research & development

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“No molecule is too difficult when you have the R&D know-how.”

“Strong patent intelligence precedes outstanding success.”

Research & Development Patent Strategies  |  Success Stories

Start Strong with our Visionary Patent Strategies and Topnotch Research & Development Capabilities

IP Advantage | Patent Intelligence | Non-infringing Formulations | Niche Molecules | Difficult Molecules

Maximise your market dominance from Day One.

With Generic Partners, a strong start heralds a strong finish:

  • Thorough IP checks on patent expiry for non-infringement strategies with legal recourse where appropriate
  • Leverage the extensive skills and experience of our patent and R&D experts
  • Reduce risks and costs on the road to success by forming strong inlicencing partnerships
  • Overcome formulation challenges posed by difficult or niche molecules

Research and Development 

“For topnotch results, we provide R&D leadership and collaborate with the best laboratories in their respective fields.”

Dr Tony Whittaker, General Manager R&D

What we do

We confidently handle niche molecules and difficult molecules in ways many others cannot. We produce commercially feasible, stable, non-infringing bio-equivalents of the most popular formulations in demand.

  • Provide vision and leadership through internal R&D team
  • Seek and cultivate relationships with laboratories who perform the best R&D in various fields
  • Collaborate only with experienced, internationally licensed Contract Research Companies (CROs) certified by national regulatory bodies (e.g.  TGA, FDA, EU, ANVISA)
  • Pick the best companies to conduct clinical trials, bio-analysis and bio-equivalence studies, essential similarity studies, phosphate studies and so on for regulatory approval

Non-infringing Patent Strategies

“Our patent strategies are thorough and complete; we deal with patent issues from inception all the way through to product release and after.”

Dr Anjali Singh, Patent Analyst

What we do

We develop non-infringing strategies for ready-to-market pharmaceutical products.

  • Review patent intelligence, identify patent-expiring molecules and provide non-infringing strategies
  • Resolve patent challenges for APIs, pharmaceutical formulations, method of treatment, use, packaging, polymorphic forms, particle size, and other intricate aspects of intellectual property rights
  • Strategise for post-market IP contests, if any

Success Stories

No molecule too difficult: Success at last in producing robust dual-release formulation

(Research & Development)

CHALLENGE - Client came to us because they had not been able to produce a stable form of a generic formulation that features both immediate release and controlled release characteristics in a single formulation.

SOLUTION - Generic Partners utilised our strong rapport with a specific laboratory with the unique and sought-after capabilities required to develop a stable formulation for the proposed shelf life.

OUTCOME - Product has progressed smoothly from R&D to regulatory approval and Generic Partners has lined up a trustworthy and cost-effective manufacturer for immediate commercial production as soon as regulatory approval is obtained.

Eye on United States' 180-day global marketing exclusivity for 2015 expansion

(Patent Advisory, New Market)

CHALLENGE - In the United States—the most demanding generic pharmaceutical marketplace in the world—the hardest regulatory challenge is to obtain First to File Paragraph IV approval. This provides the company with a billion dollar opportunity to exploit exclusive marketing rights in the US for 180 days.

SOLUTION - Generic Partners has systematically honed its R&D, IP, manufacturing and marketing capabilities in several other markets worldwide anticipating expansion into the US.

OUTCOME - Our company is on track to enter the US market in 2015 and any partners who collaborate with us shall find our business partnership highly rewarding.

Smart patent strategy drives successful first entry into new Australian market

(Patent Strategy, New Market Entry)

CHALLENGE - Our client is licenced to market a certain dossier of products in South Africa and required expert advice to obtain regulatory approval to enter the lucrative Australian market.

SOLUTION - Generic Partners’ global R&D and regulatory teams worked with top intellectual property advisory consultants in Australia to propose a strong market entry strategy.

OUTCOME - Due to the depth of expertise and experience provided by our multidisciplinary panel of patent, R&D, regulatory and manufacturing resources, we succeeded in gaining regulatory approval in record time.

Court rules in client's favour on alleged patent infringement case

(Legal Strategy, Intellectual Property)

CHALLENGE - Our client is sued by a company for allegedly infringing on their patent for a pharmaceutical product.

SOLUTION - Our team draws upon  our in-depth knowledge and experience in intellectual property, legal, R&D and regulatory arenas to come up with a sound defence.

OUTCOME - The barrister argues a strong case in court and saves our client’s reputation and substantial investment in product development.

 

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icons.png Research & Development Manufacturing Regulatory Outlicence & Supply