The US Supreme Court’s decision in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce, which overrules the longstanding Chevron doctrine that required federal courts to defer to administrative...more
7/9/2024
/ Administrative Procedure Act ,
Chevron Deference ,
Chevron v NRDC ,
Government Agencies ,
Judicial Authority ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
Relentless Inc v US Department of Commerce ,
SCOTUS ,
Statutory Interpretation
The US Patent and Trademark Office (USPTO) recently proposed a new rule for filing terminal disclaimers to overcome obviousness-type double patenting rejections. If adopted, the rule will likely spur patent applicants to...more
The Federal Trade Commission (FTC), supported by the Food and Drug Administration (FDA), issued a policy statement on September 14 indicating that the FTC intends to “scrutinize improper Orange Book listings” to identify...more
The PTAB Digest 2021/2022 provides an overview of PTAB statistics, trends, and updates that impact strategies and business decisions for patent owners and petitioners alike.
Significant developments included the...more
Welcome to the August 2020 issue of our Life Sciences International Review. This issue covers new developments within Asia, Europe, and the United States in intellectual property, regulatory, pricing, and international trade,...more
8/24/2020
/ Asia ,
Coronavirus/COVID-19 ,
Digital Health ,
EU ,
Food and Drug Administration (FDA) ,
Force Majeure Clause ,
Foreign Direct Investment ,
Fraud ,
Life Sciences ,
Medical Devices ,
Over The Counter Drugs (OTC) ,
Patent Terms ,
Pharmaceutical Industry ,
Prescription Drugs
The US Court of Appeals for the Federal Circuit held that data obtained after an asserted patent’s priority date may be used to demonstrate what is “necessarily present” in a prior art embodiment. Although the district court...more
In one of its first precedential opinions of the new year, the US Court of Appeals for the Federal Circuit held that a claim using “comprising” as a transition phrase followed by a limitation requiring a component that...more
The US Court of Appeals for the Federal Circuit recently upheld the district court’s denial of a judgment as a matter of law (JMOL) or, alternatively, motion for a new trial, reinforcing the fine line that exists between...more
Welcome to the third issue of the Morgan Lewis Pharma Review, which summarizes key recent cases from the Federal Circuit and district courts that impact the pharma space, including Federal Circuit and district court decisions...more
As of 2019, post-grant proceedings have been in use for seven years. Designed as an alternative to district court litigation, post-grant proceedings have offered litigants a faster and more cost-effective forum for resolving...more
Welcome to the Q3 2019 issue of our Life Sciences International Review. This issue covers new developments within Europe, Asia, and the United States in intellectual property, regulatory, pricing, and international trade,...more
11/21/2019
/ Asia ,
CFIUS ,
Consumer Privacy Rights ,
Damages ,
EU ,
FIRRMA ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Intellectual Property Protection ,
International Trade Commission (ITC) ,
Life Sciences ,
Medical Devices ,
Patent Litigation ,
Patent Term Adjustment ,
Patent-Eligible Subject Matter ,
Patents ,
Tariffs
A split Federal Circuit panel recently upheld the district court’s judgment of invalidity and noninfringement because the phrase “consisting essentially of” rendered the asserted claims indefinite and the proposed ANDA label...more
EU – REGULATORY -
Brexit, Notified Bodies, and Medical Devices -
The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more
8/20/2019
/ Anti-Kickback Statute ,
Asia ,
China ,
Competition ,
Data Privacy ,
Drug Pricing ,
EU ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Patents ,
Pharmaceutical Industry ,
UK Brexit
In a much-anticipated decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., the US Court of Appeals for the Federal Circuit on April 13 affirmed the district court’s holding that Vanda’s...more
The court’s ruling potentially expands the possible circumstances where the standard could be met.
In Travel Sentry v. Tropp, the US Court of Appeals for the Federal Circuit expanded the scope of direct infringement under...more
There have been two interpretations of the “acts of infringement” language in the patent venue statute regarding ANDA submissions in Hatch-Waxman litigation....more
12/8/2017
/ Abbreviated New Drug Application (ANDA) ,
Bristol-Myers Squibb ,
Hatch-Waxman ,
Life Sciences ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patents ,
Principal Place of Business ,
TC Heartland LLC v Kraft Foods ,
Teva Pharmaceuticals ,
Venue
The ruling found that the use of such evidence was proper for written description and enablement....more
Unanimous en banc Federal Circuit holds that on-sale bar only applies where a commercial sale “bears the general hallmarks of a sale.”
On July 11, in a unanimous en banc ruling, the full US Court of Appeals for the...more
In a Section 101 analysis under Alice Corp. Pty. Ltd. v. CLS Bank Intl., “[a]n inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces”—even if individual claim...more
7/6/2016
/ Abstract Ideas ,
Appeals ,
AT&T Mobility ,
CLS Bank v Alice Corp ,
Inventions ,
Patent Infringement ,
Patent Validity ,
Patent-Eligible Subject Matter ,
Patents ,
Prior Art ,
Reversal ,
Section 101