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Amgen Inc. v. Hoechst Marion Rousse

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Amgen Inc. v. Hoechst Marion Roussel[1] This is a complex case involving a non-naturally occurring erythropoietin-glycoprotein product having a defined in vivo biological activity and having glycosylation which differs from that of human urinary erythropoietin. During prosecution there had been discussion as to whether this meant that the   DNA used for production of the EPO was necessarily exogenous. However, the applicants had made no clear limitation to this effect. The defendants product was made with endogenous DNA.

In its claim construction phase, the court pointed out that:

We indulge a heavy presumption that a claim term caries its ordinary and customary meaning. … prosecution history may not be used to infer the intentional narrowing of a claim absent the applicant’s clear disavowal of claim coverage, such as an amendment to overcome a rejection.

Despite the defendant’s arguments, the court found no such disavowal. The claim therefore covered virtually all non-naturally occurring EPO. This inevitably led to a  Challenge that such a claim was too broad. In this case the attack was mounted on the basis that the written description requirement of 35 USC 112 had not been met. This  led the court to reconsider its recent decisions on this topic in University of  California[2],Gentry Gallery[3] and Enzo Biochim.[4]

The court noted that the first of these had held that the description of DNA of insulin in one species did not constitute a written description of the gene for all other species and that the third had held that a functional definition might meet the requirement of the law if in the knowledge of the art the disclosed function is sufficiently correlated to a particular known structure. It then held that both of these were “inapposite in the present case because the claim here was not to new or unknown biological material that ordinarily skilled artisans would easily miscomprehend”.

So far as Gentry Gallery was concerned, on its proper reading, this case stood for nothing more that the well established principle that “a broadly drafted claim must be fully supported by the written description and drawings”.[5] That decision had therefore not created any new rule  That a claim might be invalid simply on the ground that it failed to include an essential element.[6] The court therefore held the written description requirement to have been satisfied. The court went onto hold that the enablement requirement was also met because of the degree to which the art had developed by the relevant date of 1984.

There was a strong dissent[7] which was uneasy about the breadth of the claims arguing that Amgen should not be entitled to claim all EPO produced by mammalian cells in culture. The majority[8] noted that while such a view might be important as a policy matter, it did not comport with the relevant precedents. The issue of whether it can ever  be unobvious to claim all methods of achieving an obvious desideratum does not seem to have been argued.

65 USPQ2d 1383.
43 USPQ2d 1398.
45 USPQ2d 1498.
63 USPQ2d 1609.
[5] The district court had made a factual finding that the description of
production of EPO in two species of cells adequately supported the
See also Cameron Corp v. Kvaerner 62
USPQ2d 1846 on this issue.
By Judge Clevenger.
Judges Michel and Schall.
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