[Ip-health] Roche and City of Hope claim Pfizer biosimilar version of trastuzumab will infringe “at least” 40 patents

James Love james.love at keionline.org
Mon Nov 27 08:19:56 PST 2017


Roche and City of Hope claim Pfizer biosimilar version of trastuzumab will
infringe “at least” 40 patents
November 23, 2017

On November 17, 2017, Genentech, a subsidiary of the giant Swiss drug
company Roche, together with City of Hope, a charity, filed a complaint in
a U.S. District Court, seeking an injunction to block introduction of a
Pfizer biosimilar version of Herceptin (INN: trastuzumab), as well as other
remedies to infringement, including compensation for Roche’s lost profits
if competition occurs. The complaint illustrates the complexity of the
patent landscape on a drug placed on the market more than 19 years ago and
the need for compulsory licensing of patents.

 . . . [snip]

The development of the product has also benefited from more than a half
billion dollars of grants from the NIH that mention trastuzumab (See Table
2) and tax credits associated with two orphan drug designations.

Since entering the market in 1998, Roche has now earned more than $70
billion for Herceptin, and another $3 billion for Kadcyla, the follow-on

Despite being a drug introduced in the previous century, Roche claims that
Pfizer’s biosimilar “will infringe at least” forty patents (See Table 1)
including patents filed as late as 2015 that are in effect until 2035.

The Genentech/Roche/City of Hope complaint refers to eight categories for
the patents, including:

1. The Cabilly Patents
2. The ’213 Patent
3. The Combination Chemotherapy Patents
4. The Method of Administration Patents
5. The Acidic Variants Patents
6. Combination Therapy with Perjeta
7. HER2 Diagnostic Patents
8. Cell Culture, Purification, and Antibody Manufacturing Patents

Herceptin is a remarkable drug, but after enjoying 19 years as a monopoly
and $70 billion in sales, one might think enough is enough, as regards the
rewards to the Roche shareholders.

Pfizer may be able to avoid an injunction and defend itself from
infringement claims from the 40 patents, but policy makers need to reflect
on the barriers to competition that can exist 19 years and $70 billion into
a legal monopoly.

A robust compulsory licensing authority is needed into the United States,
so that when global revenues are massive and excessive, as is the case for
Herceptin, relevant to the rewards necessary to induce investments, the
government can effectively end the legal monopoly and permit competition
among suppliers to drive down prices. To the extent that there are useful
patented inventions that the biosimilar manufacturer will use, compulsory
licenses can provide reasonable royalties that are rationally related to
the value the inventions add.

The U.S. does not currently have such legislation.


James Love.  Knowledge Ecology International
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love

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