DAVID GRANOVSKY

Bristol-Myers, Stem Cells, Facebook: Intellectual Property

In ALL ARTICLES on October 20, 2011 at 12:04 am

While most people will read this and discuss the use of embryos in heated voices and others will discuss the effects on science (both important discussions to have), I see only one result from this.  The European Union has set a precedent which, if copied in other countries, will absolutely force pharmacuetical companies to make patentable drugs out of embryonic stem cells instead of using adult stem cells which have a long history of safety and efficacy.  Which countries are in the European Union?

Member states of the EU (year of entry)

And btw, there are also a LOT of pharma companies headquartered in the European Union…

Rank[30] Company Country Total Revenues (USD millions) Healthcare R&D 2008 (USD millions) Net income/ (loss) 2008 (USD millions) Employees 2008
1 Pfizer[33] (with Wyeth[34]) United States 70,696 11,318 14,111 137,127
2 Johnson & Johnson United States 63,747 NA 10,576 119,200
3 Hoffmann–La Roche Switzerland 43,970 NA 8,135 78,604
4 Novartis Switzerland 41,460 NA 11,946 98,200
5 GlaxoSmithKline United Kingdom 40,424 6,373 10,432 103,483
6 Sanofi-Aventis France 40,328 NA 7,204 99,495
7 AstraZeneca United Kingdom 31,601 NA 5,959 67,400
8 Abbott Laboratories[35] United States 29,527 2,688 4,880 68,697
9 Merck & Co. United States 23,850 4,678 7,808 74,372
10 Bristol-Myers Squibb United States 19,977 NA 2,165 42,000
11 Eli Lilly and Company United States 18,634 NA 2,953 40,600
12 Boehringer Ingelheim Germany 16,959 1,977 2,163 43,000
13 Takeda Pharmaceutical Co. Japan 15,697 1,620 2,870 15,000
14 Bayer [36] Germany 15,407 3,770 6,448 108,600
15 Amgen United States 14,771 3,366 3,166 48,000
16 Genentech United States 13,400 15773 3,640 33,500
17 Baxter International United States 12,300 614 1,397 38,428
18 Teva Pharmaceutical Industries Israel 11,080 495 546 26,670
19 Astellas Pharma Japan 10,701 1,435 1,122 23,613
20 Daiichi Sankyo Japan 9,682 1,459 671 20,100
21 Novo Nordisk Denmark 9,081 1,063 1,922 26,575
22 Procter & Gamble United States 8,964 NA 10,340 29,258
23 Eisai Japan 5,583 926 604 14,993
24 Merck KGaA Germany 5,175 772 1,258 13,900
25 Alcon United States 4,897 512 1,348 13,500
26 SINOPHARM China 4,700 498 1249 9700
27 Akzo Nobel Netherlands 4,694 741 1,449 13,000
28 UCB Belgium 4,426 1,024 492 12,741
29 Nycomed Switzerland 4,264 NA -105 10,533
30 Forest Laboratories United States 3,442 941 454 9,649
31 Solvay Belgium 3,268 533 1,026 9,000
32 Genzyme United States 3,187 650 -17 8,477
33 Allergan United States 3,063 1,056 -127 8,423
34 Gilead Sciences United States 3,026 384 -1,190 6,772
35 CSL Australia 2,788 161 454 6,400
36 Chugai Pharmaceutical Co. Japan 2,787 467 328 5,962
37 Biogen Idec United States 2,683 718 218 5,907
38 Bausch & Lomb United States 2,292 197 15 5,830
39 Taiho Pharmaceutical Co. Japan 2,069 244 132 5,756
40 King Pharmaceuticals United States 1,989 254 289 5,191
41 Watson Pharmaceuticals United States 1,979 131 -445 5,126
42 Mitsubishi Pharma Japan 1,945 403 208 5,111
43 Shire United Kingdom 1,797 387 278 4,958
44 Cephalon United States 1,764 403 145 4,913
45 Dainippon Sumitomo Pharma Japan 1,763 350 193 3,750
46 Kyowa Hakko Japan 1,698 268 108 2,895
47 Shionogi Japan 1,640 320 159 2,868
48 Mylan Laboratories United States 1,612 104 217 2,800
49 H. Lundbeck Denmark 1,552 329 186 2,515

– David

Embryonic Stem-Cell Patents Infringe EU Law, Top Court Says

The European Union’s highest court said that stem-cell research involving human embryos can’t be patented, in a ruling that scientists called “devastating” for medical research.

Inventions based on the use of human embryonic stem cells for scientific research purposes can’t be patented, the European Court of Justice in Luxembourg said. The case was triggered when Greenpeace challenged a German patent awarded to Oliver Bruestle, a professor and specialist in stem-cell research.

“This is an unbelievable setback for bio-medical research in the area of stem cells,” Bruestle said in an interview after the ruling. The EU court “took an extreme position on restrictions in this area, which will have huge repercussions globally, especially in the competition with the U.S. and Asia, and in scientific research.”

Under an EU law from 1998, research methods that involve human embryos for industrial or commercial purposes can’t be patented. A German court handling the dispute at the center of yesterday’s case sought the EU tribunal’s view on how to interpret the phrase “for scientific research involving human embryos” and to clarify the term “human embryo.”

“A process which involves removal of a stem cell from a human embryo at the blastocyst stage, entailing the destruction of that embryo, cannot be patented,” the EU court said. The blastocyst stage is about five days after fertilization.

Greenpeace, which said it sued for “ethical reasons,” argued the patent for a stem-cell research process developed by Bruestle to treat neural diseases is invalid because it covers cells derived from human embryos. The Federal Court of Justice, Germany’s highest civil court, last year asked the EU tribunal for guidance on the case.

The court clarified that “only use” of human embryos “for therapeutic and diagnostic purposes which are applied to the human embryo and are useful to it” are patentable.

“One consequence is that the benefits of our research will be reaped in America and Asia,” said Austin Smith, a professor at the Wellcome Trust Centre for Stem Cell Research at the University of Cambridge.

The ruling might actually allow scientists a “sigh of relief,” said Julian Hitchcock, a lawyer and intellectual property specialist in the London office of law firm Field Fisher Waterhouse LLP.

Researchers “won’t have to worry about inadvertently infringing someone else’s patent,” Hitchcock said in a phone interview. “While the ruling restricts patentability of such inventions, it doesn’t in any way restrict the use of embryonic stem cells.”

While patent protection might not be available, European scientists can seek so-called data exclusivity, which protects documentation for as much as eight years and prevents the marketing of competing products based on the same data for up to 10 years, said Hitchcock.

The case is: C-34/10, Prof. Dr. Oliver Bruestle v. Greenpeace e.V.

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