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Life Science IP

Recent Cases and Implications for

Industry

Claire Laporte January 31, 2014

© 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?


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


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.


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


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)


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


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.”


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


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


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!


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

Life Science IP

Recent Cases and Implications for

Industry

Claire Laporte January 31, 2014