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Janice Klunder and Sian Griffiths Legal Department, Millennium Pharmaceuticals, Inc.

A Beautiful Friendship

The information professional and the patent attorney/agent

4/24/2020 2

Patent and Drug Development Timelines FDA Approval Hatch-Waxman Extension US and International Applications Filed Patent Grant Patent Expiration Years 0 1 6 Development and FDA Review 11 US Provisional Application Filed 21 25

Maximum of 5 years extended term Maximum of 14 years of total patent term after NDA approval

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What is a Patent?

• A grant of a property right – Property boundaries determined by the

claims

of the patent • Right to States

exclude

others from making, using, offering for sale, or selling the invention in the United States or “importing” the invention to the United

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Patent Rights - Exclusionary Right

• A patent does

NOT

furnish the owner with the right to practice the claimed invention Company B

• Company B can exclude Company A from practicing the claimed invention

BUT

, if Company A has a dominating patent • Company A can prevent Company B from practicing the broader claims, including Company B’s own invention initials/name of pres 4/24/2020 5

Requirements for Patentability

• New (novel) • Nonobvious • Useful • Adequate Disclosure – Written description – Enablement – Best Mode

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Novelty- 35 U.S.C. § 102

• The invention must be new, and cannot be patented if: –

§102(a) - Before the applicant’s invention:

• The invention was published (by another) anywhere in the world;

• The invention was known or used by others in this country –

§102(b) - More than one year before applicant’s filing date:

• The invention was published by

anyone

anywhere in the world (1 year grace period for applicant’s publications);

• The invention was in public use or on sale in this country – e.g., manufacturing agreements for clinical trial materials

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Novelty- 35 U.S.C. § 102-Genus-Species Relationships

Example 1: Species anticipates a claim to a genus Prior art

Claim is invalid:

Prior art species anticipates the claimed genus Novel compounds Hypothetical Patent Claim: All compounds characterized by having

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Novelty- 35 U.S.C. § 102-Genus-Species Relationships

Example 2: Genus does not anticipate a claim to

an overlapping genus

Prior art patent claim

New claim is valid

: Prior art genus does not anticipate the claimed genus Prior art

Prior art patent does not disclose any specific compounds in the intersecting area

Novel compounds

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Obviousness- 35 U.S.C. § 103

• An invention cannot be patented if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious

at the time the invention was made

ordinary skill in the art to which said subject matter pertains to a person having – must be some suggestion or motivation to modify reference or to combine reference teachings – – must be a reasonable expectation of success; AND prior art reference(s) must teach or suggest all claim limitations

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Novelty- 35 U.S.C. § 102-Genus-Species Relationships

Example 2: Genus does not anticipate a claim to

an overlapping genus

Prior art patent claim

New claim is invalid

: Claimed genus is obvious in view of the prior art patent Prior art

Prior art patent suggests making the combination

Novel compound

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Triggers for Conducting a Search

Discovery and Development

• • Early stage landscape analysis – Overview of patentability and FTO issues – Competitor assessment • Patent drafting – Patentability analysis Development decision points – Freedom-to-operate analysis – Competitor assessment

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Triggers for Conducting a Search

Business Development

• Identification of business opportunities – Competitive intelligence • Due diligence – Patentability – Freedom-to-operate

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Patent Information Professional

Who are they?

• • • • Information professional/analyst supporting Intellectual Property/Legal group Specialized in patent information Technology driven - chemical structure, biological sequence, medical devices May require different tools and different knowledge 4/24/2020 14

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Patent Information Professional

Key skills required

• General information skills – Business and company data, literature searching techniques etc.

• Knowledge of patent databases – Full-text or indexed – Dates and countries of coverage

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Patent Information Professional

Key skills required cont.

• Specialized searching techniques and databases for different types of technology – Chemical structure or biological sequence • Data and Reporting – Use of tools for generation of reports – Access to full-text of patent documents

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Patent Information Professional

Key skills required cont.

• Understanding of patent law basics – Tailor searches appropriately – Provide “value-added” analysis • Patent data analysis – Manual – Using specialized software

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Examples

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Example 1

Early Stage Landscape Analysis

• Types of searches typically employed – Sequence searches on drug target – Structure searches on high-throughput screening hit families – Keyword based patent and literature searches – Competitor profiles

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Example 1

Early Stage Landscape Analysis

• Benefits to project team – May assist in the development of path forward for project team – Only one factor at early stage of project – Project should be science-driven unless significant obstacles are uncovered – Provide ongoing updates as project progresses

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Example 2

Patent Drafting – Patentability Analysis

• No obligation to conduct a search but a thorough search is essential to identify relevant prior art and to avoid novelty and obviousness issues • More focused searches – Patent literature – Scientific literature – Commercial compounds

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Example 2

Patent Drafting – Patentability Analysis

• Be aware of publication date vs date available in database • May monitor searches and update during patent application process • May do additional searches during patent prosecution in order to assist attorney in overcoming examiner’s rejections 4/24/2020 22

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Example 3

Development Decision Points

• Freedom-to-operate search and analyses – Searches on lead compound • Substructure, Markush, multiple sources – Searches on synthetic process route – Extensive keyword based patent searches across multiple databases – Often significant analyses of search results by attorneys required, information analyst assists

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Example 3

Development Decision Points

• Freedom-to-operate search considerations – What is the question being asked – Breadth and scope will depend on type of decision point – Approach from several different angles – May lead to large results sets initial reviews – consider displays for result sets that may expedite

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Example 3

Development Decision Points

• Competitor Assessment – Can be more commercial focused depending on decision point – Provide supplementary patent information as needed – May include analysis of key competitor(s) patent landscape 4/24/2020 25

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Tips and Tricks

Successful patent searching

• • • • • • Make the search process iterative Get input into strategies from other non-patent analysts and clients Have client sit with you when running searches Explain clearly the limitations and potential caveats of sources and searches Talk to clients about the best way for them to view/utilize your results Keep up-to-date with key changes in patent information eg. IPC8, database coverage

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Tips and Tricks

Keys to successful relationships with clients

• • • Mutually trusting relationship between patent attorney/agent and information professional is critical If information professional does not report into Legal, work hard to establish matrix team One information professional for several attorneys/agents – try to keep up with priorities to effectively manage everyone’s filing dates and deadlines

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Breakthrough science. Breakthrough medicine.

Slide 1

Transcript Slide 1

A Beautiful Friendship

What is a Patent?

Patent Rights - Exclusionary Right

Requirements for Patentability

Novelty- 35 U.S.C. § 102

Obviousness- 35 U.S.C. § 103

Triggers for Conducting a Search

Triggers for Conducting a Search

Patent Information Professional

Patent Information Professional

Patent Information Professional

Patent Information Professional

Examples

Example 1

Example 1

Example 2

Example 2

Example 3

Example 3

Example 3

Tips and Tricks

Tips and Tricks

Directory