Posts Tagged ‘biotechnology law’

Product-by-process claims are product claims

Tuesday, June 9th, 2015

This is being published with the permission of Kawaguti & Partners.

Kawaguti   K&P’s Court Decision Report in 2015 <<<Special News Flash>>>

 

Supreme Court Overturns Grand Panel’s Decision of IPHC and Admits that “Product-by Process” Claim should Cover Same Products Irrespective of Process, But …

Teva Gyogyszergyar Zartkoruen Mukodo Rt. (Patentee) v. Kyowa Hakko Kirin Co., Ltd. (Accused Infringer), Case No. 2012 (Jyu) 1204 (Decision rendered on June 5, 2015)

The Supreme Court overturned a decision of the Grand Panel1) of the Intellectual Property High Court (IPHC) relating to the construction of the scope of a “product-by-process” claim2) rendered in 2012, and ruled that the scope of a “product-by-process” claim should be determined as products having the same structure, properties and the like as a product produced by the process defined in the claim, even though the process of producing the product is defined in the claim. Namely, the Supreme Court admitted that a “product-by-process” claim covers all the products having the same structure or properties as a product produced by the process defined in the claim even if the actual process for producing the product is different from the process in the claim.

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FDA Finalizes Biosimilar Guidance

Thursday, April 30th, 2015

The Regulatory Affairs Professional Society (RAPS) has posted an informative article “After Three-Year Delay, FDA Finalizes Guidance Documents on Biosimilarity.”  The article includes links to the final guidance documents.

You can find the article here.

“Isolated” Natural Products Still in Purgatory Post-PTO Guidance?

Tuesday, April 28th, 2015

BacteriaRecently, a new class of antibiotic, teixobactin, was discovered in the soil in a Boston researcher’s backyard via a high throughput in situ screening chip that detected individual bacteria capable of growing in an uncultured state. The resulting isolates were extracted and the extracts screened for antibacterial activity. One peptidyl compound, isolated from a new species of bacterium and named teixobactin (“TX”), was found to kill a wide variety of pathogens without detectable resistance. The Nature pre-print I have ends, “It is likely that additional natural compounds with similarly low susceptibility to resistance are present in nature and are waiting to be discovered.”

“Discovery” seems likely, but a close reading of the examples provided with the December “2014 Interim Guidance on Patent Subject Matter Eligibility” is not encouraging. Practitioners generally hailed the revised Guidance as releasing Examiners to allow claims on nature-based products that were structurally or functionally different from their closest counterparts in nature. However, Example 4, “Purified Proteins” indicates the PTO’s unwillingness to embrace (read “treat as precedent”) cases like Parke-Davis (Adrenaline) and Merck v. Olin-Mathieson (purified vitamin B-12).

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Genetic Engineering Makes the Blacklist

Thursday, April 16th, 2015

iStock_000003273676_LargeJames Spader was quirkily funny as Denny Crane’s partner on “Boston Legal,” but NBC’s “The Blacklist” has him operating totally outside of the law. He plays Raymond Reddington, an enigmatic figure who reveals to a black-ops FBI agent the evil doings of criminals that fly under the radar of normal law enforcement – and who make “The Blacklist.” A recent episode involved trying to catch a “mad scientist,” funded by a middle-aged tech billionaire to conduct research on human subjects for his “Longevity Initiative.” When the scientist is captured, oddly, one might think, his lab contains tanks of phosphorescent jelly fish and two bunnies that glow in the dark.

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