The Benefits of Japanese Patent Law System over Those of the US’s in the Pharmaceutical Area (2)

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Patent Eligibility

Patent Eligibility in US:

35 U.S.C. § 101 INVENTIONS PATENTABLE

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter…. may obtain a patent…
・But courts have always maintained “judicial exceptions” of (a) pure laws of nature, (b) natural phenomenon, and (c) abstract idea not patentable themselves, but their application patentable.

 

Supreme Court in Myriad

“A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated…”
– BRCA1/2 genes are “law of nature”
– Isolated DNA not patent subject matter under § 101, unless it is significantly different from found in nature. (adopted the analysis of Mayo)
・cDNA is patentable because it not naturally occurring

 


 

Comparison of Examination Guidelines (Examination Guidelines JP vs US ):

USPTO Interim Guidance on Subject Matter Eligibility

・ Dec 2014, Nature-Based Product Examination Guideline (also see May 2016 Life Science Examples)
– Antibiotic L (protein) – not patent eligible
– Purified antibiotic L – patent eligible (when purified takes different form)
– “Purified Amazonic acid” – not patent eligible

 

Japanese Patent Law

・ Article 29(1),… an invention that is industrially applicable may be entitled… a patent…
・ Article 2, paragraph 1 defines invention as “the highly advanced creation of technical ideas by which a law of nature is utilized”.

 

Japanese Examination Guideline

– Invention does not include simple “natural law” or “simple observation” (same as US)
– But invention include chemical products, micro-organisms, etc. which are isolated by man from nature
・ DNA patent eligible so long as function known and having utility (2000 examination Guideline)
・ Japanese “Myriad Counterparts” lived their lives peacefully
– In 2015, FALCO (Kyoto company) took exclusive license from Myriad, and conducting BRCA1/2 tests in Japan
– Japanese gene patens and natural products patents still useful


 

[EXAMPLES]

– Not patent eligible in US, while corresponding JP patent was considered as being patent eligible.

 

What about Personalized Diagnostics Patents?

 

・ US6033857(BRCA2)-CAFC ruled not patent eligible
– Claim2. A method of diagnosing a predisposition for breast cancer… [by] compareing… BRAC2 from a subject [to] the wildtype… wherein alteration…indicates a predisposition to said cancer

・ JP3399539(BRCA1)(lived its life fullest to 2015)
– Claim1 – A method to identify the presence of breast and ovarian cancer gene in an individual by comparing BRCA1 gene from the individual to that of the wildtype wherein alteration indicates the presence of the cancer gene

・ JPO Examination Guideline(effective Oct 2015) – patent eligible
– Example 5: A method of examining the susceptibility… to hypertension by determining the type of base… in X gene… and comparing… with standard

 

Reasons behind CAFC’s decision

・ Claims are directed to natural phenomenon (paternally inherited cffDNA present in maternal blood/serum), and recited steps of amplifying and detecting cffDNA are routine methods

・ Applied analysis of Mayo
・ First determine if caim is directed to “judicial exceptions” (i.e. law of nature, natural phenomenon, or abstract ideas), if so, determine if significantly more is added to the claim.
・ Judge Dyke in denying hearing “en banc” said the claims might be patentable if “narrow in scope” otherwise they are overbroad
– Narrower the claim, the invention will be designed around

・ JP4245666 – Claim 1 substantially identical to US claim still alive, and clinical trial on the technology started 2016 in Japan

 


US patents are attacked as being not patent eligible, while JP patents may be useful for obtaining high royalty.

Another Attack under § 101

・ In 2017, the District of Delaware would have addressed Merck’s § 101 challenge (BMS/Ono v Merck) to three “Honjyo patents” for methods of treating cancers using anti-PD1 antibodies – eg US9067999
1. A method of treating a lung cancer comprising administering a composition comprising a human or humanized anti-PD-1 monoclonal antibody…
・ In April 2016, Delaware court accepted Merck’s argument that the claims were directed to the natural phenomenon of using T cells to activate the immune system, thereby satisfying the first prong of § 101 analysis under Mayo
– Second prong of whether claims “add enough” beyond the natural phenomenon would have been addressed in early 2017

・ Update

– Oct 24,2016, Ono sued Merck for infringement under counterparts JP4409430 and JP5159730

– Jan20, 2017, Merck and Ono/BMS settled in US/EP/Japan for high royalty.

・ Japanese patents also contributed to extraction of royalties!!


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