Shapes and NumbersRemember learning about shapes and counting on Sesame Street? Those basic skills still come in handy, even in complex patent cases.

Express Yourself … Genetically

Sanofi-Aventis Deutschland GmbH v. Genentech, Inc., No. 2011-1397 (Fed. Cir. Mar. 22, 2012) (Judges Newman, Lourie, and Prost) (nonprecedential)

This case involves 2 patents—5,849,522 (the ’522 patent) and 6,218,140 (the ’140 patent) that cover genetic enhancer elements. Enhancers are pieces of DNA that are usually found at the beginning or end of a gene, and they can be added to protein-based products to improve their efficiency. The enhancer involved here comes from the human cytomegalovirus (HCMV) major immediate early (IE) gene. Sanofi’s ’522 patent covers methods of using the HCMV IE enhancer to increase expression of a gene in mammalian cells. Its ’140 patent covers isolated enhancers themselves, DNA plasmids that include an enhancer and a gene, and the host cells that are transformed with these plasmids. (By the way, Wikipedia is a useful substitute for AP Biology for all of us non-geneticist types.)

Sanofi sued Genentech and Biogen, claiming that they had used infringing HCMV IE enhancers to make their Rituxan® and Avastin® drug products. The district court construed several claim terms relating to Sanofi’s two patents, and based on those constructions, granted the defendants’ motions for summary judgment of noninfringment. Sanofi appealed to the Federal Circuit.

With or Without You

In the ’522 patent, the district court construed “isolated DNA enhancer” as  “a DNA sequence, separated by human intervention from the promoter DNA in its original source …” On appeal, Sanofi argued that the patent also covers DNA enhancers that include the promoter DNA. The Federal Circuit rejected that argument because Sanofi disclaimed “enhancer + promoter” sequences during prosecution. Sanofi had emphasized the importance of separating the enhancer to overcome the examiner’s obviousness rejection. Based on Sanofi’s clear statements about this limitation during prosecution, the Federal Circuit accepted the district court’s construction.

Drawing the Line

The other key phrase from the ’522 patent that the district court construed is “DNA from the upstream region of the IE gene.” The claim construction debate is over where to draw the start line for the “upstream region.” Here’s a picture that shows the district court’s starting line (the transcription site) and Sanofi’s proposed starting line (the translation site). (The upstream region includes everything to the left of the starting line.)

Shapes and Numbers • Untitled

To decide which starting line was right, the Federal Circuit looked at how the patent used the phrase “upstream region.” It turns out that the patent claims and specification only use “upstream region” when they discuss the segment to the right of the district court’s starting line. When the patent specification refers to everything upstream of Sanofi’s proposed starting line, it uses different language. So the Federal Circuit adopted the district court’s construction of “upstream region.”

Even though the Federal Circuit agreed with the district court’s claim construction, Sanofi still argued that Genentech and Biogen infringed the ’522 patent. The defendants derived their original cell lines by inserting foreign DNA into a mammalian cell—a method that the ’522 patent covers—but they did that part before the ’522 patent issued. Sanofi said, however, that every subsequent cell line that came from that original cell line also “inserted” foreign DNA into cells every time the daughter cells divided. It argued that these activities continue to infringe its patent.

The Federal Circuit didn’t buy it, and said that Sanofi’s argument “contradicts basic scientific understanding and common sense.” Since Sanofi’s argument stretched the limit too far, the court affirmed the district court’s judgment of noninfringement.

Genetic Geometry

The key term at issue in the ’140 patent is “plasmid.” The district court relied on the Stinski patent—a reference in the prosecution history—as intrinsic evidence to determine that “plasmid” means a “circular, extrachomosomal molecule.” Sanofi argued that  “plasmid” can also include linear molecules that are integrated in chromosomes. Sanofi also said that the district court shouldn’t have considered the Stinski reference intrinsic evidence. Whether a reference is intrinsic or extrinsic evidence can make a difference in claim construction, since intrinsic evidence is considered a more reliable source.

Although intrinsic evidence usually includes only the language from the patent itself and its prosecution history, the Federal Circuit agreed that the Stinski reference could count as intrinsic evidence in this scenario. The written description of the ’140 patent doesn’t include the term “plasmid.” That term came in when Sanofi copied claims from Stinski during prosecution. Since the patent itself doesn’t offer much help in interpreting “plasmid,” the Federal Circuit agreed that Stinski could be considered intrinsic evidence and accepted the district court’s construction of “plasmid.”

The court didn’t accept Sanofi’s argument that the shape of the plasmid didn’t make a difference because the same genetic information gets transmitted. The court said that the claims require using a plasmid to transmit the information, and plasmid, correctly construed, only includes circular, extrachromosomal molecules. I guess this is one case where shape really matters!

Count Down

University of Southern California v. DePuy Spine, Inc., No. 2011-1422 (Fed. Cir. Mar. 22, 2012) (Judges Bryson, Dyk, and Moore) (nonprecedential)

In this interference action, the Federal Circuit told the Board of Patent Appeals and Interferences (BPAI) that it needed to think about what counts. In an interference, the BPAI defines a “count” that sets the limits of what subject matter it’s considering. A count can be one of the patent claims. An important function of a count is to define what evidence the parties can use to make their “I invented first” arguments. (Remember that this practice is being phased out because of the America Invents Act, and the change to a first-to-file priority system.)

The University of Southern California (USC) and DePuy Spine both filed patent applications that cover the same technology. Although DePuy filed its application 5 months before USC, USC had filed a provisional application that predated DePuy’s filing.  Their filings were ensnared in an interference proceeding.

The BPAI defined the count a couple of times, since the first and second counts involved invalid claims. Throughout the process, though, the BPAI continually defined a count that wouldn’t allow USC to rely on its provisional application. USC repeatedly asked the BPAI to redefine the count so it could rely on the provisional application, since, according to USC, the provisional application was its best proof of priority. The BPAI rejected all of USC’s requests and instead award priority to DePuy.

The Federal Circuit, however, said that the BPAI got this wrong:

The [BPAI] erred by insufficiently explaining its decision not to modify Count 3 to allow USC to claim priority to its provisional application. This failure is particularly troublesome because a party typically should be allowed to rely on its best priority proofs. The [BPAI] compounded its error by denying USC authorization to file a motion to modify the count.

(See page 5 of the DePuy opinion.) Consequently, the court sent the case back to the BPAI for a recount. USC will have the opportunity to fight for priority dating back to its provisional application, again.