Biosimilar IPRs: Timing is Everything . . . But When is The Right Time?
BioLoquitur | The Life Sciences Patent Blog
by Maria L. Maebius
3y ago
Timing the filing of an inter partes review for companies in the early stage of developing a biosimilar product should be carefully considered based on the recent Federal Circuit case, Momenta Pharmaceuticals, Inc. v Bristol-Myers Squibb Co., Appeal No. 2017-1694 (February 7, 2019). Momenta filed an IPR before the PTAB to challenge the validity of a BMS patent covering Orencia® (abatacept) while in its Phase I trials for its own biosimilar product. The PTAB instituted review, conducted trial, and sustained the validity of the BMS patent claims. During this period, however, Momenta’s own produc ..read more
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Teva Sues FDA Alleging Unlawful Interpretation of the Definition of “First Applicant”
BioLoquitur | The Life Sciences Patent Blog
by Parithosh K. Tungaturthi, Ph.D. and Dean L. Fanelli, Ph.D.
3y ago
The FDA Reauthorization Act of 2017 (FDARA) created a new type of 180-day exclusivity for ANDA applicants applying for approval of certain drugs designated as Competitive Generic Therapies. The FDARA, according to FDA commissioner, Scott Gottlieb, “is part of our broader effort to foster generic competition and help address the high cost of drugs […] key step in making safe and effective generic drugs available to patients quickly and ensuring there’s adequate competition so patients have affordable access to the treatments they need.” A drug can be designated as a Competitive Generic Therapy ..read more
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USPTO Director Proposes New Patent Eligibility Guidance
BioLoquitur | The Life Sciences Patent Blog
by Parithosh K. Tungaturthi, Ph.D.
3y ago
The test for patentable subject matter under Section 101 lies at the heart of patent system. However, very little guidance is provided in the actual statutory language. It comes as no surprise that the “seemingly’ simple provision of patent eligible subject matter has caused a great deal of confusion among inventors, patent attorneys, district court judges, and even the Justices on the U.S. Supreme Court. Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to t ..read more
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Tribal Immunity Cannot Be Asserted to Escape IPR Proceedings
BioLoquitur | The Life Sciences Patent Blog
by Dean L. Fanelli, Ph.D. and Robert Terzoli
3y ago
Indian tribes ability to shield patents from review at the United States Patent and Trademark Office’s (“USPTO”) Patent Trial and Appeal Board (“PTAB”) took another blow at the Federal Circuit.  The Federal Circuit in a precedential decision, affirming the decision of the PTAB, held that tribal sovereign immunity cannot be asserted in inter partes review (“IPR”) proceedings before the PTAB.[1] The Federal Circuit based the decision on two principles extrapolated from Supreme Court decisions.  First, the general proposition that “immunity does not apply where the federal government ac ..read more
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FDA Approves First Marijuana-Based Drug to Treat Epilepsy
BioLoquitur | The Life Sciences Patent Blog
by Tonya M. Esposito, Stanley Jutkowitz, Renee B. Appel and Robert Terzoli
3y ago
On June 25, 2018, the Food and Drug Administration (“FDA”) approved Epidiolex (cannabidiol), the first marijuana derived drug for use in the United States, to treat two rare forms of epilepsy. This decision for the FDA could have sweeping effects for the marijuana industry. While the FDA has previously approved drugs comprising synthetic (manufactured) cannabinoids, this is the first FDA approved drug comprised of an active ingredient derived from marijuana. Even with FDA approval, further action is required before Epidiolex can enter the market in the United States. Epidiolex will be the firs ..read more
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An Illustrated Guide to the USPTO’s New Memo on Method of Treatment Claims
BioLoquitur | The Life Sciences Patent Blog
by Robert Terzoli and Jamaica Szeliga
3y ago
The U.S. Patent and Trademark Office (“USPTO”) has renewed the hopes of applicants looking to patent method of treatment claims. A recent memo from the USPTO (the “Memo”) provides guidance on method of treatment claims, suggesting that when correctly drafted, such claims should generally be considered patent eligible subject matter. The Memo comes in direct response to the Federal Circuit’s decision in Vanda v. West-Ward, issued on April 13, 2018. In Vanda, the Court, inter alia, distinguished certain method of treatment claims as patent eligible from those deemed ineligible by the Supreme Cou ..read more
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Choose Your Weapon: Senate Amendment Pits ANDA/BPCIA Pathway Against Post-Grant Proceedings
BioLoquitur | The Life Sciences Patent Blog
by Jamaica Szeliga
3y ago
Per Senator Orrin Hatch, the America Invents Act has disrupted the “careful balance” he struck with Senator Waxman in the development of the decades-old Hatch-Waxman Act governing the adjudication of generic drug litigation. On June 13, 2018, Senator Hatch filed an amendment in the Senate Judiciary Committee to remedy the perceived conflict between the “carefully calibrated requirements” of Abbreviated New Drug Application (“ANDA”) litigation under the Hatch-Waxman Act and the “much blunter instrument” of post-grant proceedings before the United States Patent Trial and Appeal (“PTAB”).  ..read more
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The USDA’s Proposed National Bioengineered Food Disclosure Standard
BioLoquitur | The Life Sciences Patent Blog
by Jay Connolly, Edward F. Maluf, Joe Orzano and Owen Wolfe
3y ago
On May 3, 2018, the U.S. Department of Agriculture (“USDA”) released its much-anticipated proposed rule to establish a national standard for the disclosure of bioengineered ingredients in certain food products. The public comment period on the proposal has begun and runs through July 3, 2018. The proposed rule sheds light on certain aspects of the disclosures that food manufacturers and others will be required eventually to provide. But the USDA’s proposal leaves significant questions unanswered, providing an opportunity for the public to shape the final rule in critical ways. Background The U ..read more
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USPTO Announces Notice of Proposed Rulemaking for Claim Construction Standard used in PTAB Proceedings
BioLoquitur | The Life Sciences Patent Blog
by Thomas A. Haag, Ph.D. and Robert Terzoli
3y ago
The USPTO announced today proposed rulemaking for changing its policy related to claim interpretation in Patent Trial and Appeal Board (“PTAB”) proceedings (not including patent examination). Currently, the broadest reasonable interpretation (“BRI”) standard is applied when analyzing claims. The proposed new rules would result in “the same as the standard applied in federal district courts and International Trade Commission (“ITC”) proceedings;” i.e., “ordinary and customary meaning” according to “a person of ordinary skill in the art in question at the time of the invention,”[1] and “reasonab ..read more
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Part 2 of 2: Supreme Court and Inter Partes Review
BioLoquitur | The Life Sciences Patent Blog
by Jamaica Szeliga and Robert Terzoli
3y ago
SAS Institute Inc. v. Iancu As we recently noted in our companion piece Part 1 of 2: Supreme Court and Inter Partes Review, the Supreme Court issued decisions in two intellectual property appeals relating to inter partes review (“IPR”) before the U.S. Patent and Trademark Office. In Oil States Energy Services LLC v. Greene’s Energy Group LLC, No. 16-712, the Court decided 7–2 that the inter partes review process does not violate Article III of the Constitution or the Seventh Amendment. In SAS Institute Inc. v. IANCU, No. 16-969, the Court decided that the Patent Trial and Appeal Board (“P ..read more
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