Sharing Clinical Trial Data: CCI & Patent Concerns Benjamin Roin

Harvard Law School presentation before public workshop of the Committee on Strategies for Responsible Sharing of Clinical Trial Data, IOM, Feb. 4, 2014

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Disclosures • Hieken Assistant Professor of Patent Law, Harvard Law School • Co-Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics • Member, Committee on Confidential Commercial Information, Multi-Regional Clinical Trials Center at Harvard • Financial conflicts of interest: none 2

Confidential Commercial Information (“CCI”)

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Challenge

“Defining a trade secret is extremely difficult.” Pooley, Trade Secrets § 4.01, 2009

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EC Definition of CCI • “[I]nstitutions shall refuse access to a document where disclosure would undermine the protection of commercial interests of a natural or legal person, including intellectual property … unless there is an overriding public interest in disclosure” • Transparency Regulation (EC) 1049/2001, Art. 4(2)

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EMA Definition of CCI • “For the purpose of this guidance document, ‘commercial confidential information’ shall mean any information which is not in the public domain or publicly available and where disclosure may undermine the economic interest or competitive position of the owner of the information” – HMA/EMA Transparency Guideline (March 2012) 6

But • “In general, however, CT data cannot be considered CCI; the interests of public health outweigh considerations of CCI.” • a small number of CT data/documents can contain CCI. This applies to information such as details of the investigational medicinal product itself, some in vitro studies, or bioanalytical data characterising the product (points 2.7.1, 5.3.1 and 5.3.2 of Annex I). However, this information will only be deemed CCI in duly justified cases. – EMA Draft Policy 70 §4.111

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U.S. Definition of CCI • Section 2(a): “Confidential commercial information” means records provided to the government by a submitted that arguably contain material exempt from release under Exemption 4 of the Freedom of Information Act … because disclosure could reasonably be expected to cause substantial competitive harm.” – Section 2(a), Executive Order 126000, June 23, 1987 8

U.S. Definition of Trade Secrets • “A trade secret is any information that can be used in the operation of a business or other enterprise and that is sufficiently valuable and secret to afford an actual or potential economic advantage over others.” – Restatement (Third) of Unfair Competition §39

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Lessons • U.S. case law on protected CCI is highly factspecific • Preexisting legal standards for CCI and trade secrets are probably too vague for our purposes – unless we mimic the FOIA structure of case-bycase determinations and dispute resolution

• These are policy questions 10

Patent Concerns

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New Uses are Important “Drug rescue and repurposing … offers the key advantage of harnessing previous R&D efforts. … [D]etailed information is available on their pharmacology, formulation, dosing and potential toxicity. This can enable the rapid testing of new clinical hypothesis, leading to remarkable health outcomes.” F.S.Collins, Mining for Therapeutic Gold. 2011 12

Patent Concern 1: Hair-Trigger Novelty Bar • The PTO demands some preclinical evidence of efficacy to support a patent application – In re Brana, 51F. 3d 1560 (Fed.Cir.1995).

• Merely stating that drug A may be effective against condition B is usually enough anticipate a later patent on a method of using drug A to treat condition B

– e.g., Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs. – Same result for stating that drug A is ineffective against condition B • Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368 (Fed. Cir. 2001)

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Patent Concern 2: Inherent Anticipation • FDA approved finasteride (Proscar) in 1992 for benign prostatic hyperplasia (BPH) • later discovered that finasteride might have important chemopreventative effects – confirmed in Thompson et al. NEJM ‘03

• PTO denies patent on new cancer-prevention use – In re Gormley, No. 1997-2801 (B.P.A.I. Jan. 1, 2001)

• People already taking finasteride for BPH are inherently (albeit unknowingly) benefiting from the chemopreventative effects • the mere discovery of “a new benefit of an old process cannot make the process again patentable” 14

Underlying Patent Concern: Moving Up the Critical Date • If compound is reduced to practice & ready to be patented, clinical trials trigger the public-use bar

– In Re Omeprazole Patent Litigation, 536 F.3d 1361 (Fed. Cir. 2008)

• To invalidate the patent, defendant must prove “merely that ‘the disclosure [of the prior art] is sufficient to show that the natural result flowing from the operation as taught [in the prior art] would result in’ the claimed [invention].” – SmithKline Beecham, 403 F.3d 1331 (2005)

• Does the publication of clinical trial data make the time-of-treatment a critical date for the patentee? 15

Solution • Contractual restrictions on access to data that maintains confidentiality, and restricts disclosure/use of the data for patent litigation • Lengthening the existing period of market- or data-exclusivity for small molecules provided under Hatch-Waxman – The MODDERN Cures Act

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