The Role of Formulations in Biologics Patent Protection

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1 The Role of Formulations in Biologics Patent Protection Timothy J. Shea, Jr. Director Elizabeth Haanes - Director Sterne, Kessler, Goldstein & Fox P.L.L.C. IBC s 8 th Annual Conference on Formulation Strategies for Protein Therapeutics Anaheim, CA September 24, 2008

2 Introduction Introduction of the concept of patent life cycle management Insights from the pharma industry Key patentability issues in patent life cycle management The role of formulations in biologics patent protection Case Studies Erythropoietin Growth hormone 2

3 The Dilemma The cost to develop a drug or biologic and bring to market is hundreds of millions of $$$ Patent protection for the basic NCE or protein is generally sought very early in the R&D process Due to the extensive regulatory review period, significant patent term has been lost by the time the product goes to market 3

4 Patent Life-Cycle Management Strategic use of patents to maintain product exclusivity and revenue stream over life of blockbuster drug or biologic Involves obtaining additional patents that extend protection beyond the original patents covering the NCE or biologic per se 4

5 Insights from the Pharma Industry Patent life-cycle management is a familiar concept for big pharma Hatch-Waxman Act Recognizes regulatory delay Allows innovator to extend patent term of single patent up to 5 years BUT, provides for generic entry immediately upon expiration of patent coverage Generics often seek to market upon expiration of original patent to NCE 5

6 Insights from Pharma Industry Pharma companies have countered generics by increasing the breadth and complexity of the patent fence around their crown jewels traditional protection covered NCE, method of making, method of using (treating), and a pharmaceutical formulation Today, patents are typically also filed on: New indications Polymorphs Mechanisms of action Combination products/therapies Dosing regimens Dissolution/bio profiles NEW FORMULATIONS 0 very important Methods of stabilizing 6

7 Insights from Pharma Industry Novel formulations are extremely valuable to patent life cycle management Example: individual isomers are generally more potent than racemic mixtures Currently no formal legal/regulatory framework for approving generic but it s coming pending legislation stalled pending election, but demand for formal framework is great 7

8 Patentability Issues Term of a U.S. patent now extends 20 years from the earliest effective filing date Issue date is irrelevant To extend patent coverage on the drug or biologic, the second (improvement) patent must have a later filing date than the original patent to the product Thus, the original patent is often prior art to the later filed application 8

9 Patentability Issues To obtain an improvement patent, applicant must show claimed subject matter is novel, nonobvious, etc. over earlier patent to drug or biologic per se Generally not difficult to show novelty But must be careful regarding inherent anticipation Focus is generally on obviousness KSR Int l Co. v. Teleflex Inc., 550 U.S. (2007) Supreme Court clarified obviousness Now easier for USPTO to establish prima facie case of obviousness and shift burden to applicant to prove otherwise 9

10 Patentability Issues KSR v. Teleflex Improvement must be more than predictable use of prior art elements Not limited to references dealing with precise problem addressed Any need or problem known in the field and addressed by patent can provide reason for combining elements Obvious to try could be enough in some instances 10

11 Patentability Issues In response to KSR case, USPTO established training guidelines for examiners Identified acceptable rationales to support prima facie case of obviousness: A. Combining prior art elements according to known methods to yield predictable results 11

12 Patentability Issues USPTO Rationales for Obviousness B. Simple substitution of one known, equivalent element for another to obtain predictable results E.g. one known excipient for another? C. Use of known technique to improve similar products in the same way Application of technique to similar product must be within ordinary skill in art D. Applying a known technique to a known product ready for improvement to yield predictable results E.g. lyophilization? E. Obvious to try choosing from a finite number of predictable solutions 12

13 Patentability Issues Rebutting Obviousness Rejections Submit technical evidence showing that subject matter claimed in later (improvement) patent could not have been predicted to work Show that claimed subject matter (e.g. new formulation) has unexpected advantages (e.g., increased efficacy, stability, etc.) Clinical studies provide good opportunities for patenting improvements, since in vivo effect are difficult to predict 13

14 The Role of Formulations in Biologics Patent Protection Although no formal legal/regulatory framework for approving generic biologics exists, biologic innovators are already applying patent life cycle management strategies to extend patent protection on blockbuster biologics As in the pharma industry, formulation patents are essential components of a patent life cycle management strategy for biologics 14

15 Case Study I Erythropoietin (Amgen) U.S. Pat. No. 4,703,008 Effective filing date 12/13/83 (but 17-year term from grant since pre-gatt) Claim 2: A purified and isolated DNA sequence consisting essentially of a DNA sequence encoding human erythropoietin. U.S. Pat. No. 5,547,933 Effective filing date = 12/13/83 (17 year term) Claim 3. A non-naturally occurring erythropoietin glycoprotein product... having glycosylation which differs from that of human urinary erythropoietin. 15

16 Case Study I: Erythropoietin (Amgen) U.S. Pat. No. 5,597,562 Effective filing date = 6/3/91 (17-year term) Claim 1: An oral dosage form comprising the components: (a) GCSF or erythropoietin; (b) Surfactant(s) (c) Fatty acid(s); and (d) Enteric material, wherein said components (a), (b) and (c) are mixed in liquid phase and lyophilized prior to combination with component (d). 16

17 Case Study I: Erythropoietin (Amgen) U.S. Pat. No. 5,856,298 Effective filing date = 10/13/89 (17-year term) Claim 1: An isolated biologically active erythropoietin isoform having a single isoelectric point and having a specific number of sialic acids per molecule, said number selected from the group consisting of

18 Case Study I: Erythropoietin (Amgen) U.S. Pat. No. 7,217,689 Effective filing date = 10/13/89 (17 year term) Claim 1: An analog of human erythropoietin... comprising an amino acid sequence which differs from the amino acid sequence of human erythropoietin... by having one or more additional glycosylation site(s) as compared to human erythropoietin. 18

19 Case Study I: Erythropoietin (Amgen) U.S. Pat. No. 5,661,125 Effective filing date = 08/06/92 (almost 9 years after first patent) (17-year term) Claim 1: A stable pharmaceutical composition comprising a solution of a therapeutically effective amount of erythropoietin and a preservative selected from the group consisting of benzyl alcohol, a paraben and phenol or a mixture thereof. 19

20 Case Study I: Erythropoietin (Amgen) U.S. Pat. Pub. No. 2006/ Effective filing date = 4/7/00 If issues will expire 4/7/2020 Claim 1: A pharmaceutical composition comprising: (a) A substantially homogenous preparation of mono- PEGylated NESP, said mono-pegylated NESP consisting of a polyethylene glycol moiety connected to a NESP moiety solely at the N- terminus thereof; (b) Fewer than 5% non-pegylated NESP molecules; and (c) A pharmaceutically acceptable diluent, adjuvant or carrier. (NESP is a hyperglycosylated EPO analog having five changes in the amino acid sequence of rhuepo which provide for two additional carbohydrate chains) 20

21 Case Study II: Growth Hormone (Novo) U.S. Pat. No. 5,633,352 Effective filing date = 12/9/83 (17-year term) Claim 1: Biosynthetic ripe human growth hormone from pituitary derived human growth hormone. U.S. Pat. No. 5,547,696 Effective filing date = 10/13/94 (17-year term) Claim 1: A pharmaceutical formulation comprising a growth hormone in the amount of about 0.1 mg/ml to about 40 mg/ml and valine at a concentration up to about 100 mm. 21

22 Case Study II: Growth Hormone (Novo) U.S. Pat. No. 5,552,385 Effective filing date = 6/5/95 Claim 1: A pharmaceutical formulation comprising a growth hormone and Lys- Gly-Asp-Ser (SEQ ID No: 1). U.S. Pat. No. 6,117,984 Effective filing date = 7/12/91 Claim 1: Divalent cation crystals of human growth hormone (hgh) or derivatives thereof. 22

23 Case Study II: Growth Hormone (Novo) U.S. Pat. No. 5,849,704 Effective filing date = 12/16/92 Claim 1: A pharmaceutical composition in the form of a lyophilized powder comprising a growth hormone or a derivative thereof and histidine or histidine derivative.... U.S. Pat. No. 6,022,858 Effective filing date = 1/28/92 Claim 1: A pharmaceutical formulation comprising a human growth hormone pretreated with zinc salt for at least one hour before addition of other components to the formulation and optionally containing lysine or calcium ion. 23

24 Case Study II: Growth Hormone (Novo) U.S. Pat. No. 6,566,329 Effective filing date = 06/28/99 Claim 1: A method for preparing a soluble freezedried solid preparation of hgh.... U.S. Pat. Pub. No. 2006/ Effective filing date = 10/8/04 If issues, patent will expire in 2024 Claim 1: A sustained release formulation comprising a protein modified so as to provide a reduced clearance, wherein said protein does not comprise a methionine in which the side chain sulphur has been modified. Claim 2: The formulation according to claim 1, wherein said protein is a growth hormone compound. 24

25 Conclusions Patent life-cycle management is the strategic use of patents to maintain product exclusivity and revenue stream over the life of a commercially valuable drug or biologic Successful companies will have fully integrated patent life-cycle and product life cycle programs Companies should consider strategic patenting both before and after marketing approval Formulation patents are particularly effective at extending exclusivity Effective patent life-cycle management requires careful attention to the timing of filings and the content of the application 25

26 The Role of Formulations in Biologics Patent Protection Thank You Timothy J. Shea, Jr. Elizabeth Haanes Sterne, Kessler, Goldstein & Fox, P.L.L.C. (202)

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