Source: https://blog.wolfgreenfield.com/postgrant/topic/biopharma
Timestamp: 2019-04-21 14:38:33+00:00

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Evidence of skepticism of others in an IPR can be used to support the patentability of claims in response to obviousness challenges—skepticism is a standard “objective indicia” or secondary consideration of nonobviousness. In a recent series of IPRs filed by several generic drug makers against Eli Lilly & Co. (IPR2016-00318, IPR2016-00237 and IPR2016-00240), Eli Lilly bolstered its case for nonobviousness by pointing to the skepticism of the U.S. Food & Drug Administration (FDA) concerning its patented method. The PTAB’s decision illustrates that while skepticism by some may be helpful to patent owners, skepticism by the right people may be critical.
IPRs are often filed to challenge important patents – the same patents likely to be tested in litigation. In such circumstances, parties should pay careful attention when asserting arguments in the IPR that were addressed in the litigation. Several generic drug makers faced this circumstance in relation to obviousness arguments made in a series of IPRs against Eli Lilly & Co. (IPR2016-00318, IPR2016-00237 and IPR2016-00240), in which similar arguments made in a co-pending appeal before the Federal Circuit were found to be lacking. While the PTAB is not required to agree with courts on all issues, particularly in view of the fact that the standards of review between the two venues are different, these IPRs illustrate that petitioners and patent owners would be wise to carefully address what courts have said about the arguments at issue.
Expert testimony is a feature of most IPRs, and effective expert testimony can make or break a party’s position. When evaluating expert testimony, the PTAB may consider several issues. First, are the expert’s qualifications sufficient? Second, even if the expert does not technically qualify as a “person of ordinary skill in the art,” should the expert’s testimony be given weight? The PTAB’s decision in Lupin Ltd. v. Horizon Therapeutics, Inc. (IPR2016-00829) addresses these questions and illustrates several ways to effectively use expert testimony.
Prodrugs are inactive compounds designed to be converted into pharmaceutically active metabolites following delivery to a patient. Prodrugs have important pharmacokinetic advantages over traditional compounds, and a recent PTAB decision, Lupin Limited v. Vertex Pharmaceuticals Inc. (IPR2016-00558), illustrates how prodrugs can possess patent advantages as well. In its analysis of obviousness, the PTAB focuses on unpredictable results and whether a person of ordinary skill in the art has a reasonable expectation of success in view of the available art, as outlined in Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989 (Fed. Cir. 2009), frequently applied in pharmaceutical cases.
IPR is a common way to challenge patents covering pharmaceutical compounds, often on grounds of obviousness. As illustrated in the recent decision in in Mylan Pharmaceuticals Inc. v. AstraZeneca (IPR2015-01340), such IPRs may rely on a “lead compound analysis” involving a two-prong inquiry that asks: (i) whether a structurally similar prior art compound would have been selected as a “lead compound” and (ii) whether there was motivation to modify that compound to arrive at the claimed compound.
It is not uncommon in the biotechnology and pharmaceutical fields to file new patent applications based on results of a clinical trial or discovery of a newly appreciated feature of a compound. However, results-based claim language, such as pharmacokinetic or drug release profiles, may not confer patentable weight, as shown in a recent IPR decision.
No matter whether you are the patent owner or petitioner in an IPR, expert witness testimony is an important aspect of building your case. The Board relies on expert witnesses to provide insight into the often highly technical aspects of a given case, and will inevitably choose to give more weight to the testimony of one side’s witness over the other. This can be especially true when the testimony of the opposing experts is in direct conflict. So how does the Board choose which expert testimony to give more weight? Sometimes it’s a question of timing, as in the recent decision in Mylan Pharmaceuticals Inc. v. AstraZeneca (IPR2015-01340).
Duck salad—not the tasty Asian dish, but rather a pesky aquatic weed that grows among rice crops—is the subject of the patent challenged in the recent IPR Aceto Agricultural Chemicals Corp. v. Gowan Company, LLC (IPR2016-00076). The Board’s final written decision illustrates a point that should not be overlooked: the broadest reasonable interpretation, which the Board applies to most claims in IPR, is not the broadest conceivable interpretation. The distinction made all the difference in this case.
In IPRs regarding the patents to pharmaceutical compounds, patentability often turns on the obviousness of taking a known compound and modifying it based on a known technique. This process is known as lead compound analysis. Argentum Pharmaceuticals, Inc. v. Research Corporation Technologies, Inc. (IPR2016-00204) illustrates that even when the lead compound and the modification technique are known, the basics of patent law cannot be ignored—especially with billions of dollars in sales at stake.

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