In a non-precedential decision issued in Merck Sharp & Dohme B.V., v. Warner Chilcott Co. LLC, the Federal Circuit reversed the district court’s obviousness ruling as being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...more
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...more
9/16/2017
/ Administrative Appeals ,
Appeals ,
CAFC ,
Harmless Error ,
Inherency ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Invalidity ,
Patents ,
Prior Art ,
USPTO
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 §...more
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...more
More than five years after the Federal Circuit’s en banc decision in Therasense and its first proposed rulemaking under that decision, the USPTO has issued a new proposed rulemaking to adapt its duty of disclosure rule (37...more
The USPTO Patent Trial and Appeal Board (PTAB) has issued a final written decision upholding Shire’s Lialda® patent over the Inter Partes Review (IPR) challenge brought by Kyle Bass and his Coalition for Affordable Drugs. The...more
The USPTO is seeking input on how it can leverage prior art information available on-line in related patent applications in order to “improve patent examination quality and efficiency” and reduce “applicant’s burden to...more
In Apotex, Inc. v. Wyeth LLC, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) finding that Apotex had failed to show that claims directed to a specific formulation of tigecycline...more
In Intendis GmbH v. Glenmark Pharmaceuticals Inc., USA, the Federal Circuit affirmed the district court decision that found infringement under the doctrine of equivalents. This case shows that the doctrine of equivalents...more
5/24/2016
/ Abbreviated New Drug Application (ANDA) ,
CAFC ,
De Novo Standard of Review ,
Doctrine of Equivalents ,
Estoppel ,
FDA Approval ,
Generic Drugs ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Patents ,
Prior Art
The USPTO Patent Trial and Appeal Board (PTAB) has decided to institute inter partes review (IPR) proceedings against the Ampyra patents based on the second set of petitions filed by Kyle Bass and the Coalition for Affordable...more
The USPTO Patent Trial and Appeal Board (PTAB) decided to institute inter partes review (IPR) proceedings filed by Kyle Bass against two of the five Juxtapid patents listed in the Orange Book. Two of the cited references may...more
In In re Urbanski, the Federal Circuit upheld the decision of the USPTO Patent Trial and Appeal Board (PTAB) finding the claims of Urbanski’s patent application obvious. Urbanski had argued that the cited references taught...more
In Dynamic Drinkware, LLC v. National Graphics, Inc., the Federal Circuit held that in order for a patent to qualify as prior art as of its provisional application filing date, the provisional application must support the...more
In its 2013 decision in In re Morsa, the Federal Circuit vacated an anticipation rejection where “both the Board and the examiner failed to engage in a proper enablement analysis” to establish the enabling quality of the...more
On September 2, 2015, the USPTO Patent Trial and Appeal Board (PTAB) denied institution of another Inter Partes Review brought by Kyle Bass, the Coalition for Affordable Drugs, and other related entities. In denying the...more
9/8/2015
/ Generic Drugs ,
Hedge Funds ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art ,
USPTO
The USPTO Patent Trial and Appeal Board (PTAB) has put an end to Kyle Bass’s Ampyra patent challenge, by denying institution of Inter Partes Review (IPR) proceedings. While many were hoping the PTAB would render a decision...more
8/26/2015
/ Abuse of Process ,
Generic Drugs ,
Hedge Funds ,
Inter Partes Review (IPR) Proceeding ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent Owner Preliminary Response ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art ,
Real Party in Interest ,
USPTO
In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit affirmed the district court decision that upheld the validity of the Allergan patents relating to Lumigan® 0.01% glaucoma eye drops against obviousness, written...more
8/13/2015
/ Allergan Inc ,
Allergan v Sandoz ,
Enablement Inquiries ,
Inherency ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Prior Art ,
Written Descriptions
In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit affirmed the district court decision that upheld the validity of the Allergan patents relating to Lumigan® 0.01% glaucoma eye drops. This decision shows that it is still...more
8/13/2015
/ Allergan Inc ,
Allergan v Sandoz ,
Enablement Inquiries ,
Inherency ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Ownership ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art ,
Written Descriptions
I don’t usually write about district court decisions, but the patent indefiniteness ruling in Andrulis Pharmaceuticals Corp. v. Celgene Corp. (D. Del., July 26, 2015), caught my attention. The court held the asserted claim...more
I do not usually write about non-precedential Federal Circuit decisions, but I could not let the discussion of “simultaneous invention” in Columbia University v. Illumina, Inc., go without comment. As if protecting patents...more
In The Medicines Company v. Hospira, Inc., the Federal Circuit held that a transaction with a contract manufacturer gave rise to an on sale bar that invalidated The Medicines Company’s Angiomax® patents. Are the facts of this...more
7/14/2015
/ Abbreviated New Drug Application (ANDA) ,
America Invents Act ,
Disclosure ,
Generic Drugs ,
Manufacturers ,
On-Sale Bar ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Prior Art ,
Transfer of Title
In affirming the decision of the USPTO’s Patent Trial and Appeal Board (PTAB) in In re Cuozzo Speed Technologies, LLC, the Federal Circuit upheld the PTAB’s use of the “broadest reasonable interpretation” of the claims in...more
In Tyco Healthcare Group LP v. Ethicon Endo-Surgery, Inc., the Federal Circuit agreed with the district court that Ethicon’s prototype constituted prior art under 35 USC § 102(g) based on its earlier date of conception, but...more
In Par Pharmaceutical Inc. v. Twi Pharmaceuticals, Inc., the Federal Circuit vacated and remanded the district court decision holding the Par claims at issue obvious. The district court decision rested in part on the doctrine...more
As a leader in science, technology and innovation, the United States long has played a central role in global intellectual property matters. As the world’s largest economy, the United States has played a central role in trade...more