Further Research ConsiderationsApril 30, 2015

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Further Research & Development Considerations

April 30, 2015

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Limit use of non-Soteria personnel.

Dr. Metamorphosis at Brookhaven National Lab, circa 2001

There ain’t no such thing as a free lunch.

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Limit use of non-Soteria personnel

• Delano Farms Co. et al. v. The California Table Grape Commission, (Fed. Cir. January 9, 2015)

• Federal Circuit affirms that two plant patents not invalid under the public use bar of § 102(b) despite the fact that the patentee’s employee provided sample to third parties without authorization and without an NDA.

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Looking Back

• What do you want to claim and where are the evidential gaps?

• Traditionally bred lines?

• Plants or cells containing recombinant nucleic acids?

• e.g. plants comprising RNAi constructs targeting expression of the regulatory gene

• Plants in which regulatory gene has been actively mutated e.g. using TALENS or CRISPR technology

• Have any transformed varieties been generated?• Have the methods of generating the transformed

varieties been adequately disclosed?

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Looking Back

• A specific variety or descendant thereof?• Has a deposit been made with an International

Depository Authority?

– e.g. American Type Culture Collection (ATCC)

– http://www.wipo.int/export/sites/www/treaties/en/registration/budapest/pdf/ida.pdf

– Bring deposit to the attention of International Bureau within 18 months of priority date

• Can a deposit be made?

Can seed be deposited (i.e. are the varieties true breeding)?

Can cryo-preserved explants or suspension cultures be made?

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Looking Forward

• Plants with unusually high levels of psychoactive agents?• Have plants overexpressing the regulatory gene been

generated?

• Do they have high levels of THH?

• If not,

• How long does it take to generate such varieties?

• Is this obvious?

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Looking Forward

• Plants with unusually high levels of psychoactive agents?

• A party seeking to invalidate a patent as obvious must demonstrate “‘by clear and convincing evidence that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success from doing so.’” Proctor & Gamble Co. v. Teva Pharms. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009) (quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007)).

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Looking Forward

• Plants with unusually high levels of psychoactive agents?• Bristol-Myers Squibb Co. v. Teva Pharm. USA Inc., 752

F.3d 967 (Fed. Cir. 2014)

• reasonable expectation of success is measured “as of the date of the invention.”

• 35 U.S.C. § 103

– A patent for a claimed invention may not be obtained… if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date.

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Looking Forward

• Plants with unusually high levels of psychoactive agents?– Bristol-Myers Squibb Co. v. Teva Pharm. USA Inc., 752 F.3d

967 (Fed. Cir. 2014)• To be particularly probative, evidence of unexpected

results must establish that there is a difference between the results obtained and those of the closest prior art, and that the difference would not have been expected by one of ordinary skill in the art at the time of the invention.

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Looking Forward

• Plants with unusually high levels of psychoactive agents?

• Bristol-Myers Squibb Co. v. Teva Pharm. USA Inc., 752 F.3d 967 (Fed. Cir. 2014)

• “differences in degree” of a known and expected property are not as persuasive in rebutting obviousness as differences in “kind”—i.e., a new property dissimilar to the known property.

• Design your experiments well so that they include the controls necessary to support an unexpected result!

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Looking Forward

• What are the sources of your materials?

• Were any materials received under the Multilateral System pursuant to a Standard Material Transfer Agreement?• Materials may be encumbered by obligations to pay

royalties!

• You may be obligated to act as a stock centre.

• Is it viable/cost effective to reproduce the technology with material that is not encumbered?

• Nagoya Protocol in force as of October 12, 2014.• ratified by the European Union.