Developing an International IP Strategy that Includes Biotherapeutic Technologies Jerry L. Hefner SABPA 7th Annual Pacific Forum November 12, 2011

Developing an International IP Strategy that Includes Biotherapeutic

Technologies

Developing an International IP Strategy that Includes Biotherapeutic

Technologies

Jerry L. HefnerSABPA 7th Annual Pacific Forum

November 12, 2011

Jerry L. HefnerSABPA 7th Annual Pacific Forum

November 12, 2011

© 2011 Knobbe Martens Olson & Bear LLP2 © 2011 Knobbe Martens Olson & Bear LLP2

What is a Biotherapeutic A therapeutic molecule that is a biological product as set

forth under 42 USC § 262(i)(1) –

• “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide) or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings”

• Hormones such as insulin, glucagon, and human growth hormone are currently treated as drugs and regulated under the FDCA


Protecting a Biotherapeutic with IP Areas of special consideration

• Nature of the subject matter – what type of biological material will be subject of regulatory approval

• International filing strategy and potential subject matter exclusions

• When should I file my application

• What kind of claim scope can I obtain

• What types of claims are most useful


Protecting a Biotherapeutic with IP Areas of special consideration

• How to deal with follow on biologics (FOBs)

• How to maximize patent term

• Contemplate 2nd and 3rd generation products

© 2011 Knobbe Martens Olson & Bear LLP5

Nature of the Subject Matter

What is it that you intend to protect?

Peptide

Antibody

Cell

Tissue/Organ

Virus/VLP

Complex biological mixture

It matters!


Is it Off Limits

Subject Matter Exclusions in Major Jurisdictions

Cells of plants and animals – India

Human ES derived inventions – EU, China

Higher life forms – Canada

Methods involving surgery, treatment or diagnostics – EU, Canada, China, JP


When Should I File

As soon as you have enabled the technology

First to file is the standard worldwide

Reality in United States on March 16, 2013

File a United States provisional patent application

Provides for priority but does not count against your term

Continue to supplement provisional application with additional working embodiments for up to one year


What Can I Protect/How Much Can I Get One important object is to cover biosimilars and

interchangeables

Should I start narrow or should I start broad Depends on jurisdiction and how much data you

have

Because most jurisdictions allow continuing applications it can be useful to start narrow You may be able to capture biosimilars and

interchangeables under the doctrine of equivalents - but not if you start broad and make narrowing amendments


What Can I Protect/How Much Can I Get Other reasons to start narrow

Most jurisdictions give very little scope beyond what has been demonstrated by working examples

Several working examples may support a genus claim – especially if you identify a common structural motif that links variants together

Reasons to start broad Broad claims attract investors Broad claims can be scary for competitors Double patenting issues – e.g. Canada


What are the Most Useful Claim Types

Composition of matter

Cover approved product

Cover approved product and related variants

Prohibits making, selling, using, offering to sell and importing in most jurisdictions

Methods of Use

Good but usually third party infringement action

Watch out for two party infringement issues


What are the Most Useful Claim Types

Methods of Making

Can be difficult to prove infringement unless jurisdiction offers discovery or seizure procedure

Dealing with FOBs

Claims related to systems/devices

Can protect ultimate dosage form or delivery device

For example – Amgen v. F. Hoffman-La Roche

Amgen claims – “[a] pharmaceutical composition comprising a therapeutically effective amount of human erythropoeitin and a pharmaceutically acceptable diluent, adjuvant or carrier, wherein said erythropoietin is purified from mammalian cells grown in culture.”


Dealing with FOBs

Roche’s MICERA molecule is the same sequence but has different post-translational modifications

MICERA found to literally infringe Amgen’s claim – 580 F.3d 1340 Fed. Cir. 2009

Consider related methods

Consider obtaining IP to methods of characterizing the product

Even better – consider IP to monitoring the effect of the biotherapeutic agent


Dealing with FOBs

Consider label claims

Exemplary claim to “a method of making a biotherapeutic drug product” –

providing the biotherapeutic molecule; and

instructing a patient to fast for at least 12 hours before administering the molecule to the patient

Regulatory requirements may cause the biosimilar or interchangeable to literally infringe the claim


Dealing with FOBs

Consider keeping certain manufacturing and/or process-related details trade secret

America Invents Act – still maintains the best mode requirement but no real consequences for violating it


Maximize Patent Term in United States

Take advantage of Patent Term Adjustment (PTA)

Maximize PTA for each patent application that is filed

Be cautious of terminal disclaimers

Carefully select single best patent for Patent Term Extension (PTE)

File within 60 of first approval of biotherapeutic

The MDCO case and AIA


Consider Second Generation Products

Make FOB obsolete

Modified dosage form

Delayed release

Longer circulation time

Targeted biologic

Increase specificity for target area

Combine with device

Can provide for a second PTE


Build Value

Without a sound IP portfolio, the exits are limited

Develop a sound IP strategy from the beginning and increase the likelihood that you will see return on your investment


kmob.comkmob.com

Orange County, CASan Diego, CARiverside, CA

Los Angeles, CASan Francisco, CAWashington, D.C.

Seattle, WA

Orange County, CASan Diego, CARiverside, CA

Los Angeles, CASan Francisco, CAWashington, D.C.

Seattle, WA

Jerry L. [email protected]

Jerry L. [email protected]

Documents

Developing an International IP Strategy that Includes Biotherapeutic Technologies Jerry L. Hefner SABPA 7th Annual Pacific Forum November 12, 2011