Hospira UK Ltd v Genentech Inc.

JurisdictionEngland & Wales
CourtChancery Division (Patents Court)
JudgeThe Hon. Mr Justice Birss,Mr Justice Birss
Judgment Date10 April 2014
Neutral Citation[2014] EWHC 1094 (Pat)
Docket NumberCase No: HC12C03487
Date10 April 2014

[2014] EWHC 1094 (Pat)




Royal Courts of Justice, Rolls Building

Fetter Lane, London, EC4A 1NL


Mr Justice Birss

Case No: HC12C03487

Hospira UK Limited
Genentech Inc.

Richard Meade QC, Tom Mitcheson and Jeremy Heald (instructed by Taylor Wessing) for the Claimant

Michael Tappin QC and Mark Chacksfield (instructed by Marks & Clerk) for the Defendant


Hearing dates: 6th, 7th, 10th, 11th, 12th, 13th, 14th, 18th and 19th March 2014


Approved Judgment


I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.

The Hon. Mr Justice Birss Mr Justice Birss





The issues


The witnesses


The 115 patent


The skilled person and the common general knowledge


The 115 patent specification


Claim construction




Obviousness – the FDA label




The reaction of the clinician


Obviousness — conclusion






The 455 patent


The skilled team


Common general knowledge


The 455 patent specification


Claim construction






The disclosure of Andya compared to claim 1






Andya – obviousness


Obviousness over common general knowledge in general


Obviousness over common general knowledge based on Protein A


Declaration of non-infringement







1. Like all cancers, breast cancer is not a single disease. Much depends on the particular kind of cells which have become cancerous. The conventional therapeutic approaches were surgery, radiotherapy and chemotherapy or combinations of these various options. The agents used for chemotherapy were and are powerful drugs which are cytotoxic (i.e. cell killing). These drugs include Taxol (the trade name of paclitaxel), 5-flourouracil and many others. Generally these agents attack rapidly dividing cells. This will include cancer cells but will also include other rapidly dividing cells in the body. That is why hair loss can be a side effect of chemotherapy.


2. Some types of breast cancer can be treated with hormone therapy (such as Tamoxifen) but other types of breast cancer do not respond to hormone therapy. One class of breast cancers which was particularly difficult to treat was those in which the cells over-expressed a receptor known as HER2. The HER2 receptor (also known as the ErbB2 receptor) belongs to a class of receptors in the epidermal growth factor receptor (EGFR) family. 20% to 30% of breast cancers were classified as HER2 positive. They had a poor prognosis.


3. In general in pharmacology higher selectivity means that a drug can be given at an effective dose with fewer side effects. In other words the margin between safety and efficacy generally improves as selectivity increases. Thus an agent which could be targeted more closely to cancer cells in particular could be given at a higher dose in order to improve its efficacy, without compromising safety.


4. A major breakthrough in breast cancer therapy in recent years has been the availability of an agent known as Herceptin. Herceptin is the brand name of a monoclonal antibody called trastuzumab. This antibody targets the HER2 receptor. It was developed by Genentech and Roche.


5. Trastuzumab is different from conventional chemotherapeutic agents in a number of ways. Two important points stand out in the context of this case. First, it is highly targeted to a particular group of cancer cells, which in general terms means that the window between safety and efficacy is improved. Second, trastuzumab was at the time a new class of agent — a monoclonal antibody. Whereas conventional drug molecules are small, antibody molecules are large proteins. This difference has consequences relating to the manufacture and formulation of the drug and may also affect the manner in which the drug behaves in the body.


6. Before Herceptin was approved in the USA and then later in Europe, those working in oncology had heard about it. The positive results of a Phase II clinical trial were published in March 1996 and in May 1998 the results of the Slamon trial were published at ASCO. In September 1998 Herceptin was approved by the FDA in the United States and in Europe it was approved in August 2000. Herceptin has been and remains a huge success. Worldwide sales from 1999 to 2013 totalled 49 billion Swiss Francs (£33 billion at present exchange rates) which includes European sales from 2010 to 2013 of 8 billion Swiss Francs (£5 billion).


7. Hospira sells generic medicines, particularly in the cancer field. It wishes to sell a generic form of trastuzumab in the UK. Hospira does not challenge the basic underlying patent held by Genentech on trastuzumab (EP 0 590 058). The supplementary protection certificate for that patent (SPC/GB04/015) expires on 28 th July 2014. Hospira wishes to sell its generic trastuzumab product after that date. Genentech holds a number of patents of a later vintage which Hospira might infringe. Hospira contends that the patents are invalid and has brought this action to invalidate them. There is also a claim for a declaration of non-infringement in relation to one patent. When the case began there were three patents in suit but Genentech offered to surrender one of them a few months ago.


8. The two patents in suit are EP 1 210 115 entitled “Dosages for treatment with Anti-ErbB2 antibodies” and EP 1 308 455 entitled “A composition comprising anti-HER2 antibodies”.


9. The application for the 115 patent was filed on 25 th August 2000 claiming priority from two US applications, the first being filed on 27 th August 1999. It was granted on 5 th August 2009. The claims concern a dosing regimen for trastuzumab.


10. The application for the 455 patent was filed on 3 rd May 1999 claiming priority from a US filing on 6 th May 1998. It was granted on 22 nd March 2006. The claims concern a composition of trastuzumab with less than certain thresholds of certain impurities.


11. Both patents were opposed in the EPO. In both cases the Opposition Division has held the patent is invalid. Both are presently under appeal before the Technical Board of Appeal. The parties did not know when the appeals are likely to be heard. Even if either appeal succeeds it may not bring the EPO proceedings to an end because in that event the Board may remit the case to the Opposition Division.


The issues


12. The 115 patent relates to the use of a particular dosing schedule of trastuzumab to treat breast cancer. The dosing schedule involves administering trastuzumab every three weeks whereas the existing schedule was weekly.


13. Hospira contends that the claims of the 115 patent are not entitled to the earliest claimed priority date. Genentech maintains the claim to priority but accepts that if priority is lost the patent is invalid. Hospira also contends that even if entitled to priority, the patent is invalid. The invention is said to be obvious over the state of the art at the earliest priority date. The key item of prior art is the FDA label for Herceptin which was published when the product was approved by the FDA. Genentech accepts the FDA label is prior art but does not agree it makes the claimed dosing regimen obvious.


14. Hospira's primary case is that the invention is obvious but if the claims of the 115 patent do involve an inventive step then Hospira contends the patent is insufficient. Hospira argues essentially that if it was inventive to conduct a clinical trial over what was known from the prior art then the same logic will apply starting from the patent and the result must be insufficiency. Although it is true that the patent specification does contain more data than was in the state of the art, Hospira point out that the patent specification does not contain the result of a clinical trial of the claimed dosing regimen. Genentech does not agree with this either as a matter of reasoning or on the facts. It points out that the claimed dosing regimen is in fact safe and effective to treat the disease. Genentech also argues that, unlike the position over the prior art, a skilled person reading the patent in the light of their common general knowledge will have sufficient confidence to conduct a clinical trial.


15. Finally Hospira advanced a case based on added matter but by closing it became clear that the point does not need to be addressed.


16. The only relevant claim of the 115 patent is claim 1. In response to the way in which the arguments on priority developed, Genentech made an application to amend the claim to include a reference to “intravenously”. By the closing this was the only claim to be focussed upon.


17. The 455 patent is concerned with purifying trastuzumab and claim 1 relates to a composition of trastuzumab with less than about 25% of certain acidic variants of the antibody. Hospira argues that claims 1, 2 and 4 lack novelty over a previous Genentech PCT application PCT/US96/12251 (“Andya”) which was published as WO 97/04801 on 13 th February 1997 and entitled “Stable Isotonic Lyophilised Protein Formulation”. Andya describes stability tests on various trastuzumab formulations. Hospira contends Andya is an enabling disclosure of a composition of trastuzumab with 82% native protein and therefore no more than 18% acidic variants. Genentech does not agree. In addition to a point about exactly what is disclosed, the main debate over Andya concerns enablement. Hospira also contends that Andya makes...

To continue reading

Request your trial
13 cases
  • Hospira UK Ltd v Cubist Pharmaceuticals LLC
    • United Kingdom
    • Chancery Division (Patents Court)
    • 10 Junio 2016
    ...v) Plausibility, as part of the requirement of an enabling disclosure, applies to issues of priority as well as sufficiency; Hospira UK Ltd v Genentech Inc [2014] EWCH 1094 at [149]. 115 There was a dispute between the parties as to the legal effect of G 2/98. First, relying on the proposit......
  • Merck Sharp & Dohme Ltd v Ono Pharmaceutical Company Ltd and Another
    • United Kingdom
    • Chancery Division (Patents Court)
    • 22 Octubre 2015
    ...experiments, that the product has an effect on a disease process so as to make the claimed therapeutic effect plausible. I held in Hospira v Genentech [2014] EWHC 1094 (Pat) at paragraph 149 that this reasoning, including the requirement for plausibility, was part of the law of priority de......
  • Teva UK Ltd and Another v Astrazeneca AB
    • United Kingdom
    • Chancery Division (Patents Court)
    • 2 Septiembre 2014
    ...Pharmaceuticals Inc. v Genentech Inc. [2013] EWCA Civ 93; [2013] RPC 28, in particular at [103] per Kitchin LJ, and in Hospira UK Ltd v Genentech Inc. [2014] EWHC 1094 (Pat) at [56]-[64] per Birss J. However, in order to justify being allowed a patent monopoly before proceeding to the expe......
  • Illumina, Inc. and Others (Claimants to case no HC-2015-001175) Illumina, Inc. and Another (Claimants in case no HP-2015-000047) v Premaitha Health Plc and Another (Defendants in case nos HC-2015-001175 HP-2015-000047)
    • United Kingdom
    • Chancery Division (Patents Court)
    • 21 Noviembre 2017
    ...is not enough to establish lack of inventive step. There is no single standard of what amounts to a fair expectation of success; Hospira UK Ltd v Genentech Inc [2016] EWCA 780per Floyd LJ at [13] – [16]. There are some steps which can be characterised as so routine that the skilled person w......
  • Request a trial to view additional results
3 firm's commentaries
  • IP Bulletin - June 2014
    • United Kingdom
    • Mondaq United Kingdom
    • 3 Julio 2014
    ...treatment drug is likely to be available in July 2014 (subject to Genentech appealing the decision). Hospira UK Ltd v Genentech Inc [2014] EWHC 1094 (Pat), 10 April 2014 To read this Bulletin in full, please click here. The content of this article is intended to provide a general guide to t......
  • The Nexus Between IP And Clinical Trials: An Australian Perspective
    • Australia
    • Mondaq Australia
    • 25 Octubre 2021
    ...Inc [2012] EWHC 657 (Pat); Hospira UK Limited v Genentech Inc [2015] EWHC 1796 (Pat); [2016] RPC 1; Hospira UK Ltd v Genentech Inc [2014] EWHC 1094 (Pat) The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your s......
  • The Nexus Between IP And Clinical Trials: An Australian Perspective
    • Australia
    • Mondaq Australia
    • 25 Octubre 2021
    ...Inc [2012] EWHC 657 (Pat); Hospira UK Limited v Genentech Inc [2015] EWHC 1796 (Pat); [2016] RPC 1; Hospira UK Ltd v Genentech Inc [2014] EWHC 1094 (Pat) The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your s......

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT