The Claim Game

Glatt's invention applies coats to particles such as pharmaceutical ingredients.

This case involves the Federal Circuit reversing the U.S. Board of Patent Appeals and Interferences decision that claim 5 of US5236503 was obvious.

Claim 5 follows as:

In a fluidized bed coater having a product container opening upwardly into an expansion chamber and downwardly into a lower plenum chamber through an air distribution plate/screen having openings formed therethrough for upward air flow from said lower plenum chamber into said product container, said product container including a substantially cylindrical partition spaced above said air distribution plate/screen for defining an inner upbed area and an outer downbed area, and an upwardly discharging spray nozzle mounted substantially centrally within said cylindrical partition, the improvement comprising shielding means positioned adjacent said spray nozzle for shielding the initial spray pattern developed by said nozzle against the entrance of particles moving upwardly through the upbed. 

The initial obviousness rejection was on the basis of a german patent DE 3323418:

Naunapper describes the removal of agglomerates by "blowing through" with increases air flow. Based on this, the PTO examiner found the device claimed for "shielding means" and made a case for obviousness (1)

The Federal Circuit disagreed and stated that Naunapper can be used to "(1) circulate particles and (2) clear blockages. The air source cannot perform both of these functions simultaneously, and more importantly, neither of these functions constitutes shielding" (1). In doing so, the Federal Circuit determined that PTO failed to make a case for obviousness.

Sources
(1) https://www.pharmapatentsblog.com/2011/01/06/an-ounce-of-prevention-can-be-patentable-over-a-pound-of-cure/

Background: This case involves Caraco's alleged infringement of one of Novo Nordisk's patents on Prandin, and anti-diabetic drug. Caraco filed for an Abbreviated New Drug Application (ANDA) in 2005, in regards to a Prandin generic. In its ANDA, Caraco notes that it would not be infringing upon Novo Nordisk's patent on the grounds of invalidity and unenforceability. Novo Nordisk responded with a law suit.

Patent: The patent at issue in this case is NIDDM (Non-Insulin Dependent Diabetes Mellitus) regimen, US6677358. This patent covers 1) the regimen of short-acting, oral hypoglycemic agents used to treat type 2 diabetes, and 2) a method improving glycemic control by the combined use of repaglinide (Prandin) and metformin in NIDDM patients. The particular claim at issue is claim 4:

A method for treating non-insulin dependent diabetes mellitus (NIDDM) comprising administering to a patient in need of such treatment repaglinide in combination with metformin. 

In other words, the claim at issue is a claim regarding the method of using repaglinide (Prandin) and metformin in combination to treat NIDDM. 

District Court:

The district court found claim 4 of the '358 patent to be obvious, holding that the patent was unenforceable. This decision was grounded in that 1) it was well known in the art that both drugs had different mechanisms of action for treating diabetes and were hence often used in combination and 2) combination therapy was common at the time of filing the '359 patents and metformin was the most widely used insulin sensitizer. Novo Nordisk appealed this decision to the federal circuit.

Federal Circuit Court:

The circuit court affirmed the district court decision in that claim 4 of the '358 patent is obvious.

Stemcentrx is a biotech unicorn that aims to create novel cancer therapeutics by targeting cancer stem cells. 



Valuation: $5 Billion
Patents: 23
Pending Patents: 2
Trademarks: 2
Competitors: Juno Therapeutics, Oncomed Pharmaceuticals, AbbVie Inc

Most of Stemcentrx's patents involve anti-DLL3 antibodies. Some examples follow: 

• US9089617B2: Anti-DLL3 antibody drug conjugates

• US9090683: Methods of Detection, Diagnosis, and Monitoring Using Anti-DLL3 Antibodies

• US9155803: ANTI-DLL3 ANTIBODY DRUG CONJUGATES AND METHODS OF USE

• US9107961: Anti-DLL3 Antibody Drug Conjugates for Treating Cancer

• US9089615: ANTI-DLL3 ANTIBODIES

Sources:
http://blogs.wsj.com/venturecapital/2015/09/16/peter-thiel-backed-stemcentrx-emerges-with-5-billion-valuation/
http://assignment.uspto.gov/#/search?q=STEM%20CENTRX%20INC&sort=patAssignorEarliestExDate%20desc%2C%20id%20desc&synonyms=false
https://patents.google.com/patent/US9089617B2/en

Blue Apron is a Unicorn that delivers ingredients and recipes for various meals to individuals seeking to learn more about cooking, and master gourmet techniques. One distinguishing factor between Blue Apron and its competitors is its delivery of wine, and wine pairing suggestions.



Estimated Valuation: $2 Billion
# of patents owned: 0
Competitors: HelloFresh, Plated, Instacart

As an IP strategy I would recommend that Blue Apron consider protecting their packaging (patent), as well as their brand (trademark).

Sources:
http://accounts.ktmine.com/company/ipreport?q=BLUE+APRON+INC&start=&end=
http://finance.yahoo.com/news/the-surprisingly-simple-reason-blue-apron-reached--2b-so-fast-182928633.html
https://www.crunchbase.com/organization/blue-apron

Today I am going to discuss patent claims involved in the case Supreme Court case Teva Pharmaceuticals USA, Inc. v. Sandoz Inc. 

Case Background: Teva sued Sandoz for patent infringement of Copaxone, a drug used to treat the neurological disorder Multiple Sclerosis. In defense, Sandoz claimed that Teva's patent claims were indefinite in that the term "molecular weight" had three possible meanings, and was not defined. The district court ruled that the claims regarding molecular weight were definite, and that Sandoz had infringed on Teva's patents. Sandoz appealed this decision and the appellate court found that Teva's molecular weight claims were indeed indefinite, and therefore the claims were invalid.



Patent at Issue: The patent at hand is U.S. Patent No. 5,800,808: Copolymer-1 Improvements in Compositions of Copolymers.

The claims of the the '808 patent follow as:

1. A method of manufacturing copolymer-1 

1. comprising reacting protected copolymer-1 with hydrobromic acid 
2. to form trifluoroacetyl copolymer-1
3. treating said trifluoroacetyl copolymer-1 with aqueous piperidine solution 
4. to form copolymer-1, 
5. and purifying said copolymer-1, 
6. to result in copolymer-1 
7. having a molecular weight of about 5 to 9 kilodaltons.

1.  of a gene whose transcription is regulated by NF-.kappa.KB
2. the method comprising reducing NF-.kappa.B activity 
3. in the cell such that expression of said gene is inhibited. 

A method inhibiting gene expression of genes regulated by NF-.kappa.B.

2. A method for selectively inhibiting expression

1. in a eukaryotic cell
2. of genes whose transcription is regulated by NF-.kappa.B
3.  the method comprising reducing NF-.kappa.B activity
4. in the cell such that expression of said genes is inhibited

A method selectively inhibiting gene expression of genes regulated by NF-.kappa.B.
3. A method for reducing the level of expression of a viral gene

1. whose transcription is regulated by NF-.kappa.B in a eukaryotic cell
2. the method comprising reducing NF-.kappa.B activity
3.  in the cell such that expression of said viral gene is reduced. 

A method reducing viral gene expression of viral genes regulated by NF-.kappa.B.
4. The method of claim 3, 

1. wherein the viral gene is a cytomegalovirus (CMV), 
2. human immunodeficiency virus (HIV) 
3. or simian virus 40 (SV40) gene. 

A method reducing viral gene expression of a CMV, HIV, SV40 genes regulated by NF-.kappa.B.
5. A method for reducing the level of expression

1. of a cytokine gene 
2. whose transcription is regulated by NF-.kappa.B 
3. in a eukaryotic cell 
4. comprising reducing NF-.kappa.B activity in the cell 
5. such that expression of said cytokine gene is reduced. 

A method reducing gene expression of a cytokine gene regulated by NF-.kappa.B.
6. A method for diminishing induced NF-.kappa.B-mediated intracellular signaling 

1. comprising reducing NF-.kappa.B activity in cells 
2. such that NF-.kappa.B-mediated intracellular signaling is diminished. 

A method for diminishing induced NF-.kappa.B-mediated intracellular signaling.

7. A method for modifying effects of external influences on a eukaryotic cell

1. which external influences induce NF-.kappa.B-mediated intracellular signaling
2.  the method comprising altering NF-.kappa.B activity in the cells 
3. such that NF-.kappa.B-mediated effects of external influences are modified. 

A method for modifying the impact of extracellular influences that induce NF-.kappa.B-mediated intracellular signaling.

8. The method of claim 7

1. wherein NF-.kappa.B activity in the cell is reduced. 

A method for modifying the impact of extracellular influences that induce NF-.kappa.B-mediated intracellular signaling such that NF-.kappa.B activity is reduced.

9. A method for reducing, in eukaryotic cells, the level of expression of genes 

1. which are activated by extracellular influences which induce NF-.kappa.B-mediated intracellular signaling,
2.  the method comprising reducing NF-.kappa.B activity in the cells 
3. such that expression of said genes is reduced. 

A method for reducing gene expression of genes activated by extracellular influences that induce  NF-.kappa.B-mediated intracellular signaling.

10. A method for reducing the effects of bacterial infection on mammalian cells 

1. comprising reducing NF-.kappa.B activity in mammalian cells 
2. so as to reduce bacterial lipopolysaccharide-induced gene expression in the mammalian cells. 

Sources:
http://www.patentdocs.org/2014/05/in-re-roslin-institute-fed-cir-2014.html
http://patentlyo.com/media/2014/05/13-1407.Opinion.5-6-2014.1.pdf
https://upload.wikimedia.org/wikipedia/commons/6/6e/Dolly_face_closeup.jpg