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LimeGreenIP News

Tag Archives: Life Sciences

China: Are you up-to-date on SPC draft guidelines on patent examination and administrative cases concerning patent rights?

China’s Supreme People’s Court (SPC) recently circulated its Draft “Provisions on Several Issues concerning the Adjudication of Administrative Cases on Granting and Affirming Patent Rights (I)” (最高人民法院关于审理专利授权确权行政案件若干问题的规定(一)). This Draft aims to address issues concerning administrative court adjudication and Patent Review Board (“PRB”) decisions regarding both patent examination and patent validity. The Provisions apply to: patent grant

3D printing: Opportunities & risks for the pharma industry

3D printing is transforming certain industries – so why hasn’t it been widely adopted in the pharma sector? There are likely to be a number of barriers to entry for 3D printing in this field, including identifying how to make it economically viable. Whilst a number of the key patents relating to 3D printing have

Wearable technology: IP opportunities and risks – LimeGreen Live webinar

Join us on 16 or 21 August for the fourth in our LimeGreen Live webinar series in conjunction with the Hogan Lovells Consumer Industry Sector Group. This webinar will explore the IP opportunities and risks for businesses operating in, or looking to enter the wearable technology market. Our presenters will discuss the lifecycle of a wearable technology product, from building or

A changing competitive landscape: the role of the ITC in the biosimilars space

As biosimilar competition from companies outside the United States continues, innovator companies are increasingly likely to turn to the International Trade Commission as a first line of defense for protecting critical IP. Competition for innovator biologics companies has traditionally been relatively low, but since the FDA’s first biosimilar approval in 2015, the U.S. marketplace is

France – Rejection of a second SPC for a biological medicinal product

Cour de cassation, Commercial Chamber, 16 May 2018, No. 16-21638 The French Cour de cassation upholds the Paris Court of Appeal’s decision to reject an SPC application for a biological medicinal product which was based on the same patent as a first SPC but on a different market authorization. The Government of the United-States of

ITC Section 337 Investigations Webinar – Recording

On 1 March we held our first webinar in the LimeGreen Live series which focussed on International Trade Commission (ITC) Section 337 Investigations. The webinar was a panel discussion with former ITC Administrative Law Judge, Theodore Essex, Head of Hogan Lovells IP, Media & Technology Americas Practice, Celine Crowson, and former ITC Trial Lawyers Association President, Tony Pezzano. The panel provides background

LimeGreen Live: ITC Section 337 Investigations Webinar – 1 March

Join us for the first webinar in the LimeGreen Live series which will focus on the International Trade Commission (ITC) Section 337 Investigations. The webinar will include a panel discussion with former ITC Administrative Law Judge, Theodore Essex, Head of Hogan Lovells IP, Media & Technology Americas Practice, Celine Crowson, and former ITC Trial Lawyers Association President, Tony Pezzano. The panel

Generic drugs taking hold in the Asian marketplace: STAT News interview

Aging populations and rising healthcare costs across Asia — particularly in Japan — have created new market opportunities for generic drug makers operating in the region. For originator drug manufacturers, that means increased competitive pressures, and a new urgency to protect patents. In this interview with STAT News, Tokyo partner Dr. Fred Ch’en explains the political

The China Food and Drug Administration pushes forward on conditional approval and compassionate use of new drugs

On December 20, 2017, the China Food and Drug Administration (“CFDA“) released two draft documents for public comment: (1) Conditional Approval for Urgently Needed Drugs Technical Guidance  (the “Draft Conditional Approval Guidance“); and (2) Compassionate Use of Clinical Trial Drugs Administrative Measures (the “Draft Compassionate Use Measures” and, together with the Draft Conditional Approval Guidance,

Life Sciences: Spotlight interview on false advertising claims in Europe

Life sciences businesses dedicate huge resources to advertising material in a fiercely competitive market. Partner Tanja Eisenblätter discusses false advertising in this sector and why it is important for clients looking to launch new products. Preliminary injunctions in Germany Tanja presents a typical business case in which a client’s global advertising and its competitors’ advertising are assessed for misleading or unlawful content. In

U.S. – NJIPLA CLE event: Blockchain Technology: The Legal Landscape And How It Will Change Everything

Please join us at the upcoming NJIPLA CLE event: Blockchain Technology: The Legal Landscape And How It Will Change Everything, taking place on September 18th from 2pm to 6pm at the APA Hotel Woodbridge in Iselin, New Jersey. This event will feature a comprehensive tutorial on blockchain technology as well as two panels of impressive experts explaining

U.S. – What does the Impression Products v. Lexmark decision mean for drug companies? 5 takeaways

Last May, the U.S. Supreme Court issued a highly-anticipated decision in Impression Products, Inc. v. Lexmark Int’l, Inc., reversing the Federal Circuit and holding that, when a patent holder sells a product, it exhausts all of its patent rights in the product, regardless of certain restrictions that the patent holder sought to impose on further resale.

Pharma advertising in Italy – Online publication of OTC medicinal products list, prices and reimbursability

The Court of Milan held in a Judgment recently handed down in the proceedings brought by Bayer S.p.a. against the generic manufacturer DOC Generici S.r.l. that online publication of over-the-counter (OTC) medicinal products in the manner specified in the proceedings is in breach of Italian law on advertising of medicinal products and amounts to an

US: Bioprinting – A life sciences and legal innovation

The patent eligibility of bioprinted products and processes has not been squarely addressed by the legislature or tested in courts. Arlene Chow and Nitya Anand explain what could be done in the future in this article, first published in issue #35 of IPPro Patents. The medical industry is undergoing a radical transformation, thanks to recent

Major IP reforms foreshadowed in China’s Pharma sector.

On 12 May 2017, the Chinese Food and Drug Administration (the “CFDA”) issued several draft policies aimed at overhauling of the current regulations governing the Chinese pharma and medical device sector (the “Draft Policies”). Amongst the Draft Policies, those outlined in Circular No.55 would, if implemented, establish a more robust patent linkage system, a more

IP Enforcement Focus : Europe – round-up

IP Enforcement Focus is our series of written, video and audio posts which plug into your current European enforcement issues. These posts cover IP related court cases as well as relevant political and economic developments in this area. Since January, we have published 13 summaries of key IP enforcement developments, including 8 v-logs. This round-up outlines each commentary with a link to the full post,

3D Printing: Are you 3DP Ready?

3D printing has already been around for decades and has disrupted certain industries, such as hearing aids. One likely impact is an increase in IP infringement, with Gartner predicting that this could reach $100 billion a year by 2018. Now that a number of key patents have expired, 3D printers are becoming cheaper and offer

Brexit webinar – What’s next for Life Sciences companies?

With the UK Government having issued its Article 50 notice, we are holding a webinar to further analyse the implications for the life sciences sector of the momentous decision that the UK has made to leave the EU. On 3 April 12:00 pm BST and 5 April 4:00 pm BST, our Life Sciences lawyers Charles Brasted, Elisabethann Wright, Fabien Roy, Helen Kimberley

Combatting illegal pharma trade – IP enforcement brochure

We are delighted to announce the launch of our Combatting illegal pharma trade enforcement guide. This publication is a pharmaceutical industry-specific brochure which complements our suite of brand and trademark protection and enforcement guides (Integrated IP Enforcement in Europe and Global Brand Protection). This guide analyses the challenges facing the pharmaceutical industry with a focus on the international black market on one

U.S. – Protecting IP in Digital Health deals

Industry sources estimate that more than $4 billion worth of deals in digital health have been signed globally this year so far, as pharmaceutical manufacturers look for “beyond the pill” solutions to medical problems, health care providers seek more efficient means to monitor their patients’ wellbeing, and technology companies aim to commercialize their products and

Europe – False Advertising : Avoiding pitfalls in the Life Sciences sector

With advertising high on the agenda for Life Sciences companies, but litigation a real threat, we have published guidelines for companies looking to advertise in this highly regulated industry. Globalization and rationalization have made it increasingly common for companies to develop and implement cross-border marketing campaigns encompassing several jurisdictions. Successful advertising often depends on making