The IP Landscape for Combination Products

The IP Landscape for Combination Products MassMEDIC Seminar March 3, 2011 presented by Jason Honeyman Wolf, Greenfield & Sacks, P.C. 600 Atlantic Avenue Boston, Massachusetts 02210 617.646.8000 617.646.8646 fax wolfgreenfield.com

Optimizing the Path Through the Patent Office NO special department/office for combination products Art unit and classification system Examiners knowledgeable/academic training in focused field of art Art unit 1600 - Biotechnology and Organic Chemistry Class 424 Drug, Bio Affecting and Body Treating Composition Art unit 3700 - Mechanical Engineering, Manufacturing and Products Class 623 Prosthesis Class 606 Surgery/ Instruments Application assigned to single art unit 2011 Wolf, Greenfield & Sacks, P.C. All rights reserved. 2

Optimizing the Path Through the Patent Office (cont) Who do you want to have examine application directed to drug + device Patentability typically hinges on whether claimed invention would have been obvious over prior art Draft claims/advance arguments with Examiner s technical expertise in mind 2011 Wolf, Greenfield & Sacks, P.C. All rights reserved. 3

Optimizing the Path Through the Patent Office (cont) Tactical Steps: Voluntary identification of art unit at initial filing Draft claims with art unit in mind Compare: Mesh implant with adhesion resistant coating, and Adhesion resistant composition reinforced by mesh structure 2011 Wolf, Greenfield & Sacks, P.C. All rights reserved. 5

Patent Coverage Want to be in position to block/license direct and indirect competitors, so claims should cover: Final product (i.e., drug and device) Individual components Special interface/feature that enables combination or enhances functionality Method of use (maybe manufacturing too) Surgical methods patentable in U.S. but not in Europe, Japan or most other industrialized nations Broadly disclose and claim to cover other drugs/ biologics/devices beyond preferred embodiment 2011 Wolf, Greenfield & Sacks, P.C. All rights reserved. 6

Patent Coverage (cont) Evergreening Patent on device or combination of device/drug can extend effective proprietary protection for off-patent drug/ biologic 2011 Wolf, Greenfield & Sacks, P.C. All rights reserved. 7

Infringement Risks May Multiply Alert Simply having patent doesn t mean it s OK to commercialize patented technology May infringe other patents even though patentably distinct Example - unique release profile of drug eluting stent is patentable but may still infringe basic stent patent If any component of combination infringes patent, then combination product infringes Patent covering drug will be infringed by device + drug combination Use of combination may infringe method claim 2011 Wolf, Greenfield & Sacks, P.C. All rights reserved. 8

Infringement Risks May Multiply (cont) Selling component of patented combination product may infringe combination patent Inducing/ contributory infringement Infringement clearance should assess all potential threats Indemnity be wary of reliance Will indemnitor have resources/ stand behind obligation Read fine print! indemnity may be limited to particular component and not combination or method of use 2011 Wolf, Greenfield & Sacks, P.C. All rights reserved. 9

The Potential Trap of Joint IP Ownership Determination of inventorship is not discretionary (unlike article authorship) Equal level of contribution not required Joint inventor of merely one claim in patent becomes co-owner of patent Consider deleting/amending claims to address potential issue In U.S., co-owner of patent may unilaterally license patent No obligation to share royalties Can license to your direct competitors 2011 Wolf, Greenfield & Sacks, P.C. All rights reserved. 10

The Potential Trap of Joint IP Ownership (cont) Written agreement (MTA, NDA, JD, Dist, Jt Research) is critical, indicate: Ownership of joint inventions, and inventions in respective party s field, conceived during alliance Responsibility to file/prosecute patent applications Patent enforcement Whether any right to use joint inventions/ pre-existing technology after relationship terminates 2011 Wolf, Greenfield & Sacks, P.C. All rights reserved. 11

Patent Term Extension Regular patent term 20 yrs from filing Patent term adjustment due to PTO delay Hatch-Waxman patent term extension (max. 5 years) for time lost to clinical testing/ regulatory approval Applies to medical devices/combination products ACS Xience V EECSS drug eluting stent Stent + drug + polymer carrier + delivery system Yock patent on rapid exchange catheter Catheter sold for many years / prior approval First FDA approval for this particular combination product 2011 Wolf, Greenfield & Sacks, P.C. All rights reserved. 12

Patent Term Extension (cont) Yock patent previously enforced against Medtronics (2000) ACS obtained injunction against Medtronics selling rapid exchanged catheters until patent expiration of October 29, 2008 July 25, 2008 ACS files for patent term extension based on testing/regulatory approval of Xience PTO granted extension of almost 3 years (just on rapid exchange catheter patent) Ruling so long as patent covers any component of combination product subject to FDA review, patent eligible for extension 2011 Wolf, Greenfield & Sacks, P.C. All rights reserved. 13

Patent Term Extension (cont) Judge limits injunction to original patent expiration Acknowledges that Medtronics would be liable for patent infringement damages Settled Medtronics paid $400M to settle all suits 2011 Wolf, Greenfield & Sacks, P.C. All rights reserved. 14