• No se han encontrado resultados

5.2.1 Conjugated biological molecules and their preparation Applicants: PolyTherics Limited

Inventors: Antony Godwin, Elisa Pedone, Ji-Won Choi, Sunil Shaunak, Stephen Brocchini.

Right of ownership: By employment or other contract of inventors with Imperial College of Science Technology and Medicine or School of Pharmacy University of London, and a Research Collaboration and New Technology Agreement dated 24 May 2002 between Imperial College of Science Technology and Medicine, Imperial College Innovations Ltd., School of Pharmacy University of London, and PolyTherics Limited. Confirmatory Assignment effective 10 July 2003 between Antony Godwin, Elisa Pedone, Ji-Won Choi, Sunil Shaunak, Stephen Brocchini, School of Pharmacy University of London, Imperial College Innovations Ltd., and PolyTherics Limited.

Patent Family Details:

Country Application No. Patent No. Status

Australia 2004257448 2004257448 Granted

Australia (divisional application) 2010257308 2010257308 Granted

China 200480019814.4 ZL200480019814.4 Granted

China (divisional application) 201010139943.4 ZL201010139943.4 Granted

EPO 04743335.4 1648518 Granted

EPO (divisional application) 09167191.7 Pending

EPO (divisional application) 10175140.2 Pending

EPO (divisional application) 10175143.6 Pending

India 5752/DELNP/2005 236772 Granted

India (divisional application) 7343/DELNP/2009 Pending

Japan 2006-518372 4958549 Granted

Japan (divisional application) 2011-170597 5349552 Granted

Republic of Korea 10-2006-7000278 10-1152500 Granted

USA 10/564340 7595292 Granted

USA (continuation application) 12/458931 7939630 Granted

USA (continuation application) 13/077980 Allowed

Summary of the invention

The family claims priority from a GB application filed 11 July 2003. A PCT application was filed on 12 July 2004 and published as WO2005/007197. Normal expiry is 2024. The granted European patent has been validated in Austria, Belgium, Switzerland, Germany, Denmark, Spain, France, UK, Hungary, Ireland, Italy, Netherlands, Poland and Sweden.

This invention relates to reagents with the ability to conjugate a polymer to 1 or 2 proteins/peptides, thereby improving the pharmacological properties of the protein. The technology is of wide applicability, being capable of conjugating a wide range of polymers, including functionalised polymers, to a wide range of proteins through conjugation and bridging at disulfide bonds. The technology has utility with antibody/protein drug conjugates as well as pegylated compounds.

Patents have been granted in all of the countries where applications were made.

Following grant, the European patent was opposed by Bayer. PolyTherics Limited defended this opposition, and following oral proceedings before the Opposition Division of the EPO, the patent was successfully maintained without amendment. Bayer did not appeal the decision, the deadline for appeal has passed, and accordingly the European patent continues in full force. The fact that a European patent has survived an opposition is generally regarded as a mark of strength.

This is the core patent family for Abzena’s conjugation technologies.

5.2.2 Novel Conjugated Proteins and Peptides (Conjugation reactions using histidine tags) Applicants: PolyTherics Limited

Inventors: Stephen Brocchini, Penny Bryant, Yuehua Cong, Ji-Won Choi, Antony Godwin, Keith Powell.

Right of ownership: By employment in the case of Penny Bryant, Yuehua Cong, Ji-Won Choi, Antony Godwin, Keith Powell; by secondment agreement from School of Pharmacy University of London in the case of Stephen Brocchini; Confirmatory assignment effective 8 October 2007 between Stephen Brocchini, Penny Bryant, Yuehua Cong, Ji-Won Choi, Antony Godwin, Keith Powell, School of Pharmacy University of London, and PolyTherics Limited.

51 Patent Family Details:

Country Application No. Patent No. Status

Brazil PI0818288-4 Pending

China 200880110579.X Pending

EPO 08806549.5 Pending

India 790/DELNP/2010 Pending

Japan 2010-528477 Pending

Republic of Korea 10-2010-7010204 Pending

Singapore 201000843-1 159589 Granted

USA 12/682057 Pending

Summary of the invention

The family claims priority from a GB application filed 9 October 2007 and a European application filed 21 July 2008. A PCT application was filed on 8 October 2008 and published as WO2009/047500.

Normal expiry is 2028.

When manufacturing proteins, it is common to attach a “his-tag”, a short chain of histidine residues, to aid purification. This invention is based on the realisation that certain polymer conjugation reagents, and specifically the reagents used in the patent family of Sec. 5.2.2, can be made to react with histidine residues present in the his-tag of a protein to form a conjugate.

5.2.3 Novel Reagents and Method for Conjugating Biological Molecules (Monofunctional reagents)

Applicants: PolyTherics Limited Inventor: Antony Godwin

Right of ownership: By employment. Confirmatory assignment effective 20 July 2008 between Antony Godwin and PolyTherics Limited.

Patent Family Details:

Country Application No. Patent No. Status

Australia 2009275358 Pending

China 200980128495.3 Pending

EPO 09784718.0 Pending

EPO (divisional application) 11171786.4 Pending

India 161/DELNP/2011 Pending

Japan (divisional application) 2011-519228 Pending

Japan 2011-180530 Pending

Republic of Korea 10-2011-7003833 Pending

USA 13/055455 Pending

USA (continuation application) 13/175820 8618333 Granted

USA (continuation application) 14/086702 Pending

Summary of the invention

The family claims priority from two GB applications filed 21 July 2008 and 2 April 2009. A PCT application was filed on 17 July 2009 and published as WO2010/010324. Normal expiry is 2029.

This invention relates to a reagent for conjugating a polymer to a protein or peptide. The reagent is a monofunctional conjugating reagent which binds to a single amino acid residue in a protein.

5.2.4 Conjugated Proteins and Peptides (C1 Reagents) Applicants: PolyTherics Limited

Inventors: Antony Godwin, Stephen Brocchini.

Right of ownership: Employment in the case of Antony Godwin; agreements with School of Pharmacy University of London in the case of Stephen Brocchini. Confirmatory assignment effective 3 March 2009 between Stephen Brocchini, Antony Godwin, School of Pharmacy University of London, and PolyTherics Limited.

Patent Family Details:

Country Application No. Patent No. Status

EPO 10707337.1 Pending

USA 13/254003 Pending

Summary of the invention

The family claims priority from three GB applications filed 4 March 2009, 17 July 2009, and 21 December 2009. A PCT application was filed on 4 March 2010 and published as WO2010/100430.

Normal expiry is 2030.

This patent family covers reagents for conjugating polymers to proteins which lead to a bridge across a disulfide bond in the protein having one carbon atom.

5.2.5 Novel Process for Preparation of Antibody Conjugates and Novel Antibody Conjugates (Antibodies with Single Hinge Disulfide)

Applicants: PolyTherics Limited

Inventors: Antony Godwin, John Burt, George Badescu.

Right of ownership: By employment; confirmatory assignment effective 18 June 2012 between Antony Godwin, John Burt, George Badescu, and PolyTherics Limited.

Patent Family Details:

Country Application No. Patent No. Status

Patent Cooperation Treaty GB2013/051593 Pending

Summary of the invention

The family claims priority from two GB applications filed 19 June 2012 and 12 April 2013. A PCT application was filed on 19 June 2013 and published as WO2013/190292. Normal expiry is 2033.

Entry into the National Phase is not yet due, and prosecution has not yet started.

Antibody drug conjugates (ADCs) are a growing class of chemotherapeutic agents for the treatment of cancer. The attachment of a cytotoxic drug to a targeting antibody allows selective delivery while minimising toxic side effects from exposure of the drug to healthy tissue. Established approaches to attaching the cytotoxic drug molecules to the antibody involve conjugating the drug molecules to amino acid residues present in the antibody, typically resulting in heterogeneous mixture of conjugates with varying numbers of drug molecules. Such conjugation also potentially leads to structural changes and impaired antibody function. This invention provides a novel way to prepare more homogenous and stable ADCs by using antibodies engineered to have a single inter-heavy chain disulfide bond.

5.2.6 Conjugation reagents (Branching Linker) Applicants: PolyTherics Limited

Inventors: Antony Godwin (in the PCT Application)

Antony Godwin and Stephen Brocchini (in the US Application)

Right of ownership: for countries outside the US: by employment and confirmatory assignment effective as of 17 June 2012 between Antony Godwin and PolyTherics Limited. For the US: the inventors have signed a formal assignment of their rights in the US Application to PolyTherics Limited.

At time of writing, a confirmatory assignment from UCLB (the successor in title to School of Pharmacy University of London which was taken over by University College London, and employer of Stephen Brocchini) to PolyTherics Limited is awaiting signature.

Patent Family Details:

Country Application No. Patent No. Status

USA 13/919217 Pending

Patent Cooperation Treaty GB2013/051567 Pending

53 Summary of the invention

The family claims priority from a GB application filed 18 June 2012. A PCT application was filed on 17 June 2013 and was published as WO2013/190272, and a US National Application was filed on the same day and published as US2013/338231. Normal expiry is 2033. Entry into the National Phase is not yet due, and prosecution has not yet started.

This patent family claims a conjugation reagent containing a specific branching linker, capable of conjugating two separate polymer chains to a single protein.

5.2.7 Novel Drug Protein Conjugates (Auristatins) Applicants: PolyTherics Limited

Inventors: Antony Godwin; John Burt; Mark Frigerio; George Badescu.

Right of ownership: By employment. Confirmatory assignment effective as of 23 October 2012 between Antony Godwin, John Burt, Mark Frigerio, George Badescu, and PolyTherics Limited.

Patent Family Details:

Country Application No. Patent No. Status

Patent Cooperation Treaty GB2013/052661 Pending

Summary of the invention

The family claims priority from two US applications filed 24 October 2012, a US application filed 12 April 2013, and a PCT application filed 19 June 2013. A PCT application was filed on 11 October 2013 and published as WO2014/064423. Normal expiry is 2033. Entry into the National Phase is not yet due, and prosecution has not yet started.

This patent family includes two different inventions: (i) specific antibody-drug conjugates including a specific linker, together with an auristatin; and (ii) antibody drug conjugates including a specific linker together with a drug, the linker having a particular branching structure.

5.2.8 Novel Drug Protein Conjugates (Maytansines) Applicants: PolyTherics Limited

Inventors: Antony Godwin; John Burt; Mark Frigerio; George Badescu.

Right of ownership: By employment. Confirmatory assignment effective as of 23 October 2012 between Antony Godwin, John Burt, Mark Frigerio, George Badescu, and PolyTherics Limited.

Patent Family Details:

Country Application No. Patent No. Status

Patent Cooperation Treaty GB2013/052662 Pending

Summary of the invention

The family claims priority from a US application filed 24 October 2012. A PCT application was filed on 11 October 2013 and published as WO2014/064424. Normal expiry is 2033. Entry into the National phase is not yet due, and prosecution has not yet started.

This patent family claims specific antibody-drug conjugates including at least part of a specific linker together with a maytansine.

5.2.9 Conjugated Blood Coagulation Factor VIIA

Applicants: Cantab Biopharmaceuticals Patents Limited and PolyTherics Limited (joint).

Inventor: William Henry

Right of ownership: The inventor, William Henry, was a Director of Cantab Biopharmaceuticals Limited; confirmatory assignment from William Henry to Cantab Biopharmaceuticals Limited dated 6 April 2011. The priority application was filed in the name of Leverton Licence Holdings Limited and an assignment from Cantab Biopharmaceuticals Limited to Leverton Licence Holdings Limited was executed on 6 April 2011. The PCT application claiming priority was filed in the name of Leverton Licence Holdings Limited also. An assignment from Leverton Licence Holdings Limited to Cantab

Biopharmaceuticals Patents Limited and PolyTherics (giving Cantab Biopharmaceuticals Patent Limited and PolyTherics Limited joint ownership) was executed on 12 October 2012.

Patent family details:

Country Application No./Patent No. Case Status

African Regional Intellectual Property

Organisation (designating Kenya) AP/P/2012/006574 Pending

Australia 2011247148 Pending

Brazil BR 11 2012 027592 5 Pending

Canada 2796870 Pending

Chile 2012-3038 Pending

China CN 102971013 A Pending

Colombia 12207049 Pending

Costa Rica 2012-580 Pending

Eurasian Patent 201290941 Pending

Ecuador SP-12-12315 Pending

Egypt PCT1807/2012 Pending

EPO 2563403 Proceeding to grant

United Kingdom 2492738 Granted

Georgia 12907/01 Pending

Gulf Cooperation Council 2011/18315 Pending

Hong Kong 1175999 Pending

Indonesia W00201204870 Pending

Israel 222565 Pending

India 9336/DELNP/2012 Pending

Japan 2013-506736 Pending

Republic of Korea 10-2013-0055620 Pending

Mexico MX/a/2012/012684 Pending

Malaysia PI 2012004682 Pending

Nicaragua 2012-000161 Pending

New Zealand 603938 Granted

Perú 2104-2012 Pending

Philippines 1-2012-502149 Pending

Russian Federation 2012144554 Pending

Singapore 201207679.0 Pending

Ukraine a201213631 Pending

USA US-2013-0129698-A1 Pending

Uzbekistan IAP 2012 0482 Pending

Vietnam 1-2012-03269 Pending

South Africa 2012/08988 Proceeding to grant

Summary of invention

The family claims priority from a GB application filed 30 April 2010. A PCT application was filed on 28 April 2011 and published as WO2011/135308. Normal expiry is 2031.

This family relates to PEGylated compositions of blood factor VIIa, where PEG is attached via a linker moiety through two cysteine residues.