The document discusses the importance of intellectual property (IP) in pharmaceutical development, particularly focusing on crystalline forms and related materials which can offer enhanced protections throughout the product lifecycle. It highlights the role of strong scientific data in securing patents for solid forms and outlines the IP services provided, including collaboration with patent attorneys and laboratory experiments. Additionally, the document introduces Almac as a provider of scientific services to the pharmaceutical industry with over 30 years of experience.

1. Crystals and IP Linda McCausland Head of Physical Sciences April 2011

2. Overview Some of the most important subject matters in Pharmaceutical IP are also the key solutions in pharmaceutical development. They are: Crystalline forms (polymorphs, hydrates and solvates) Salts Cocrystals Amorphous materials They form creative solutions to the challenges of pharmaceutical development, which is often fraught with failure. Rescuing the drug can in turn provide enhanced IP protection throughout the product lifecycle.

3. Issues or Advantages? Purity Yield Crystal size Solids handling Solubility Polymorphism Crystal shape Scale-up Solvates & Hydrates Isolation Dissolution

4. Protecting Invention Patents of solid forms, especially crystalline forms, are successfully protecting the market share of the innovators of current top selling pharmaceuticals. In order to protect invention in the pharmaceutical field, scientifically strong data are absolutely essential in making strong patents. We provide such scientific service to ensure your patents on solid forms become successful.

5. IP services Based on the screening studies on your compound (performed by yourselves, here at Almac or a 3rd party) we can provide the following services 1. Collaborate with your patent attorney to determine additional work needed (or recommend an experienced patent attorney for prosecuting solid form patents) 2. Perform prior art search

6. IP services continued… 3. Determine potential issues from prior art (that relates to your new invention) 4. Perform necessary laboratory experiments to overcome the prior art issues 5. Perform necessary laboratory experiments to provide good working examples and advantages for each solid form 6. Provide your patent attorney with a technical package to draft a patent application form

7. About us Almac has served global pharmaceutical industry for over 30 years in discovery, process development, manufacturing, formulation and clinical services. We can utilize over 300 highly skilled scientists who are organic chemists, solid state chemists, analysts, and formulation scientists, operating in state of the art facilities in the UK and the USA.

8. Experience Our expertise built from a large volume of diverse projects puts us in a unique position to provide expert witnessing services to pharmaceutical litigation cases, as a testifying or non-testifying witness. We provide services to both infringement and Paragraph IV cases.

9. Technical consultancy & support We provide technical expertise to assist in successful patent prosecution This service includes technical consultancy for IP and technical support for successful prosecution to overcome rejections and oppositions.