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Ingestible e-Pill Approved For Use in Hospitals

BodyCap, a France-based company said to be dedicated to the development of miniature wireless electronic sensors, recently announced that its e-Celsius® device has earned CE mark approval and is now commercially available for...more

Amgen Has Filed for EU Approval for Herceptin® (Trastuzumab) Biosimilar

During his presentation this month at the Cowen and Company 37th Annual Health Care Conference, Amgen’s Executive Vice President and Chief Financial Officer David Meline indicated that Amgen has filed for approval in the EU...more

Supreme Court limits liability for shipping parts of patented inventions abroad

Generally, to infringe a U.S. patent, the infringing activity — the unauthorized making, using, offering to sell, selling, or importation — occurs within the United States. However, there are exceptions to this rule. Under 35...more

New Amendments to SIPO's Guidelines for Patent Examination

The State Intellectual Property Office of China (“SIPO”) on March 1, 2017 finalized the amendment to its Guidelines for Examination; the amendments included patentability of business method patents, enhanced claiming options...more

Life Technologies Corp. v. Promega Corp.: Supreme Court Limits Patent Infringement Liability for Suppliers Under § 271(f)(1)

The Supreme Court in Life Technologies Corp. v. Promega Corp held that providing a single component of a multicomponent invention for manufacture abroad does not give rise to patent infringement liability under 35 U.S.C. §...more

First Biosimilar Monoclonal Antibody in Oncology Granted EU Approval: Implications for the U.S. Market

Recent developments in Europe may augur a new push for oncology biosimilars in the United States. On February 22, 2017, the European Commission approved Celltrion’s Truxima™ for all indications of reference rituximab...more

Importance of patents in Chinese pharmaceutical tendering

China has a complicated and unique tendering system for drugs – and patents play an important role in almost every tender. What adds to the complexity is that tendering rules vary between provinces. Providing necessary patent...more

China’s New Cyber Security Law Goes into Effect June 1, 2017

China’s new cyber security law (Law) could have far-reaching impacts for companies that do business there. The Law goes into effect on June 1, 2017. As is typical of legislation passed by the Standing Committee of the...more

Section 337 Actions at the ITC: another forum for pharma and biosimilars litigation?

With the growing volume of biosimilar and pharma litigation in district courts and before the PTAB, the U.S. International Trade Commission may emerge as another forum for patent holders against imported biosimilars. Section...more

Mylan Obtains Global License to Trastuzumab in IPR Settlement

Mylan announced today that it had reached a settlement with Genentech, Inc. and F. Hoffman-La Roche Ltd. that provides Mylan with global licenses to commercialize its biosimilar to Genentech’s Herceptin® (trastuzumab). As...more

One is Not Enough – Infringement Liability under § 271(f)(1)

In Life Technologies Corp. v. Promega Corp., Slip Op. 14-1538 (Feb. 22, 2017), the U.S. Supreme Court held that the supply of a single component of a multicomponent invention for manufacture abroad does not give rise to...more

Judge gives .AFRICA the green light to proceed

As previously reported here, the Internet Corporation for Assigned Names and Numbers (ICANN) has been sued by the disgruntled new generic Top Level Domain (gTLD) applicant, DotConnectAfrica, in order to prevent the delegation...more

Limiting Extraterritorial Reach of U.S. Patents: "Substantial" Means More than One

Last week, the Supreme Court provided much-needed clarity to U.S. companies concerned about their potential liability for supplying a single component of a multicomponent invention abroad. The Court’s decision in Life...more

Quantity - Not Quality - Matters in Assessing Liability for Patent Infringement under Section 271(f)(1)

In Life Technologies Corp. v. Promega Corp., the Supreme Court ruled that, as a matter of law, “the supply of a single component of a multicomponent invention” from the United States does not trigger liability under Section...more

Lithium Metal Oxide Cathode Materials: Commission Grants Relief after First Oral Hearing in a 337 Investigation in 10 Years

On January 26, 2017, after taking the unusual step of ordering a full International Trade Commission oral hearing to consider issues including laches, remedy, and public interest, the Commission issued a limited exclusion...more

Supreme Court Patent Ruling on Global Exportation of Component Parts

The Supreme Court’s recent decision in Life Technologies Corp. v. Promega Corp. raises important issues regarding the extraterritorial effect of patent law on global supply chains. The primary issue in the case is whether the...more

Supreme Court Decision Limits Patent Infringement Risk for Exporting a Single Component of a Multi-Component Invention

On February 22, 2017, the Supreme Court held that there is no patent infringement when an entity supplies "a single component" from the United States for combination into "a multicomponent invention" outside the United...more

The Song says 2 out of 3 Ain’t Bad; The Supreme Court says 1 is not “Substantial”

In Life Technologies Corp. v. Promega Corp. [14-1538] (February 22, 2017), the Supreme Court reversed a Federal Circuit decision that supplying a single component of a multi-component invention from the United States is an...more

News from Abroad -- Swiss-style Patent Claims Can Be Very Valuable in Australia

The scope for enforcement of Swiss-style claims may be broader in Australia than for method of medical treatment claims. Second medical use inventions can be claimed in an ever increasing number of claim formats depending on...more

Supreme Court Restricts the Extraterritorial Reach of U.S. Patent Law for Exported Goods

On February 22, 2017, the Supreme Court in a landmark decision held that the supply of a single component of a multicomponent invention for manufacture abroad does not give rise to liability under 35 U.S.C. § 271(f)(1). See...more

Supreme Court Addresses Scope of Patent Infringement Under Section 271(f)(1)

Section 271(f)(1) of the Patent Act provides that a party infringes a patent claim when it "supplies or causes to be supplied in or from the United States all or a substantial portion of the components of a patented invention...more

"US Supreme Court Holds That Exporting One Component of Invention Abroad Does Not Suffice for Patent Infringement"

In a 7-0 decision issued on February 22, 2017, in Life Technologies Corp. v. Promega Corp., the U.S. Supreme Court held that exporting a single component of a multicomponent invention for combination abroad does not give rise...more

Supreme Court Limits § 271(f)(1) Overseas Infringement Reach: More than One Exported Component Required for Offshore Manufacturing...

The US Supreme Court held in Life Techs. Corp. v. Promega Corp., Slip No. 14-1538 (Feb. 22, 2017) that supplying a single component of a multi-component invention manufactured abroad does not give rise to patent infringement...more

Amicus Brief Imaging Supplies Coalition

STATEMENT OF INTEREST OF AMICUS CURIAE - Imaging Supplies Coalition submits this brief in support of Lexmark International, Inc. to urge the Court to uphold the rulings of the en banc Court of Appeals for the Federal...more

Supreme Court Reverses § 271(f)(1) Ruling in Biotech Case

In Life Technologies Corp. v. Promega, the Supreme Court reversed the Federal Circuit’s interpretation of 35 U.S.C. § 271(f)(1), and held that a single component does not constitute a “substantial portion of the components of...more

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