Category Archives: Federal Circuit Decisions

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Claim Construction Of An Enantiomeric Chemical Structure

In Sumitomo Dainippon Pharma Co. V. Emcure Pharm. Ltd., the Federal Circuit affirmed the district court’s decision that construed a chemical structure as reading on the lurasidone enantiomer that is the active ingredient of Latuda®. While the decision was in favor of the patentee, the required analysis suggests that applicants may want to consider using … Continue reading this entry

Federal Circuit Finds ANDA Jurisdiction Before PIV Certification

Our first article on Vanda Pharmaceuticals, Inc. v. Aventisub, LLC focused on the subject matter eligibility of the personalized method of treatment claims under 35 USC § 101. Next, we considered how the Fanapt® label was sufficient to establish infringement in the ANDA context. Here, we highlight the Federal Circuit’s threshold decision that the district court … Continue reading this entry

How The Fanapt Product Label Established Infringement Of Personalized Treatment Claims

Our first article on Vanda Pharmaceuticals, Inc. v. Aventisub, LLC focused on the Federal Circuit’s decision upholding the subject matter eligibility of the personalized method of treatment claims under 35 USC § 101. Here, we consider how the Fanapt label was sufficient to establish infringement of personalized treatment claims in the ANDA context.… Continue reading this entry

Federal Circuit Upholds Vanda Fanapt Personalized Method Claims Against Patent Eligibility Challenge

In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd., a divided panel of the Federal Circuit upheld Vanda’s personalized method of treatment claims relating to its Fanapt® (iloperidone) product against a patent eligibility challenge. Interestingly, where the district court had found the claims eligible at step two of the Mayo/Alice analytical framework, the Federal Circuit … Continue reading this entry

Federal Circuit Finds Composition of Matter Ineligible For Patenting

In a non-precedential decision issued in In re Bhagat, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that claims directed to certain lipid compositions were ineligible for patenting under 35 USC § 101. Did the court do more or less harm by rendering its decision without much explanation?… Continue reading this entry

An Economic Test For Patent Eligibility?

In the non-precedential decision issued in Exergen Corp. v. Kaz USA, Inc., Judge Moore considered the time and money it took to develop the invention at issue when deciding that the claims satisfy the patent eligibility requirement of 35 U.S.C. § 101. While other patent eligibility decisions make clear that an inventor’s investment will not always … Continue reading this entry

Federal Circuit Emphasizes Need For Reasonable Expectation Of Success

In Genzyme Corp. v. Dr. Reddy’s Labs. Ltd., the Federal Circuit affirmed the district court decision upholding Genzyme’s Orange Book listed patent for the cancer drug Mozobil® against an obviousness challenge, because the asserted prior art references failed to provide a reasonable expectation of success. While a non-precedential decision, this case illustrates the important role that … Continue reading this entry

Federal Circuit Breathes More Life Into Divided Infringement

Enforcing a patent with claims that raise the specter of divided infringement can be a difficult plight for patent owners. Even under the more liberal standard set forth in the Federal Circuit’s en banc decision in Akamai v. Limelight, it has proven difficult for patent owners to establish the necessary levels of control or cooperation … Continue reading this entry

Prosecution History Informs Claim Meaning Even Without Unmistakable Disclaimer

Although non-precedential, the Federal Circuit decision in Aptalis Pharmatech, Inc. v. Apotex Inc. is worth a read to see how the court “tiptoes” the “fine line between reading a claim in light of the specification, and reading a limitation into the claim from the specification.” Here, the court also notes that the prosecution history can … Continue reading this entry

Federal Circuit Finds NuvaRing Patent Nonobvious Without Hindsight

In a non-precedential decision issued in Merck Sharp & Dohme B.V., v. Warner Chilcott Co. LLC, the Federal Circuit reversed the district court’s obviousness ruling as being improperly grounded in hindsight. This decision provides a welcome reminder that even simple-sounding inventions can be nonobvious, but why is it non-precedential?… Continue reading this entry

Federal Circuit Questions Written Description For Antibody Claims

The October 5, 2017 Federal Circuit decision in Amgen Inc. v. Sanofi is getting a lot of attention for its commercial impact, because the court vacated the permanent injunction that prevented Sanofi and Regeneron from marketing their cholesterol-lowering Praluent® (alirocumab) product, which will compete with Amgen’s Repatha® (evolocumab) product. But the decision also addresses several … Continue reading this entry

CAFC Finds Harmless Error in USPTO Reliance On Doctrine of Inherency

In Southwire Co. v. Cerro Wire LLC, the Federal Circuit upheld the USPTO decision rendered in an inter partes reexamination proceeding that found Southwire’s patent invalid as obvious. Although the court found that the USPTO Board had erred in relying on the doctrine of inherency,  it concluded the error was harmless because the Board’s factual findings … Continue reading this entry

CAFC Vacates USPTO Single Reference Obviousness Rejection For Inadequate Showing Of Expectation of Success

In a split decision with Judge Lourie dissenting, the Federal Circuit vacated an obviousness rejection that had been affirmed in an ex parte appeal to the USPTO Patent Trial and Appeal Board. The decision was rendered in In re Stepan Co., where the majority found inadequate explanation of the reasonable expectation of success elements of obviousness, … Continue reading this entry

Federal Circuit Criticizes PTAB Reliance On Routine Testing

In Honeywell International, Inc. v. Mexichem Amanco Holdings S.A. DE C.V., the Federal Circuit vacated the decision of the USPTO Patent Trial and Appeal Board that invalidated Honeywell’s patent in an inter partes reexamination proceeding. The court’s decision could be important to applicants and patent owners facing obviousness rejections based on inherency and routine testing. Any … Continue reading this entry

Cleveland Clinic Decision Highlights Catch-22 Of Personalized Medicine Patents

The Federal Circuit decision in Cleveland Clinic Foundation v. True Health Diagnostics LLC, strikes another blow against the patent eligibility of diagnostic methods and highlights the difficulty of enforcing personalized medicine patents. The court affirmed the invalidity of claims related to a blood test for atherosclerotic cardiovascular disease, and agreed with the district court that diagnostic … Continue reading this entry

Court Questions Applicability of Function Way Result Test In Chemical Cases

In Mylan Institutional LLC v. Aurobindo Pharma Ltd., the Federal Circuit reviewed a preliminary injunction based in part on a finding of likelihood of success in establishing infringement under the doctrine of equivalents. Although the district court had applied the “function-way-result” test, the Federal Circuit suggested that the “insubstantial differences” test might be more appropriate for … Continue reading this entry

CAFC Finds ANDA Infringement Despite Differences Between FDA Labeling And Claim Language

In a non-precedential decision issued in Braintree Labs., Inc. v. Breckenridge Pharmaceutical, Inc., the Federal Circuit reversed the district court’s grant of summary judgment of noninfringement in favor of Breckenridge, and remanded for entry of judgment in favor of Braintree. In reaching its decision, the court held Breckenridge to its previous stipulations, and found that proposed ANDA labeling … Continue reading this entry

Are Secret Sales Prior Art Under The AIA?

In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit found that a publicly-announced “Supply and Purchase” agreement triggered the on-sale bar under pre-AIA 35 USC § 102(b) and under AIA 35 USC § 102(a)(1).  With this case, the court offered its first interpretation of the on-sale bar of the America Invents Act. … Continue reading this entry

No Nexus For Novartis Gilenya Patent

In Novartis AG v. Torrent Pharmaceuticals Ltd., the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) invalidating all claims of U.S. Patent 8,324,283, which is one of four Orange Book-listed patents for GILENYA. Among other issues, the court affirmed the PTAB’s finding that the asserted objective indicia of non-obviousness lacked sufficient … Continue reading this entry

Angiomax Patents Limited To Example

In The Medicines Co. v. Mylan, Inc., the Federal Circuit construed composition claims of two Angiomax patents as requiring the recited “batches” to be made by a specific “efficient mixing” process illustrated in one of the examples. While doing so may have preserved the validity of the patents, it required reversal of the district court’s … Continue reading this entry

PTAB Not Bound By Prior Court Decisions Upholding Exelon Patents

In Novartis v. Noven Pharmaceuticals, Inc., the Federal Circuit affirmed the USPTO Patent Trial and Appeal Board (PTAB) decisions invalidating certain claims of two Orange Book-listed Exelon patents. This decision has garnered attention because the patents previously were upheld by the U.S. District Court for the District of Delaware in a decision that also was … Continue reading this entry

Federal Circuit Finds "Consisting Of" Requires Reversing Infringement Of Shire Lialda Patent

The Federal Circuit focused on the “consisting of” language in the claims at issue when it reversed the district court’s finding that Watson’s ANDA product would infringe the only Orange Book-listed Shire Lialda patent. In so doing, the court emphasized the narrow scope of the Norian exception to the “closed” nature of “consisting of” language that … Continue reading this entry

Court Rejects Theory Of Derivation Based On FDA Requirement

The Federal Circuit decision in Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC may be more interesting for what Mylan argued than for what the Federal Circuit decided. However, it could be an important decision for pharmaceutical companies who need to innovate in order to satisfy FDA requirements.… Continue reading this entry

Federal Circuit Finds Infringement Under Akamai Of Two-Step Method Of Treatment

In Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., the Federal Circuit affirmed the district court decision finding infringement under Akamai of a two-step method of treatment when the prescribing information for the prescription drug component required coadministration of the other active agent. The appeal arose from ANDA litigation surrounding Eli Lilly’s ALIMTA® product, … Continue reading this entry