Taking Advantage of the New Purple Book Patent Requirements for Biologics
`
`LAWFLASH
`
`TAKING ADVANTAGE OF THE NEW
`PURPLE BOOK PATENT REQUIREMENTS
`FOR BIOLOGICS
`
`April 26, 2021
`
`AUTHORS
`Zachary D. Miller
`
`New federal legislation will take effect this year that will require a reference product sponsor to submit to the
`FDA a list of any patents identified to a biosimilar applicant during the patent dance. The FDA is required to list
`these patents in the Purple Book. Small and medium-sized enterprises (SMEs)—and others in the industry—can
`take advantage of this new source of information by using it to identify (i) potential partnerships for licensing of
`existing IP; (ii) targets for IPRs; or (iii) design around opportunities for the development of new technology.
`The Consolidated Appropriations Act was signed into law on December 27, 2020. While perhaps most
`newsworthy for its provisions related to COVID-19 relief and spending, the Consolidated Appropriations Act
`(the longest bill ever passed by Congress) included several provisions on biosimilars. One of these provisions,
`Section 325 of Division BB, is directed to “Biological Product Patent Transparency.” This section requires a
`reference product sponsor to provide to the FDA a list of any patents identified to a biosimilar applicant as part
`of the patent dance (subsections (l)(3)(A) or (l)(7)), not later than 30 days after those patents were identified
`to the applicant. The FDA is then required to “include such information for such biological product” in a
`searchable, electronic format.
`
`BACKGROUND ON BIOLOGICS
`
`Biological products, commonly referred to as biologics, can be used in the prevention, diagnosis, treatment, or
`cure of various diseases. Biologics are distinguished from traditional “small molecule” pharmaceuticals by their
`size and method of synthesis. While “small molecule” drugs are chemically synthesized, biologics are more
`complex—they are typically proteins that are derived and manufactured from living cells.
`
`While small molecule drugs have “generic” versions of the brand name products, biologics have “biosimilars.”
`Because biologics are more complex and are derived from living cells, biosimilars are unlikely to be identical
`replicas of the comparable biologic developed by the reference product sponsor.
`
`Congress enacted the Biologics Price Competition and Innovation Act of 2009 (BPCIA) to create an abbreviated
`approval pathway for biosimilars (42 USC § 262 subsection (k)) and to create a process for biosimilar applicant
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`https://www.morganlewis.com/pubs/2021/04/taking-advantage-of-the-new-purple-book-patent-requirements-for-biologics?p=1
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`1/4
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`Mylan Exhibit 1175
`Mylan v. Regeneron, IPR2021-00881
`Page 1
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`Taking Advantage of the New Purple Book Patent Requirements for Biologics
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`and the sponsor of the reference product to resolve patent disputes (subsection (l)). The patent dispute
`procedure is commonly referred to as the “patent dance.”
`
`To start the patent dance, the biosimilar applicant provides the reference product sponsor with its Abbreviated
`Biologics License Application (aBLA) and additional information about its manufacturing process (subsection (l)
`(2)). Within 60 days of this initial exchange, the reference product sponsor must provide the biosimilar
`applicant with a list of unexpired patents for which a claim of infringement could reasonably be made
`(subsection (l)(3)(A)). The biosimilar applicant has 60 days to provide noninfringement and invalidity positions
`(subsection (l)(3)(B)(ii)), after which the reference product sponsor has 60 days to respond with its positions
`(subsection (l)(3)(C)). The reference product sponsor can update its list with any newly issued patents within
`30 days after those patents issue (subsection (l)(7)). Following these initial rounds of disclosures, the parties
`engage in a series of responses and negotiations, culminating with the reference product sponsor bringing a
`lawsuit for patent infringement in US federal court.
`
`WHAT IS THE ‘PURPLE BOOK?’
`
`In connection with small molecule drugs, the FDA has published the “Approved Drug Products with Therapeutic
`Equivalence Evaluations” since 1980. This publication is generally known as the “Orange Book.” Congress
`codified the publication of the Orange Book in 1984, and since then, the Orange Book has provided information
`on approved small molecule drugs, patent, and other exclusivity information related to those drugs and generic
`equivalents.
`
`In 2014, with the development of biologics and biosimilars, the FDA began publishing a “List of Licensed
`Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations,” which
`is commonly known as the “Purple Book.” Originally, the Purple Book consisted of two lists—one containing
`biologics regulated by the Center for Drug Evaluation and Research (CDER) and the other containing biologics
`regulated by the Center for Biologics Evaluation and Research (CBER). The lists included the biologic’s name,
`BLA number, licensure date, exclusivity information, biosimilar information, and whether the biologic had been
`withdrawn—but did not include any information about patents covering biologics. Eventually, the FDA
`transitioned the Purple Book to an online searchable database with the same information. However, the
`publication of the Purple Book was not codified until the recent passage of the Consolidated Appropriations Act.
`
`THE NEW PURPLE BOOK REQUIREMENTS
`
`With Section 325 of Division BB of the Consolidated Appropriations Act, Congress codified the Purple Book and
`established new requirements for information to be included. There are a number of key provisions which set out
`different aspects of the Purple Book requirements:
`
`Timing: The FDA must begin publication of the new Purple Book information within 180 days of enactment—
`June 25, 2021.
`Revisions: The FDA must update the publication at least every 30 days.
`General Information: The Purple Book must include (i) the nonproprietary or proper name of the biologic, (ii)
`the date of licensure of the marketing application and the application number, (iii) and the licensure and
`marketing status.
`Patent Information: As part of Section 325, any reference product sponsor engaged in a patent dance must
`provide to the FDA a list of patents identified to a biosimilar applicant as part of subsection (l)(3)(A) or (l)
`(7). The information must be provided within 30 days of the disclosure to the biosimilar applicant and must
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`https://www.morganlewis.com/pubs/2021/04/taking-advantage-of-the-new-purple-book-patent-requirements-for-biologics?p=1
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`2/4
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`Mylan Exhibit 1175
`Mylan v. Regeneron, IPR2021-00881
`Page 2
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`Taking Advantage of the New Purple Book Patent Requirements for Biologics
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`patent expiry information. The FDA is then required to include the patent and expiry information in the Purple
`Book in connection with the biologic.
`Exclusivity Information: If the biologic or biosimilar is still entitled to exclusivity, the Purple Book must
`identify the exclusivity period.
`
`The key difference between the new Purple Book requirements and the information in the existing Purple Book
`published by the FDA is the inclusion of patent information. Previously, information exchanged between a
`reference product sponsor and a biosimilar applicant during the patent dance was treated as confidential.
`
`Historically, third parties have had few strategies to identify potential biologic patent coverage other than
`traditional patent searching and competitive patent landscaping exercises. Companies can always find
`information by perusing relevant publications (e.g., Morgan Lewis’s Blockbuster Biologics Review). Of course,
`parties can also conduct patent searches to identify potential patents, but given the various types of patents
`involved, such searches are expensive and not guaranteed to be comprehensive. Alternatively, later biosimilar
`applicants can identify some of the patents related to a biologic after a patent infringement lawsuit was filed—
`but that information would only include the patents that were eventually asserted, not all patents identified by
`the reference product sponsor as being reasonably infringed. The publication of patent information in the Purple
`Book changes the accuracy, scope, and access to available patent information.
`
`This additional information will not affect the first biosimilar to file an application. They will still be in the dark as
`to patents likely to be identified by a reference product sponsor during the patent dance. But publication of the
`patent information in the Purple Book will allow subsequent applicants to more easily prepare noninfringement
`and invalidity positions before the patent dance even starts. This advance notice could be critical to a biosimilar
`applicant’s legal and business strategies when pursuing a biosimilar filing. The publication of this information
`will also open opportunities for others in the biologics arena—including SMEs.
`
`SMES’ INVOLVEMENT IN BIOLOGICS
`
`Why are these new Purple Book requirements relevant to SMEs? Well, a large portion of SMEs in medical
`development research are working on biologics rather than traditional small molecule drugs. A report from the
`UK found that over 50% of UK SME companies involved in medicine discovery are focused on non-small
`molecule work. This includes over 150 companies working to develop antibody therapies, therapeutic proteins,
`vaccines, and cell and gene therapies.
`
`SMEs are also very active in the development of intellectual property related to their technology. According to a
`report by the European Patent Office, SMEs account for over one-fifth of new patent applications. The same
`report notes that SMEs often prefer to use their intellectual property resources to collaborate with others in the
`industry. However, a lack of specific experience with intellectual property protection can impact the ability of
`SMEs to find potential partners. As a result, almost 60% of collaborations result in SMEs partnering with already
`known clients or customers.
`
`HOW SMES CAN USE THE PURPLE BOOK’S PATENT INFORMATION
`
`The availability of patent information in the Purple Book will allow SMEs in the biologics space to identify new
`business opportunities in a variety of different ways.
`
`First, SMEs should review the Purple Book’s patent information with their own existing technology in mind. SMEs
`can use the information to identify potential licensing or collaboration opportunities with the reference product
`
`https://www.morganlewis.com/pubs/2021/04/taking-advantage-of-the-new-purple-book-patent-requirements-for-biologics?p=1
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`3/4
`
`Mylan Exhibit 1175
`Mylan v. Regeneron, IPR2021-00881
`Page 3
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`Taking Advantage of the New Purple Book Patent Requirements for Biologics
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`sponsor or with a biosimilar applicant. For example, if there is a clear gap in a reference product sponsor’s patent
`coverage, and an SME has relevant patent coverage in that area, there may be an opportunity for the SME to
`license its intellectual property to the sponsor to improve patent protection. Alternatively, if a reference product
`sponsor has patent coverage in a specific area, and the SME has technology that would allow a biosimilar
`applicant to design around that coverage, the applicant may be interested in collaborating with the SME related
`to that technology.
`
`An SME can also use the Purple Book’s patent information to commercialize intellectual property that is similar
`to or overlaps with the reference product sponsor’s patents. For example, a reference product sponsor may be
`interested in licensing intellectual property from an SME even if the sponsor already has patent coverage in the
`same area. Or, a biosimilar applicant may be interested in collaborating with an SME in filing an IPR, especially if
`the SME’s intellectual property could invalidate a reference sponsor’s patent.
`
`Finally, when reviewing the Purple Book’s patent information, SMEs should consider areas for future
`technological development. If an SME has expertise in a specific area, it may be able to utilize that expertise to
`collaborate with a biosimilar applicant in developing technology to design around the reference product
`sponsor’s existing patents.
`
`CONCLUSION
`
`The new Purple Book requirements on the disclosure of patent information open up opportunities for SMEs (and
`others) to identify specific targets for collaboration regarding the SMEs’ existing technology or for the
`development of new technology.
`
`CONTACTS
`
`If you have any questions or would like more information on the issues discussed in this LawFlash, please
`contact any of the following Morgan Lewis lawyers:
`
`Chicago
`Zachary D. Miller
`Michael J. Abernathy
`Christopher J. Betti
`
`Century City
`Olga Berson
`
`Copyright © 2022 Morgan, Lewis & Bockius LLP. All rights reserved.
`
`https://www.morganlewis.com/pubs/2021/04/taking-advantage-of-the-new-purple-book-patent-requirements-for-biologics?p=1
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`4/4
`
`Mylan Exhibit 1175
`Mylan v. Regeneron, IPR2021-00881
`Page 4
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