Claire Laporte, "Recent Cases and Implications for Industry"
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Transcript of Claire Laporte, "Recent Cases and Implications for Industry"
© 2008 Foley Hoag LLP. All Rights Reserved. Presentation Title | 2 2
The Battleground: Patents Background What does a patent do? How does it do that? How important are patents in the life sciences?
© 2008 Foley Hoag LLP. All Rights Reserved. Presentation Title | 3 3
1. What Can Be Patented?
Myriad Genetics enforces patents on BRCA genes The defense counterattack: 35
U.S.C. § 101 Backdrop: diagnostics take a hit in
Prometheus (2012) (“[O]ne must do more than simply state [a] law of nature while adding the words ‘apply it.’”) Challenged claims involved
“determining” a level of a drug in the bloodstream such that certain levels indicated a need to increase or decrease dose
© 2008 Foley Hoag LLP. All Rights Reserved. Presentation Title | 4 4
1. What Can Be Patented? Myriad: the next step against
patents perceived to limit progress in life sciences
Question presented: “Are human genes patentable?”
Answer: mostly, yes.
© 2008 Foley Hoag LLP. All Rights Reserved. Presentation Title | 5 5
Myriad Fallout
Full-length genes with intronic sequences not patent-eligible Bacterial genes not patentable anymore cDNAs patent-eligible “Method/process” claims not affected Myriad sues its competitors for
infringement of surviving claims
© 2008 Foley Hoag LLP. All Rights Reserved. Presentation Title | 6 6
Myriad Fallout
Biologics mostly unaffected Diagnostics – mostly unaffected by
Myriad but in trouble from Prometheus Future debates: Protein products Isolated cell cultures of pluripotent human embryonic stem cells (WARF case)
© 2008 Foley Hoag LLP. All Rights Reserved. Presentation Title | 7 7
2. Can Method Patents Be Enforced?
Patent claims may cover a Machine Composition of matter Process Process claims in life sciences Diagnostics Treatment methods Surgical methods Hesitancy to sue customers & patients Suits are for inducing infringement under
35 U.S.C. § 271(b) Global Tech and Commil: enforcement of
process claims gets tougher
© 2008 Foley Hoag LLP. All Rights Reserved. Presentation Title | 8 8
Global Tech and Commil Global Tech: Inducer must “know” that the “induced acts constitute patent infringement.” Constructive “knowledge”: Deliberate indifference not enough But willful blindness will do
But Commil: A “good-faith belief of invalidity may negate the requisite intent for induced infringement.”
© 2008 Foley Hoag LLP. All Rights Reserved. Presentation Title | 9 9
GT and Commil Fallout Hurdles to enforcing process claims: Demonstrate direct infringement Demonstrate causal inducement Demonstrate knowledge that induced acts are infringing Demonstrate absence of good faith belief in Non-infringement Invalidity
For “composition” claims, only first demonstration is necessary Significant new burdens to enforce
key life sciences patents
© 2008 Foley Hoag LLP. All Rights Reserved. Presentation Title | 10 10
3. Can a Patent Case Be Settled? War between drug innovators and generics Public debate over patent-protected drug
profits Hatch-Waxman Act procedure for generics
to challenge drug patents “Reverse payment” settlements: pay-for-
delay FTC goes to battle for per se rule Circuits split, mostly not agreeing Supreme Court in Actavis: settlement may
be a restraint of trade – subject to rule of reason analysis
© 2008 Foley Hoag LLP. All Rights Reserved. Presentation Title | 11 11
Actavis Fallout
Settlements that fall within the time-scope of the patent may still be illegal Possibility for opportunistic antitrust litigation Unclear if the problem is limited to reverse
payments The sport of kings gets sportier!
© 2008 Foley Hoag LLP. All Rights Reserved. Presentation Title | 12 12
Conclusions
Pendulum is swinging away from patents Many “discoveries” cannot be patented Process claims are diminishing in value Litigation is more expensive than ever – and harder to settle