Patent InnovationChristine Chen

9/15/2008

In general, patents must be: Novel (not known previously) genetic

sequences Non-obvious (not just a simple

improvement) Have a useful purpose so that someone

in the field can use it by that stated way State the sequence’s product Specify how the product is used in nature

Completion of Human Genome Project in 2003◦ After completion, much of the federal government

research transferred to the private sector.◦ Since then, US Patent and Trademark Office has

issued a few patents for gene fragments.◦ ESTs are expressed sequence tags, making up 10-

30% of cDNA, which are laboratory-made genes of the exon region (the expressed part of the mRNA)

◦ ESTs allow researchers to directly study important biological regions

DNA is not patentable in its raw form. Only when DNA is isolated, purified, or

modified is it patentable. When a biotech patent is given, new

invention is deposited in 1 of 26 worldwide culture depositories

3-million genome-related patents have been filed

Sequences found in public databases may have been patented by private sector. Users could face injunction.

Some say patenting an EST find is of less importance than isolating the gene product, discovering its purpose, and making a commercial product

Allowing multiple parts on the same genome sequence makes it so that researchers who want to look at that sequence have to pay the patent holder to look at the sequence, which critics feel is unfair

Invitrogen has mainly been the plaintiff in biotech patent infringement cases

Invitrogen is a $26 billion research tool industry- focus on genomics, cell biology, bioinformatics

Agilent is a tech leader in communications, electronics, life sciences and chemical analysis

Case:◦ June 2000: Invitrogen sued Strategene, which was

purchased by Agilent in 2007, for infringing on 3 of Invitrogen's patents

◦ Invitrogen filed these patents between 1993-2000◦ All 3 patents have to do with a gene which encodes reverse

transcriptase (RT) having DNA polymerase activity and substantially no RNase H activity, which is undesirable

Reverse Transcriptase

Reverse transcriptase contains at least two enzymatic activities, DNA polymerase and RNase H, that are on 1 polypeptide.

RT DNA polymerase activity is responsible for transcribing RNA into double-stranded DNA

function of RNase H in replication is less clear, but it is thought to degrade genomic RNA during DNA synthesis

Continuations: extend the patent of an applicant’s patent info previously disclosed in parent patent

#3 -> continuation of #11. #5,244,797 (issued 1993) - polypeptide having DNA polymerase activity

and substantially no RNase H activity2. #5,405,776 (issued 1995) - isolated DNA encoding a polypeptide

having DNA polymerase activity and substantially no RNase H activity3. #6,063,608 (issued 2000) - isolated polypeptide having DNA

polymerase activity and substantially reduced RNase H activity RT is used extensively in recombinant DNA technology to

synthesize cDNA from mRNA. One major problem with cDNA synthesis is that the RNase H activity of RT degrades the mRNA template during first-strand synthesis.

The invention is related to the discovery that portions of the RT gene can be deleted to give a deletion mutant having DNA polymerase activity but no detectable RNase H activity. This purified mutant RT lacking RNase H activity can be used to effectively synthesize cDNA from mRNA.

In February 2008, Invitrogen and Agilent settled patent infringement where Agilent agreed an undisclosed payment to Invitrogen. In return, Agilent had to stop sale of its RNase H minus reverse transcriptase products.

In a settlement of a separate case in November 2001 where Agilent sued Invitrogen for infringing on their patent, Invitrogen had to take out a license from Agilent for its DNA polymerase blend products and pay undisclosed royalty fees.

"The patent system, as it presently operates, provides the incentive necessary to fuel the development of innovative and beneficial research tools by granting an inventor the exclusive right to control the use of his invention for a limited time.”

-Invitrogen representative------------------------------------------- Law of intellectual property rests on an

assumption that, without exclusive rights, no one will be willing to invest in research and development.

-Human Genome Project site

http://www.ornl.gov/sci/techresources/Human_Genome/home.shtml http://www.ornl.gov/sci/techresources/Human_Genome/elsi/patents.shtml http://www.labtechnologist.com/Industry-Drivers/Invitrogen-sues-GE-Healthcare-over-patent-infringement http://en.wikipedia.org/wiki/Continuing_patent_application http://tiger.gatech.edu/files/gt_tiger_patent.pdf http://www.genengnews.com/news/bnitem.aspx?name=29953532 http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FP

TO%2Fsrchnum.htm&r=1&f=G&l=50&s1=6,610,522.PN.&OS=PN/6,610,522&RS=PN/6,610,522 http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO

%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=5244797.PN.&OS=PN/5244797&RS=PN/5244797

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=5,405,776.PN.&OS=PN/5,405,776&RS=PN/5,405,776

http://www.signonsandiego.com/uniontrib/20080206/news_1b6invitro.html http://www.patentdocs.net/patent_docs/2008/02/invitrogen-and.html

THANKS FOR LISTENING! ANY QUESTIONS?