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Top Articles - Will Wisconsin's Patents Block Embryonic Stem Cell Research?
The stem cell article by Jennifer Washburn in the April 12, 2006 issue of the Los Angeles Times mentioned Jeanne Loring, an embryologist at the Burnham Institute in La Jolla: In
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
1999, Loring tried to launch a company to work with stem cells, but the firm quickly collapsed when it couldn't raise the $100,000 in upfront fees the Wisconsin foundation [WARF] cha
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
rged.
Washburn's article did not mention an earlier article by Loring and co-author Cathryn Campbell, entitled "Intellectual Property and Human Embryonic Stem Cell Research," wh
Washburn's article did not mention an earlier article by Loring and co-author Cathryn Campbell, entitled "Intellectual Property and Human Embryonic Stem Cell Research," wh
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ch appeared in 311 Science 1716 on March 24, 2006. Therein, Loring and Campbell mentioned the changing royalty fees charged by WARF in response to a "memo of understanding" (MOU) wi
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
th the federal funding agency. Loring/Campbell mentioned the "SBIR paradox" as to funding of small businesses, which may be a problem, but not one associated with patent law.
Both
Both
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
the Washburn and Loring/Campbell articles suggested that the WARF/Thomson patents would pose a long-term threat to stem cell science. Washburn noted the position of the Foundation f
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
or Taxpayer and Consumer Rights, based in Santa Monica, which urges California's stem cell agency to challenge the Wisconsin patents. In greater detail, the Santa Monica group stat
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
ed: The stem cell institute faces a threat from a foundation associated with the University of Wisconsin [WARF], which claims that it is owed licensing fees because it holds paten
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
s on all human embryonic stem cells in the United States. John M. Simpson stated: "This is an outrageous raid on the treasury of California based on over-reaching patents. No other
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
nation in the world recognizes them. They are blocking vital research in the United States. I call on the stem cell institute to challenge the patents' validity."
Neither the W
Neither the W
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
shburn nor Loring/Campbell articles discuss the possible research safe harbor created in the Hatch-Waxman Act and codified at 35 USC 271(e)(1). The breadth of this safe harbor was r
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ecently affirmed in the Supreme Court decision of Merck v. Integra. Neither the Washburn nor Loring/Campbell articles discuss that patent infringement suits against states and state
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
bodies (such as California's CIRM) are likely to be heard in state court, not federal court, according to the Supreme Court decision in Florida Prepaid Postsecondary.
Although ther
Although ther
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
may be a visceral reaction to lash out against patents perceived to be overbroad, the cautionary tale of NTP v. RIM suggests that sometimes negotiation is the better path for infrin
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
gement defendants. Further, Loring/Campbell mention the possibility of an interference with Plurion, although this most likely would change only the identity of the owner of control
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
ing patents. Separately, one recalls that the Thomson patents are about creating stem cells from blastocysts; they are not about "cloning" [SCNT] technology. To date, traditional m
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ethods for stem cell separation from blastocysts have failed wherein SCNT is involved. There may be a question of enablement as to the Thomson patents for cases involving SCNT, whic
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
h is where the holy grail of patient-specific stem cell lines resides.
As a general proposition, the state taxpayers underwriting efforts such as Proposition 71 have the expectation
As a general proposition, the state taxpayers underwriting efforts such as Proposition 71 have the expectation
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
that money will be used for research, not to litigate the patent positions of prior researchers. Extrapolating further, state funding to achieve patent positions could lead to a bal
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
kanization of research, in which entities from individual states (such as California, New Jersey, Maryland, Illinois, Connecticut) are fighting one another, rather than collaborating
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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