Greenblum & Bernstein, P.L.C.


Recent News in Intellectual Property


April 2017

In This Issue:

·    Janssen v. Celltrion: Finish the Patent Dance or Risk Payment of Lost Profits

·    Purple Book Updated

·    Number of PCT Applications Filed by Chinese Applicants Continues to Increase

·    Amgen submits brief to Supreme Court






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Walter Schlapkohl, Ph.D., Esq.

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Biosimilar Defendants that Start but Fail to Complete the “Patent Dance” May be Required to Pay Lost Profits

The U.S. District Court for the District of Massachusetts explained in an order issued on March 2, 2017, that an alleged infringer must comply with each step of the “patent dance” – not just partially engage in the dance – in order to limit the patentee to a reasonable royalty as to patents asserted under 35 U.S.C. § 271(e)(6). 

The order requires Janssen Biotech, Inc. (“Janssen”) and Celltrion Healthcare, Co. and Celltrion, Inc. (together “Celltrion) to consider the court’s guidance in their settlement negotiations.  

Janssen sued Celltrion for patent infringement under the Biologics Price Competition and Innovation Act (“BPCIA”).  However, after Celltrion moved to dismiss the complaint based on an alleged lack of standing, both parties requested the court’s guidance on the appropriate measure of damages to which Janssen would be entitled if Celltrion is found to have infringed Janssen’s U.S. Patent No. 7,598,083.

Under the BPCIA, a biosimilar applicant and a reference product sponsor participate in a statutory information exchange process that has come to be known as the “patent dance.” Further to this, the reference product sponsor must sue as to the patents subject to an initial infringement suit (identified in the dance) within 30 days of the end of that process or be limited to recovery of a reasonable royalty.  Janssen had argued that under the relevant provisions of the BPCIA, the parties in the “patent dance” must complete, not just begin, the information exchange process related to the patents subject to an initial infringement suit.  Celltrion had argued that it agreed with Janssen’s initial list of patents and that it had completed its “patent dance” obligations.

The court agreed with Janssen that Celltrion had not complied with the relevant BPCIA provisions and that in view of the same, Janssen would not be limited to reasonable royalty damages should Celltrion ultimately be found to infringe the ‘083 patent.  Thus, while biosimilar applicants may opt out of all or just part of the “patent dance,” doing so may result in increased damages to be paid by the biosimilar applicant if it is later found to infringe one or more of the reference product sponsor’s patents.

                                                --By Walter Schlapkohl

FDA Updates the Purple Book

The U.S. Food and Drug Administration (FDA) announced the availability of a revised copy of the “Purple Book” on February 21, 2017 and FDA’s Center for Drug Evaluation and Research has since updated its list of licensed biological products on March 29, 2017.

Like the FDA’s “Orange Book” which lists brand-named pharmaceuticals and their generic equivalents, the Purple Book is intended to do the same, but for biological products and biosimilars.  The updated Purple Book includes, for example, the date of licensure for certain new reference products.  The date of licensure begins a period of market exclusivity during which interchangeable products cannot enter the market unless their manufacturers challenge and invalidate the underlying patents for the reference products.  For the products listed in the Purple Book, this period is 12 years and can be extended further another six months if the sponsor of the product conducts pediatric studies.  Moreover, interested parties may not file a biosimilar application for review to the FDA until 4 years after the date of first licensure for the reference product.  Thus, with the most recent update, competitors and challengers of the underlying patents will take note of, for example, the additions of Siliq (brodalumab) and Bavencio (avelumab). 

While there are no interchangeable products yet listed, the Purple Book does list biosimilars for which the reference product’s period of exclusivity has expired; these include Amjevita (adalimumab-atto) a biosimilar of Humira, Erelzi (etanercept-szzs) a biosimilar of Enbrel, Inflectra (infliximab-dyyb) a biosimilar to Remicade, and Zarxio (filgrastim-sndz), a biosimilar of Neupogen.  

                                                --By Christopher L. Wright

Number of International Patent Applications in 2016 Increases, Led by US, Japanese, and Chinese Applicants[1]

With 56,595 PCT applications filed by U.S. applicants last year, the United States continues to lead the rest of the world with regard to the number of international patent application filings.  Japanese applicants filed 45,239 PCT applications in 2016 making Japan second in the number of international patent application filings. However, China was a close third with 43,168 international patent applications filed.  Germany and the Republic of Korea were fourth and fifth, respectively.

China has seen very strong growth in the number of international patent applications filed since 2002; in fact, barring any change in trajectory, China appears to have the position and momentum to overtake the U.S. in the number of international patent application filings by 2019.

The total number of all PCT filings increased by 7.3% in 2016.

                                                   --By Walter Schlapkohl


Amgen Submits Brief to Supreme Court

On March 14, 2017, Amgen submitted its “Opening and Response Brief” in the matter of Sandoz v. Amgen before the Supreme Court.

In its brief, Amgen argued strenuously that parties must participate in the “patent dance” for the statute to have its intended effect.  Amgen also argued that an applicant can provide 180-day notice of biosimilar marketing only after licensure to ensure timely and efficient enforcement of the patents at issue.

Both conclusions are correct, Amgen argues, because they reflect the statute’s text and structure as well as its purpose.

According to Amgen, the BPCIA creates two phases of patent litigation: an immediate action for patents identified for early litigation and a secondary action for all remaining patents and later-acquired patents.  In Amgen’s view, the marketing notice triggers the start of the second phase.

Amgen further argues that the patent dance is required because the statute explicitly mandates that parties “shall” participate and because Sandoz has failed to provide any reason why compliance with the statute’s mandate is not possible or unworkable.

                                                   --By Walter Schlapkohl




[1] Figures are provisional and obtained from