Posts Tagged: "patent claims"

In order to obtain exclusive rights on an invention, you must file for and obtain a patent. Many inventors will initially opt to file a provisional patent application to initiate the application process, which is a perfectly reasonable decision to make, and will result in a “patent pending” that can even result in a licensing deal. Ultimately, if a patent is desired, a nonprovisional patent application must be filed, and it is this nonprovisional patent application that will mature into an issued patent. U.S. patent laws require that the patent applicant particularly point out and distinctly claim the subject matter which the inventor regards as his or her invention. Any patent, or patent application, contains a variety of different sections that contain different information. Generally speaking, a patent is divided into a specification, drawings and patent claims. Only the patent claims define the exclusive right granted to the patent applicant; the rest of the patent is there to facilitate understanding of the claimed invention. Therefore, patent claims are in many respects the most important part of the patent application because it is the claims that define the invention for which the Patent Office has granted protection.

The USPTO’s 2019 Revised Patent Subject Matter Eligibility Guidance provides that if an abstract idea represented in one or more claim elements is integrated into a practical application by other limitations in the claim, then the claim as a whole would not be directed to a judicial exception and, as such, would be considered patentable under section 101. The revised guidance states that “a claim that integrates a judicial exception into a practical application will apply, rely on or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.” This would seem to be in line with the public policy underlying the judicial exception of not allowing a claim to preempt all means of achieving a desired result. Often, patent claims are drafted such as to contain claim elements directed to desired outcomes as opposed to specific ways of achieving the desired outcomes. Claim elements directed only to desired outcomes have the effect of preempting all ways of achieving the desired outcome, and, as such, are considered to “monopolize the judicial exception”. The public policy behind the judicial exception seeks to prevent the monopolization of the judicial exception by a claim reciting only the desired outcome.

Patents covering an antibody are often claimed by the antibody’s function (the residues where it binds to the antigen) rather than its structure (amino-acid sequence). This tactic can successfully cast a very wide net of patent protection over potentially millions of different antibodies. In doing so, even if the patent holder’s own antibodies never make it out of the laboratory, the patents can nevertheless corner the market on intellectual property covering a new class of inhibitors. The risk of this strategy, however, is that extremely broad patent scope can simultaneously doom a patent’s validity for not being sufficiently enabled or lacking written description. As an example, a recent decision from the District of Delaware, MorphoSys AG v. Janssen Biotech, Inc., No. 16-221 (LPS) (Dkt. 471) (Jan. 25, 2019), invalidated broad antibody patents for not being sufficiently enabled, as well as coming near to invalidating the same patents for lacking written description. The case is important to the growing body of patents covering biologic drugs because it delineates more precisely when functionally-claimed antibody patents can survive enablement and written description challenges.

If the claim is directed to an abstract idea, then abstractness is an essential property of the claimed subject matter as a whole. As such, a claim directed to an abstract idea cannot be transformed to possess non-abstractness by whether or not it embodies an inventive concept, since whether the inventive concept is inventive or not depends upon when the concept was conceived, which is an accidental property rather than an essential property of the claimed subject matter… Mayo may make sense for natural laws and physical phenomena but given the very different nature of abstract ideas the test logically falls apart when one thinks they can turn something that is by its fundamental nature abstract into something that is not abstract.

In order to establish that the commercial success factor supports a non-obviousness finding, the patentee must establish that a connection (or nexus) exists between the novel aspects of the patent claim(s) and the alleged commercial success. Id.; WesternGeco LLC v. ION Geophysical Corp., 889 F.3d 1308, 1330 (Fed. Cir. 2018). In other words, the patentee must show that the novel aspects of the claim(s) are driving sales and not aspects of the claim(s) that were known in the prior art. In re Huai-Hung Kao, 639 F.3d 1057, 1069 (Fed. Cir. 2011); WesternGeco, 889 F.3d at 1330. In cases brought pursuant to the Hatch-Waxman Act, while there are exceptions, it is most common that patent challengers’ arguments focus predominantly or entirely on an alleged lack of nexus given the substantial sales typically enjoyed by the brand-name drug products that are the subject of such litigation. Though it bears noting that the mere fact that a company is pursuing a generic version of a brand-name drug, by itself, does not support a “commercial success” finding. Galderma Labs., Inc. v. Tolmar, Inc., 737 F.3d 737, 740 (Fed. Cir. 2013).

Particularize the claims.  This helps overcome the “abstract” part of a 101 rejection. Put details into the claims to define the steps performed in the software and hardware to a granular degree.  Don’t claim a result; claim the steps performed in accomplishing the result. That is, define the software computer program and hardware in discrete steps. Define what’s going on in each step of the computer program code. Go to the level of a software design engineer that annotates their code, to inform others as to what’s going on in the code.  If there is an algorithm claimed, particularize the claims to include the steps performed in implementing the algorithm.

The United States Patent and Trademark Office (USPTO) provides invalidity tools via inter partes review (IPR) and post-grant review (PGR), but which route is better? …  PGRs are estimated to cost more because of their broader discovery rules.  If cost is a major factor, IPRs are a less-expensive option due to restricted allowance of discovery, the most expensive aspect of patent litigation… If the invalidating arguments or art are not strong, an IPR may be a better option due to its lower threshold for institution.  The same prior art arguments that failed in a petition for a PGR may have succeeded in an IPR petition due to the lower standard.

TF3’s patent-in-suit is for a “hair styling device” that automated the curling of hair. TF3 appealed the decision of the Board in an IPR requested by Tre Milano. Based upon its broad construction of certain claim terms, the Board held that two prior art references made the challenged patent claims invalid for anticipation. TF3 appealed. The Federal Circuit reversed the Board’s decision because it imposed a claim construction that was broader than the description in the patent specification. This enlarged the claims beyond their correct scope, even under a “broadest reasonable interpretation” standard. The Federal Circuit noted that “[a]bove all, the broadest reasonable interpretation must be reasonable in light of the claims and specification.”

This article reviews recent Federal Circuit and Supreme Court decisions addressing the scope of appellate review of institution of inter partes review (IPR) by the Patent Trial and Appeal Board. The America Invents Act, 35 U.S.C. § 314(d), provides that: “[t]he determination… whether to institute an inter partes review under this section shall be final and nonappealable.” Federal courts initially interpreted Section 314(d) to bar appellate review of institution decisions entirely. However, recent decisions have narrowed Section 314(d) and expanded the scope of appellate review of matters decided by the Board at institution. This article will review decisions interpreting Section 314(d) to date, and explain how recent precedents have created new opportunities for appellate review of the Board’s decisionmaking in IPR proceedings.

Proving inducement to infringe requires showing that the accused infringer possessed “specific intent” to infringe. In pharmaceutical cases, particularly those arising in the Hatch-Waxman framework, specific intent may be supplied by the wording of a drug label. Vanda sheds light on several issues relevant to inferring inducement to infringe based on a drug’s label. For example, can a label’s clear recommendations on ultimate dosage be negated by how a medical provider arrives at the dosage? Or, does finding specific intent require that every practitioner prescribe an infringing dose? Or, can evidence of substantial non-infringing use negate a finding of inducement when the drug’s label instructs performing the patented method?

This article examines Supreme Court and Federal Circuit analyses of patent eligibility under 35 U.S.C. § 101 where the patent claims at issue were directed to Life Sciences-related technologies. I first examine this topic in the context of composition of matter patent claims and then in the context of method claims. As reflected in the below discussion, while the § 101 case law is fairly straightforward with respect to composition claims, the case law is murkier when it comes to method claims.

On June 7, 2018, the USPTO issued new guidance to its examining corps in the form of a memorandum discussing the Federal Circuit’s April 13, 2018 decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Circ. 2018). The memo indicates that it is intended to “addresses the limited question of how to evaluate the patent eligibility of ‘method of treatment claims’ in light of the Federal Circuit decision in Vanda” and also states, perhaps in a nod to the leadership of new USPTO Director Andrei Iancu, that “[t]he USPTO is determined to continue its mission to provide clear and predictable patent rights in accordance with this rapidly evolving area of the law, and to that end, may issue further guidance in the area of subject matter eligibility in the future.”

The Amgen v. Sanofi decision put most functional antibody claims into question, including epitope and competitive binding claims, as well as antibody claims based on a newly characterized antigen. After Amgen v. Sanofi, non-sequence based antibody claims may become more difficult to obtain before the USPTO from a written description standpoint.  Yet, to fully protect the essence of the invention and avoid design-arounds, such claims are extremely valuable to patent owners. To obtain antibody genus claims beyond those defined by sequences, the patent applicant will need to make and test a sufficient number of representative antibodies across the claimed genus, or establish a clear structure/function relationship among the members of the genus.  Patent applicants should carefully assess the amount of data they have acquired, in comparison to the scope of claims that they wish to obtain, before rushing to the Patent Office.