AbbVie Corporation v Janssen Inc. [2014 FC 55]
Background
The action is in respect of a patent directed to human antibodies capable of binding a human cytokine (interleukin 12). This binding is useful for the treatment of diseases especially psoriasis.
AbbVie is the patent owner and plaintiff in this action. Janssen has secured a Notice of Compliance (NOC) to sell an injectable product containing a substance they call ustekinumab to treat chronic, moderate or severe plaque psoriasis. The product is sold as Stelara. AbbVie does not market any such product in Canada.
The patent at issue is Canadian Patent 2,365,281 (the ‘281 Patent). The application was filed with CIPO on March 24, 2000 and is thus a ‘new’ act patent. The patent will expire on March 24, 2020 unless otherwise expunged. The application claims priority from a United States patent filed on March 25, 1999. The Canadian patent was laid open for public inspection on September 28, 2000. The patent was issued and granted on August 4, 2009.
The patent is for an interleukin identified as interleukin-12 (IL-12) which has been identified as having a role in dealing with immunity. IL-12 is targeted by antibodies when introduced into the human body and is thus considered an antigen.
Example nine in the Canadian PCT application (it does not appear in the priority patent) indicates that a person was treated by chance with the antibody. The person suffered from psoriasis and was treated by administration of the antibody.
The ‘281 Patent contains two hundred and twenty-three claims. Claims 143 and 222 are the claims at issue. These are dependent claims that incorporate numerous precedent claims.
Claim 143 reads:
The use of a neutralizing isolated human antibody, or antigen-binding portion thereof, that binds to human IL-12 and dissociates from human IL-12 with a koff rate constant of 1 x 10-4s-1 or less, as determined by surface plasmon resonance and which inhibits phytohemagglutin blast proliferation in an in vitro PHA assay with an IC50 of 1 x 10-9 M or less, to treat psoriasis.
Claim 222 reads:
The use of an isolated human antibody, or antigen-binding portion thereof, which binds to a human interleukin comprising a p40 subunit and dissociates from the human interleukin with a koff rate constant of 1 x 10-2 s-1 or less, as determined by surface plasmon resonance, and which inhibits phytohemagglutinin blast proliferation in an in vitro PHA assay with an IC50 of 1 x 10-9M or less, which neutralizes the activity of the interleukin, to treat psoriasis.
Analysis
For the following reasons the Judge concluded that the claims of the patent at issue are valid and the patent is infringed.
Janssen chose not to personally test its own product STELARA but instead only leveled criticisms of the tests performed by AbbVie. It is expected that Janssen would have provided evidence as to testing if it felt that its product did not fall within certain parameters. Janssen made a motion to exclude the evidence collected via third party testing.
At present there is no rule directed at testing conducted for the purposes of trial. Ex parte testing may be admissible subject to weight particularly where the opposite party had the opportunity to conduct similar tests. Additionally where ample notice has been given about testing a party cannot argue admissibility on the basis that they failed to attend the testing.[64] The evidence is ultimately admissible given Janssen’s ample opportunity to respond with their own studies or via cross examination.
AbbVie stated that it was the first company to develop human antibodies capable of neutralizing IL-12. Janssen denied this in its Statement of Defence and alleged that its product was developed in 1997. From the table of evidence provided in the Judgment it is clear that at around the same time AbbVie had isolated antibodies. It appears that Abbvie and Janssen had concurrently (or near concurrently) discovered the psoriasis clinical indication. AbbVie filed first in early 1999 in the United States while Janssen filed in the middle of 2000.
Justice Hughes concluded that the discoveries were made wholly independent of one another.[81]
A United States Trial Decision in the District Court of Massachusetts was filed. It was noted that the matter is on appeal to the US Court of Appeal for the Federal Circuit. These decisions are not relevant to the present case since they deal with different patents under a different legal regime.
Person of Ordinary Skill
This person was defined as a person with reasonably high levels of knowledge and experience in dealing with human antibodies as well as possessing good technical skills for performing the tests with respect to ‘stickiness’ and potency.
The Claims
Both claims at issue are use claims. The claims are directed to the use of a substance to treat psoriasis with the substance being an isolated human antibody. Neither claim restricts the preparation method. Both claims were thus construed to be directed to the use of human antibodies that bind and dissociate from IL-12 at a stickiness of at least 1×10-4s-1 or at least 1×10-2s-1 and which have a potency of at least 1×10-9M to treat psoriasis.
Infringement
Janssen conceded that if the claims were construed to cover human antibodies made by any method STELARA would fall within the scope of the claims. As well the testing by AbbVie is admissible and as a result the STELARA stickiness and potency fall within the scope of claims 143 and 222.
Where a person sells a product for an infringing use by another and where the product has no other significant commercial use the person has induced infringement and is itself an infringer.[106]
Validity
Janssen has led sufficient evidence that the presumption of validity has been overcome. Only claims 143 and 222 are at issue with respect to validity. The findings will not impact all of the other claims of the patent.
The state of the art was adequately identified by two of the experts Dr. George and Dr. Weiner.[122]
The inventive concept of the claims is “…that psoriasis may be treated by the use of human antibodies that bind to human IL-12 which antibodies have a stickiness of at least the claimed amount and a potency of at least the claimed amount.”[132]
The difference between the prior art and the invention claimed is the difference “between hope and certainty”.[133] The invention indicates that psoriasis would be treatable where as the development of antigens was more typically characterized as being potentially capable of treating disease.
AbbVie discovered an antibody amongst a very large pool of potential antibodies capable of binding to cytokine IL-12 and thus treating psoriasis. Many of the experts who had significant time in research in the field had never experienced the discovery of an antibody that actually worked to cure a disease. The patented invention was not self evident with regard to the prior art – it was not obvious.[140]
Overbreadth
The fundamental issue is whether a phage-display-created antibody can be claimed despite not being constrained by the method of creation.[144] The methods of creation of antibodies were well known at the time and the techniques for measuring stickiness and potency were also well known.
There is nothing indeterminate in the claims, nothing either lacks utility or cannot be soundly predicted. The issue is that they have claimed the invention without reference to the specific antibody described in the patent or even the specific method by which it was to be made in the patent.[148]
Janssen has not identified parameters outside of those found in claims 143 and 222 that are essential for the antibody to treat psoriasis.
The present claims were held to not be overly broad or covetous. The evidence available was capable of soundly predicting all of the claimed compounds despite the limited number of examples. The claims are readily understandable by a person of skill and there is no evidence that antibodies that fall within the outlined parameters will not work to bind IL-12 to treat psoriasis.
Janssen raised issues of functional claiming however what their argument ignores is that AbbVie identified minimum parameters that must be met in order to treat the disease. This is an acceptable form of claiming and is reflective of AbbVie’s discovery. Sufficiency or overbreadth must be considered on a case by case basis with much depending on the evidence and opinions put before the Court.
Ambiguity
Janssen initially raised a question about whether the claims were ambiguous. Particularly they were concerned with the statement “or less” with respect to stickiness and potency. No evidence was provided to show that a person of skill would be confused by this wording.
The claims set minimum standards for stickiness and potency and are therefore not ambiguous.
Costs
The parties failed to avail them of trial management or case management Prothonotaries. This led to unnecessary orders, undue delay and confusion at trial. As a result the parties will bear their own costs unless otherwise covered by a particular previous order.