WANTED: PARTICIPANTS FOR FREE ENERGY/WATER AUDIT

The City of San Diego and the County Water Authority are still looking for candidates to participate in their water/energy pilot program. They would perform a water/energy audit on your facility free of charge. Several BIOCOM members have taken advantage of this opportunity. If you would like more information, please contact Chris Robbins with the City of San Diego Water Department or Jeff Stephenson with the San Diego County Water Authority.

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ASEEMBLYMAN FLETCHER: SEEKING A BALANCED STATE BUDGET

On May 1st, BIOCOM had the pleasure of hosting Assemblyman Nathan Fletcher for BIOCOM’s continued Legislative Roundtable series. Assemblyman Fletcher, who represents a large portion of the San Diego Life Science cluster, has been a staunch supporter ofthe life science community since his election to the Assembly in 2008.

Assemblyman Fletcher spoke to members regarding California’s budget deficit. The Assemblyman believes that the state budget has some structural problems, primarily how the legislature receives money. “We cannot sustain the massive spikes and drops in our revenue” said Fletcher. Ascurrently structured, the vast majority of the state’s revenues are based on personal and corporate income taxes, leaving the state budget exposed to wild revenue swings depending on the overall state of the economy. The Assemblyman went on to discuss his idea towards creating a balanced budget by potentially passing a two year budget.

During the meeting, the Assemblyman announced that he was recently named Vice Chair of the Assembly Select Committee on Biotechnology. Assemblyman Fletcher has already proven his commitment to the life science industry by being a champion for revisions of the state tax code revised to include single sales factor corporate income tax. This was a huge victory for the life science industry and has given companies the opportunity to not be penalized for expanding their California operations. This change, which BIOCOM has advocated for many years, allows companies to elect to be taxed based on sales, instead of the current formula which also factors employee headcount and property in the tax calculation. Assemblyman Fletcher told the audience that, “When you have a system where if you add jobs, your tax rate goes up- it’s just illogical.” He also shared with members that he looks forward to continuing to advocate for the life science industry in Sacramento and believes that our industry will play a significant role in California’s economic recovery.

BIOCOM Legislative Roundtables are regular events which bring together our members and their elected officials in a casual environment to discuss the relevant political and policy issues of the day. We would like to thank Assemblyman Fletcher for his insight and taking the time to meet with our members. For more information on Legislative Roundtables, please contact Faith Picking.

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IP Update: ANTICIPATE BIOTECH INVENTIONS TO BE OBVIOUSLY HARDER TO GET

Two recent Federal Circuit decisions, one related to anticipation,the other to non obviousness, will make it potentially more difficult for biotech companies to obtain patents.

In re Gleave: In his case, the patent applicants attempted to obtain claims to antisense polynucleotide compounds (typically short nucleic acids (e.g.15-25 nucleotides long) that are complementary to the mRNA encoded by agene). Antisense polynucleotides are expected to modulate gene expression by virtue of the complementarity. The court sided with the USPTO’s stance that a paper disclosure of sense strand oligonucleotides, along with a generic teaching that anti senseoligonucleotides can be used, was sufficient to anticipate the claimed invention. This was a surprising result, not only because the prior art was not enabled (there were no examples of functioning antisenseeffect), in addition, there was no actual disclosure of antisense compounds within the four corners of the presumed anticipating reference. Ironically, if that’s the word, while the disclosure in the prior art reference was held sufficient to anticipate the invention of another, its disclosure would not be considered enabling to support a patent itself. This decision is likely to make obtaining patents in the field much harder – for example, it is not much of a stretch to then suggest that any disclosure of a gene sequence with a mere inference that antisense compounds can be made would anticipate any anti sensecompound for that gene, regardless of whether such a compound had antisense effect or not.

In re Kubin: In this case, the patent applicants attempted to obtain claims to a cDNA to a known protein. The court overturned precedent set in In re Deuel where it had held that knowledge of the protein sequence, owing to the degeneracy of the genetic code, was insufficient to make obvious the coding nucleotide sequence. Here, the court decided that the field had advanced enough that cloning was routine and, in view of the lowered obviousness standard set by KSR v. Teleflex, was “obvious to try.” In another bit of irony, this result was obtained even though the protein sequence was not disclosed in the prior art reference.

Consequently, patent applicants should expect to regularly be faced with anticipationand obviousness rejections while attempting to obtain composition claims for biotech inventions.

Submitted by BIOCOM's Intellectual Property Committee, by Les Overman with Stephen Reiter and Bernie Greenspan. The opinions expressed herein are those of the contributors and not their respective employers.

Please send your comments or suggestions to BiocomIP@gmail.com.

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