Two Herceptin® Patents Survive IPR: A Lesson in Separately Arguing Motivation to Combine and Reasonable Expectation of Success

October 4, 2018

Motivation to combine and reasonable expectation of success are separate requirements that must be independently considered. By capitalizing on shortcomings in the petitions related to separately arguing these issues, Genentech was able to save two of three patents covering its blockbuster drug Herceptin®.... Read more

Trustees of Boston University v. Everlight Electronics Co. (Fed. Cir. July 25, 2018): Specification Must Enable the Full Scope of the Claimed Invention

October 3, 2018

Plaintiff-cross-appellant Trustees of Boston University ("BU") sued defendants-appellants Everlight Electronics Co., Ltd. and others for infringing BU's U.S. Patent No. 5,686,738. A jury found that Defendants infringed the '738 patent and failed to prove the patent's invalidity.... Read more

Helsinn – The Government Sides with Reality

October 1, 2018

On September 24, 2018, the Solicitor General filed a motion to participate in oral argument as amicus curiae in Helsinn Healthcare v. Teva Pharmaceuticals. The U.S. government's interest in this case is obvious, as the decision would have a direct impact on how the USPTO examines and determines patentability of invention.... Read more

Travatan Z® Patent Survives IPR: A Lesson in Successfully Arguing Hindsight Bias

September 27, 2018

Hindsight bias is not simply an old chestnut argued ad infinitum in response to obviousness challenges. In this week's final written decision in IPR2017-01053 upholding all claims of U.S. Patent No. 8,268,299, the PTAB illustrated that—under the right circumstances—this argument can have teeth.... Read more

JTEKT v. GKN: Federal Circuit Finds Competitor Lacks Standing to Appeal PTAB's Final Written Decision

September 7, 2018

After determining that its competitor GKN's patent raised a potential risk of infringement for a product under development, JTEKT[1] challenged the patentability of claims 1–7 of U.S. Patent No. 8,215,440 via inter partes review (IPR2016-00046). When claims 2 and 3 were confirmed as patentable in the final written decision—and thus the risk of infringement remained—JTEKT appealed, and GKN moved to dismiss the appeal based on lack of standing.... Read more

WHAT DOES AND/OR MEAN? IT DEPENDS

September 7, 2018

In an interesting, but non-precedential, decision from the Court of Appeals for the Federal Circuit (Supernus Pharmaceuticals, Inc. v TWI Pharmaceuticals, Inc et al (Fed. Cir., September 6, 2018-http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/17-2513.Opinion.9-6-2018.pdf), the Court affirmed a decision from the U.S. District Court of New Jersey.... Read more

Recent Pharmaceutical House and Senate Bills

August 28, 2018

Over the summer, representatives introduced bills and amendments of interest to the pharmaceutical industry. First, Senator Orrin Hatch, co-author of the Hatch-Waxman Act, filed an amendment in the Senate Judiciary Committee that would require a generic manufacturer wishing to challenge a brand-name drug patent to choose between Hatch-Waxman litigation and IPR, removing the option to use both. According to Senator Hatch, this Hatch-Waxman Integrity Act of 2018 would ensure that Hatch-Waxman continues to operate as originally intended by protecting the ability of generic drug companies to develop lower-cost drugs, while at the same time providing innovators a period of exclusivity to recoup investments. Specifically, Senator Hatch commented that the availability of an alternative path to challenge patents through IPRs has threatened to upend the carefully-crafted Hatch-Waxman balance by enabling companies to put added litigation pressure on drug innovators above and beyond what Hatch-Waxman already provides.... Read more

A Different Lesson from Vanda v. West-Ward

August 20, 2018

Last week the Federal Circuit denied West-Ward's petition for rehearing en banc. At the time of the original Federal Circuit decision (Vanda Pharms. Inc. v. West-Ward Pharms. Int'l Ltd., 887 F.3d 1117 (Fed. Cir. 2018), the case generated substantial commentary in regard to its patent eligibility context. West-Ward's petition focused on the question of whether "adjusting a dose of an old drug based on a patient's genetic risk of poorly metabolizing it" is patent eligible subject matter, so the pro-patent crowd will no doubt be pleased. There is another aspect of the case, however, which is worthy of consideration.... Read more

PTAB Removes "Informative" Designation From Ex Parte Jung

August 13, 2018

In July, the U.S. Patent & Trademark Office's Patent Trial and Appeal Board designated its ex parte Jung decision as informative (see here and here). In this decision, the Board held that the phrase "at least one of A and B" was presumed to be conjunctive. That is, the phrase was presumed to mean "at least one of A and at least one of B."... Read more

Boston University v. Everlight: Claim Invalid For Lack Of Enablement Because 17% Was "Physically Impossible"

August 10, 2018

Last week, the Federal Circuit issued its opinion in Boston University (BU) v. Everlight, in which the court found that the only asserted claim (claim 19) was invalid for lack of enablement because 1/6 (17%) of the claimed subject matter was "physically impossible." Claim 19 was the only claim asserted at trial. The claim was directed to a semiconductor device comprising a substrate, a non-single crystalline buffer layer, and a growth layer grown on the buffer layer.... Read more