Greenblum & Bernstein, P.L.C.


Recent News in Intellectual Property


October 2017

In This Issue:

·    Amgen Obtains $70M Damages Award Against Hospira For Infringement Of Amgen’s Erythropoetin Patent

·    FDA Releases Draft Guidance on Statistical Approach for Determining whether Biosimilar is Highly Similar to Reference Product






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Amgen Obtains $70M Damages Award Against Hospira For Infringement Of Amgen’s Erythropoetin Patent

On September 22, 2017, a federal jury awarded Amgen $70 million in damages for Hospira’s infringement of Amgen’s patent covering the manufacture of Epogen® (EPO). 

Hospira filed an abbreviated Biologics License Application (aBLA) with the FDA in early 2015 for a biosimilar version of EPO. Amgen subsequently filed suit in the District of Delaware asserting infringement of two of its patents related to the manufacturing of EPO. One patent covered specific EPO isoforms and methods of selecting them, and the other patent covered a cell line suitable for making EPO. At the time the lawsuit was filed, the cell line patent had already expired, and the isoform patent was about to expire.

At issue during the trial were 21 batches of EPO that Hospira had manufactured between the years 2013 and 2015. Hospira asserted that the manufacture of these batches of EPO was protected under the “safe harbor” of 35 U.S.C. §271(e)(1), which provides that uses of a patented invention that are solely reasonably related to the development and submission of information under a Federal law that regulates the manufacture, use, or sale of drugs or veterinary biological products is not an act of infringement. Amgen countered that Hospira’s manufacture of the 21 batches of EPO was not reasonably related to obtaining FDA approval, but instead was intended to create a stockpile of commercial product that was worth nearly $1 billion ahead of its anticipated regulatory approval by the FDA.

The jury agreed that seven of the 21 batches in question fell under the protection of the safe harbor because they were shown to have been used in testing for regulatory purposes, but found that the other 14 batches were not protected by the safe harbor and infringed Amgen’s isoform patent, and that the patent was not invalid. The jury awarded Amgen $70 million in reasonable royalty damages.

This is the first verdict award of significant infringement damages to a patent owner under the Biologics Price Competition and Innovation Act (BPCIA). Even more remarkable is the size of the award in view of the fact that Hospira had not yet obtained FDA approval for its biosimilar product and thus had not marketed or sold any of the product in the United States.

                                                            --By Jeffrey R. Bousquet

FDA Releases Draft Guidance on Statistical Approach for Determining whether Biosimilar is Highly Similar to Reference Product

Under the Biologics Price Competition and Innovation Act (BPCIA), a first manufacturer to produce the biologic (the sponsor) may obtain a license from FDA if it can demonstrate that the biologic is “safe, pure, and potent.”  42 U.S.C. §262(a)(2)(C)(i)(I). Subsequent manufacturers of a biologic may piggy-back on the first license, via an abbreviated showing that the second product (the biosimilar) is “highly similar” to the first-licensed product (the reference product) and that there are no “clinically meaningful differences” in terms of “safety, purity, and potency.” 42 U.S.C. §§262(i)(2)(A), (B), and §262(k)(2)(A)(i)(I).

On September 22, 2017, FDA released draft guidance entitled Statistical Approaches to Evaluate Analytical Similarity Guidance for Industry.  The guidance provides a framework for evaluating whether the biosimilar is highly similar and does not exhibit clinically meaningful differences in safety, purity, and potency.  As proposed, the analysis should be risk-based, testing a minimum of 10 biosimilar lots and 10 reference product lots.  The reference product lots should be from U.S.-licensed supplies and represent the reference product variability including a range of expiration dates.  The biosimilar lots should also be manufactured with different processes or scales.

To conduct the Analytical Similarity Plan under the draft guidance, the biosimilar applicant will have to:

1)      Determine the quality attributes that characterize the reference product in terms of structural/physiochemical and functional properties,

2)      Rank these attributes according to risk and potential clinical impact, and then

3)      Evaluate these attributes based on the following three tiers of statistical approaches,

a.      For the attributes having the highest potential clinical impact, formal statistical equivalence testing should be conducted,

b.     For the attributes having a moderate or medium-clinical impact, acceptable ranges should be set, and

c.      For those attributes that have the lowest risk of potential clinical impact or are not amenable to formal tests or quantitative evaluation, subjective observations and assessments should be made.

Reinforcing the previous guidance entitled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product,” once evidence under this analytical framework has been submitted, FDA will then assess whether the biosimilar is highly similar to the reference product based upon the totality of the evidence rather than by evaluating whether the biosimilar passes each and every statistical tier.  The comment period for the draft guidance, ends November 21, 2017.  

                                                            --By Christopher L. Wright