This is a guest post from Donald Chisum and Janice Mueller of the Chisum Patent Academy.
Below are highlights of the Critical  Patentability & Validity Developments of 2016-2017.

• The Federal Circuit’s January 2017 decision in Sonix Tech. Co. v. Publications Int’l, Ltd. illustrates that using a “term of degree” (such as “visually negligible”) in a patent claim does not necessarily render the claim indefinite under 35 U.S.C. §112, second paragraph. The Circuit also clarified in Sonix the standard of review for definiteness. Paralleling the Supreme Court’s important 2015 decision on standard of review for patent claim construction by federal courts, Teva Pharms. USA, Inc. v. Sandoz, Inc., the ultimate determination of claim definiteness is reviewed de novo, but any underlying factual findings based on extrinsic evidence are reviewed for clear error. See §§2.04[A], 2.04[D][1][f].
• For a §112, sixth paragraph means-plus-function claim element in which the recited function is implemented by a programmed computer or microprocessor, the Federal Circuit holds that the “corresponding structure” is the algorithm disclosed in the patent’s specification. The interpretation of such a claim element must identify the corresponding algorithm with particularity (or conclude that an algorithm is lacking). The PTAB failed to do so in the Circuit’s July 2017 decision in IPCom GMBH & Co. v. HTC Corp. See §2.05[A][3][c].
• In the wake of the Supreme Court’s 2014 Alice Corp. decision, the number of cases in which the Federal Circuit has invalidated claims as patent-ineligible under 35 U.S.C. §101 far outweighs those with a patent-sustaining outcome. Notable post-Alice exceptions that sustained challenged claims as patent-eligible include DDR Holdings (2014), Enfish (2016), Rapid Litigation (2016), Bascom (2016), McRO (2016), Amdocs (Israel) (2016), and Thales Visionix (2017). These decisions are examined in detail in §3.02[D][4][e][ii] and §3.02[E][3].
• The unintended consequences of the Supreme Court’s 2012 Mayo decision concerning patent-ineligibility of laws of nature and natural phenomena continue to play out in the Federal Circuit’s invalidation under §101 of claims to ground-breaking diagnostic methods and personalized medical testing. Notable recent examples are Ariosa (2015), Genetic Technologies (2016), and Cleveland Clinic (2017). See §3.02[E][2][c].
• Enablement under 35 U.S.C. §112, first paragraph takes into consideration multiple factors including the predictability or unpredictability of the claimed subject matter. For example, chemical compounds having a particular stereochemistry (i.e., a certain three-dimensional arrangement of molecules) may fall within the unpredictable arts. In the Federal Circuit’s June 2017 decision in Storer v. Clark, an appeal from an interference contest, the court agreed with the PTAB that the senior party’s priority document (coupled with knowledge in the prior art) did not adequately enable how to make the novel drug recited in the claimed method of treating hepatitis C. See §4.02[B][2].
• The Federal Circuit’s February 2017 decision in Los Angeles Biomedical Research Institute v. Eli Lilly and Co. aptly illustrates the written description of the invention requirement exercising its traditional and proper priority-policing role. See §6.06.
• The strict identity standard for anticipation is “demanding,” as the Federal Circuit reinforced in the February 2017 decision, Eli Lilly & Co. v. Los Angeles Biomedical Research Inst. at Harbor-UCLA Med. Ctr. Prior art merely “suggesting” claimed subject matter is not sufficient to meet the “clear disclosure” standard for anticipation. See §7.02[B][5].
• An inventor’s declaration submitted under 37 C.F.R. §1.132 may be an effective means of overcoming a rejection under pre-AIA §102(e) (or §102(a)). But such declarations generally need to include detailed and thorough explanations of the asserted facts, not mere assertions, and are advantageously bolstered by corroborating evidence such as supportive contemporaneous documentation. The Federal Circuit’s June 2017 decision in EmeraChem Holdings LLC v. Volkswagen Group of America, Inc. illustrates a patentee’s failure to overcome a §102(e)/§103 rejection in the course of an inter partes review. To show that an earlier-filed reference patent could not disclose the invention of “another” as required by §102(e), the patentee submitted a Rule 132 declaration asserting that the challenged patent’s inventorship was identical to that of the cited portion of the reference patent, which was commonly-owned and named the inventor plus other individuals. The effort failed. The Federal Circuit deemed the declaration a “naked assertion” by an interested inventor that was not supported by any contemporaneous documentary evidence, testimony of the other co-inventors of the reference patent, or other evidence. Although corroboration is not necessarily required for all declarations by inventors, the circumstances of the case before it compelled the Circuit to affirm the PTAB’s decision that the declaration was not sufficient to remove the putative §102(e) reference as prior art. See §7.05[E].
• The Federal Circuit decided its first-ever en banc case turning on the 35 U.S.C. §102 on-sale bar provision in the July 2016 decision, The Medicines Co. v. Hospira, Inc. The Circuit has previously held that the bar can be triggered through pre-critical date sales or offers of the invention by parties other than the inventor or patentee. For example, the Circuit has rejected the notion of a “supplier exception” that would excuse an otherwise bar-triggering commercialization involving transactions between a patentee and its supplier. However, in a very fact-specific decision, the en banc court in Medicines Co. held that the on-sale bar was not triggered by the paid provision of services to make “validation batches” of the claimed pharmaceutical formulation for the patentee before the critical date. Notably, the contract manufacturer merely acted as a “pair of hands” in reducing the invention to practice; the patentee provided the active pharmaceutical ingredient and title never transferred to the manufacturer. Although the transaction allowed the patentee to restore its depleted stockpiles, this commercial benefit was not a “commercial marketing” of the invention such as to invalidate the patent. See §7.06[G][4][c].
• In May 2017, the Federal Circuit issued its first decision interpreting the 35 U.S.C. §102 prior art category of placing an invention “on sale” as amended by the AIA. In this important case of first impression, the Circuit in Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc. concluded that “after the AIA, if the existence of the sale is public, the details of the invention need not be publicly disclosed in the terms of the sale.” In other words, the AIA’s addition to §102 of the “otherwise available to the public” category of prior art did not change the law so as to require that an invalidating pre-critical date sale put the public in possession of the details of a claimed invention. However, the Helsinn court declined to decide the larger questions whether a truly secret or confidential sale (e.g., a pre-critical date commercial transaction subject to a nondisclosure agreement), or a Metallizing-type commercialization of products made by a secret but later-patented process, will still trigger the post-AIA on-sale bar. These important issues await further judicial consideration. See §7A.03[D][3][b].
• The Federal Circuit in Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc. also held that for the pre-AIA patents in that case, a pre-critical date contract for future sales of a pharmaceutical formulation triggered the §102(b) (2006) on-sale bar, even though the patentee’s contractual arrangement with its U.S. distributor was contingent on FDA (U.S. Food and Drug Administration) approval of the claimed formulation. See §§7.06[G][4][d], 7A.03[D][3][b][iii].
• To invalidate a patent under pre-AIA 35 U.S.C. §102(f) based on a theory of derivation, the validity challenger must prove by clear and convincing evidence that someone other than the named inventor earlier conceived the claimed invention, as it is claimed; i.e., that the other entity conceived all limitations of the claimed invention (and thereafter communicated that conception to the named inventor). The Federal Circuit’s January 2017 decision in Cumberland Pharms. Inc. v. Mylan Inst. LLC rejected the validity challenger’s contention that the USFDA, rather than the patent’s named inventor, conceived the patented pharmaceutical invention. At most, the FDA had suggested a “general goal or research plan,” but never possessed a “definite and permanent idea” of the invention as it was ultimately claimed. See §8.05[B][3].
• In analyzing nonobviousness under 35 U.S.C. §103, the Federal Circuit traditionally has emphasized the importance of so-called “secondary considerations” evidence (e.g., commercial success, long-felt but unsolved need, failure of others, etc.). Although the Supreme Court in its 1966 landmark Graham v. John Deere Co. decision stated that such evidence “might be utilized” and “may have relevancy,” it has undoubtedly taken on far greater significance in the Federal Circuit era. Recently, certain Federal Circuit decisions have signaled a growing rift within the appellate court concerning the weight to be assigned to secondary considerations evidence (or “objective indicia”) of nonobviousness. See §9.06[A].
• The Circuit’s controversial October 2016 en banc decision in Apple Inc. v. Samsung Elecs. Co. Ltd. starkly illustrates the burgeoning disagreement. Apple v. Samsung was decided in an unusual procedural posture for an en banc case, with some Circuit judges questioning whether the case even merited en banc consideration. Nevertheless, the decision merits close attention because it marked the first time that the Circuit has decided an obviousness case as an en banc court since its 1990 decision in In re Dillon. Among a number of hotly debated issues, some dissenting judges advocated a return to (or at least a reconsideration of) the Supreme Court’s view that secondary considerations evidence is not always or necessarily relevant or useful. One Circuit dissenter asserted that “under Supreme Court authority, secondary considerations are insufficient to outweigh a strong case of obviousness involving small advances over the prior art.” See §9.06[A].
• An extensive body of Federal Circuit case law requires that for secondary considerations evidence to be probative of nonobviousness, a “nexus” or causal relationship must connect the proffered evidence and the merits of the claimed invention. When a patentee establishes that its asserted objective evidence is tied to a specific product and that product “is the invention disclosed and claimed in the patent,” the Circuit recognizes a presumption of nexus for objective considerations. For example, the patentee in the Circuit’s July 2016 decision, WBIP, LLC v. Kohler Co., gained the benefit of the presumption of nexus for each of the several types of secondary considerations evidence it relied on. See §9.06[B][1].
• In contrast, nexus could not be presumed in the Circuit’s April 2017 decision, Novartis AG v. Torrent Pharm. Ltd. Agreeing with the PTAB, the Circuit rejected Novartis’ nexus argument because it was based solely on the premise that its product, a solid oral multiple sclerosis treatment, was first on the marketplace. However, the treatment of multiple sclerosis with a solid oral composition was “indisputably known in the prior art.” The appellate court explained that nexus for the nonobviousness inquiry must involve a causal relationship between the proffered objective evidence and what was not known in the prior art (which “may well be the novel combination or arrangement of known individual elements.”) But simply being the first on the marketplace with an embodiment of the claimed invention is not the test. See §9.06[B][1].

On Tuesday, a Delaware district court judge ruled that a group of Mallinckrodt patents failed the Alice/(mostly)Mayo test as claiming a natural phenomenon. The patents are directed to a method of safely using the Innomax system, which administers nitric oxide to infants exhibiting hypoxic respiratory failure associated with pulmonary hypertension. (See, e.g., U.S. Patent No. 8282966.) Continue reading →