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At least since 1819, courts have prohibited double patenting--where an inventor has two patents on the same or obvious variations of the same invention. There have always been two basic justifications for prohibiting double patenting. The first focused on the patentee: bad actors might try to improperly extend their patent monopoly by filing serial applications. The second focused on the public's rights: the bargain of the patent is that in exchange for the inventor getting a term-limited patent, the public is entitled to use the claimed invention (and its obvious variations) once the patent expires. This public-rights rationale is broader, and it applies independent of whether the patentee's filing of serial applications allows her to extend the patent term. The patentee-based justification had more purchase in the olden days--when a patent's term was determined by its issue date. Every new patent that issued would get a new term. Since 1995, though, a patent's term is 20 years from the earliest effective filing date--a date that stays the same independent of whether the inventor strings out her patent applications--so the inventor cannot really game the system. On the other hand, the public still cannot receive the fruit of its bargain if it cannot use a claimed invention as soon as a patent expires. The previously low-stakes debate about the reason for prohibiting double patenting now matters. Most significantly, is there a doublepatenting problem for a parent patent where the parent gets patent-term adjustment, but the child does not? On the patentee-based justification, there may well not be a problem for the parent, but on the public-rights based justification, there would be. Inventors that receive patent-term adjustment on a parent patent have to decide whether to pursue continuation applications, as continuation applications are likely to not receive the same amount of adjustment. Depending on how the law on double patenting evolves, the continuation patents may cut short the term of the parent patent--what this article will call patent patricide. For patents on pharmaceutical drugs, the question of patent patricide can be worth billions of dollars. [ABSTRACT FROM AUTHOR]

Prices for pharmaceutical products over the last 10 years have skyrocketed, increasing far more rapidly than the general cost of living. This article argues there should be greater competition for the production of follow-on drugs through the strengthening of the double patenting prohibition: preventing extending exclusive rights beyond the original patent term by dressing up part of that invention as a new one. This prohibition against the same party holding two patents covering the same composition announced by the Supreme Court in the 1800’s has been weakened by lower federal courts to (1) only considering the claims and not the rest of the specification in determining if the same invention is being claimed by the inventor in two patents and (2) only applying the prohibition when the earlier patent did not satisfy the technical meaning of “prior art” within §102 of the Patent Act. The rulings weakening the double patenting doctrine have disregarded that the “invention” of a genus patent is not determined only by the claims, but also by the embodiments disclosed in the specification, and under Supreme Court and Federal Circuit precedent it must be presumed that the party with a genus patent has invented the full scope of the genus. These weakening rulings have also disregarded that the double patenting doctrine arises from §101 of the patent statutes, rather than §§102 and 103, which the Federal Circuit models it double patenting test on, often incorrectly concluding there is no double patenting. §§102 and 103 serve different purposes than §101. This article argues that when the same inventor holds a genus patent for a pharmaceutical product, it should be estopped from obtaining a patent on a species within the scope of the genus, whether or not the genus patent constitutes prior art. Applying this strengthened double patenting doctrine would increase competition for the development of follow-on pharmaceutical products. [ABSTRACT FROM AUTHOR]

The article discusses U.S. patent law as it relates to patentable inventions that result from collaborative research and development by different organizations. Topics include patent suits and patentability for separate contributions to joint research projects; patent rights and terms; and the application of the obviousness-type double patenting doctrine, which existed before the 1995 Patent Act.

The article presents information on the decisions of Commissioner of Patents on issues related to double patenting, novelty and obviousness. It further discusses the function and nature of Patent Appeal Board and the appeal procedures. It also focuses on several trials decided by the commissioner including Sanofi-Synthelabo Canada v. Apotex and Lawson v. Commissioner of Patents based on the Patent Act.

The article discusses several court cases ruled by the U.S. Court of Appeals for the Federal Circuit in relation to patent infringement based on obviousness-type double patenting. The court ruled an invalidity defense for Sun Pharmaceutical Industries Ltd. in Sun v. Eli Lilly & Co. case. The court will apply safe harbor provision of § 121 in Amgen Inc. v. Hoffmann-La Rouch Ltd. case. The court also applies § 121 in the Boehringer Ingelheim International GmbH v. Barr Labs Inc.

The author discusses aspects of the case concerning the patent for the Gleevec anti-cancer drug from Novartis AG. He praises the judgment of the two judges on April 1, 2013. He states that the dismissal of the claims opens the door for generics manufacturing, which lower the cost of patient care. He also adds that the Supreme Court judgment is remarkable in science and law.

The US Patent and Trademark Office (USPTO) adopts recent patent courts' opinions (such as KSR In re Fisher and Ariad v. Lilly) in patent examinations, which would certainly create barriers to biotech patent prosecution. To identify the barriers to Candida vaccine patent prosecution, we analyzed 99 US-granted patents from January 2001 to May 2012 related to Candida vaccines. The rejections were based on factors that included obviousness, novelty, indefiniteness, double patenting, enablement, written description and utility. Based on this investigation, we find that some of these rejections were actually avoidable, and then further provide workable solutions to avoid some of the barriers, especially those related to patentability. These principles recited in this study should also be applicable to other fields of vaccines and immunotherapeutics.