Bromberg & Sunstein LLP STRATEGIC APPROACHES FOR PROTECTING PHARMACEUTICAL INNOVATIONS IN THE CHANGING US PATENT ENVIRONMENT Bruce D. Sunstein Barbara J. Carter, Ph.D. Bromberg & Sunstein LLP Boston www.bromsun.com © 2008 Bromberg & Sunstein LLP

KSR v. Teleflex: new rules for non-obviousness (inventive step) KSR Intern. Co. v. Teleflex Inc., 127 S. Ct. 1727 (April 30, 2007) Why it matters to Biopharma Issued patents are now more readily attacked. Patents applied for may be harder to get. Evaluating or managing a patent portfolio requires new approaches.

Dealing with KSR v. Teleflex How to determine whether a patentable invention is present How the rules governing obviousness have developed KSR v. Teleflex What KSR v. Teleflex held in a nutshell Who are the losers and winners under KSR v. Teleflex? New rationale for obviousness Obviousness since KSR in the Federal Circuit: an overview Strategic implications of KSR v. Teleflex KSR and Inter Partes Reexamination: A Double Blow USPTO Examination Procedure: New Guidelines Writing and prosecuting patents Portfolio management The heightened position of prior art searching Take Home Lessons

How to determine whether a patentable invention is present Patent Act, law since 1952, requires an invention to be non-obvious. “Obviousness” was drafted to be an objective standard.

The obviousness standard of the law A patent will be denied for an invention “if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art.” 35 U.S.C. § 103(a).

How the obviousness standard has been applied Before KSR v. Teleflex, the Supreme Court last spoke about obviousness in 1966. The 1952 law was intended by Congress to ban the “flash of creative genius” test for patentable invention articulated by the Supreme Court in 1941. Graham v. John Deere Co., 383 U.S. 1 (1966) Over recent decades the Federal Circuit has refined the obviousness standard.

The Pre-KSR Federal Circuit Standard for Obviousness: “Teaching, Suggestion, Motivation” (TSM) An invention would have been obvious only “if ‘some motivation or suggestion to combine the prior art teachings’ can be found in the prior art, the nature of the problem, or the knowledge of a person having ordinary skill in the art.”

KSR v. Teleflex Involved a gas pedal assembly with electrical sensor KSR’s gas pedal assembly similar to that patented and exclusively licensed by Teleflex Teleflex sued KSR for Infringement KSR defense: patents invalid for obviousness

What KSR v. Teleflex held The Federal Circuit TSM test was applied erroneously “There is no necessary inconsistency between the idea underlying the TSM test” and the standard for non-obviousness “But a court errs where, as here, it transforms general principle into a rigid rule limiting the obviousness inquiry.” The patent licensed to Teleflex was invalidated on basis of prior art not considered by the PTO when the patent was granted

KSR v. Teleflex cont. Summary judgment in favor of defendant KSR on the question of obviousness was appropriate, so a trial is not necessary. “Where, as here, the content of the prior art, the scope of the patent claim, and the level of ordinary skill in the art are not in material dispute, and the obviousness of the claim is apparent in light of these factors, summary judgment is appropriate.”

Who are the losers under KSR v. Teleflex? Those holding patents with close prior art, not considered by the PTO, are at risk in: Litigation, whether pending, threatened, or unasserted License negotiations Other business transactions, including equity financing Those seeking patents Higher standards for non-obviousness = more difficulty obtaining a patent

Who are the winners under KSR v. Teleflex? The Supreme Court decision benefits companies on the receiving end of infringement risk, in: Litigation, whether pending, threatened, or unasserted License negotiations Other business transactions, including equity financing

KSR v. Teleflex: New rationales for Obviousness I. Combining Prior Art Elements according to Known Methods to Yield Predictable Results II. Simple Substitution of one Known Element for Another to Obtain Predicable Results “A person of ordinary skill is also a person of ordinary creativity, not an automaton.” III. Use of Known Techniques to Improve Similar Devices in Same Way “… familiar items may have obvious uses beyond their primary purposes, and in many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.”

New Rationales for Obviousness, cont. IV. Applying Known Technique to Known Device Ready for Improvement to Yield Predictable Results V. Obvious to Try When design need or market pressure exists to solve problem And finite number of identified, predictable solutions Then a person of ordinary skill has good reason to pursue known options within technical grasp If anticipated success achieved, success likely not innovative but merely ordinary skill and common sense. Then, combination that was “obvious to try” might show invention was obvious.

New Rationales for Obviousness, cont. VI. Known work in one field prompts variations for use in same or new field if variations predictable to one or ordinary skill variations prompted by design incentives or market forces If person of ordinary skill can implement a predictable variation, § 103 likely bars patentability If technique used to improve one device, recognized by person of ordinary skill could improve similar device in same way, using technique is obvious unless actual technique is beyond person’s skill VII. Teaching, Suggestion, Motivation (TSM) Motivation may be implicit Motivation may be found in common knowledge, the prior art as a whole, or the nature of the problem itself

Obviousness Since KSR Supreme Court has raised the standard for non-obviousness. Patents are easier to invalidate for obviousness. Patents are harder to get. “Common sense” in the obviousness standard adds subjectivity and unpredictability

Obviousness in the Federal Circuit Since KSR Federal Circuit cases in wake of KSR v. Teleflex use modified TSM test DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1367 (2006) Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1291 (2006) Ortho-McNeil Pharmaceutical v. Mylan Labs., 520 F.3d 1358 (Fed. Cir. 2008) Modified TSM means motivation to combine references may be found implicitly in the prior art or nature of problem to be solved.

Obviousness in Federal Circuit Since KSR, Cont. Obviousness avoidable when there is not a “finite number” of predictable results Finite number: small in the context of the art Ortho-McNeil Pharmaceutical v. Mylan Labs., 520 F.3d 1358 (Fed. Cir. 2008). Upholding finding of non-obviousness Cites “secondary considerations”: unexpected results, skepticism of experts and copying, commercial success Provides a road map for proving non-obviousness after KSR in biopharma

Obviousness in Federal Circuit Since KSR, Cont. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed.Cir. 2007) Obviousness of a patent claim cannot be avoided simply by a showing of some degree of unpredictability in the art so long as there was a reasonable (i.e. not absolute) probability of success Evidence showed a motivation to combine At the other end of the spectrum from Ortho-McNeil Pharmaceutical v. Mylan Labs., 520 F.3d 1358 (Fed. Cir. 2008).

Obviousness in Federal Circuit Since KSR, Cont. Takeda Chem. Indus. V. Alphapharm Pty., Ltd. 492 F.3d 1350 (Fed. Cir. 2007) “in cases involving new chemical compounds, it remains necessary to identify some reason that would have led a chemist to modify a known compound in a particular manner to establish prima facie obviousness….” Takeda at 1357 Disclosure of a broad selection of compounds, any one of which could have been selected as the lead compound Prior art taught away from the invention by “direct[ing] one of ordinary skill in the art away from that compound.” Id. at 1359 If no rationale in prior art to establish a prima facie case of obviousness, then no need to consider objective indicia of nonobviousness Id. at 1360.

Obviousness in Federal Circuit Since KSR, Cont. In re John B. Sullivan and Findlay E. Russell, 498 F.3d 1345 (Fed. Cir. 2007) Improvement of existing technology found in prior art sufficient to establish prima facie case of obviousness Rebuttal evidence -including inventor’s declaration- sufficient to prove non-obviousness Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1373 (Fed. Cir. 2008) Expert’s report may be deficient under Fed. R. Civ. P. 26 if declaration merely lists a number of prior art references and then concludes with a stock phrase that it would have been obvious to one skilled in the art to combine them

Obviousness in District Court Since KSR Abbott Laboratories v. Sandoz, Inc., 529 F.Supp.2d 893, 916 (N.D. Ill. 2007) Prior art references do not need to explicitly teach or suggest the motivation to combine the references, BUT, each of the claimed limitations must still be found to exist somewhere in the prior art

Strategic implications of KSR v. Teleflex: Weakness arises from prior art not considered Patents may be strengthened by getting prior art considered, through: Reexamination proceedings Requires prior art raising substantial new question of patentability Reissue proceedings Requires showing, typically, that the patent claims more or less than patentee had right to claim in the patent, and the error arose without deceptive intent

KSR and Inter Partes Reexamination: A Double Blow Risk is unavoidable that claims will be narrowed or rejected in Inter Partes Reexamination proceedings Inter Partes Reexamination allows back and forth between third party requester, patentee, and PTO Statistics strongly favor the requestor

KSR and Inter Partes Reexamination: A Double Blow, cont. As of Sept. 2007: 12% result in all claims cancelled 91% of Reexamination requests granted 71% result in narrowed/cancelled claims 29% result in all claims intact As of May ’08 (of First 250 Reexamination Requests filed): 14 of 17 (>82%) cancelled all claims challenged 31 of 44 are on appeal by patent owners

KSR and Inter Partes Reexamination: A Double Blow, cont. Duty of Candor Incredibly Important File all prior art known in any proceeding File RCE and seek withdraw from allowance if more prior art discovered Disclose adverse proceedings immediately, and any associated prior art Keep Continuation Alive May be able to write/obtain claims that build on knowledge learned from I. P Reexamination

NEW USPTO Guidelines Adopted KSR Rationales for Finding Obviousness I. Combining Prior Art Elements according to Known Methods to Yield Predictable Results II. Simple Substitution of one Known Element for Another to Obtain Predicable Results III. Use of Known Techniques to Improve Similar Devices in Same Way IV. Applying Known Technique to Known Device Ready for Improvement to Yield Predictable Results V. Obvious to Try Precedential Opinion: Ex Parte Kubin, Appeal 2007-0819, Appln No. 09/667,859, Technology Center 1600 (May 31, 2007) VI. Known work in one field, variations in same or different field predictable VII. Teaching, Suggestion, Motivation (TSM)

Strategic implications of KSR v. Teleflex: New MPEP Sections § 2141.01-02 - Minor modifications since KSR § 2141.03 –Expanded Adds list of factors to consider when determining level of skill Adds observation in KSR that a “person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” § 2142 – Significantly Changed Three criteria for prima facie case gone (TSM test gone) Key to supporting an obviousness rejection is the clear articulation of the reason(s) why the claimed invention would have been obvious The examiner should provide “some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”

Strategic implications of KSR v. Teleflex: New MPEP Sections § 2143 – Completely Re-written Balloons from ½ page to over 11 pages Provides examples for each of the 7 enumerated rationale for obviousness § 2144 – Unchanged § 2145 – Revised Adds “obvious to try” and “ordinary skill and common sense” from KSR Once Examiner provides rationale for prima facie obviousness, burden shifts to applicant to rebut Adds specific positive examples of rebuttal evidence still acceptable after KSR § 2146 - Unchanged

Writing and prosecuting patents—some principles remain intact Graham Factors Still the Legal Basis for Obviousness Scope and Content of Prior art Differences between claimed invention and Prior Art Level of Skill Secondary Considerations Examiner must still articulate reason/rationale to support obviousness rejection Rebuttal Evidence must still be considered

Writing and prosecuting patents—some principles remain intact, cont. Rebuttal Evidence Explicitly Mentioned by USPTO New Guidelines as Still Valid Commercial success Long-felt but unsolved needs Failure of others Unexpected results Elements could not have been combined – i.e., for technological difficulties (a teaching away type rebuttal) Elements in combination do not perform same function each did individually (an In re Gordon type rebuttal)

Writing and prosecuting patents—some principles are new Examiner fulfills critical role of Fact finder in Graham Inquiries! Ultimate determination is legal, but Graham inquiries are factual Precedential Opinion: Ex Parte Kubin, Appeal 2007-0819, Appln No. 09/667,859, Technology Center 1600 (May 31, 2007) Written record must include findings of fact by examiner concerning teachings of references and state of the art. Examiner may also need: Explicit findings as to how person of ordinary skill would have understood prior art teachings What a person of ordinary skill would have known What a person of ordinary skill could have done

Writing and prosecuting patents—some principles are new, cont. New rebuttal evidence explicitly mentioned by new USPTO guidelines Actual application of known technique (to improvement of “base” device) was beyond one of ordinary skill Rationale for obviousness must be explicitly stated But, if facts wrong, rationale wrong Major impact will be at level of appeal Reversal rate at Board of Patent Appeals and Interferences (BPAI) decreased dramatically since KSR Pre-KSR reversal rate for TC 1600– 70-80%* Post-KSR reversal rate for TC 1600 – 30-40%* Actual post-KSR reversal rate for TC 1600 29%

Strategic implications of KSR v Strategic implications of KSR v. Teleflex: Combination drugs particularly vulnerable When each component of a combination drug contributes properties to the combination that are expected, then the combination will be attacked as obvious. To resist the attack for obviousness, it is important to show synergistic or unexpected results.

Strategic implications of KSR v. Teleflex: Combination drugs, cont. Even when the prior art looks overwhelming, sometimes special claim strategies can make a difference. When the basic combination may be taught, consider claims to a unit dosage of the combination with specific ranges or ratios that may be novel and unexpected. Consider method claims that address use of the composition under specific conditions or with specific types of administration that may be novel and unexpected.

Strategic implications of KSR v. Teleflex: Portfolio management A good-looking patent portfolio before KSR v. Teleflex may not be a good-looking patent portfolio after KSR v. Teleflex Evaluate each U.S. patent property in the portfolio for invalidity risk based on obvious combinations of prior art Weak patent properties should be evaluated for possible Rehabilitation through reexamination or reissue Pruning from the portfolio Licensing or selling

Strategic implications of KSR v. Teleflex: Portfolio management, cont. Revisit clearance problems—infringement risks—in light of KSR Heretofore nearly invulnerable patents may be vulnerable to prior art attacks under KSR v. Teleflex For newly vulnerable patents consider the following approaches: Renewed licensing negotiations Reexamination proceedings, particularly inter partes (contested) - outcomes often favorable to attacking party Litigation - declaratory judgment actions are much easier to maintain after Medimmune v. Genentech (127 S.Ct. 764 (January 9, 2007))

Prior art searching now critically important Helps reduce risk of KSR v. Teleflex attack for obviousness on applications in portfolio Helps efficient claiming of subject matter under new compact prosecution rules Without knowledge of prior art, one risks needlessly extending prosecution by claiming more broadly than warranted by prior art, thereby potentially wasting the limited number of continuations and requests for continued examination available under the new rules Helps identify vulnerabilities in competitors’ patents

The new regime under KSR v. Teleflex Issued patents are at greater risk of attack for obviousness, which may be found in summary judgment without trial. Pending applications must contend with the higher and more subjective bar of the new obviousness standard. Strategy is more important in drafting and prosecuting applications and in handling properties in patent portfolios. Early and deep knowledge of prior art is of critical importance in formulating and implementing strategy.

Strategic implications of KSR v Strategic implications of KSR v. Teleflex: Writing and prosecuting patents— further strategic principles Draft applications bearing in mind prospective downstream rejections based on obviousness. Knowing prior art in detail when drafting application is critical! Tell a story that includes a convincing showing of unexpected or synergistic results. The story should make good sense in relation to the prior art. Questions of judgment and advocacy affect the extent to which prior art is discussed explicitly.

KSR v. Teleflex: Take Home Lessons “obvious to try” may show obviousness “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.” Patentability of new compounds Seems to hinge on finite number of predictable results – i.e., Are there unexpected results?

KSR v. Teleflex: Take Home Lessons, cont. Prior art references can be distinguished on if they “teach away” from the combination cited for obviousness It is critical to study cited prior art references with great care to understand what they teach. Prior art references do not always actually teach what they seem to teach Frequently misconstrued by examiners Sometimes not enabling; i.e., do not permit a person of ordinary skill to practice the subject matter for which the reference is cited Unexpected results can demonstrate non-obviousness

KSR v. Teleflex: Take Home Lessons, cont. Combination or rationale must extend to all the limitations of claimed invention If not, then a prima facie case of obviousness has not been established It is critical to make a rigorous analysis of the rejection to determine whether all limitations of the claim have been accounted for by the examiner in the rejection More patent claims – and creative ones – can make a difference Prior art attacks on claims must be mounted separately for each claim A well crafted claim that captures the inventor’s creativity may be just the one for which a “common sense” combination of prior art references simply does not exist

Learn and deal with the prior art early and often Learn and deal with the prior art early and often. Tell a story about the innovation. Good luck!