commercialization and patent infringement

Commercialization and Patent Infringement

Terry K. Tullis, JD, MBA

May 4, 2013

SABPA 8th Annual Biomedical Forum

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1. What is a patent?

2. Why do you need patents to commercialize your product?

3. FDA related patent issues

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• Public invention disclosure in exchange for an exclusivity period

• An issued patent gives the owner the right to stop others from:

– making

– using

– selling

– offering to sell

– importing

the patented invention in that country.

• But - an issued Patent does not necessarily give the patent owner the right to make, use or sell the invention


Example patent claim

• Claim 1: A drug composition, comprising:

– Agent A;

– Agent B;

– Agent C; and

– Agent D (your improvement).

• Competitor can sue you if they own any of A, B, or C.

• You can sue if Competitor makes, uses, sells, offers to sell, or imports all of A+B+C, and D.


Requirements to get a Patent

• No requirement to develop any product or prototype

• Full disclosure of invention

– Enable ordinary person in the field to make the invention

– Describe the “best mode” of making the invention

• The invention - as claimed - must be

– Novel

– Not Obvious over “Prior Art”


What is Prior Art? (simplified)

• Prior publication, knowledge or use of the invention by others

• Any patent or article published more than one year before the filing date of the application

• Any public use or offer to sell the invention in the U.S. more than one year before the filing date of the application


Steps To Get a Patent

• Prior Art Search

• Prepare patent application – carefully craft claims

• File Patent Application with Patent Office

• Patent Application Publishes (18 mos. after filing)

• Examination

• Argue with Examiner

• Appeal (if necessary)

• Gain Allowance, Pay Issue Fee

• Patent Granted

• Pay Maintenance Fees

REPEAT


International Patent Protection

• No “world-wide” patent

• File within one year of U.S. Priority date

• Expensive to file and prosecute

• Priority must be before any public disclosure


PCT (International) Patent Application

• Prepare and file single application, with claims

• Secures option to pursue patent protection in all PCT member countries (over 100), including U.S. and China (but not Taiwan)

• Can hold national phase prosecution for up to 30 months

• Obtain non-binding preliminary examination

• Can be filed instead of a U.S. Patent Application or within 1 year of U.S. filing date.

• Cost: about $5000 – 8000 in filing fees


Patent Protection in China (and elsewhere)

• Use foreign patents as a tool to enter foreign markets

• Seek patent protection where products are made, used or sold

• Patents must be filed before public disclosure

• Costs can be high

• Medical methods are not patentable outside of the U.S. and Australia

• Consider enforcement challenges



• Patents protect your investment

– Protect your market and secure financing

• 94% of venture-backed start-ups own patent or application (average 25 patents & applications)

• Branded drugs: Millions in revenue for each day of exclusivity

– Defensive purposes

– Leverage in deals

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Seek Patents That Block Competitive Alternatives

Commercial Product

Patent Relevant Scope Market


Survey competitive patent landscape

• Look for freedom to operate or patent clearance obstacles early on to avoid pitfalls

– Assess patentability

– Assess risk (“freedom to operate”)

– Identify competitors and their patent claims, and potential design around

– Work with your patent counsel to understand the patent roadblocks to commercialization

• Delay can be a costly mistake!

It’s not just about what you have, it’s about what they have


4. Coordinating Patents with Regulatory Issues

• ANDA Generic Drug litigation

• Safe Harbor 271(e) exceptions to infringement for clinical trials

• Biologics Price Competition and Innovation Act

• Patent Term Extension to Coordinate with FDA Approval

• Consistency with 510k submissions


Generic Drug Litigation and Exclusivity

• Clinical Trials: Investigational New Drug application (IND)

• Market “branded” drugs: New Drug Application (NDA) approvals, patents listed in the Orange Book

• Generics: Abbreviated New Drug Application (ANDA)

– Hatch-Waxman Act and patents: the first drug manufacturer to

• successfully challenge FDA-listed patent and market an approved generic, or

• prevail in litigation establishing the patent is invalid or not infringed

is rewarded with 180 days of generic marketing exclusivity


Allergan, Inc. v. Sandoz Inc. (Fed. Cir. May 2, 2013)

• Appeal court finds 3 of 4 patents for COMBIGAN ophthalmic glaucoma drug treatment are “nonobvious”

• Generic drug waits until last patent expires in 2022


Safe Harbor 271(e): generic drug experiments

• Exceptions to infringement for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.

– Experimenting for generic FDA approval

– Dissemination of data developed for FDA approval

– Use of patented compounds in preclinical studies that were not included in FDA submission

• Once generic ANDA is filed, action is considered “infringement”


Biosimilars – approval short cut for biologics

Abbreviated approval for ‘biological products’ that are highly similar (i.e., biosimilar) to or interchangeable with an FDA-licensed reference biological product.

– Biological products therapies used to treat health conditions e.g., vaccines, blood and blood components, gene therapies, tissues, and proteins (except any chemically synthesized polypeptide).

• Generally are made from human and/or animal materials rather than chemical process.

• Cell lines not identical: only similar.

– A biosimilar

• Highly similar to an approved biological product

• No clinically meaningful differences in terms of the safety, purity, and potency.


Biologics – examples

Figure shared under Creative Commons license from Pharmaceuticals 2012, 5(12), 1393-1408; doi:10.3390/ph5121393 http://www.mdpi.com/1424-8247/5/12/1393

//upload.wikimedia.org/wikipedia/commons/4/4c/BiologicsPatentCliff2011.pdf


• Biosimilar approval application may not be submitted until four years after the date the reference product was first FDA licensed

• The filing of a biosimilar application constitutes an artificial act of patent infringement that confers jurisdiction on the federal courts.

Biosimilar Basics

Hatch-Waxman Biosimilars

Exclusivity First-filer has the

potential to have 180 days

exclusivity

Up to 42 months exclusivity but

only if biosimilar is determined

to be interchangeable

Determining

Patent Coverage

for Reference

Product

Orange Book No Orange Book equivalent

Statutorily required pre-

litigation exchange of patent

information

Stay of FDA

Approval

Automatic 30-month stay

before generic can enter

market absent a court

decision

No automatic stay, however, the

biosimilar application cannot

be approved until 12 years after

first licensure of the reference

product


Patent Term Extension

• Hatch Waxman Act (1984): PTE to compensate for potential delays in FDA approval, available only for:

– new drug, antibiotic drug, or human biological product

– new animal drug, veterinary biological product

– new medical device Class 3 pre-market approval (PMA) (not Class 1 or 2 abbreviated 510k)

• Get up to 5 more years patent term based on FDA approval timing (must file within 60 days)


Patent Term Extension examples

• http://www.uspto.gov/patents/resources/terms/index.jsp

http://www.uspto.gov/patents/resources/terms/index.jsp


Statements about Predicate Devices

• Consider implications of declaring similarity to predicate devices

• Patentability

• Infringement

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Conclusion: Patent Pitfalls

1. Failing to appreciate the value of IP to your business

2. Misunderstanding the rights conferred by a patent

3. Ignoring your competition

4. Protecting a product instead of a market space

5. Ignoring overlap and interactions with regulatory agencies

Thank you. [email protected]

(949) 760-0404

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