November Common Sense Approach to Obviousness. g Obvious to Try. g Obviousness-Type Double Patenting

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1 Federal Circuit Review Obviousness Volume Three Issue Two November 2010 In This Issue: g Common Sense Approach to Obviousnesss g Obvious to Try g Obviousness-Type Double Patenting = Pharmaceutical Compounds and Their Uses = Retroactive Terminal Disclaimers This issue of the Federal Circuit Review discusses recent developments in the law of patent invalidity due to obviousness under 35 U.S.C First, we will examine cases that discuss the flexible, common sense approach to obviousness that has developed since KSR. Next, we will look at a Federal Circuit ruling that addresses the obvious to try test in a non-pharmaceutical context. Finally, we will turn to the related topic of obviousness-based double patenting. In particular, we will explore the effect of this doctrine on pharmaceutical composition patents and retroactive terminal disclaimers. It is important to note that there were two key events relating to the law of obviousness that are beyond the scope of the Federal Circuit Review. First, the Patent Office has issued guidelines by which patent examiners will apply the principles of KSR v. Teleflex. Second, Microsoft filed a petition for a writ of certiorari to the Supreme Court in Microsoft v. i4i to consider whether the burden of proof for proving invalidity should change. Microsoft s cert petition has received significant support from various amicus curie briefs and a decision on the petition is expected at the end of November. Common Sense Approach to Obviousness In rejecting the rigid application of the teaching, suggestion, or motivation test for obviousness, the Supreme Court noted that common sense can serve as a reason to combine or modify prior art references in KSR Int l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Common sense teaches... that 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. Id. at In these situations, the fact that a combination was obvious to try might show that it was obvious under 103. Id. at 421. This section discusses three recent Federal Circuit decisions that apply this common sense approach to obviousness. The first two demonstrate how common sense can be used to support a finding of obviousness while the last decision shows the limits to this approach. In the first decision, Perfect Web Techs., Inc. v. InfoUSA, Inc., the patentat-issue claims methods of managing bulk distribution to groups of targeted customers. 587 F.3d 1324 (Fed. Cir. 2009). The method

2 Federal Circuit Review in Perfect Web s patent comprises four steps: (1) matching a target recipient profile with a group of target recipients; (2) transmitting bulk to the target recipients; (3) calculating the number of successfully received s; and (4) repeating the first three steps until a minimum quantity of s is successfully received. Id. at InfoUSA moved for summary judgment of invalidity after it was sued for infringement by Perfect Web. The district court found that the first three steps in the patented method were known previously and that the question was whether the final step was obvious to marketers of ordinary skill. Id. at It found that the final step is merely the logical result of common sense application of the maxim try, try again and, therefore, was obvious. Id. Perfect Web appealed to the Federal Circuit. The Federal Circuit found that the district court properly applied common sense in its determination of obviousness. It explained that in order to invoke common sense, an obviousness analysis requires a factual foundation and a reasoned explanation that avoids conclusory generalizations. Id. at The court added that while an obviousness analysis always depends on evidence that supports the Graham factors, it also may include recourse to logic, judgment, and common sense available to the person of ordinary skill that do not necessarily require explication in any reference or expert opinion. Id. at Here the court found that the last step in the patented process simply recites repetition of a known procedure until success is achieved. Id. at Furthermore, it found that the last step would have been obvious to try, given that experts identified only three potential solutions to the problem. Id. The first potential solution is to send bulk to a larger set of addresses to ensure the quota is met. The second is to re-send bounced messages. The third solution, which is the approach chosen by Perfect Web in the patent-in-suit, is to identify a new group of addresses and send messages to them. Id. The court therefore affirmed the district court s ruling of invalidity due to obviousness. The second decision discussing the use of common sense in an obviousness inquiry involved patents that cover hitch pin locks that secure trailers to motor vehicles. Wyers v. Master Lock Co., No , 2010 U.S. App. LEXIS (Fed. Cir. July 22, 2010). Wyers held several patents that describe a barbell-shaped lock with a stop portion on one end, a locking head on the other end, and a shank portion which passes through the hitch receiver and towball mount. Id. at *2. Wyers filed suit against Master Lock, claiming it infringed its hitch pin lock patents. The parties agreed that the use of barbellshaped hitch pin locks was well known in the prior art. Id. Wyers argued that its patents claimed improvements to the prior art locks because they disclosed external seals and removable sleeves to increase the shank s diameter and enabling their use with trailer hitch receivers of different apertures. Id. at *6-7. Thus, the district court noted that the only questions for the jury were whether Master Lock presented evidence that the use of a sleeve to adjust the operative thickness of a shank and the use of an external flat flange seal would have been obvious. Id. at *9-10. At trial, the district court prohibited the jury from considering certain prior art combinations and ultimately entered a judgment for Wyers awarding it $5.4M in damages and a continuing injunction against future sales. Id. at * Master Lock appealed to the Federal Circuit after its motions for judgment as a matter of law for obviousness were denied. Id. 2

3 The Federal Circuit noted that there are two criteria in determining whether prior art is relevant: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor s endeavor, whether the reference is still reasonably pertinent to the particular problem with which the inventor is involved. Id. at *12. The Federal Circuit found that prior art related to padlock seals and other types of towing attachments were from the same field, or at least reasonably pertinent, and thus it was error to exclude that prior art. Id. at * The Federal Circuit then addressed whether there was a motivation to combine these references for determining obviousness. Id. at * Looking back at KSR and its subsequent cases, it determined that the ultimate inference as to the existence of a motivation to combine references may boil down to a question of common sense, appropriate for resolution on summary judgment or a judgment as a matter of law. Id. at * This determination may be made in lieu of expert testimony. Id. at *19. It concluded that it was a matter of common sense to combine the known barbell-shaped hitch pin locks with other prior art locking mechanisms, and that an individual with ordinary skill in the art would have had a reasonable expectation of success in doing so. Id. at * It therefore reversed the district court s holding of nonobviousness. In the third case involving the use of common sense in an obviousness inquiry, TriMed, Inc. v. Stryker Corp., the patent at issue covers an implantable device used to set bone fractures. 608 F.3d 1333 (Fed. Cir. 2010). The implantable device includes screws, pins, and a plate with screw holes on one end and pin holes on the opposite end. Id. at TriMed asserted that Stryker infringed its patent by manufacturing and selling a wrist fixation device that covered its patent claims. Stryker moved for summary judgment of invalidity that two prior art publications, an article by Leibovic ( Leibovic article ) and a patent application by May ( May application ), each anticipate the asserted claims. Id. at The Leibovic article contains images of a fracture set with pins and plates. Id. The May application discloses a plate with screw holes and smaller holes for guide wires. Id. Stryker also argued that TriMed s patent was obvious when these references were combined with the Clancey article, which disclosed a conventional pinning technique. Id. Stryker asserted that the patent claims were a combination of known elements from these references combined using a logical, commonsense solution. Id. at TriMed contested each of these arguments in its responsive briefs. Id. The district court granted summary judgment by merely signing Stryker s motion, but crossing out the section on anticipation. Id. TriMed appealed to the Federal Circuit. The Federal Circuit acknowledged that reliance on common sense does not require a specific evidentiary basis. Id. at But the district court must nevertheless articulate its reasoning with sufficient clarity for review to demonstrate some rational underpinning to support the legal conclusion of obviousness. Id. Here, neither the record nor the district court s order explains why one of ordinary skill in the art at the time of the invention would have found replacing a cast normally used to stabilize a pin with a subcutaneous metal plate to be a logical, commonsense solution to this problem. Id. at The Federal Circuit added, merely saying that an invention is a logical, commonsense solution to a known problem does not make it so. Id. The court reversed the district court s grant of summary judgment of invalidity and took the extraordinary step of remanding the case to a different district judge. Id. at

4 Federal Circuit Review Cases Referenced: KSR Int l Co. v. Teleflex Inc., 550 U.S. 398 (2007) Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324 (Fed. Cir. 2009) TriMed, Inc. v. Stryker Corp., 608 F.3d 1333 (Fed. Cir. 2010) Wyers v. Master Lock Co., No , 2010 U.S. App. LEXIS (Fed. Cir. July 22, 2010). Obvious to Try A patent claim may be invalidated if a person of ordinary skill in the art would have found it obvious to try a particular course of action. KSR Int l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). The Federal Circuit has applied the obvious to try rationale in cases involving pharmaceutical compositions. See, e.g., the November 2009 issue of Federal Circuit Review. But in the past year, the court has employed the test in a non-pharmaceutical context. The Federal Circuit reviewed an interference decision between a patent and patent application that covered turbine fan blades used in jet aircrafts. Rolls-Royce, PLC v. United Techs. Corp., 603 F.3d 1325 (Fed. Cir. 2010). Jet aircraft engines generally consist of a cascade of fan blades that extend radially outward from a central rotatable hub. Id. at The blades rotate and provide propulsive thrust to air entering the engine by increasing the momentum and pressure of the air. Id. The fan and the rest of the engine are enclosed in a casing. Id. Jet engine noise and other inefficiencies are caused by shockwaves that arise from the supersonic flow of air over the fan blades and the bouncing of pressure waves off the engine casing. Id. United Technologies (UTC) held a patent application for turbine fan blades with a rearward sweep in the outer region to reduce shockwaves. Id. at Rolls-Royce owned an issued patent that was nevertheless junior to UTC s patent application, that addressed shockwaves by claiming a forward sweep in the outer region. Id. UTC argued that the forward sweep would have been an easily predictable and achievable variation in view of its rearward sweep disclosure and thus it would have been obvious to try to reverse the sweep angle from rearward to forward to minimize endwall shock. Id. at The Federal Circuit began its analysis by noting that an invention would have been obvious to try if the possible approaches and selection to solve the problem are known and finite. Id. at 1339 (quoting Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341, 1351 (Fed. Cir. 2008)). When performing this analysis, the important question is whether an invention is an identified, predictable solution and an anticipated success. Id. In this case, the Federal Circuit held that a person of ordinary skill in the art would have had no reason to try a forward sweep in the outer region. Id. The court did not view sweep angle as a matter of two choices, forward or rearward, but rather as a broad selection of choices for further investigation, which included any degree of sweep. Id. The court noted that such a large number of choices goes against obvious to try. Id. Also, the record did not show any design need or market pressure or other motivation to try the forward sweep. Id. The court thus found that Rolls- Royce s invention would not have presented itself as an option at all, let alone an option that would have been obvious to try. Id. 4

5 Cases Referenced: Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341 (Fed. Cir. 2008) KSR Int l Co. v. Teleflex Inc., 550 U.S. 398 (2007) Rolls-Royce, PLC v. United Techs. Corp., 603 F.3d 1325 (Fed. Cir. 2010). Obviousness-Type Double Patenting Applicants are barred from obtaining multiple patents for the same invention by the doctrine of double patenting. This doctrine prevents a patent owner from receiving a term extension of a patent by claiming the identical invention or an obvious modification in subsequent patent applications. The first step in an obviousness-type double patenting analysis is to construe the claims in the original patent and later patent application and determine the differences. Pfizer, Inc. v. Teva Pharms. USA, Inc., 518 F.3d 1353, 1363 (Fed. Cir. 2008). The next step is to determine whether those differences render the claims patentably distinct. Id. This year, the Federal Circuit addressed obviousness-type double patenting for pharmaceutical compounds and looked at the effect of retroactive terminal disclaimers. Pharmaceutical Compounds and Their Uses In Sun Pharm. Indus., Ltd. v. Eli Lilly and Co., the patents relate to gemcitabine, the active ingredient in Lilly s Gemzar product. 611 F.3d 1381 (Fed. Cir. 2010). Lilly s first patent claimed the gemcitabine compound as well as a method of using it to treat viral infections. Lilly s second patent claimed a method of using gemcitabine for treating cancer. After filing an ANDA application, Sun Pharmaceutical sought a declaratory ruling that the latter patent was invalid and not infringed. The district court granted Sun s motion for partial summary judgment and held that claims from the latter patent were invalid for obviousness-type double patenting. Lilly appealed to the Federal Circuit. This was not the first time in recent years that the Federal Circuit performed a double patenting analysis for pharmaceutical compounds and their uses. See, e.g., Pfizer, 518 F.3d at 1353; Geneva Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003). In Geneva, the earlier patent claimed a compound and the specification disclosed its effectiveness in inhibiting beta-lactamase. 349 F.3d at The later patent claimed a method of using the compound to affect beta-lactamase inhibition. Id. Similarly, in Pfizer, the earlier patent claimed several compounds and the specification disclosed their use in treating inflammation. 518 F.3d at The later patent claimed a method of using these compounds for treating inflammation. Id. In both cases, the Federal Circuit ruled that the claims of the later patents were not patentably distinct and thus were invalid for obviousness-type double patenting. 5

6 Federal Circuit Review Lilly attempted to distinguish these cases, contending that, in Pfizer and Geneva, the specification of the earlier patent disclosed a single use for the claimed compound, which was an essential part of the patented invention and thus necessary to patentability. Sun Pharm., 611 F.3d at Lilly claimed that the double patenting analysis of these cases does not apply because, although the specification of the earlier patent disclosed gemcitabine s use in treating both viral infections and cancer, the antiviral use provided the essential utility necessary to [its] patentability. Id. at The Federal Circuit disagreed with Lilly s analysis and held that obviousness-type double patenting encompasses any use for a compound that is disclosed in the specification of an earlier patent claiming the compound and is later claimed as a method of using that compound. Id. Lilly also argued that the specification of an earlier application should have been consulted, as opposed to the specification of the first patent, for the double patenting analysis. Id. at The earlier application disclosed only the compound s antiviral use, not its anticancer use. Id. at Lilly added the anticancer disclosure to the specification in a continuation-in-part application that eventually resulted in the first patent. Id. The court rejected Lilly s argument, noting that the double patenting doctrine is concerned with the issued patent and the invention disclosed in that issued patent, not earlier drafts of the patent disclosure and claims. Id. at The Federal Circuit affirmed the district court s invalidity judgment of the claims of the latter patent. Retroactive Terminal Disclaimers Terminal disclaimers are permitted under 35 U.S.C. 253 to avoid the improper extension of the statutory term that results from obviousness-type double patenting. They may restrict the slight variation to the term of the original patent and cure the double patenting rejection. Geneva Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1378 (Fed. Cir. 2003). The patent at issue in Boehringer Ingelheim Int l. GMBH v. Barr Labs., Inc. dealt with pramipexole, marketed by Boehringer as Mirapex for the treatment of Parkinson s disease symptoms. 592 F.3d 1340 (Fed. Cir. 2010). Litigation ensued after Barr and Mylan filed ANDA applications concerning Boehringer s U.S. Patent No. 4,866,812. Id. at Barr and Mylan argued that the 812 patent was invalid for obviousness-type double patenting over a parent patent application. Id. Boehringer sought to overcome the double patenting argument by disclaiming the approximately six months of patent term that extended beyond the term of the parent patent application. Id. The district court held that this terminal disclaimer was invalid because the patent resulting from the parent application had expired. Id. Boehringer appealed to the Federal Circuit. 6

7 The court first noted that a patentee may file a disclaimer after issuance of the challenged patent or during litigation, even after a finding that the challenged patent is invalid for obviousness-type double patenting. Id. at But that is not the question here. Instead the question is whether a retroactive terminal disclaimer i.e., a terminal disclaimer that is filed after the expiration date of an earlier commonly owned patent is effective to overcome obviousness-type double patenting. Id. The court answered that this type of terminal disclaimer is not effective. Id. at Allowing such a disclaimer would give the patentee an unjustified advantage because it has already enjoyed rights that it seeks to disclaim. Id. The Federal Circuit affirmed the district court s ruling. Cases Referenced: Boehringer Ingelheim Intl. GMBH v. Barr Labs., Inc., 592 F.3d 1340 (Fed. Cir. 2010) Geneva Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003) Pfizer, Inc. v. Teva Pharms. USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008) Sun Pharm. Indus., Ltd. v. Eli Lilly and Co., 611 F.3d 1381 (Fed. Cir. 2010). 7

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