Presenting a live 90-minute webinar with interactive Q&A Obviousness Standard After the AIA: Leveraging Latest PTO and Court Guidance Overcoming Challenges of Obviousness and Attacks on Patent Validity THURS DAY, NOVEMBER 14, 2013 1pm East ern | 12pm Cent ral | 11am Mount ain | 10am Pacific Today’s faculty features: Barry J. Herman, Part ner, Womble Carlyle Sandridge & Rice, Balt imore Jon S chuchardt, Part ner, Dilworth IP , Trumbull, Conn. The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions emailed to registrants for additional information. If you have any questions, please contact Customer Service at 1-800-926-7926 ext. 10 .
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The Evolving Obviousness Standard – Strategies to Prevail at District Court and Inter Partes Review Barry Herman November 14, 2013
New AIA Provisions took effect on March 16, 2013 • Change in Timing – New § 103 – A patent may not be obtained “if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.” – The previous law was “at the time the invention was made.” – Shifts obviousness inquiry forward in time 5
New AIA Provisions took effect on March 16, 2013 • Change in Definition of Prior Art – A public disclosure anywhere in the world before the effective filing date of the claimed invention – Patent filing disclosures (in U.S. or PCT application designating the U.S.) that later become public, name another inventor, and were filed before effective filing date – No more geographic limitations 6
How is KSR v. Teleflex playing out in district court decisions appealed to Federal Circuit? • District courts are generally trying to follow KSR and raise the patentability bar, but Fed. Cir. is often reversing or remanding • Dissension among panelists – Celsis in Vitro v. CellzDirect (Fed. Cir. Jan. 2012), Gajarsa complains that the court has “reinvigorate[d] the pre- KSR standard for obviousness.” • Petition for cert. – Artesyn Techs. v. SynQor (Fed. Cir. Mar. 2013) – petitioner alleges that a single prior art reference discusses all of the relevant pre-existing technologies and the possibility of combining them, but court found patent nonobvious because reference did not expressly provide motivation to combine – In October 2011, Chief Judge Rader was quoted in IP Watchdog, stating that he “would challenge anyone to demonstrate how the Supreme Court decision in KSR v. Teleflex did anything to change the law of obviousness and how the Federal Circuit addresses the issue.” 7
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Reason to modify • Alcon Research v. Apotex Inc. (Fed. Cir. Aug. 2012) – District court found 8 asserted claims nonobvious – Federal Circuit reversed on 6 claims • District court applied “overly strict reason to modify requirement” and that the motivation need not be the same that the patentee had (citing to KSR for proposition that it is error to look “only to the problem the patentee was trying to solve”) • Only dispute was whether formulation in prior art, which was tested in guinea pigs, would motivate one to use in treating allergic eye disease in humans. • “Courts do not rewrite the claims to narrow them for the patentee to cover only the valid portion.” – Federal Circuit upheld 2 claims • Claims did not overlap with prior art • “No reasonable expectation of success” for increasing highest dosage disclosed in prior art by an order of magnitude. 9
Challenger needs to knock out EVERY claim • Allergan v. Sandoz (Fed. Cir. May 2013) – District court found all claims nonobvious – Federal Circuit reversed on every claim but 1 • Primary prior art reference provided express motivation • Motivation to combine may be found in many different forms – not limited to reasons FDA sees fit to consider in approving new drug application • District court over-relied on recognized unpredictability in the art • Teaching away – insufficient to overcome motivation • Federal Circuit found 1 claim non-obvious (2-1 decision) – Reducing the number of treatments from 3 to 2 times a day without loss of efficacy was not obvious because this was contrary to understanding in the art at the time – Dyk’s dissent – “loss of efficacy” is not a separate step, but is a result of the claimed method. “Newly discovered results of known processes directed to the same purpose are not patentable.” – Allergan wins! 10
Lead Compound Cases • Shortly after KSR , the Federal Circuit decided Takeda v. Alphapharm (Fed. Cir. 2007) – Prior art patent described genus of millions of compounds, any one of which could have been selected as a lead compound for further investigation – Asserted basis for obviousness was not suggested to be best and actually exhibited negative properties that would have directed those of OSIA away from that compound – Not obvious 11
Lead Compound Cases • Abilify Litigation ( Otsuka v. Sandoz) Fed. Cir. May 2012 • Endorsed the framework of Takeda: – “Our case law demonstrates that whether a new chemical compound would have been prima facie obvious over particular prior art compounds ordinarily follows a two-part inquiry. First, the court determines whether a chemist of ordinary skill would have selected the asserted prior art compounds as lead compounds, or starting points, for further development efforts....The second inquiry in the analysis is whether the prior art would have supplied one of ordinary skill in the art with a reason or motivation to modify a lead compound to make the claimed compound with a reasonable expectation of success.” • Sandoz argued that this was contrary to KSR . The Court disagreed, noting that the reason or motivation for a POSITA to modify a lead compound may come from a variety of sources, or not even be explicit in the prior art. • Upheld district court’s finding that a POSITA would not have selected the prior art compounds for use as lead compounds. Poster child for impermissible hindsight reasoning • 12
Lead Compound Cases • Crestor Litigation (Astrazeneca v. Aurobindo) Fed. Cir. Dec. 2012 • Ordinary chemist would not have expected the chemical structure to have the most desirable combination of properties – Prior art would not be a good lead compound because of unexpected increased toxicity – No reasonable expectation of success – Unpredictability of statin development • Fed. Cir. relies on KSR (be aware of hindsight analysis) • Need a reason that would have led chemist to modify known compound in a particular manner • Cf. Pfizer v. Apotex (Fed. Cir. 2007) – “obviousness cannot be avoided simply by a showing of some degree of unpredictability in the art so long as there was a reasonable probability of success.” 13
Common Sense 14
Guard against hindsight • Plantronics v. Aliph (Fed. Cir. July 2013) – Patent on headsets used with cell phone receivers – District court granted SJ of obviousness • Found that common sense would motivate a skilled artisan to combine prior art – Fed. Cir. reversed • Obviousness analysis is somewhat flexible (citing KSR ), but must find support in the record • No expert testimony on motivation to combine. • “Where, as here, the necessary reasoning is absent, we cannot simply assume that ‘an ordinary artisan would be awakened to modify prior art in such a way as to lead to an obviousness rejection.’ It is in such circumstances, moreover, that it is especially important to guard against the dangers of hindsight bias.” 15
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