Supreme Court Rules on IP Case Life Sciences Manufacturers Are Following

By Mary An Merchant, Ph.D. / Intellectual Property and Life Sciences Groups – Morris, Manning & Martin, LLP

Do U.S. patent rights protect a patent owner from competitors that export key parts of inventions for reassembly in other countries? Competitive international activity is a common challenge for companies that only hold U.S. patents, especially when deciding whether, and where, to seek patent protection in other countries.  Diagnostic companies, medical device companies and others who hold patents on multicomponent inventions have followed this case closely.

The U.S. Supreme Court answered a part of the question recently, determining that exporting a staple article or commodity of a multicomponent

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FDA Releases Guidance for Biosimilar Data and Names

The end of 2016 and start of 2017 found the FDA releasing guidance documents for biosimilar products that detail the conduct and analysis used for clinical pharmacology studies and how to name biosimilar products that are seeking FDA approval under the Biologics Price Competition and Innovation Act of 2009 (BCPIA).  The clinical pharmacology guidance (released in December 2016) provides recommendations for studies that assess the presence or absence of clinically meaningful differences between the proposed biosimilar product and the U.S.-licensed reference product.

In keeping with previous biosimilar guidance from the FDA, the December 2016 guidance document reaffirms the “totality of evidence”

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Commercial Offer For Sale Does Not Include Third Party Manufacturing Services

July 18th, 2016
Life Sciences/Pharma

By Mary An Merchant, PhD & Richard T. Timmer

The biopharmaceutical world breathed a collective sigh of relief when the Court of Appeals for the Federal Circuit (“CAFC”) issued its ruling regarding the “on sale bar” as it relates to patent eligibility. In the ruling on Monday, July 11, 2016, the CAFC in The Medicines Company v. Hospira, Inc.(CAFC Case No. 2014-1469, 2014-1504) affirmed the district court ruling and held that to be “on sale” under 35 U.S.C. § 102(b), “a product must be the subject of a commercial sale or offer

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Notice By Biosimilar Maker To Biologic Originator Is Always Required

July 6th, 2016
Life Sciences/Pharma

By Mary An Merchant, PhD & Richard Timmer

The Court of Appeals for the Federal Circuit (“CAFC”) issued an important ruling today in the ongoing evolution of biosimilar product regulation.  In the ruling today, the CAFC in Amgen Inc., Amgen Manufacturing Limited v. Apotex Inc., Apotex Corp. (CAFC Case No. 2016-1308) affirmed the district court ruling and held that the commercial-marketing provision in 42 U.S.C. § 262(l)(8)(A) is mandatory and enforceable by injunction, even where the biosimilar applicant has triggered the “patent dance” provisions of the BCPOA by providing

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USPTO Throws a Lifeline to the Life Sciences Industry

By Mary An Merchant, JD, PhD, & Richard T. Timmer, PhD

U.S. Supreme Court decisions in Alice Corp., Myriad, and Mayo invalidated claims in critical life sciences and computer technology areas in finding that many inventions are not eligible patent subject matter, meaning that a patent cannot be granted for certain types of technologies. The U.S. Patent and Trademark Office (USPTO) has applied these decisions to patent examination, and in doing so, many pending patent application claims have been rejected as not being patent-eligible subject matter. On May 4, 2016, the USPTO published guidance that updates the

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