API and IP Newsletter

 

Contents

• Analysis of Import of Cipla in Last two Years

• General information

• US FDA approval and panel tracker: May 2023

• Strathclyde partners in the new Intracellular Drug Delivery Centre

• Intellectual Property

• T 2351/19 (Animal food/HILL'S PET NUTRITION) of 4.5.2023

Analysis of Cipla’s Import in the last two years

We try and understand more about the development pipeline of the company by combining information from patent databases and import/export databases. Last week we analyzed a patent database of Cipla, and this week we invested time in analyzing the import database of Cipla.  Some of the interesting observations are as below. 

Import month	Intermediate	End USE	QTY in KG	Sidvim Comments
Apr-21	4-BROMO-2-ETHYLBENZENEMETHANOL	Siponimod	0.01	Siponimod was approved in March 2019. Cipla filed DMF in November 2022. They ordered basic RM in April 2021. So one could reasonably conclude Cipla had filed DMF in 18 months' time. In our last week’s Newsletter, we covered patent family WO2021240547A2. This patent application is for Form C3 for the fumarate salt of Siponimod. From this information, it could be inferred that polymorph, different salts and DMF filing strategies were worked in parallel in Cipla’s R&D.
Jun-21	N-(2-AMINO-4,6-DICHLORO-5-PYRIMIDINYL) FORMAMIDE	Abacavir	0.15	This is Abacavir intermediate. Cipla had filed DMF in 2012, and this could be scouting for additional RM sources.
Oct-21	METHYL S-2-TERT-BUTOXYCARBONYLAMINO-3-S-2-OXOPYRROLIDIN-3-YLPROPANOATE	Nirmatrelvir	0.20	This is Plaxcovid (Nirmatrelvir) intermediate. This intermediate was imported in October 2021! Cipla filed DMF in January 2023.
Dec-22	2-((2-((6-BROMOHEXYL)OXY)ETHOXY)METHYL)-1,3-DICHLOROBENZENE	Vilanterol Trifenatate	0.20	Cipla had not filed DMF yet. There are five other DMFs. Cipla is very strong in inhalation products and might file DMF soon. Cipla filed a patent family for the composition of a combination of Vilanterol and fluticasone about 10 years ago, but it is withdrawn in most of the jurisdictions. So, Cipla might have attempted earlier circumventing compositions, perhaps might not have achieved the desired success, and could have shelved the project then and now restarted it near the time of generic entries.
Nov-22	3-METHYL-3-(METHYLSULFONYL) BUT-1-YNE	Lenacapavir	0.25	Lenacapavir was approved for medical use in the European Union in August 2022, in Canada in November 2022, and in the United States in December 2022. Nobody had filed DMF yet. There is a high likelihood that Cipla would file one soon.

General information

US FDA approval and panel tracker: May 2023

Project	Company	Indication(s)	2028e SBI ($m)	Outcome
SRP-9001 (delandistrogene moxeparvovec)	Sarepta	Ambulatory patients with Duchenne muscular dystrophy with a confirmed mutation in the DMD gene	2,036	Delayed from 29 May until 22 June, positive adcom
Veozah (fezolinetant)	Astellas	Moderate-to-severe vasomotor symptoms associated with menopause	1,904	Approved
Arexvy	GSK	Prevention of lower respiratory tract disease caused by RSV in adults ≥60 years	1,729	Approved
Abrysvo	Pfizer	Prevention of lower respiratory tract disease caused by RSV in adults ≥60 years	1,306*	Approved
Epkinly (epcoritamab, DuoBody-CD3xCD20)	Genmab/Abbvie	Relapsed/refractory large B-cell diffuse lymphoma after ≥2 lines of systemic therapy	1,187	Approved (accelerated)
Bimzelx	UCB	Plaque psoriasis	718	FDA issued a Form 438 relating to manufacturing deficiencies
Vyjuvek (B-Vec, beremagene geperpavec)	Krystal	Dystrophic epidermolysis bullosa	636	Approved
Inpefa (sotagliflozin)	Lexicon	Heart failure (HFrEF & HFpEF pts with/out diabetes)	333	Approved
Alhemo (concizumab)	Novo Nordisk	Haemophilia A and B with inhibitors	198	CRL (additional information requested)
Xacduro (sulbactam-durlobactam, Sul-Dur)	Innoviva (Entasis)	Hospital‐acquired and ventilator‐associated bacterial pneumonia caused by Acinetobacter baumannii‐calcoaceticus complex in adults	82	Approved
Mydcombi	Eyenovia	Drug-device combination for in-office pupil dilation (mydriasis)	54	Approved
Elfabrio (pegunigalsidase alfa, PRX-102)	Chiesi/ Protalix	Fabry disease	-	Approved
Trastuzumab duocarmazine (SYD985)	Byondis	Her2-positive unresectable breast cancer	-	CRL (additional information requested)
Brixadi	Camurus	Opioid use disorder	-	Approved
Anktiva (N-803)	Immunitybio	BCG-unresponsive non-muscle-invasive bladder cancer	-	CRL (manufacturing deficiencies and CMC problems)
Miebo (NOV03)	Bausch & Lomb	Dry eye disease	-	Approved
Posluma (flotufolastat F 18/ 18F-rhPSMA-7.3)	Blue Earth Diagnostics/ Bracco	PSMA-targeted PET imaging agent for prostate cancer	-	Approved

News here.

Strathclyde partners in the new Intracellular Drug Delivery Centre

Innovation organisation CPI is establishing a brand-new Intracellular Drug Delivery Centre in partnership with Medicines Discovery Catapult, the University of Strathclyde, the University of Liverpool and Imperial College London to help develop novel drug delivery technologies and support promising RNA vaccines and therapeutics. 

News here

Intellectual Property 

T 2351/19 (Animal food/HILL'S PET NUTRITION) of 4.5.2023

Summary of Facts and Submissions

This appeal at EPO is regarding EP2934173B1. This patent was issued to Hills Pet Nutrition Inc.

This decision concerns the opponent's (Mars) appeal against the opposition division's decision to reject the opposition. In its notice of opposition, the opponent Mars requested the revocation of the patent under for lack of novelty and inventive steps.

The documents cited during the opposition proceedings are as below.

D1: |US 6,455,083 B1 |

D2: |N.N., "Corn Starch", 11th edn., Washington: Corn Refiner's Association, 2006 |

D3: |US 7,678,406 B2 |

D4: |US 4,251,556 |

D5: |EP 0 154 039 A1 |

D10:|US 4,044,158 |

D13:|Product information: AmyloGel 03001I (Cargill) |

D18:|Declaration by Ms Garzino (filed by letter dated 12 April 2019) |

D19:|N. J. Cave, "Hydrolyzed protein diets for dogs and cats", Veterinary Clinics Small Animal Practice, 2006, 1251-1268|

D20:|Technidog blog: "Hill's Z/D : croquette contre les allergies alimentaires du chien", https://www.technidog.com/actualites/hills-zd-chien.html|

D21:|Product information accessible via hyperlink in D20 |

D23:|R. Kumar et al., "Enzymatically modified soy protein", Journal of Thermal Analysis and Calorimetry, 75, 2004, 727-738|

D24:|Declaration by Gary Semjenow dated 23 May 2019 |

Claims 1 and 8 of the patent as granted read as follows:

"1. An animal food composition comprising a protein source and corn starch, wherein native high-amylose corn starch comprises at least 50% by weight of the corn starch, wherein the composition comprises corn starch in an amount of from 40 to 70 wt% based on the total weight of the composition on a dry matter basis, wherein the protein source is hydrolysed protein, and wherein the native high-amylose corn starch has an amylose content of from 50 wt% to 70 wt% on a dry matter basis."

"8. A process for the preparation of an animal food composition, the process comprising (i) mixing a protein source, corn starch and water to form a mixture and (ii) heating the mixture, wherein native high-amylose corn starch comprises at least 50% by weight of the corn starch, and wherein the composition comprises corn starch in an amount of from 40 to 70 wt% based on the total weight of the composition on a dry matter basis, wherein the protein source is hydrolysed protein, and wherein the native high-amylose corn starch has an amylose content of from 50 wt% to 70 wt% on a dry matter basis."

Closest prior art

The invention in the patent concerns an animal food composition that comprises a protein source such as poultry liver hydrolysate (i.e. protein hydrolysate). When such a protein source and conventional starch are heated, in the preparation of the product, issues with viscosity are observed.

D3 will be discussed first and comprehensively as the closest prior art. The Board considered other documents as starting points too. However, in this write-up, we will study inventive steps from D3 as the starting point

The patentee argued that the distinguishing features over D3 (US 7,678,406 B2 ) were:

(a) native high-amylose corn starch comprising at least 50% by weight of the corn starch

(b) corn starch in an amount of 40 to 70 wt% based on the total weight of the composition

(c) hydrolysed protein

The board agreed on formulation of the technical problem as “to modulate the viscosity of the animal food composition”.

The next step is to decide whether the skilled person would have provided the distinguishing features in combination to solve the technical problem.

Mars (opponent) argued that the skilled person would have known that amylose was suitable for modifying and controlling the viscosity of compositions. In view of this, the skilled person would have increased the amount of amylose. The relevant teaching was to be found, for example, in D2 (N.N., "Corn Starch", 11th edn., Washington: Corn Refiner's Association, 2006) or D5 (EP 0 154 039 A1).

There are three distinguishing features. All three of these features contribute to modifying the viscosity of the composition.

The composition of D3 is designed to provide a pet food having a low energy density that is nutritionally complete. The composition requires as a mandatory feature a specific mixture of starches. The starches required are cereal starch, pre-gelatinised starch and high-amylose starch. The latter starch is present in a relatively low amount compared to the other starches.

The Board opined the appellant did not convincingly explain why the skilled person would have been motivated to modify the teaching of D3 to arrive at a composition with corn starch in an amount of 40 to 70 wt% based on the total weight of the composition and at least 50% by weight of the corn starch being native high-amylose corn starch.

Even if the skilled person had arrived at such a combination, the composition obtained would still lack hydrolysed proteins.

Now, the protein source of claim 1 of the patent in suit, hydrolysed protein, has an impact on viscosity. It contributes to modulating the composition's viscosity. This is one of the findings set out in the patent in suit. In view of this, the appellant's secondary line of argument, that adding hydrolysed protein merely solved the partial problem of providing a hypo-allergenic composition, cannot be followed.

To conclude, starting from D3 as the closest prior art, the skilled person would not have provided the combination of features (a) to (c) to solve the technical problem. Therefore, the subject matter of claims 1 and 8 involves an inventive step.

The Board said the appellant (Mars) did not present arguments that justify reversing the opposition division's decision on inventive step. 

Case here