly authorized customers to use third-party transmitters, Skylink’s universal garage door opener did not violate § 1201(a)(2).
The Federal Circuit affirmed rejection of a patent application for lack of novelty, holding that a slide presentation displayed for several days at professional conferences constitutes a ‘printed publication’ under 35 U.S.C. § 102(b) based on public accessibility — even without distribution of copies or library indexing — when the relevant technical audience could view and reproduce the disclosure.
The Federal Circuit vacated summary judgment of non-infringement, holding that the claim term ‘operatively connected’ means components must be connected in a way that permits them to perform their designated function — not that they must be physically attached in a unitary structure.
The Federal Circuit established that a generic drug company’s filing of an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification cannot, by itself, constitute willful patent infringement or justify enhanced damages and attorney fees.
The Federal Circuit affirmed a jury verdict that LabCorp indirectly infringed Metabolite’s patent on a method of detecting vitamin B12 and folate deficiency by measuring and correlating homocysteine levels, a case that later reached the Supreme Court and raised fundamental questions about patenting natural phenomena.
The Federal Circuit held that a patent applicant’s cancellation of an independent claim and rewriting of a dependent claim as a new independent claim during prosecution triggers prosecution history estoppel, creating a presumptive bar to capturing the surrendered subject matter through the doctrine of equivalents.
The Federal Circuit affirmed invalidity of Chiron’s HER2 antibody patent, holding that claims broadly encompassing chimeric and humanized antibodies were not enabled by a specification that only disclosed murine antibodies, even though the claims were filed years before Herceptin was developed.
The Federal Circuit held that a Hatch-Waxman patent term extension covers all salt forms of an active pharmaceutical ingredient, not just the specific salt approved by the FDA.
The Federal Circuit affirmed invalidation of the University of Rochester’s COX-2 inhibitor method patent, holding that a patent claiming a method of using a compound fails the written description requirement when the specification does not disclose the actual compounds needed to perform the method.
The Federal Circuit reversed summary judgment of non-infringement, reaffirming that courts may not import limitations from the specification into patent claims and that a single described embodiment does not limit the scope of broader claim language.
The Federal Circuit affirmed a $521 million judgment against Microsoft for infringing Eolas Technologies’ patent on interactive embedded objects in web browsers — holding that Internet Explorer’s implementation of interactive plug-ins and applets infringed the Eolas patent covering methods and systems for enabling interactive content in web browsers.
The Federal Circuit vacated a summary judgment of non-infringement, holding that the claim term ‘a substantial helical flow path’ is a meaningful approximation — not an absolute requirement for a geometrically perfect helix — and that the district court erred by construing the term to require a precise helical path emanating from the tank center and completing a full rotation, which improperly imported geometric precision into an approximation term.
The Federal Circuit held that method-of-use claims on a pharmaceutical compound are not patentably distinct from an earlier patent claiming the same compound when the earlier patent’s specification already disclosed that use, affirming invalidity for nonstatutory obviousness-type double patenting.
The Federal Circuit reversed summary judgments of invalidity for lack of enablement and unenforceability for inequitable conduct in a semiconductor wafer-cleaning patent case, holding that enablement requires only that skilled artisans be able to make and use the full scope of the claimed invention — not that the invention meet commercial cleanliness standards — and that advantages statements and undisclosed test data lacked sufficient materiality to support an inequitable conduct finding.
The Federal Circuit affirmed the ITC’s non-infringement finding in a section 337 flooring patent dispute, holding that an applicant’s reliance on ‘play’ between panels to distinguish prior art during prosecution constituted a clear disclaimer that limited claim scope to systems incorporating play.
The Federal Circuit reversed the TTAB’s refusal to register BLUE MOON for beer, holding that beer and restaurant services are not presumptively related goods and services, and that the USPTO must point to something more than the mere relatedness of industries to refuse registration under the likelihood-of-confusion standard.
The Federal Circuit affirmed the ITC’s finding that Honeywell’s PET yarn patent claims were insolubly ambiguous — and therefore invalid as indefinite — because the claims specified measurement parameters without identifying which of four sample preparation methods should be used to make those measurements.
The Federal Circuit held that 35 U.S.C. § 271(g) — which prohibits importing products made by a patented U.S. process — covers only physical products actually manufactured by the patented process, not information or drug leads identified by using the patented research method.
The Federal Circuit held that Schering’s patent on a metabolite of Claritin (loratadine) was invalid because the metabolite is necessarily and inherently formed when a patient takes a dose of the previously patented loratadine — establishing that inherent anticipation does not require recognition in the prior art.
The Federal Circuit reversed a declaratory judgment of non-infringement, holding that the doctrine of claim differentiation creates a strong presumption that an independent claim has a broader scope than its dependent claims, and that the narrow limitation in a dependent claim should not be read back into the independent claim.
The Federal Circuit reversed summary judgments of non-infringement and invalidity, holding that the district court improperly added a negative limitation to patent claims without intrinsic evidence support, and that prosecution disclaimer applies only when a patentee makes clear and unmistakable surrenders of claim scope — ambiguous prosecution statements do not give rise to disclaimer.
The Federal Circuit held that the Hatch-Waxman safe harbor of § 271(e)(1) does not immunize basic pre-clinical research conducted by drug companies even when the research might eventually lead to FDA submissions, adopting a narrow reading later reversed by the Supreme Court.
The Supreme Court held that the Lanham Act’s false designation of origin provision applies to the physical source of goods, not to the communicative content of expressive works — so unaccredited copying of a public domain film does not violate the Act.
The Federal Circuit held that NAFTA’s amendments to the Lanham Act require proof of actual consumer deception before a mark can be refused registration as primarily geographically deceptively misdescriptive, overturning a TTAB refusal of the CALIFORNIA INNOVATIONS mark.
The Federal Circuit held that a shrink-wrap license contractually prohibiting reverse engineering of software is enforceable and not preempted by federal copyright law, even though copyright law itself permits reverse engineering in certain circumstances.
The Federal Circuit held that an ANDA applicant seeking approval to sell a generic drug for an FDA-approved use does not infringe a method-of-use patent claiming an unapproved, off-label use of the same drug — establishing important limits on Hatch-Waxman patent infringement actions.
The Supreme Court held 7–2 that the Sonny Bono Copyright Term Extension Act, which added 20 years to existing and future copyright terms, does not violate the Copyright Clause’s “limited Times” requirement or the First Amendment.
The Supreme Court held that the Federal Trademark Dilution Act requires proof of actual dilution of the famous mark, not merely a likelihood of dilution — a standard Congress later reversed by enacting the Trademark Dilution Revision Act of 2006.
The Federal Circuit affirmed rejection of claims for a nickel-base superalloy composition, holding that a prior art reference disclosing a range that overlaps a claimed range establishes a prima facie case of obviousness, and that the normal desire of scientists to optimize within known ranges provides motivation to combine — the applicant must then come forward with evidence of unexpected results to overcome the presumption.
The Federal Circuit affirmed the validity of Amgen’s erythropoietin (EPO) patents covering recombinant human erythropoietin, finding the claims satisfied written description and enablement requirements, while remanding certain issues for further consideration.
The Federal Circuit sharply limited the common-law experimental use defense by holding that universities infringe patents when they use patented technology in their research programs, even without profit motive, because such use advances the university’s legitimate business objectives.
The Federal Circuit held that dictionaries, encyclopedias, and technical treatises are valuable starting points for determining the ordinary and customary meaning of patent claim terms, and should be consulted before examining the specification for limitations.
The Federal Circuit held that the written description requirement is separate from the enablement requirement and that a deposit of biological materials in a recognized depository can satisfy written description — setting an important standard for biotechnology patent claims directed to biological sequences and genus inventions.
The Federal Circuit held that a farmer who saved patented Roundup Ready soybean seeds from his harvest and replanted them violated Monsanto’s patent rights, because patent exhaustion does not apply to seeds that were copied rather than purchased from the patentee.
The Federal Circuit affirmed invalidation of patents covering methods of preparing cruciferous sprout food products for cancer prevention, holding that the patents were anticipated because the glucosinolate content and Phase 2 enzyme-inducing properties of broccoli sprouts were inherent characteristics of previously known sprouting methods — discovering naturally existing properties of known subject matter does not create patentable invention.
The Federal Circuit affirmed infringement of an offshore platform installation patent under the doctrine of equivalents but vacated the damages award, holding that all three damage models presented by the patentee’s expert were legally flawed because they based royalty calculations on the entire platform cost rather than the economic value attributable to the patented method, and because they improperly assumed an injunction would prevent use of the entire structure.
The Federal Circuit held that a patent claiming the priority date of a provisional application is invalid under the on-sale bar if the provisional specification failed to adequately describe the claimed invention, because the patent cannot claim priority it did not earn.
The Federal Circuit held en banc that a patent’s reference to biological material deposited in a public repository satisfies the written description requirement of 35 U.S.C. § 112, reversing a panel decision that had threatened biotechnology patents relying on ATCC deposits.
The Federal Circuit held that a government laboratory researcher’s pre-critical-date demonstrations of his internet database system to colleagues without confidentiality restrictions triggered the public use bar, invalidating his patents.
The Federal Circuit affirmed infringement and reversed the district court’s overly narrow claim construction, reaffirming that claim terms carry their ordinary and accustomed meaning unless the patentee clearly redefined the term or disclaimed certain subject matter in the intrinsic record.
The Supreme Court rejected an absolute bar to claiming equivalents after a narrowing claim amendment, instead establishing a flexible presumption that the patentee surrendered equivalents within the amended scope — rebuttable on three specific grounds.
The Federal Circuit affirmed non-infringement in an e-commerce coupon patent case, holding that preamble language in a method claim does not limit the claim’s scope when the claim body describes a structurally complete invention and the patentee did not rely on the preamble to distinguish prior art — but preamble language that provides antecedent basis or defines essential structure may be limiting.
The Supreme Court held that the Federal Circuit lacks appellate jurisdiction over a case when patent law appears only in the defendant’s compulsory counterclaim and is absent from the plaintiff’s well-pleaded complaint.
The Federal Circuit reversed a narrow claim construction, holding that the claim term “reciprocating member” in an exercise equipment patent should be given its ordinary meaning encompassing multi-component and curved structures, not limited to the single straight bar depicted in the specification’s drawings.
In an en banc decision, the Federal Circuit held that subject matter disclosed in a patent specification but not claimed is dedicated to the public and cannot be recaptured through the doctrine of equivalents — patentees who fail to claim a disclosed alternative cannot later assert it as equivalent to what they did claim.
The Federal Circuit held that the equitable doctrine of prosecution laches can bar enforcement of patent claims that issued after an unreasonable and unexplained multi-decade delay in patent prosecution — a landmark ruling against Jerome Lemelson’s famous ‘submarine patent’ strategy.