September 17, 2019

Doug Robinson Authors Article on Amgen v. Sandoz for Biosimilar Development

Following a trial in the District Court of New Jersey, Sandoz has been barred from marketing a biosimilar version of Amgen’s Enbrel product. Due to the scarcity of biologics patent case rulings, this case provides an interesting precedent for how future decisions may treat biologics patent issues.

This case involved a fusion protein called etanercept, which is made by combining the extracellular region of a 75kD human tumor necrosis factor receptor with a portion of an IgG1 immunoglobulin. Specifically, etanercept is a dimeric fusion protein consisting of the extracellular region of the ’75 TNF receptor, which is fused to exon-encoded “hinge CH2-CH3” of the constant region of a human IgG1 antibody heavy chain.

The most interesting takeaway from the Enbrel decision concerns secondary considerations (also known as objective indicia) of nonobviousness. As noted, secondary considerations are objective indications of the value of the invention that are based on the real-world performance of the invention. One such secondary consideration is whether another party copied the patented product. The theory is that if a patented product is copied, that is a good indication that the invention was a valuable advance over available alternatives. Otherwise, the competitor would have pursued one of those alternatives.

Secondary considerations are historically rather difficult to prove for a couple of reasons. First, courts require that the commercial product is commensurate with the scope of the patent’s claims. This can be a high hurdle for products where the patented component is simply a part of a larger commercial device (for example, consumer electronics). However, this hurdle is generally easier for pharma patentees to overcome because pharmaceutical products in general track very closely to the claims that cover them (rather than the product containing other unclaimed active ingredients).

This case is interesting in that it’s one of the few patent decisions concerning a biosimilar product. Biosimilar makers should note that the court’s analysis that “copying” a biologic does not tend to show the patent on the biologic is not invalid as obvious — that is, the general rule from generic litigation was applied here in the biologic context. Another important takeaway is to carefully consider the patent implications of licensing vs. buying patents. This case is an illustration that licensing instead of buying a patent can save patent claims from a finding of invalidity for double patenting.

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