Amgen v. Roche

Here are a few points gleaned from this 80-page opinion.

Obviousness-type double patenting. The Federal Circuit held that §121’s safe harbor from obviousness-type double patenting for divisional applications did not apply to continuations. “We conclude that, because the … applications were filed as continuation—rather than divisional—applications, the … patents do not receive the benefit of § 121.” (p. 14.) It also reviewed the law of obviousness-type double patenting, which “entails two steps: (1) construction of the claims in the earlier patent and the claim in the later patent to identify any differences, and (2) determination of whether the differences in subject matter between the claims render the claims patentably distinct.” (30-31.) And the second “part of the obviousness-type double patenting analysis is analogous to an obviousness analysis under 35 U.S.C. § 103, except that the ’008 patent is not considered prior art.” (p. 32.) In this case, involving the “production of the protein erythropoietin (‘EPO’) using … DNA technology,” it found that those of “ordinary skill in the art would not have reasonably expected to successfully produce isolatable quantities of glycosylated EPO having the stated biological activities in transfected CHO cells. Put most simply, CHO cells transfected with the EPO DNA sequence and the production of recombinant, in vivo biologically active EPO glycoprotein are patentably distinct inventions.” (p. 34.)

Product-by-process claims. “It has long been the case that an old product is not patentable even if it is made by a new process.” (p.41.) “However, a new product may be patented by reciting source or process limitations so long as the product is new and unobvious.” (p.42.) Therefore, “[i]n determining validity of a product-by-process claim, the focus is on the product and not on the process of making it.” (p. 47.) And so “a product-by-process claim can be anticipated by a prior art product that does not adhere to the claim’s process limitation.” On the other hand, for infringement, “the focus is on the process of making the product as much as it is on the product itself.” This quirk creates an unusual situation:
“For product-by-process claims, that which anticipates if earlier does not necessarily infringe if later. That is because a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim. Similarly, that which infringes if later does not necessarily anticipate if earlier. That is because an accused product may meet each limitation in a claim, but not possess features imparted by a process limitation that might distinguish the claimed invention from the prior art.” (p. 48.)

Indefiniteness. The court noted that the purpose of product-by-process claims is to allow “the patentee to obtain a patent on the product even though the patentee cannot adequately describe the features that distinguish it from prior art products.” They are therefore used when the patentable distinctions are “ difficult-to-describe.” “Thus, to call the process limitation indefinite in this situation would defeat one of the purposes of product-by-process claims, namely permitting product-by-process claims reciting new products lacking physical description.” (p. 55-56.)

Infringement under §271(g). This section provides for infringement when a product made by a patented process is imported. It applies unless “the product made by the patented process is ‘materially changed by subsequent processes’ prior to importation.” (p. 62.) In discussing materiality, the court noted the following: “Materiality is context-dependent.” (p. 65.) “A good source for determining whether a change in a product of a process is material under § 271(g) is the patent. Where the specification or asserted claims recite a structure or function for the product of the processes, then significant variations from the recited structure and function are material. What makes a variation significant enough to be a ‘material change,’ however, is a question of degree.” (p. 65-66.)

Jury instructions. The court left open the issue of whether jury instructions should be reviewed under its own law or the law of the regional circuit. (p. 44, n. 13.)